• Collaboration extends existing relationship with the Tier 1 pharmaceutical customer into cell therapy programs
  • End-to-end supply chain combines 4basebio’s proprietary opDNA® enzymatic DNA starting material with TriLink’s industry-leading GMP mRNA manufacturing capabilities and proprietary CleanCap® co-transcriptional capping technology

CAMBRIDGE, UK – 28 September, 2026 – 4basebio PLC (AIM: 4BB), a specialist in enzymatically-produced DNA for new genetic medicines, announces they will supply clinical-grade opDNA® starting material for a multi-national pharmaceutical innovator’s (“the Client”) latest cell therapy program.

Under the agreement, 4basebio will supply synthetic DNA to be used as a critical material for the Client’s upcoming Phase I clinical trial. TriLink BioTechnologies (TriLink), part of Maravai LifeSciences has been selected as the contract development and manufacturing organisation (CDMO) to manufacture the mRNA drug substance, applying its proprietary CleanCap® co-transcriptional capping technology. The agreement reflects 4basebio’s commitment and mission to provide a safer, cost-effective replacement for plasmid DNA in the development of genetic medicines.

Christine Wolosin, Chief Commercial Officer at 4basebio, added: “We’re excited to continue our relationship with this leading pharmaceutical innovator as they advance new molecules into the clinic. This collaboration is a testament to the quality and consistency of our opDNA® platform, and to the strength of the partnerships we’ve built across the CDMO ecosystem. Working alongside TriLink – a world-class mRNA manufacturer – allows us to plug our starting material seamlessly into established manufacturing workflows, giving customers a faster, lower-risk path to the clinic without having to change how they already work with their chosen manufacturing partners.”

Chad Decker, Senior Vice President, Global Sales at TriLink commented: “TriLink is proud to be the CDMO of choice for this important cell therapy program. With our CleanCap® technology paired with 4basebio’s high-purity opDNA® as starting material, we can offer this program with exceptional consistency from DNA template through finished drug substance. This is exactly the kind of end-to-end, quality-forward collaboration that accelerates programs from IND to first patient. We look forward to applying our mRNA manufacturing expertise to help bring this therapy closer to patients.”

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 as amended by regulation 11 of the market abuse (amendment) (EU Exit) regulations 2019/310.

For further enquiries, please contact:

4basebio PLC                
Dr Amy Walker, CEO
+44 (0)12 2396 7943
Cairn Financial Advisers LLP (Nominated Adviser)
Jo Turner / Sandy Jamieson / Ed Downes
+44 (0)20 7213 0880
 
Cavendish Capital Markets Limited (Joint Broker)
Geoff Nash
+44 (0)20 7220 0500
 
RBC Capital Markets (Joint Broker)
Kathryn Deegan / Sandrine Cailleteau
+44 (0)20 7653 4000
 
ICR Healthcare (Media and Investor Relations)
Mary-Jane Elliott / Jessica Hodgson
+44 (0)203 707 5700

About 4basebio

4basebio (AIM: 4BB) is a Cambridge-based biotechnology company pioneering the use of synthetic DNA to enable next-generation therapeutics and vaccines. Through its proprietary enzymatic DNA synthesis platform, 4basebio produces GMP-grade synthetic DNA and mRNA with superior speed, purity, and scalability, overcoming the limitations of plasmid-based systems. The company offers application-specific DNA constructs tailored to the diverse needs of gene therapies, genome editing, mRNA production, and DNA vaccines, helping partners accelerate proof-of-concept studies and reach clinical milestones more efficiently while maintaining the highest standards of safety and quality.

For more information, visit 4basebio.com.

About TriLink BioTechnologies

TriLink BioTechnologies, part of Maravai LifeSciences, is a global leader in nucleic acid technologies and manufacturing solutions for RNA therapeutics, vaccines, gene editing, and diagnostics. The company’s portfolio includes modified nucleotides, mRNA products, proprietary technologies such as CleanCap® capping analogs and ModTail® technology, and a growing portfolio of high-performance enzymes marketed under the Alphazyme brand. Supported by robust GMP manufacturing capabilities, TriLink enables customers from early-stage research through commercial production.

For more information, visit trilinkbiotech.com

About Maravai LifeSciences

Maravai LifeSciences is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines and to support research on human diseases. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapies companies.

For more information, visit Maravai.com

Forward-looking statements

This announcement may contain certain statements about the future outlook for 4basebio. Although the directors believe their expectations are based on reasonable assumptions, any statements about future outlook may be influenced by factors that could cause actual outcomes and results to be materially different.

