CTS Introduces Its First Digital Temperature Sensor Platform, Expanding Smart Sensing Capabilities
Built around a high-accuracy digital sensing architecture, CTS Digital Temperature Sensors are designed to deliver reliable temperature measurement and digital communication capabilities for applications requiring precise monitoring and system-level intelligence
LISLE, Ill., Sept. 30, 2026 (GLOBE NEWSWIRE) — CTS Corporation (NYSE: CTS), a leading designer and manufacturer of sensors, connectivity components, and actuators, today announced the introduction of its first Digital Temperature Sensor platform, expanding the company’s temperature sensing portfolio with high-accuracy digital sensing solutions designed to support a broad range of industrial, medical, transportation, and electronics applications.
This introduction marks a significant expansion of CTS’s temperature sensing capabilities, complementing the company’s established portfolio of temperature sensing technologies with digital communication functionality that enables simplified integration into modern connected systems.
Built around a high-accuracy digital sensing architecture, CTS Digital Temperature Sensors are designed to deliver reliable temperature measurement and digital communication capabilities for applications requiring precise monitoring and system-level intelligence. The platform supports a variety of probe styles and configurations, enabling engineers to select solutions that best fit their performance and installation requirements.
“With the introduction of our Digital Temperature Sensor platform, CTS is broadening its temperature sensing portfolio to better serve both existing and future customers,” said Shahela Ali, Product Manager at CTS Corporation.
CTS Digital Temperature Sensors are designed for applications requiring accurate temperature monitoring, digital communication, and flexible packaging options. By adding digital sensing technology to its portfolio, CTS further strengthens its ability to support customers throughout the product development lifecycle, from initial design through production.
Key benefits include:
High-accuracy digital temperature measurement
Digital communications designed for simplified system integration
Multiple probe and housing configurations
Traceable temperature measurement capability
CTS engineering and application support
The Digital Temperature Sensor platform is available in multiple configurations to support a wide range of application requirements.
CTS (NYSE: CTS) is a leading designer and manufacturer of products that Sense, Connect, and Move. The company manufactures sensors, actuators, and electronic components in North America, Europe, and Asia, serving customers in the aerospace/defense, industrial, medical, and transportation markets. For more information, visit www.ctscorp.com.
Media Relations Contact Amela Smajlovic Marketing Director
CTS Corporation 4925 Indiana Avenue Lisle, IL 60532
FDA indicated previously completed ABP-450 head-to-head studies versus BOTOX® may be submitted as supportive evidence; AEON expects to advance the required scientific bridging work
AEON plans to submit an IND for CMAP pharmacodynamic study in the fourth quarter of 2026
AEON plans to leverage its analytical, pharmacodynamic, and existing comparative human evidence to support a potential streamlined development path
ALISO VIEJO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) — AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced receipt of the official minutes from its Biosimilar Biological Product Development (“BPD”) Type 2b meeting held with the U.S. Food and Drug Administration (“FDA” or the “Agency”) regarding ABP-450’s development pathway.
“The Type 2b meeting feedback provides greater clarity on the development pathway for ABP-450 and, consistent with FDA’s recent biosimilar guidance, supports a potentially more efficient clinical development program,” said Rob Bancroft, President and Chief Executive Officer of AEON. “Our strategy is to bring together the most sensitive, complementary and relevant evidence available, including our analytical program, comparative human pharmacodynamic data and the substantial comparative human experience already generated with ABP-450. Where those lines of evidence converge, we believe they may support proceeding without a standalone comparative efficacy study or narrowing the clinical work required, improving the capital and time efficiency with which we advance ABP-450 toward its potential commercial opportunity. We are excited to embark on this next phase of ABP-450’s development and look forward to submitting the IND for the CMAP study later this year.”
