Tag: GlobeNewswire

Milestone marks the first regional franchise group to complete pilot evaluation and advance to commercial deployment following the multinational restaurant parent company’s global vendor approval

Commercial rollout is supported by an initial commercial product order and an exclusive regional distribution agreement in Eastern Europe

VANCOUVER, British Columbia, Oct. 06, 2026 (GLOBE NEWSWIRE) — Beyond Oil Ltd. (TSX: BOIL) (OTCQB: BEOLF) (“Beyond Oil” or the “Company”), a food-tech innovation company dedicated to reducing health risks associated with fried food while improving food quality, lowering operational costs, minimizing waste and enhancing sustainability, today announced that a prominent regional franchise group in Eastern Europe has successfully completed its pilot evaluation and is proceeding with a commercial rollout of Beyond Oil’s product across 60 restaurant locations of a leading global fast-food brand in the region. The commercial rollout follows the Company’s news release dated October 1, 2026 regarding the receipt of global vendor approval from the brand’s multinational restaurant parent company, which operates tens of thousands of locations worldwide.

To support the commercial execution of the rollout and establish a localized supply chain, Beyond Oil has entered into an exclusive regional distribution agreement (the “Agreement”) with an established regional foodservice distributor in Eastern Europe. The initial deployment is supported by a committed commercial product order.

This commercial deployment marks the first regional franchisee rollout following Beyond Oil’s corporate approved vendor status with the multinational restaurant parent company, building on more than two years of commercial sales to brand franchise locations in the Middle East. While global approved vendor status establishes corporate procurement clearance across the parent company’s worldwide network of tens of thousands of locations, this milestone demonstrates the direct conversion of corporate validation into franchise-level adoption, committed container volume, and commercial revenue. The regional distributor will also lead broader commercial expansion across eligible regional foodservice operators throughout the territory.

“This commercial rollout represents a pivotal progression for Beyond Oil: moving from operational validation to global corporate approval, and now directly into franchise-level commercial adoption and product sales,” said Jonathan Or, CEO of Beyond Oil. “Securing corporate approved vendor status with one of the world’s largest restaurant parent companies opened the door to tens of thousands of locations globally. Today, with our first regional franchise partner completing its pilot and advancing to a 60-location rollout backed by an initial full container order and dedicated local distribution, we are demonstrating how that corporate clearance translates into commercial execution on the ground. We look forward to executing this initial deployment with the regional distributor and expanding adoption across the brand’s extensive international franchise network.”

Under the terms of the Agreement, the regional distributor has secured exclusive distribution rights in its designated operating territory in Eastern Europe for an initial six-month term, and will oversee regional logistics, customer onboarding, and ongoing product delivery across the participating franchise restaurants. Subject to the distributor maintaining the commercial rollout across its locations in the region and to meeting the Agreement’s ongoing minimum order requirements, the Agreement may remain in effect for an aggregate term of up to three years and six months.

About Beyond Oil Ltd.

We all love fried food. Let’s make it better. Not by changing what people love. By improving the system behind it. Beyond Oil Ltd. (TSX: BOIL, OTCQB: BEOLF) is a food-tech innovation company on a mission to help foodservice operators improve fried food across every dimension that matters: quality, health, consistency, safety, sustainability and profitability. We achieve these outcomes by improving the system behind every kitchen, the frying performance and oil management that determine what lands on the plate. The Company’s patented technology, cleared by the FDA and Health Canada, integrates into existing kitchen workflows to improve frying performance and oil management, helping operators deliver more consistent food, strengthen operational control and reduce oil waste. Beyond Oil’s solution serves restaurant chains, supermarkets, hotels, catering, institutions and industrial frying operations worldwide, turning frying into a measurable, repeatable and scalable brand standard. The result is a better frying standard, helping every fryer, every shift and every plate live up to the food people love. For more information, please visit: www.beyondoil.co.

Forward-Looking Statements and Information

This news release contains “forward-looking statements” within the meaning of the U.S. Securities Act of 1933, the U.S. Securities Exchange Act of 1934, “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of other relevant securities legislation, including applicable securities laws in Canada, which reflect Beyond Oil Ltd.’s current views with respect to, among other things, its operations and financial performance (collectively, “forward-looking statements”). Forward-looking statements include statements that are predictive in nature, depend upon or refer to future results, events or conditions, and include, but are not limited to, statements which reflect management’s current estimates, beliefs and assumptions. Forward-looking statements are typically identified by words such as “expect”, “anticipate”, “believe”, “foresee”, “could”, “estimate”, “goal”, “intend”, “plan”, “seek”, “strive”, “will”, “may” and “should” and similar expressions. In particular, this news release contains forward-looking statements regarding: the timing, pace, and execution of the commercial rollout across franchise restaurant locations in Eastern Europe; the delivery and fulfillment of the initial commercial product order; the ability of the regional distributor to satisfy commercial commitments and rollout milestones required to maintain commercial exclusivity; the potential extension of the Agreement for up to three years and six months; customer retention, re-order rates, oil life extension, and operational performance in commercial kitchens; the expansion of commercial distribution across additional foodservice operators in the region; and management’s expectations regarding regional franchisee adoption and commercial execution under the multinational restaurant parent company’s global approved products list. Forward-looking statements are subject to specific risks and uncertainties, including that the commercial rollout may not result in expected order volumes or sustained product adoption; potential delays in international shipping, logistics, or customs clearance; the risk that individual restaurant locations may discontinue product use; the risk that minimum purchase requirements may not be met, resulting in the loss of exclusivity or termination of the Agreement; and that discussions with other restaurant chains or franchisees may not lead to commercial agreements or system-wide rollouts. Although Beyond Oil Ltd. believes that such forward-looking statements are based upon reasonable estimates, beliefs and assumptions, certain factors, risks and uncertainties, which are described from time to time in our documents filed with the securities regulators in the USA and Canada, could cause actual results to differ materially from those contemplated or implied by forward-looking statements. Readers are urged to consider these risks carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements, which are based only on information available to us as of the date of this news release. Except as required by law, Beyond Oil Ltd. undertakes no obligation to publicly update or revise any forward-looking statements, whether written or oral, that may be as a result of new information, future events or otherwise.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Company Contact:
Adi Olesker, VP of Investor Relations
Phone: +972-50-694-2517
adio@beyondoil.co