  • Collaboration extends existing relationship with the Tier 1 pharmaceutical customer into cell therapy programs
  • End-to-end supply chain combines 4basebio’s proprietary opDNA® enzymatic DNA starting material with TriLink’s industry-leading GMP mRNA manufacturing capabilities and proprietary CleanCap® co-transcriptional capping technology

CAMBRIDGE, UK – 28 September, 2026 – 4basebio PLC (AIM: 4BB), a specialist in enzymatically-produced DNA for new genetic medicines, announces they will supply clinical-grade opDNA® starting material for a multi-national pharmaceutical innovator’s (“the Client”) latest cell therapy program.

Under the agreement, 4basebio will supply synthetic DNA to be used as a critical material for the Client’s upcoming Phase I clinical trial. TriLink BioTechnologies (TriLink), part of Maravai LifeSciences has been selected as the contract development and manufacturing organisation (CDMO) to manufacture the mRNA drug substance, applying its proprietary CleanCap® co-transcriptional capping technology. The agreement reflects 4basebio’s commitment and mission to provide a safer, cost-effective replacement for plasmid DNA in the development of genetic medicines.

Christine Wolosin, Chief Commercial Officer at 4basebio, added: “We’re excited to continue our relationship with this leading pharmaceutical innovator as they advance new molecules into the clinic. This collaboration is a testament to the quality and consistency of our opDNA® platform, and to the strength of the partnerships we’ve built across the CDMO ecosystem. Working alongside TriLink – a world-class mRNA manufacturer – allows us to plug our starting material seamlessly into established manufacturing workflows, giving customers a faster, lower-risk path to the clinic without having to change how they already work with their chosen manufacturing partners.”

Chad Decker, Senior Vice President, Global Sales at TriLink commented: “TriLink is proud to be the CDMO of choice for this important cell therapy program. With our CleanCap® technology paired with 4basebio’s high-purity opDNA® as starting material, we can offer this program with exceptional consistency from DNA template through finished drug substance. This is exactly the kind of end-to-end, quality-forward collaboration that accelerates programs from IND to first patient. We look forward to applying our mRNA manufacturing expertise to help bring this therapy closer to patients.”

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 as amended by regulation 11 of the market abuse (amendment) (EU Exit) regulations 2019/310.

For further enquiries, please contact:

4basebio PLC                
Dr Amy Walker, CEO
+44 (0)12 2396 7943
Cairn Financial Advisers LLP (Nominated Adviser)
Jo Turner / Sandy Jamieson / Ed Downes
+44 (0)20 7213 0880
 
Cavendish Capital Markets Limited (Joint Broker)
Geoff Nash
+44 (0)20 7220 0500
 
RBC Capital Markets (Joint Broker)
Kathryn Deegan / Sandrine Cailleteau
+44 (0)20 7653 4000
 
ICR Healthcare (Media and Investor Relations)
Mary-Jane Elliott / Jessica Hodgson
+44 (0)203 707 5700

About 4basebio

4basebio (AIM: 4BB) is a Cambridge-based biotechnology company pioneering the use of synthetic DNA to enable next-generation therapeutics and vaccines. Through its proprietary enzymatic DNA synthesis platform, 4basebio produces GMP-grade synthetic DNA and mRNA with superior speed, purity, and scalability, overcoming the limitations of plasmid-based systems. The company offers application-specific DNA constructs tailored to the diverse needs of gene therapies, genome editing, mRNA production, and DNA vaccines, helping partners accelerate proof-of-concept studies and reach clinical milestones more efficiently while maintaining the highest standards of safety and quality.

For more information, visit 4basebio.com.

About TriLink BioTechnologies

TriLink BioTechnologies, part of Maravai LifeSciences, is a global leader in nucleic acid technologies and manufacturing solutions for RNA therapeutics, vaccines, gene editing, and diagnostics. The company’s portfolio includes modified nucleotides, mRNA products, proprietary technologies such as CleanCap® capping analogs and ModTail® technology, and a growing portfolio of high-performance enzymes marketed under the Alphazyme brand. Supported by robust GMP manufacturing capabilities, TriLink enables customers from early-stage research through commercial production.

For more information, visit trilinkbiotech.com

About Maravai LifeSciences

Maravai LifeSciences is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines and to support research on human diseases. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapies companies.