The Type 2b meeting provided feedback across the following components of AEON’s development plan:
Comparative Pharmacodynamic Study
AEON proposed a two-stage design for a comparative pharmacodynamic (“PD”) study using Compound Muscle Action Potential (“CMAP”) measurement in the extensor digitorum brevis muscle consisting of an initial dose-finding stage followed by a comparative PD evaluation. The FDA agreed in principle with the initial dose-finding stage which will be conducted in healthy volunteers. The FDA also provided recommendations intended to strengthen the study’s ability to demonstrate assay sensitivity. AEON intends to incorporate the FDA’s feedback and advance the study under an investigational new drug application (“IND”), which the Company expects to submit in the fourth quarter of 2026.
In a biosimilar development program, PD measures are tests that evaluate the biological, molecular, and physiological effects a drug has on the body to confirm that the biosimilar interacts with its intended therapeutic target in a similar way as the original reference biologic. PD evidence is particularly important for a botulinum toxin, which acts locally and is not present at reliably measurable systemic concentrations following therapeutic administration, making conventional comparative pharmacokinetic studies infeasible.
Previously Completed Comparative Studies
The FDA indicated that comparative clinical studies previously conducted by Daewoong Pharmaceutical across several indications including studies in blepharospasm, upper limb spasticity, glabellar lines and lateral canthal lines, can be submitted for consideration as supportive evidence, subject to appropriate scientific bridging to U.S.-licensed BOTOX® and between the ABP-450 drug product used in each study and ABP-450 as currently manufactured. Blepharospasm and upper limb spasticity are therapeutic indications included on the U.S. BOTOX® label, while glabellar lines and lateral canthal lines are included on the BOTOX Cosmetic® label.
These studies evaluated ABP-450 relative to BOTOX® across a range of indications, doses and muscles, with each study meeting its pre-specified non-inferiority endpoint. AEON intends to complete the scientific bridging work necessary to support their consideration within the totality of evidence for ABP-450. If appropriately bridged, AEON believes these studies could complement the analytical and PD programs by providing additional comparative human evidence supportive of biosimilarity.
Comparative Clinical Study Considerations
The FDA’s scientific approach to biosimilar development has continued to evolve toward greater reliance on evidence that is most sensitive to detecting meaningful differences between a proposed biosimilar and its reference product. In October 2025, the FDA issued draft guidance recognizing that traditional comparative efficacy studies (“CES”) generally have limited sensitivity to detect product differences and may not be necessary where more sensitive evidence sufficiently supports a determination of biosimilarity. The guidance reflects the FDA’s growing experience that traditional clinical efficacy endpoints may provide limited additional discriminatory information in biosimilar development.
Consistent with this evolving framework, during the Type 2b meeting, the FDA emphasized that, if additional clinical evidence is ultimately needed, such evidence should be sufficiently sensitive to detect a meaningful difference between the products, if one exists. The FDA also indicated that more sensitive measures of biological activity, rather than traditional clinical efficacy endpoints, could be considered and that the design of any additional clinical study should be guided by the specific residual uncertainty remaining following completion of the comparative analytical assessment (“CAA”). Accordingly, AEON does not intend to initiate a CES at this time and will first evaluate the totality of its analytical, pharmacodynamic and comparative human evidence to determine whether additional clinical evidence is scientifically necessary and, if so, the most appropriate approach to address any remaining residual uncertainty.
Indication-Specific Considerations
The FDA feedback also addressed indication-specific considerations, including chronic migraine. During the meeting, the FDA invited the Company to provide analyses supporting the rationale for the outcome of the previously conducted Phase 2 study for the prevention of migraine headache, which the Company intends to complete and provide to the FDA as part of its 351(k) Biologics License Application (“BLA”) submission.
Comparative Analytical Assessment
The CAA is the scientific foundation of development under the 351(k) pathway and provides a sensitive means of identifying potential structural and functional differences between a proposed biosimilar and its reference product. AEON is conducting a broad CAA of ABP-450 and U.S.-licensed BOTOX® across structural, physicochemical and functional attributes. The Company recently reported progress across multiple dimensions of that program, including expanded primary-sequence characterization, confirmation of critical disulfide-bond architecture, and pilot forced-degradation results demonstrating highly similar degradation behavior between ABP-450 and BOTOX® under thermal and oxidative stress conditions.