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
BOIL@arxhq.com

New DNA and RNA tests expand CNSide beyond leptomeningeal metastases to molecular profiling across CNS oncology

HOUSTON, Oct. 06, 2026 (GLOBE NEWSWIRE) — CNSide Diagnostics, LLC, a wholly owned subsidiary of Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), today announced the commercial launch of two new cerebrospinal fluid (CSF)-based molecular profiling tests, available to health care professionals in the United States beginning October 12, 2026:

• CNSide^® CSF Molecular Profile – Solid Tumor (DNA & RNA)
• CNSide^® CSF Molecular Profile – Hematologic Malignancies (DNA & RNA)

CNSide CSF Molecular Profile provides comprehensive DNA and RNA profiling of CNS disease biology from cerebrospinal fluid. The tests analyze more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts by RNA sequencing, enabling broad characterization of genomic and transcriptomic alterations, including sequence variants, copy-number alterations, and gene fusions. The Hematologic Malignancies test also supports molecular assessment of clonality.

The launch significantly expands the patient population that can be served by CNSide. While CNSide® CSF Tumor Cell Enumeration (TCE) is focused on patients with suspected or confirmed leptomeningeal metastases, Molecular Profile extends CSF-based molecular testing to primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS.

“Physicians managing cancer in the CNS need more than confirmation that disease is present. They need information they can act on,” said Russell Bradley, President and General Manager of CNSide Diagnostics, LLC. “Molecular Profile adds DNA and RNA findings, including potentially actionable alterations, to the cellular information CNSide already provides, and extends CNSide beyond leptomeningeal metastases to primary CNS tumors and hematologic cancers involving the CNS.”

For patients with leptomeningeal metastases, Molecular Profile can be ordered independently or alongside TCE when both cellular and molecular assessment are clinically appropriate. TCE detects and quantitatively enumerates tumor cells, while Molecular Profile characterizes the DNA and RNA biology of disease, providing complementary cellular and molecular information from the same CSF collection.

The approach underlying CNSide CSF Molecular Profile was recently evaluated in a peer-reviewed, real-world study by Albitar et al., investigators at Genomic Testing Cooperative (GTC), published in The Journal of Liquid Biopsy¹. The study analyzed 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS. Cancer-related molecular findings were identified in 78.4% of evaluable specimens. The study characterized multiple classes of molecular abnormalities, including sequence variants, copy-number and chromosomal alterations, gene fusions, and clonality. 

CNSide CSF Molecular Profile is offered through CNSide Diagnostics’ collaboration with GTC, announced in July 2026. GTC performs the DNA and RNA sequencing and bioinformatics analysis. CNSide Diagnostics manages test ordering, results delivery, physician support and billing.

The launch builds on CNSide’s established experience in CSF-based oncology diagnostics. Since 2020, more than 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions. The clinical utility of CNSide CSF tumor-cell analysis in leptomeningeal metastases has been evaluated in 12 peer-reviewed publications, prospective multicenter evidence from the FORESEE clinical study, and real-world clinical experience. 

Ordering Information

Beginning October 12, 2026, health care professionals may order CNSide CSF Molecular Profile tests through CNSide Diagnostics. The tests may be ordered independently or, when appropriate, alongside CNSide CSF Tumor Cell Enumeration. Coverage and reimbursement vary by payer and patient benefit design.

CNSide CSF Tumor Cell Enumeration is a laboratory developed test performed by CNSide Diagnostics, LLC in its CLIA-certified, CAP-accredited laboratory in Houston, Texas. CNSide CSF Molecular Profile tests are laboratory developed tests currently performed for CNSide Diagnostics by Genomic Testing Cooperative, LCA, a CLIA-certified and CAP-accredited reference laboratory. These tests have not been cleared or approved by the U.S. Food and Drug Administration and are available through CNSide Diagnostics to health care professionals in the U.S.

About CNSide Diagnostics, LLC

CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes cerebrospinal fluid-based diagnostic tests for cancers involving the central nervous system. The CNSide^® CSF diagnostics platform combines cellular analysis, biomarker characterization, and molecular profiling to support the detection, characterization, and longitudinal assessment of CNS malignancies.

Current offerings include CNSide^® CSF Tumor Cell Enumeration for patients with suspected or confirmed leptomeningeal metastases and CNSide^® CSF Molecular Profile tests for molecular characterization of primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS. For more information, visit www.cnside-dx.com.