For more information, visit Maravai.com

Forward-looking statements

This announcement may contain certain statements about the future outlook for 4basebio. Although the directors believe their expectations are based on reasonable assumptions, any statements about future outlook may be influenced by factors that could cause actual outcomes and results to be materially different.

Originally published by the Bristol Myers Squibb Foundation

Francis Kwoba is a 68-year-old retired policeman from Bungoma County, Kenya. During one of his usual morning runs, he experienced a sudden sharp pain in his chest. Concerned by the symptoms, he sought medical attention at the nearest health facility and was prescribed an anti-tuberculosis medication for treatment. After three months, Francis’s chest pain persisted and he began experiencing breathlessness. At Moi Teaching and Referral Hospital (MTRH), doctors found fluid in his lungs and a chest CT scan revealed aggressive lung cancer.

In much of sub-Saharan Africa, that diagnosis can be a death sentence, not because treatment doesn’t exist, but because cancer is so often caught too late.

Through the Bristol Myers Squibb Foundation (BMS Foundation) Multinational Lung Cancer Control Program (MLCCP) in partnership with Academic Model Providing Access to Healthcare (AMPATH) at MTRH, Francis received targeted treatment, patient navigation and psychosocial support that, in his words, helped “strengthen my spirit.”

As MLCCP Principal Investigator Prof. Lameck Diero shared, “Once you are in the program, you are family.”

Today, Francis is a survivor and an advocate, showing others there can be a second act.

Francis Kwoba and his wife Susan
Francis Kwoba and his wife Susan

A 25-year commitment to systems that last

Stories like Francis’ are what the BMS Foundation has spent more than 25 years working to make possible in Africa, and in other geographies around the world. What began with the HIV/AIDS crisis in sub-Saharan Africa now spans lung cancer, cervical cancer, pediatric cancers and pediatric blood disorders across multiple countries.

“What 25 years has taught us is that sustainable impact comes from strengthening local systems from within — building the capacity that remains long after any single program ends, so care can reach patients earlier and keep reaching them over time,” says Catharine Grimes, president of the BMS Foundation.

When care comes to you

The same philosophy shapes the fight against cervical cancer in western Kenya. Through Cure Cervical Cancer Kenya’s Mobile Health for Mamas program, trained Community Health Promoters (CHPs) reach women where they are — at home and at mobile treatment outreach sites — guiding them from HPV self-collection through treatment. A portable, solar-powered mobile laboratory processes samples on-site and returns results in roughly 90 minutes.

More than 37,000 women have been screened to date; for many, it was their first. The World Health Organization recommends screening by age 35 and again by 45, benchmarks that remain out of reach for millions across sub-Saharan Africa.

During one household visit in Vihiga County, the power of that model was impossible to miss. Beatrice Kadesa Kidagi is 49 years old, widowed since 2012, and the sole provider for her seven children. She supports her family by picking tea on local farms, and at 49, had missed both of those recommended screening windows. Getting to an outreach site simply was not possible with her responsibilities at home.

On a February morning in 2026, a CHP arrived at Beatrice’s home in Jemaga Village. She sat with Beatrice, explained HPV, walked her through self-sampling and stayed until apprehension gave way to trust.

When her screening results came back invalid, she didn’t give up. She called her CHP. She asked what came next. And she is now waiting for her follow-up test.

“Beatrice’s story is what a system built on trust looks like in practice,” says Wendy Short Bartie, board member of the BMS Foundation. “It makes clear how much of a difference it can make when care is not only available, but truly within reach. And when you see the system working, it affirms everything the Foundation has built over 25 years — and that there is still more to do.”

Beatrice Kadesa Kidagi (left) with Joyce Kinyangi, Community Health Promoter (CHP)
Beatrice Kadesa Kidagi (left) with Joyce Kinyangi, Community Health Promoter (CHP)

Building the next generation of care

For children, the impact has been just as great. Launched in 2016 with Texas Children’s Hospital and Baylor College of Medicine, Texas Children’s Global Hematology-Oncology Pediatric Excellence (HOPE) program set out to build pediatric hematology-oncology capacity across sub-Saharan Africa. The results are measurable and undeniable: early death rates for children on cancer treatment have fallen from 85% to 14%, and survival rates have more than quadrupled.

A father described learning that his young child had cancer, a diagnosis that, not long ago, would have offered little hope. Through the health system being built by local leaders and supported by Global HOPE, his child received the care she needed and is now thriving.