Next Steps: Converging Evidence
AEON’s next phase of development will integrate its maturing comparative analytical foundation with multiple independent and complementary lines of evidence, including human PD evidence, existing comparative human evidence scientifically bridged to the biosimilar program, and targeted evidence addressing indication-specific questions. The Company intends to leverage the convergence of these evidence streams to build a scientifically supported case whereby a standalone CES may not further inform a determination of biosimilarity. AEON plans to return to the FDA in 2027 with its integrated evidence package.
Anticipated milestones for ABP-450’s development program include:
Continued completion of CAA studies in support of biosimilarity between ABP-450 and BOTOX®
Filing an IND for CMAP PD study in Q4 2026
CMAP PD study initiation in Q1 2027
Scientific bridging of ABP-450 and BOTOX® to support previously completed comparative studies
About the U.S. Biosimilar Pathway
The 351(k) biosimilar pathway is grounded in a totality-of-the-evidence approach. The FDA evaluates a proposed biosimilar using the most sensitive and scientifically informative methods available to identify potential differences from its reference product, with comparative analytical assessment providing the scientific foundation. The nature and extent of any additional studies the FDA may require prior to approval are informed by the residual uncertainty remaining after that assessment. Once biosimilarity is established, the FDA has the authority to approve a biosimilar for additional indications of the reference product through scientifically justified extrapolation, without requiring separate clinical studies in each indication.
In October 2025, the FDA issued draft guidance proposing that a comparative efficacy study — a comparative clinical study with efficacy endpoints — may not be necessary where a comparative analytical assessment demonstrates that a proposed product is highly similar to its reference product. The draft guidance reflects the FDA’s view that comparative analytical methods are generally more sensitive than comparative efficacy studies for detecting differences between products.
About AEON Biopharma
AEON Biopharma is a biopharmaceutical company pursuing full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX®. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. ABP-450 is manufactured by Daewoong Pharmaceutical in a facility that has been authorized by the U.S. Food and Drug Administration, Health Canada, and the European Medicines Agency for the manufacture of certain third-party botulinum toxin products. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements generally relate to future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Forward-looking statements in this press release include, among others, (i) statements regarding the Company’s plans and expected timing to submit an IND and initiate the CMAP pharmacodynamic study; (ii) the design, execution and potential evidentiary value of that study; (iii) the Company’s ability to complete its comparative analytical assessment and the scientific bridging necessary to support consideration of previously completed comparative studies; (iv) the potential for analytical, pharmacodynamic and existing comparative human evidence, individually or collectively, to support a determination of biosimilarity or reduce the need for a standalone comparative efficacy study; (v) the nature and scope of any additional clinical studies that may be required; (vi) the timing and outcome of future interactions with the FDA, including the Company’s planned engagement with the FDA in 2027; and (vii) the Company’s ability to advance ABP-450 through the 351(k) pathway toward potential full-label therapeutic approval and commercial entry. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “potential,” “will,” “predict” and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the Company’s forward-looking statements include, among others, (viii) the FDA’s interpretation of the data and information generated or submitted by the Company; (ix) the possibility that the FDA may require additional analytical, pharmacodynamic, clinical or other studies; (x) the Company’s ability to successfully complete its planned studies and scientific bridging activities; (xi) whether the results of those activities will support the Company’s proposed development approach; (xii) changes in FDA guidance, regulatory requirements or interpretations, including with respect to the role of comparative clinical studies in biosimilar development; (xiii) the Company’s ability to obtain sufficient capital to fund its planned development activities; (xiv) and other risks described in the Company’s filings with the Securities and Exchange Commission. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update such statements except as required by applicable law.