About Cerenome

Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company’s CNSide^® Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing.

Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value. For more information, visit https://www.cerenome.com.

Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof.

Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements regarding the timing of availability of CNSide CSF Molecular Profile tests; its expected turnaround time, performance and clinical utility; physician adoption and ordering patterns; the timing and content of additional CNSide menu tests; coverage, billing and reimbursement for CNSide CSF Molecular Profile and other CNSide tests; the Company’s reliance on third-party laboratory service providers; the potential market for CNSide tests; the timing in which CNSide tests are commercially launched and commercialization is expanded; the development and utility of CNSide tests; and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.

Actual results may differ materially due to a variety of risks and uncertainties, including those described in the Company’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements, except as required by law.

¹ Albitar M, Charifa A, Agersborg S, et al. Using cell free DNA (cfDNA) and RNA (cfRNA) in the diagnosis and monitoring of primary and metastatic CNS tumors. The Journal of Liquid Biopsy. 2026;14:100500.

Investor Contact
CORE IR
IR@cerenome.com

New DNA and RNA tests expand CNSide beyond leptomeningeal metastases to molecular profiling across CNS oncology

HOUSTON, Oct. 06, 2026 (GLOBE NEWSWIRE) — CNSide Diagnostics, LLC, a wholly owned subsidiary of Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), today announced the commercial launch of two new cerebrospinal fluid (CSF)-based molecular profiling tests, available to health care professionals in the United States beginning October 12, 2026:

• CNSide^® CSF Molecular Profile – Solid Tumor (DNA & RNA)
• CNSide^® CSF Molecular Profile – Hematologic Malignancies (DNA & RNA)

CNSide CSF Molecular Profile provides comprehensive DNA and RNA profiling of CNS disease biology from cerebrospinal fluid. The tests analyze more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts by RNA sequencing, enabling broad characterization of genomic and transcriptomic alterations, including sequence variants, copy-number alterations, and gene fusions. The Hematologic Malignancies test also supports molecular assessment of clonality.

The launch significantly expands the patient population that can be served by CNSide. While CNSide® CSF Tumor Cell Enumeration (TCE) is focused on patients with suspected or confirmed leptomeningeal metastases, Molecular Profile extends CSF-based molecular testing to primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS.

“Physicians managing cancer in the CNS need more than confirmation that disease is present. They need information they can act on,” said Russell Bradley, President and General Manager of CNSide Diagnostics, LLC. “Molecular Profile adds DNA and RNA findings, including potentially actionable alterations, to the cellular information CNSide already provides, and extends CNSide beyond leptomeningeal metastases to primary CNS tumors and hematologic cancers involving the CNS.”

For patients with leptomeningeal metastases, Molecular Profile can be ordered independently or alongside TCE when both cellular and molecular assessment are clinically appropriate. TCE detects and quantitatively enumerates tumor cells, while Molecular Profile characterizes the DNA and RNA biology of disease, providing complementary cellular and molecular information from the same CSF collection.

The approach underlying CNSide CSF Molecular Profile was recently evaluated in a peer-reviewed, real-world study by Albitar et al., investigators at Genomic Testing Cooperative (GTC), published in The Journal of Liquid Biopsy¹. The study analyzed 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS. Cancer-related molecular findings were identified in 78.4% of evaluable specimens. The study characterized multiple classes of molecular abnormalities, including sequence variants, copy-number and chromosomal alterations, gene fusions, and clonality. 

CNSide CSF Molecular Profile is offered through CNSide Diagnostics’ collaboration with GTC, announced in July 2026. GTC performs the DNA and RNA sequencing and bioinformatics analysis. CNSide Diagnostics manages test ordering, results delivery, physician support and billing.

The launch builds on CNSide’s established experience in CSF-based oncology diagnostics. Since 2020, more than 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions. The clinical utility of CNSide CSF tumor-cell analysis in leptomeningeal metastases has been evaluated in 12 peer-reviewed publications, prospective multicenter evidence from the FORESEE clinical study, and real-world clinical experience. 

Ordering Information

Beginning October 12, 2026, health care professionals may order CNSide CSF Molecular Profile tests through CNSide Diagnostics. The tests may be ordered independently or, when appropriate, alongside CNSide CSF Tumor Cell Enumeration. Coverage and reimbursement vary by payer and patient benefit design.

CNSide CSF Tumor Cell Enumeration is a laboratory developed test performed by CNSide Diagnostics, LLC in its CLIA-certified, CAP-accredited laboratory in Houston, Texas. CNSide CSF Molecular Profile tests are laboratory developed tests currently performed for CNSide Diagnostics by Genomic Testing Cooperative, LCA, a CLIA-certified and CAP-accredited reference laboratory. These tests have not been cleared or approved by the U.S. Food and Drug Administration and are available through CNSide Diagnostics to health care professionals in the U.S.

About CNSide Diagnostics, LLC

CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes cerebrospinal fluid-based diagnostic tests for cancers involving the central nervous system. The CNSide^® CSF diagnostics platform combines cellular analysis, biomarker characterization, and molecular profiling to support the detection, characterization, and longitudinal assessment of CNS malignancies.