A continent aligned

The legacy of Global HOPE’s work and impact reached a historic milestone when leaders from across the continent recently gathered to validate and launch the Africa Centres for Disease Control and Prevention Continental Framework for Sickle Cell Disease, with more than two-thirds of African Union member states aligned behind a shared plan.

“Of the 300,000 children born with sickle cell disease in Africa every year, 80% will not live to see their fifth birthday, despite the availability of effective, low-cost interventions,” says Dr. Joseph Lubega, director of Texas Children’s Global HOPE.

For Foundation leadership, including BMS Foundation Board Member Cristian Massacesi, the number is a call to action.

“The Continental Framework for Sickle Cell Disease is about children and families — ensuring that access to life-saving care does not depend on where a child is born, or the circumstances into which they arrive,” Massacesi says. “It is the standard we hold ourselves to, and the reason the BMS Foundation remains committed to Africa for the long term.”

A legacy still being written

From CHPs reaching women who have never been screened to specialists trained under Global HOPE now leading pediatric oncology departments and mentoring the next generation, the Foundation’s work in Africa is a compounding commitment — felt in every system strengthened, every clinician trained and every patient, like Francis and Beatrice, who are still here to tell their stories.

Examples like these offer a model for the BMS Foundation and others working to impact medically underserved communities around the world.

The Bristol Myers Squibb Foundation is an independent charitable organization dedicated to its mission to improve global health through strong, local healthcare systems.

The Group!

 

Originally published by the Bristol Myers Squibb Foundation

Francis Kwoba is a 68-year-old retired policeman from Bungoma County, Kenya. During one of his usual morning runs, he experienced a sudden sharp pain in his chest. Concerned by the symptoms, he sought medical attention at the nearest health facility and was prescribed an anti-tuberculosis medication for treatment. After three months, Francis’s chest pain persisted and he began experiencing breathlessness. At Moi Teaching and Referral Hospital (MTRH), doctors found fluid in his lungs and a chest CT scan revealed aggressive lung cancer.

In much of sub-Saharan Africa, that diagnosis can be a death sentence, not because treatment doesn’t exist, but because cancer is so often caught too late.

Through the Bristol Myers Squibb Foundation (BMS Foundation) Multinational Lung Cancer Control Program (MLCCP) in partnership with Academic Model Providing Access to Healthcare (AMPATH) at MTRH, Francis received targeted treatment, patient navigation and psychosocial support that, in his words, helped “strengthen my spirit.”

As MLCCP Principal Investigator Prof. Lameck Diero shared, “Once you are in the program, you are family.”

Today, Francis is a survivor and an advocate, showing others there can be a second act.

Francis Kwoba and his wife Susan
Francis Kwoba and his wife Susan

A 25-year commitment to systems that last

Stories like Francis’ are what the BMS Foundation has spent more than 25 years working to make possible in Africa, and in other geographies around the world. What began with the HIV/AIDS crisis in sub-Saharan Africa now spans lung cancer, cervical cancer, pediatric cancers and pediatric blood disorders across multiple countries.

“What 25 years has taught us is that sustainable impact comes from strengthening local systems from within — building the capacity that remains long after any single program ends, so care can reach patients earlier and keep reaching them over time,” says Catharine Grimes, president of the BMS Foundation.

When care comes to you

The same philosophy shapes the fight against cervical cancer in western Kenya. Through Cure Cervical Cancer Kenya’s Mobile Health for Mamas program, trained Community Health Promoters (CHPs) reach women where they are — at home and at mobile treatment outreach sites — guiding them from HPV self-collection through treatment. A portable, solar-powered mobile laboratory processes samples on-site and returns results in roughly 90 minutes.

More than 37,000 women have been screened to date; for many, it was their first. The World Health Organization recommends screening by age 35 and again by 45, benchmarks that remain out of reach for millions across sub-Saharan Africa.

During one household visit in Vihiga County, the power of that model was impossible to miss. Beatrice Kadesa Kidagi is 49 years old, widowed since 2012, and the sole provider for her seven children. She supports her family by picking tea on local farms, and at 49, had missed both of those recommended screening windows. Getting to an outreach site simply was not possible with her responsibilities at home.

On a February morning in 2026, a CHP arrived at Beatrice’s home in Jemaga Village. She sat with Beatrice, explained HPV, walked her through self-sampling and stayed until apprehension gave way to trust.

When her screening results came back invalid, she didn’t give up. She called her CHP. She asked what came next. And she is now waiting for her follow-up test.