Contacts Investor Contact: Hershel Berry Blueprint Life Science Group hberry@bplifescience.com Source: AEON Biopharma
Ranks #1 globally with lowest Mean Absolute Error on Visa, Application, and Mugshots datasets, strengthening its position in age assurance
Independent NIST results signal ROC’s progression from U.S. leader to global leader in facial age estimation
DENVER, CO, Sept. 30, 2026 (GLOBE NEWSWIRE) — Rank One Computing Corporation d/b/a ROC (Nasdaq: ROC) (“ROC” or the “Company”), a U.S. leader in Vision AI, building unified biometric, video analytics, and digital evidence solutions, today announced that its latest NIST submission achieved #1 global ranking in age estimation demonstrating accuracy across three primary datasets in the National Institute of Standards and Technology (“NIST”) Face Analysis Technology Evaluation for Age Estimation and Verification (“FATE AEV”). ROC also maintained its previously recognized #1 global position in the Child Online Safety evaluation for ages 13-16.
“ROC’s latest NIST achievement moves us from U.S. leader to ranking #1 globally across three primary age estimation datasets, while maintaining our leading position in Child Online Safety,” said ROC Chief Executive Officer B. Scott Swann. “These results provide important independent validation of our technology, which we believe strengthens ROC’s competitive position to grow across government and commercial customers seeking accurate, scalable, and cost-efficient age intelligence solutions.”
These results extend ROC’s leadership in age estimation, adding Visa and Application to its #1 rankings in Mugshots and Child Online Safety. For organizations evaluating identity and biometrics technology, NIST’s third-party measures offer an important benchmark for assessing performance across different operational environments and informing technology selection and procurement decisions.
ROC Chief Scientist and Co-Founder Dr. Brendan Klare, commented, “Six months ago, ROC landed the top spot among U.S. age estimation vendors in NIST FATE testing. Today, our ROC-003 algorithm ranks #1 globally in MAE on three of NIST’s four primary datasets. This progress reflects the skill and persistence of the team behind our algorithms as we continue to push the science forward.”
“Age estimation is ready to play a bigger role in age assurance. Our goal is to give organizations a precise, low friction signal they can use to shape an experience, apply protections, or determine when additional verification is needed. ROC’s latest NIST results demonstrate the accuracy this technology can achieve and its potential to support high-impact missions like child online safety,” added ROC Chief Operating Officer Blake Moore.
ROC’s latest algorithm submission, ROC-003, achieved the lowest Mean Absolute Error (“MAE”) across the Visa, Application and Mugshots datasets for adults ages 18–30, ranking first globally on three of the four primary datasets evaluated. Importantly, the lower the MAE, the greater the accuracy to the age estimate. These results expand ROC’s previously established leadership in age estimation and demonstrate continued improvements in algorithmic accuracy to confidently guide critical identification decisions.
NIST FATE is a government-run benchmarking program for face analysis tasks beyond recognition. For age estimation, the FATE Age Estimation & Verification (AEV) track is an ongoing evaluation of software algorithms that inspect face photos and produce an age estimate. NIST publishes results on accuracy and computational efficiency, and notes that facial age verification has been mandated in legislation in a number of jurisdictions, typically to protect minors. The AEV track is open to a worldwide community of developers under a standardized submission process.
About ROC ROC is a leading U.S. developer and manufacturer of Vision AI, delivering sovereign biometrics, video analytics, and digital evidence through a unified platform. This enables agency and integrator partners to unlock faster, more accurate, and cost-efficient capabilities. At its core, ROC transforms raw pixels into real-time operational awareness for defense, public safety, and digital commerce. The Company is headquartered in Denver, Colo., with additional hubs in Grand Rapids, Mich., and Morgantown, W.Va. For more information, please visit the Company’s website: www.roc.ai.