Current offerings include CNSide^® CSF Tumor Cell Enumeration for patients with suspected or confirmed leptomeningeal metastases and CNSide^® CSF Molecular Profile tests for molecular characterization of primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS. For more information, visit www.cnside-dx.com.

About Cerenome

Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company’s CNSide^® Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing.

Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value. For more information, visit https://www.cerenome.com.

Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof.

Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements regarding the timing of availability of CNSide CSF Molecular Profile tests; its expected turnaround time, performance and clinical utility; physician adoption and ordering patterns; the timing and content of additional CNSide menu tests; coverage, billing and reimbursement for CNSide CSF Molecular Profile and other CNSide tests; the Company’s reliance on third-party laboratory service providers; the potential market for CNSide tests; the timing in which CNSide tests are commercially launched and commercialization is expanded; the development and utility of CNSide tests; and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.

Actual results may differ materially due to a variety of risks and uncertainties, including those described in the Company’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements, except as required by law.

¹ Albitar M, Charifa A, Agersborg S, et al. Using cell free DNA (cfDNA) and RNA (cfRNA) in the diagnosis and monitoring of primary and metastatic CNS tumors. The Journal of Liquid Biopsy. 2026;14:100500.

Investor Contact
CORE IR
IR@cerenome.com

New DNA and RNA tests expand CNSide beyond leptomeningeal metastases to molecular profiling across CNS oncology

HOUSTON, Oct. 06, 2026 (GLOBE NEWSWIRE) — CNSide Diagnostics, LLC, a wholly owned subsidiary of Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), today announced the commercial launch of two new cerebrospinal fluid (CSF)-based molecular profiling tests, available to health care professionals in the United States beginning October 12, 2026:

• CNSide^® CSF Molecular Profile – Solid Tumor (DNA & RNA)
• CNSide^® CSF Molecular Profile – Hematologic Malignancies (DNA & RNA)

CNSide CSF Molecular Profile provides comprehensive DNA and RNA profiling of CNS disease biology from cerebrospinal fluid. The tests analyze more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts by RNA sequencing, enabling broad characterization of genomic and transcriptomic alterations, including sequence variants, copy-number alterations, and gene fusions. The Hematologic Malignancies test also supports molecular assessment of clonality.

The launch significantly expands the patient population that can be served by CNSide. While CNSide® CSF Tumor Cell Enumeration (TCE) is focused on patients with suspected or confirmed leptomeningeal metastases, Molecular Profile extends CSF-based molecular testing to primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS.

“Physicians managing cancer in the CNS need more than confirmation that disease is present. They need information they can act on,” said Russell Bradley, President and General Manager of CNSide Diagnostics, LLC. “Molecular Profile adds DNA and RNA findings, including potentially actionable alterations, to the cellular information CNSide already provides, and extends CNSide beyond leptomeningeal metastases to primary CNS tumors and hematologic cancers involving the CNS.”

For patients with leptomeningeal metastases, Molecular Profile can be ordered independently or alongside TCE when both cellular and molecular assessment are clinically appropriate. TCE detects and quantitatively enumerates tumor cells, while Molecular Profile characterizes the DNA and RNA biology of disease, providing complementary cellular and molecular information from the same CSF collection.

The approach underlying CNSide CSF Molecular Profile was recently evaluated in a peer-reviewed, real-world study by Albitar et al., investigators at Genomic Testing Cooperative (GTC), published in The Journal of Liquid Biopsy¹. The study analyzed 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS. Cancer-related molecular findings were identified in 78.4% of evaluable specimens. The study characterized multiple classes of molecular abnormalities, including sequence variants, copy-number and chromosomal alterations, gene fusions, and clonality. 

CNSide CSF Molecular Profile is offered through CNSide Diagnostics’ collaboration with GTC, announced in July 2026. GTC performs the DNA and RNA sequencing and bioinformatics analysis. CNSide Diagnostics manages test ordering, results delivery, physician support and billing.

The launch builds on CNSide’s established experience in CSF-based oncology diagnostics. Since 2020, more than 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions. The clinical utility of CNSide CSF tumor-cell analysis in leptomeningeal metastases has been evaluated in 12 peer-reviewed publications, prospective multicenter evidence from the FORESEE clinical study, and real-world clinical experience. 

Ordering Information

Beginning October 12, 2026, health care professionals may order CNSide CSF Molecular Profile tests through CNSide Diagnostics. The tests may be ordered independently or, when appropriate, alongside CNSide CSF Tumor Cell Enumeration. Coverage and reimbursement vary by payer and patient benefit design.

CNSide CSF Tumor Cell Enumeration is a laboratory developed test performed by CNSide Diagnostics, LLC in its CLIA-certified, CAP-accredited laboratory in Houston, Texas. CNSide CSF Molecular Profile tests are laboratory developed tests currently performed for CNSide Diagnostics by Genomic Testing Cooperative, LCA, a CLIA-certified and CAP-accredited reference laboratory. These tests have not been cleared or approved by the U.S. Food and Drug Administration and are available through CNSide Diagnostics to health care professionals in the U.S.

About CNSide Diagnostics, LLC

CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes cerebrospinal fluid-based diagnostic tests for cancers involving the central nervous system. The CNSide^® CSF diagnostics platform combines cellular analysis, biomarker characterization, and molecular profiling to support the detection, characterization, and longitudinal assessment of CNS malignancies.