Forward-Looking Statements This Press Release may contain forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident,” and similar statements and expressions that predict or indicate future events or trends or that are not statements of historical fact. Therefore, caution must be exercised in relying on forward-looking statements as actual results may differ materially and adversely from those expressed in any forward-looking statements. ROC may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. Statements that are not historical facts, including statements about the parties’ beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: (i) ROC’s goals and strategies and (ii) ROC’s future business development, financial condition, and results of operations. Further information regarding these and other risks is included in ROC’s filings with the SEC. All information provided in this press release is provided, and the forward-looking statements included herein are made, solely as of the date of this press release, and neither party undertakes any obligation to revise or update any forward-looking statement, except as required under applicable law.
Media inquiries: Matt Aitken, VP of Marketing media@roc.ai
CARSON CITY, Nev., Sept. 30, 2026 (GLOBE NEWSWIRE) — American Lithium Minerals, Inc. (OTC: AMLM) today announced that it has successfully completed its PCAOB-standard financial audit, marking a major milestone in the Company’s capital-markets strategy. With audited financials now finalized, AMLM confirms its intention to uplist to the OTCQB Venture Market in the fourth quarter of 2026.
Audit Completion and OTCQB Eligibility
The Company’s completion of a full PCAOB audit satisfies one of the core eligibility requirements for OTCQB, including:
Audited annual financial statements prepared in accordance with U.S. GAAP
Current SEC-equivalent reporting compliance
Minimum bid price and corporate governance standards
This achievement positions AMLM to transition from the OTC market to OTCQB, a tier recognized for higher reporting transparency and investor-focused disclosure.
Strategic Advantages of Uplisting to OTCQB
Uplisting to OTCQB is expected to provide AMLM with several material benefits:
Enhanced Credibility — OTCQB issuers must meet stringent financial reporting and governance standards, improving institutional and investor confidence.
Greater Market Visibility — OTCQB companies receive expanded market data distribution, including real-time quotes through major financial platforms.
Improved Liquidity — The OTCQB tier historically supports higher trading liquidity due to increased investor access and transparency.
Broader Investor Base — Many U.S. and international brokers permit trading of OTCQB securities but restrict OTC securities.
Strengthened Capital-Markets Positioning — OTCQB status supports future financing initiatives, strategic partnerships, and potential uplisting to senior exchanges.
Management Commentary
President Frank Kristan stated: “Completing our PCAOB audit is a foundational step in strengthening the company’s financial reporting and governance. Uplisting to OTCQB in the fourth quarter will significantly expand our visibility, credibility, and access to capital as we advance our critical-minerals portfolio.”
About American Lithium Minerals, Inc.
American Lithium Minerals, Inc. (OTC: AMLM) is a multi-commodity critical minerals exploration company headquartered in Carson City, Nevada. The Company holds active project interests in gold, silver, copper, lithium, and rare earth elements across Nevada (USA), Chile, British Columbia, Yukon and Quebec (Canada), and Western Australia. AMLM’s portfolio includes 11 active project interests, including the Higginsville gold project in Western Australia, silver and copper exploration in Chile, rare earth interests in Quebec, and lithium properties in Nevada.(www.americanmineralresources.com)
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results. Such statements involve a number of risks and uncertainties, including, without limitation, statements regarding the Company’s strategic initiatives, project development plans, expected commodity exposure, anticipated market conditions, the strength of macro tailwinds across critical minerals sectors, and the Company’s ability to advance its multi-commodity portfolio.
REVTORPYK is indicated for patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting
REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to comprehensively blockade the PI3K/AKT/mTOR (“PAM”) pathway
In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet and REVTORPYK doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant
Healthcare providers can visit www.revtorpykhcp.com to access a comprehensive patient support program through REVTORPYK Support Services
MINNEAPOLIS, Sept. 30, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive (“HR+”), human epidermal growth factor receptor 2-negative (“HER2-”), locally advanced or metastatic breast cancer (“ABC”) without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK was approved in combination with palbociclib and fulvestrant (“REVTORPYK triplet”) and in combination with fulvestrant (“REVTORPYK doublet”), by the U.S. Food and Drug Administration (“FDA”) on July 14, 2026.
“Our experienced commercial and medical affairs teams have been laying the groundwork for a successful launch with healthcare providers, payers, and patient advocacy partners since REVTORPYK was approved,” said Brian Sullivan, CEO and co-founder of Celcuity. “Now that REVTORPYK is commercially available, we are focused on working with physicians to bring this new treatment option to patients living with HR+/HER2- advanced breast cancer.”
As part of its commitment to patient access, Celcuity has launched the REVTORPYK Support Services program to provide financial assistance and treatment enrollment resources for physicians and eligible patients. The program offers support with insurance coverage, including access and reimbursement, and facilitates access to financial assistance, including Copay Assistance and Patient Assistance Programs. For more information, healthcare providers can visit www.revtorpykhcp.com or contact REVTORPYK Support Services at 877-4-CELCUITY (877-423-5284).
“There is an urgent need for new and differentiated treatment options for patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer in the second-line setting,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “REVTORPYK demonstrated unprecedented clinical benefit in the pivotal VIKTORIA-1 study, and we believe, provides an important new therapeutic option to address this need. We are excited now to make this new therapy available to physicians and their patients.”
Celcuity submitted a supplemental New Drug Application to the FDA in August for REVTORPYK to treat patients with HR+/HER2-, PIK3CA mutated, advanced breast cancer based on the results of Study 2 of the VIKTORIA-1 trial. If approved, physicians would have the option to prescribe REVTORPYK for patients with advanced breast cancer regardless of their PIK3CA tumor status.
About HR+/HER2- Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2
About REVTORPYK (gedatolisib) REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.3,4,5
REVTORPYK is in development for the first-line treatment of HR+/HER2- ABC and for the second-line treatment of metastatic castration-resistant prostate cancer.
Indication Statement REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.
Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.
Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.
Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
ADVERSE REACTIONS
REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.
REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.
USE IN SPECIFIC POPULATION
Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products.
Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility.
You may report side effects related to Celcuity products to Celcuity Medical Information at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.
Forward Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s supplemental New Drug Application (“sNDA”) for REVTORPYK, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for REVTORPYK; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for REVTORPYK; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
References:
Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5′-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p
Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694
Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0
Clinical-stage agenT-797 iNKT platform selected as therapeutic cell platform for ARPA-H BoSS program aimed at taking living medicines from cryogenic storage toward room temperature
ARPA-H has committed up to $87 million across the four-year BoSS program to reduce cold-chain dependence and expand access to cell-based medicines
NEW YORK, Sept. 30, 2026 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced that its clinical-stage agenT-797 iNKT platform has been selected as a therapeutic cell system within an Advanced Research Projects Agency for Health (ARPA-H)-funded team developing technologies intended to enable living cell therapies to be stored and transported at room temperature.
The effort is part of ARPA-H’s BioStabilization Systems (BoSS) program, a four-year initiative pursuing what the agency describes as a “200-degree leap” from cryogenic storage near -196°C toward room-temperature storage near 21°C. ARPA-H has committed up to $87 million across the BoSS program to develop technologies designed to reduce dependence on cold-chain infrastructure and expand the reach of advanced biologic medicines.
MiNK is a member of the Reversible Ambient Biostabilization (RAB) team led by The Charles Stark Draper Laboratory, Inc. (“Draper”), with participation from Likarda, CPSI Biotech, OFC Life Sciences, Case BioSciences, the University of Colorado Boulder, and Fresenius Kabi. The team will use artificial intelligence (AI)-assisted design of experiments to optimize formulation, quiescence induction parameters, hydrogel composition, and recovery media. They will use freeze-assisted droplet drying to achieve a stable product.
“Cold-chain logistics remain one of the most significant barriers to scaling access to allogeneic cell therapies,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “In our randomized Phase 2 trial in acute lung injury, we have already delivered agenT-797 to mechanically ventilated patients within days of regulatory authorization, even in an active conflict zone. Removing the cold chain could take that deployability to a new level: a living immune therapy stocked like a conventional drug and administered wherever critically ill patients present, including remote, resource-limited, and austere settings.”