Current offerings include CNSide^® CSF Tumor Cell Enumeration for patients with suspected or confirmed leptomeningeal metastases and CNSide^® CSF Molecular Profile tests for molecular characterization of primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS. For more information, visit www.cnside-dx.com.

About Cerenome

Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company’s CNSide^® Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing.

Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value. For more information, visit https://www.cerenome.com.

Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof.

Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements regarding the timing of availability of CNSide CSF Molecular Profile tests; its expected turnaround time, performance and clinical utility; physician adoption and ordering patterns; the timing and content of additional CNSide menu tests; coverage, billing and reimbursement for CNSide CSF Molecular Profile and other CNSide tests; the Company’s reliance on third-party laboratory service providers; the potential market for CNSide tests; the timing in which CNSide tests are commercially launched and commercialization is expanded; the development and utility of CNSide tests; and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.

Actual results may differ materially due to a variety of risks and uncertainties, including those described in the Company’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements, except as required by law.

¹ Albitar M, Charifa A, Agersborg S, et al. Using cell free DNA (cfDNA) and RNA (cfRNA) in the diagnosis and monitoring of primary and metastatic CNS tumors. The Journal of Liquid Biopsy. 2026;14:100500.

Investor Contact
CORE IR
IR@cerenome.com

OREM, Utah, Oct. 06, 2026 (GLOBE NEWSWIRE) — SunPower Inc. (“SunPower” or the “Company”) (Nasdaq: SPWR), a solar technology, services, and installation company, today announced it broke ground on a solar power system for a new AI data center located in Reno, Nevada.

John Paul Bergh, EVP of Cobalt Power Systems and SunPower New Homes, said, “While not yet at the 100-megawatt-plus scale, this solar project is complex, and its installation is a learning opportunity for us. As such, SunPower is honored to have been awarded the first phase of the Reno AI data center project, reflecting our target of expanding our commercial system capability when rigorous performance specs are required.”

T.J. Rodgers, CEO of SunPower, said, “Our ASP for a residential solar job is about $32 thousand, but our high-tech Silicon Valley installations average $44 thousand with some commercial installations running well over $1 million. Bigger is better on the bottom line.”

About SunPower
SunPower (Nasdaq: SPWR) is a solar technology, services, and installation company focused on delivering reliable and affordable energy solutions. Through its national operating platform and specialized subsidiaries, SunPower serves residential, commercial, new-home, and multifamily customers across the United States. For more information visit www.sunpower.com.

Forward Looking Statements
This press release contains forward-looking statements, including statements concerning the equity for interest exchange and related impacts of the transactions. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “seek,” “plan,” “project,” “target,” “looking ahead,” “look to,” “move into,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements represent SunPower’s current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing SunPower’s estimates as of any subsequent date. Forward-looking statements are subject to risks, uncertainties, and assumptions. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Risks include, but are not limited to market risks, trends and conditions. These risks are not exhaustive. For additional information on these risks and uncertainties and other potential factors that could cause actual results to differ from the results predicted, readers should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of our annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on April 14, 2026, our quarterly reports on Form 10-Q filed with the SEC, and other documents that we have filed with, or will file with, the SEC. Such filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SunPower assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Company Contacts:
Sioban Hickie
VP Investor Relations
IR@sunpower.com
(801) 515-8727

Source: SunPower

OREM, Utah, Oct. 06, 2026 (GLOBE NEWSWIRE) — SunPower Inc. (“SunPower” or the “Company”) (Nasdaq: SPWR), a solar technology, services, and installation company, today announced it broke ground on a solar power system for a new AI data center located in Reno, Nevada.

John Paul Bergh, EVP of Cobalt Power Systems and SunPower New Homes, said, “While not yet at the 100-megawatt-plus scale, this solar project is complex, and its installation is a learning opportunity for us. As such, SunPower is honored to have been awarded the first phase of the Reno AI data center project, reflecting our target of expanding our commercial system capability when rigorous performance specs are required.”

T.J. Rodgers, CEO of SunPower, said, “Our ASP for a residential solar job is about $32 thousand, but our high-tech Silicon Valley installations average $44 thousand with some commercial installations running well over $1 million. Bigger is better on the bottom line.”

About SunPower
SunPower (Nasdaq: SPWR) is a solar technology, services, and installation company focused on delivering reliable and affordable energy solutions. Through its national operating platform and specialized subsidiaries, SunPower serves residential, commercial, new-home, and multifamily customers across the United States. For more information visit www.sunpower.com.

Forward Looking Statements
This press release contains forward-looking statements, including statements concerning the equity for interest exchange and related impacts of the transactions. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “seek,” “plan,” “project,” “target,” “looking ahead,” “look to,” “move into,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements represent SunPower’s current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing SunPower’s estimates as of any subsequent date. Forward-looking statements are subject to risks, uncertainties, and assumptions. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Risks include, but are not limited to market risks, trends and conditions. These risks are not exhaustive. For additional information on these risks and uncertainties and other potential factors that could cause actual results to differ from the results predicted, readers should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of our annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on April 14, 2026, our quarterly reports on Form 10-Q filed with the SEC, and other documents that we have filed with, or will file with, the SEC. Such filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SunPower assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Company Contacts:
Sioban Hickie
VP Investor Relations
IR@sunpower.com
(801) 515-8727

Source: SunPower

OREM, Utah, Oct. 06, 2026 (GLOBE NEWSWIRE) — SunPower Inc. (“SunPower” or the “Company”) (Nasdaq: SPWR), a solar technology, services, and installation company, today announced it broke ground on a solar power system for a new AI data center located in Reno, Nevada.