As a core member of the RAB team, MiNK will bring its clinical-stage allogeneic iNKT platform, proprietary cGMP manufacturing infrastructure, cell-therapy development expertise, and clinically relevant production requirements to the development and evaluation of room-temperature stabilization technologies.
“iNKT cells are a rigorous benchmark for stabilization because their value lies in rapid, coordinated function: they activate within hours and orchestrate both innate and adaptive immunity, so any approach must preserve that full functional program, not just viability,” said Nils Rudqvist, Ph.D., Senior Director, Research at MiNK Therapeutics. “And because iNKT cells do not require human leukocyte antigen (HLA) matching, one manufacturing run can supply many patients. Pairing that scalability with room-temperature stability could take cell therapy beyond the specialized centers equipped for cryopreserved products and bring it to community hospitals and patients worldwide.”
For MiNK, the collaboration advances a broader strategy of developing deployable living medicines: allogeneic immune therapies designed not only for scalable manufacturing but ultimately for practical distribution and administration wherever there are patient needs.
About the ARPA-H BoSS Program
The Advanced Research Projects Agency for Health’s (ARPA-H) BioStabilization Systems (BoSS) program aims to develop technologies that enable cell therapies and other biologic medicines to be produced, stored, and transported at room temperature. If successful, the program has potential to eliminate the need for deep-freeze “cold chain” infrastructure that biologics rely on today. Drawing on approaches inspired by nature and materials science, BoSS seeks to make advanced medicines more affordable, resilient, and accessible to patients across the country, including remote and resource-limited communities. Additional information is available at arpa-h.gov/explore-funding/programs/boss.
About MiNK Therapeutics
MiNK Therapeutics, Inc. (NASDAQ: INKT) is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies for cancer and other immune-mediated diseases. Its lead program, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy in clinical development for solid tumors, graft-versus-host disease (GvHD), and severe pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-directed iNKT programs designed for tissue-specific immune activation, supported by a scalable manufacturing platform intended to make immune reconstitution therapies more durable, accessible, and globally deployable.
About agenT-797
agenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy that harnesses the dual power of innate and adaptive immunity. iNKTs function as “master regulators,” combining the cytotoxic capabilities of NK cells with T-cell–like antigen recognition and memory. This unique biology enables a robust, pathogen-agnostic immune response that can be directed against hard-to-treat tumors. Manufactured by MiNK Therapeutics in Lexington, MA, agenT-797 is a scalable, off-the-shelf product designed to provide accessible, transformative treatment options. In clinical trials, agenT-797 can bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers (Cytryn et al. AACR IO 2024, Oncogene. 2024) and combat inflammation in critically ill patients with severe respiratory pathology (Nature Communications. 2024).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the goals, timelines, and potential outcomes of the ARPA-H BoSS program, the potential benefits of biostabilization technology for agenT-797 and MiNK’s broader iNKT platform, and MiNK’s role within the RAB team. These statements are subject to risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings, and actual results may differ materially. MiNK undertakes no obligation to update or revise these statements except as required by law.
LONDON–(BUSINESS WIRE)– Funds Date TIDM ISIN Code Shares in Issue Currency Net Asset Value NAV/per Share First Trust Dow Jones International Internet UCITS ETF 29.09.2026 FDNI.LN IE00BT9PVG14 425,002.00 USD 7,311,258.06 17.203
LONDON–(BUSINESS WIRE)– Funds Date TIDM ISIN Code Shares in Issue Currency Net Asset Value NAV/per Share First Trust Dow Jones International Internet UCITS ETF 29.09.2026 FDNI.LN IE00BT9PVG14 425,002.00 USD 7,311,258.06 17.203
LONDON–(BUSINESS WIRE)– Funds Date TIDM ISIN Code Shares in Issue Currency Net Asset Value NAV/per Share First Trust US Equity Income UCITS ETF 29.09.2026 UIGB IE00079WNSI6 5,866.00 GBP 156,042.67 26.601