John Paul Bergh, EVP of Cobalt Power Systems and SunPower New Homes, said, “While not yet at the 100-megawatt-plus scale, this solar project is complex, and its installation is a learning opportunity for us. As such, SunPower is honored to have been awarded the first phase of the Reno AI data center project, reflecting our target of expanding our commercial system capability when rigorous performance specs are required.”

T.J. Rodgers, CEO of SunPower, said, “Our ASP for a residential solar job is about $32 thousand, but our high-tech Silicon Valley installations average $44 thousand with some commercial installations running well over $1 million. Bigger is better on the bottom line.”

About SunPower
SunPower (Nasdaq: SPWR) is a solar technology, services, and installation company focused on delivering reliable and affordable energy solutions. Through its national operating platform and specialized subsidiaries, SunPower serves residential, commercial, new-home, and multifamily customers across the United States. For more information visit www.sunpower.com.

Forward Looking Statements
This press release contains forward-looking statements, including statements concerning the equity for interest exchange and related impacts of the transactions. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “seek,” “plan,” “project,” “target,” “looking ahead,” “look to,” “move into,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements represent SunPower’s current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing SunPower’s estimates as of any subsequent date. Forward-looking statements are subject to risks, uncertainties, and assumptions. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Risks include, but are not limited to market risks, trends and conditions. These risks are not exhaustive. For additional information on these risks and uncertainties and other potential factors that could cause actual results to differ from the results predicted, readers should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of our annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on April 14, 2026, our quarterly reports on Form 10-Q filed with the SEC, and other documents that we have filed with, or will file with, the SEC. Such filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SunPower assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Company Contacts:
Sioban Hickie
VP Investor Relations
IR@sunpower.com
(801) 515-8727

Source: SunPower

– Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic option for children with achondroplasia

– If approved, oral infigratinib would be the first and only approved oral therapy and a potential best-in-class treatment option for children with achondroplasia

– PROPEL 3 met its primary endpoint and key secondary endpoints, delivering the strongest efficacy package reported to date in achondroplasia: the largest AHV treatment effect of any Phase 3 study (+2.10 cm/yr; p<0.0001), and the first and only statistically significant improvement in both body proportionality and arm span in an achondroplasia Phase 3 trial (Proportionality: mean difference of -0.05 in ages 3–8, p<0.05; arm span z-score: +0.37 SD, p<0.0001)

-Treatment with oral infigratinib for 52 weeks in PROPEL 3 also resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events

– BridgeBio anticipates U.S. launch of oral infigratinib upon approval

PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.

“Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia,” said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. “We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”

PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children with achondroplasia, met its primary endpoint of change from baseline in annualized height velocity (AHV) at Week 52 (LS mean treatment difference of +1.74 cm/year; mean treatment difference of +2.10 cm/year; p<0.0001) and its key secondary endpoint of change from baseline in height Z-score (p<0.0001). In a pre-specified exploratory analysis in children younger than 8 years (more than half of participants), oral infigratinib became the first therapeutic option to show a statistically significant improvement in body proportionality against placebo in a randomized achondroplasia trial. Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug. These data were published as an original research article in The New England Journal of Medicine and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. The results can be found here. Additionally, BridgeBio also shared emerging data for oral infigratinib at ESPE about improvements beyond height for people with achondroplasia, including stabilizing sleep apnea measures, reducing rate of ear infections, and impacting body composition. The results can be found here.

“For children and families living with achondroplasia, today’s news represents meaningful progress toward potentially expanding the range of available options,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Our community holds diverse priorities and perspectives, and what matters is that individuals and families have meaningful choices as they consider their own healthcare goals. This milestone brings us one step closer to potentially having another option for families to consider together with their healthcare providers. We appreciate BridgeBio’s continued engagement with the achondroplasia community and its efforts to incorporate community perspectives throughout the development process.”

BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.

Oral infigratinib has received Breakthrough Therapy Designation from the FDA based on results from the PROPEL 2 clinical trial, which met the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. Oral infigratinib is the only therapeutic option in development for achondroplasia to hold Breakthrough Therapy Designation. In addition, oral infigratinib has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA, as well as Orphan Drug Designation from the EMA.

Information about PROPEL I&T trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia, and other skeletal dysplasia conditions, which hold significant unmet needs for families.

About Achondroplasia
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia can be associated with medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis, which may impact overall health and wellbeing. The condition is uniformly caused by an activating variant in FGFR3.

About Oral Infigratinib
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3. Oral infigratinib has received Breakthrough Therapy Designation, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. FDA, as well as Orphan Drug Designation from the European Medicines Agency (EMA).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding oral infigratinib, including the potential for oral infigratinib to provide benefits beyond growth and to meaningfully affect a broader range of medical and functional outcomes associated with achondroplasia; the potential for oral infigratinib to become the first and only approved oral therapy and a potential best-in-class option for children living with achondroplasia; the potential regulatory approval and commercialization of oral infigratinib, including the timing and likelihood of potential FDA approval and BridgeBio’s anticipated U.S. launch upon approval; BridgeBio’s plans to submit a Marketing Authorization Application for oral infigratinib in achondroplasia to the European Medicines Agency in the fourth quarter of 2026; BridgeBio’s plans to further evaluate and share the potential impact of oral infigratinib on measures beyond growth; and BridgeBio’s plans to continue exploring the potential of oral infigratinib to address broader medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions.

Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials; the risk that results from exploratory endpoints, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed trends or improvements in medical or functional outcomes may not be replicated in additional analyses or studies or translate into meaningful long-term clinical benefits; that oral infigratinib may not demonstrate benefits beyond growth or achieve the anticipated clinical, regulatory or commercial profile; that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, including by the FDA’s February 4, 2027 PDUFA target action date, or may require additional data, studies or other information; that BridgeBio may not launch oral infigratinib in the U.S. upon approval or on the anticipated timeline; that BridgeBio’s planned regulatory submissions, including its planned MAA submission in the fourth quarter of 2026, may be delayed or may not occur as expected; that oral infigratinib may not become the first and only approved oral therapy or a best-in-class option for achondroplasia; and that BridgeBio’s plans to further evaluate, share, study or develop oral infigratinib for broader medical and functional impacts or additional skeletal dysplasia conditions may change or may not result in successful development or regulatory approval; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
ir@bridgebio.com

– Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic option for children with achondroplasia

– If approved, oral infigratinib would be the first and only approved oral therapy and a potential best-in-class treatment option for children with achondroplasia

– PROPEL 3 met its primary endpoint and key secondary endpoints, delivering the strongest efficacy package reported to date in achondroplasia: the largest AHV treatment effect of any Phase 3 study (+2.10 cm/yr; p<0.0001), and the first and only statistically significant improvement in both body proportionality and arm span in an achondroplasia Phase 3 trial (Proportionality: mean difference of -0.05 in ages 3–8, p<0.05; arm span z-score: +0.37 SD, p<0.0001)

-Treatment with oral infigratinib for 52 weeks in PROPEL 3 also resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events

– BridgeBio anticipates U.S. launch of oral infigratinib upon approval

PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.

“Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia,” said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. “We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”

PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children with achondroplasia, met its primary endpoint of change from baseline in annualized height velocity (AHV) at Week 52 (LS mean treatment difference of +1.74 cm/year; mean treatment difference of +2.10 cm/year; p<0.0001) and its key secondary endpoint of change from baseline in height Z-score (p<0.0001). In a pre-specified exploratory analysis in children younger than 8 years (more than half of participants), oral infigratinib became the first therapeutic option to show a statistically significant improvement in body proportionality against placebo in a randomized achondroplasia trial. Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug. These data were published as an original research article in The New England Journal of Medicine and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. The results can be found here. Additionally, BridgeBio also shared emerging data for oral infigratinib at ESPE about improvements beyond height for people with achondroplasia, including stabilizing sleep apnea measures, reducing rate of ear infections, and impacting body composition. The results can be found here.

“For children and families living with achondroplasia, today’s news represents meaningful progress toward potentially expanding the range of available options,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Our community holds diverse priorities and perspectives, and what matters is that individuals and families have meaningful choices as they consider their own healthcare goals. This milestone brings us one step closer to potentially having another option for families to consider together with their healthcare providers. We appreciate BridgeBio’s continued engagement with the achondroplasia community and its efforts to incorporate community perspectives throughout the development process.”

BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.

Oral infigratinib has received Breakthrough Therapy Designation from the FDA based on results from the PROPEL 2 clinical trial, which met the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. Oral infigratinib is the only therapeutic option in development for achondroplasia to hold Breakthrough Therapy Designation. In addition, oral infigratinib has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA, as well as Orphan Drug Designation from the EMA.

Information about PROPEL I&T trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia, and other skeletal dysplasia conditions, which hold significant unmet needs for families.

About Achondroplasia
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia can be associated with medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis, which may impact overall health and wellbeing. The condition is uniformly caused by an activating variant in FGFR3.

About Oral Infigratinib
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3. Oral infigratinib has received Breakthrough Therapy Designation, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. FDA, as well as Orphan Drug Designation from the European Medicines Agency (EMA).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding oral infigratinib, including the potential for oral infigratinib to provide benefits beyond growth and to meaningfully affect a broader range of medical and functional outcomes associated with achondroplasia; the potential for oral infigratinib to become the first and only approved oral therapy and a potential best-in-class option for children living with achondroplasia; the potential regulatory approval and commercialization of oral infigratinib, including the timing and likelihood of potential FDA approval and BridgeBio’s anticipated U.S. launch upon approval; BridgeBio’s plans to submit a Marketing Authorization Application for oral infigratinib in achondroplasia to the European Medicines Agency in the fourth quarter of 2026; BridgeBio’s plans to further evaluate and share the potential impact of oral infigratinib on measures beyond growth; and BridgeBio’s plans to continue exploring the potential of oral infigratinib to address broader medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions.

Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials; the risk that results from exploratory endpoints, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed trends or improvements in medical or functional outcomes may not be replicated in additional analyses or studies or translate into meaningful long-term clinical benefits; that oral infigratinib may not demonstrate benefits beyond growth or achieve the anticipated clinical, regulatory or commercial profile; that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, including by the FDA’s February 4, 2027 PDUFA target action date, or may require additional data, studies or other information; that BridgeBio may not launch oral infigratinib in the U.S. upon approval or on the anticipated timeline; that BridgeBio’s planned regulatory submissions, including its planned MAA submission in the fourth quarter of 2026, may be delayed or may not occur as expected; that oral infigratinib may not become the first and only approved oral therapy or a best-in-class option for achondroplasia; and that BridgeBio’s plans to further evaluate, share, study or develop oral infigratinib for broader medical and functional impacts or additional skeletal dysplasia conditions may change or may not result in successful development or regulatory approval; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
ir@bridgebio.com

– Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic option for children with achondroplasia

– If approved, oral infigratinib would be the first and only approved oral therapy and a potential best-in-class treatment option for children with achondroplasia

– PROPEL 3 met its primary endpoint and key secondary endpoints, delivering the strongest efficacy package reported to date in achondroplasia: the largest AHV treatment effect of any Phase 3 study (+2.10 cm/yr; p<0.0001), and the first and only statistically significant improvement in both body proportionality and arm span in an achondroplasia Phase 3 trial (Proportionality: mean difference of -0.05 in ages 3–8, p<0.05; arm span z-score: +0.37 SD, p<0.0001)

-Treatment with oral infigratinib for 52 weeks in PROPEL 3 also resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events

– BridgeBio anticipates U.S. launch of oral infigratinib upon approval

PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.

“Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia,” said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. “We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”

PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children with achondroplasia, met its primary endpoint of change from baseline in annualized height velocity (AHV) at Week 52 (LS mean treatment difference of +1.74 cm/year; mean treatment difference of +2.10 cm/year; p<0.0001) and its key secondary endpoint of change from baseline in height Z-score (p<0.0001). In a pre-specified exploratory analysis in children younger than 8 years (more than half of participants), oral infigratinib became the first therapeutic option to show a statistically significant improvement in body proportionality against placebo in a randomized achondroplasia trial. Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug. These data were published as an original research article in The New England Journal of Medicine and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. The results can be found here. Additionally, BridgeBio also shared emerging data for oral infigratinib at ESPE about improvements beyond height for people with achondroplasia, including stabilizing sleep apnea measures, reducing rate of ear infections, and impacting body composition. The results can be found here.

“For children and families living with achondroplasia, today’s news represents meaningful progress toward potentially expanding the range of available options,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Our community holds diverse priorities and perspectives, and what matters is that individuals and families have meaningful choices as they consider their own healthcare goals. This milestone brings us one step closer to potentially having another option for families to consider together with their healthcare providers. We appreciate BridgeBio’s continued engagement with the achondroplasia community and its efforts to incorporate community perspectives throughout the development process.”

BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.

Oral infigratinib has received Breakthrough Therapy Designation from the FDA based on results from the PROPEL 2 clinical trial, which met the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. Oral infigratinib is the only therapeutic option in development for achondroplasia to hold Breakthrough Therapy Designation. In addition, oral infigratinib has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA, as well as Orphan Drug Designation from the EMA.

Information about PROPEL I&T trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia, and other skeletal dysplasia conditions, which hold significant unmet needs for families.

About Achondroplasia
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia can be associated with medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis, which may impact overall health and wellbeing. The condition is uniformly caused by an activating variant in FGFR3.

About Oral Infigratinib
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3. Oral infigratinib has received Breakthrough Therapy Designation, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. FDA, as well as Orphan Drug Designation from the European Medicines Agency (EMA).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding oral infigratinib, including the potential for oral infigratinib to provide benefits beyond growth and to meaningfully affect a broader range of medical and functional outcomes associated with achondroplasia; the potential for oral infigratinib to become the first and only approved oral therapy and a potential best-in-class option for children living with achondroplasia; the potential regulatory approval and commercialization of oral infigratinib, including the timing and likelihood of potential FDA approval and BridgeBio’s anticipated U.S. launch upon approval; BridgeBio’s plans to submit a Marketing Authorization Application for oral infigratinib in achondroplasia to the European Medicines Agency in the fourth quarter of 2026; BridgeBio’s plans to further evaluate and share the potential impact of oral infigratinib on measures beyond growth; and BridgeBio’s plans to continue exploring the potential of oral infigratinib to address broader medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions.

Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials; the risk that results from exploratory endpoints, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed trends or improvements in medical or functional outcomes may not be replicated in additional analyses or studies or translate into meaningful long-term clinical benefits; that oral infigratinib may not demonstrate benefits beyond growth or achieve the anticipated clinical, regulatory or commercial profile; that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, including by the FDA’s February 4, 2027 PDUFA target action date, or may require additional data, studies or other information; that BridgeBio may not launch oral infigratinib in the U.S. upon approval or on the anticipated timeline; that BridgeBio’s planned regulatory submissions, including its planned MAA submission in the fourth quarter of 2026, may be delayed or may not occur as expected; that oral infigratinib may not become the first and only approved oral therapy or a best-in-class option for achondroplasia; and that BridgeBio’s plans to further evaluate, share, study or develop oral infigratinib for broader medical and functional impacts or additional skeletal dysplasia conditions may change or may not result in successful development or regulatory approval; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
ir@bridgebio.com