“Beatrice’s story is what a system built on trust looks like in practice,” says Wendy Short Bartie, board member of the BMS Foundation. “It makes clear how much of a difference it can make when care is not only available, but truly within reach. And when you see the system working, it affirms everything the Foundation has built over 25 years — and that there is still more to do.”

Beatrice Kadesa Kidagi (left) with Joyce Kinyangi, Community Health Promoter (CHP)
Beatrice Kadesa Kidagi (left) with Joyce Kinyangi, Community Health Promoter (CHP)

Building the next generation of care

For children, the impact has been just as great. Launched in 2016 with Texas Children’s Hospital and Baylor College of Medicine, Texas Children’s Global Hematology-Oncology Pediatric Excellence (HOPE) program set out to build pediatric hematology-oncology capacity across sub-Saharan Africa. The results are measurable and undeniable: early death rates for children on cancer treatment have fallen from 85% to 14%, and survival rates have more than quadrupled.

A father described learning that his young child had cancer, a diagnosis that, not long ago, would have offered little hope. Through the health system being built by local leaders and supported by Global HOPE, his child received the care she needed and is now thriving.

A continent aligned

The legacy of Global HOPE’s work and impact reached a historic milestone when leaders from across the continent recently gathered to validate and launch the Africa Centres for Disease Control and Prevention Continental Framework for Sickle Cell Disease, with more than two-thirds of African Union member states aligned behind a shared plan.

“Of the 300,000 children born with sickle cell disease in Africa every year, 80% will not live to see their fifth birthday, despite the availability of effective, low-cost interventions,” says Dr. Joseph Lubega, director of Texas Children’s Global HOPE.

For Foundation leadership, including BMS Foundation Board Member Cristian Massacesi, the number is a call to action.

“The Continental Framework for Sickle Cell Disease is about children and families — ensuring that access to life-saving care does not depend on where a child is born, or the circumstances into which they arrive,” Massacesi says. “It is the standard we hold ourselves to, and the reason the BMS Foundation remains committed to Africa for the long term.”

A legacy still being written

From CHPs reaching women who have never been screened to specialists trained under Global HOPE now leading pediatric oncology departments and mentoring the next generation, the Foundation’s work in Africa is a compounding commitment — felt in every system strengthened, every clinician trained and every patient, like Francis and Beatrice, who are still here to tell their stories.

Examples like these offer a model for the BMS Foundation and others working to impact medically underserved communities around the world.

The Bristol Myers Squibb Foundation is an independent charitable organization dedicated to its mission to improve global health through strong, local healthcare systems.

The Group!

 

Accomplished executive to lead strategy and corporate development function driving TransUnion’s next chapter of global growth and innovation

CHICAGO, Sept. 28, 2026 (GLOBE NEWSWIRE) — Malte Bernholz will join TransUnion (NYSE: TRU) as Executive Vice President, Chief Strategy and Corporate Development Officer, effective today.

In this newly created role, Bernholz will lead TransUnion’s Enterprise Strategy and Corporate Development function, aligning the organization around a long-term strategy to drive global innovation and scale. He will report to TransUnion President and Chief Executive Officer Chris Cartwright and serve on the executive leadership team.

“TransUnion is expanding how we use data, analytics and technology to drive growth from our broader range of solutions across markets globally, building up our leadership in Credit,” said Cartwright. “I’m confident Malte will strengthen our ability to shape strategy, execute enterprise change, monetize our assets and acquire new capabilities.”

Bernholz will join TransUnion with significant experience leading corporate strategy, M&A and large-scale organizational transformation across global software businesses, private equity investments, and top-tier consulting. Most recently at Adobe, he oversaw enterprise-wide growth strategy across the company’s creativity, productivity and customer experience businesses, and founded and scaled its new product incubator. Prior to Adobe, he served as Vice President of Corporate Strategy Consulting at EMC, as well as Chief Operating Officer at iVize and a consultant at McKinsey & Company. He earned an M.S. from Institut Polytechnique de Grenoble.

“Driving growth in the era of agentic AI requires every organization to develop strategy, plan and execute differently to meet customer needs,” said Bernholz. “I’m excited to join TransUnion at the most innovative point in its history and accelerate how we scale that innovation around the world.”
  
About TransUnion (NYSE: TRU)
TransUnion is a global information and insights company with over 13,000 associates operating in more than 30 countries. We make trust possible by ensuring each person is reliably represented in the marketplace. We do this with a Tru™ picture of each person: an actionable view of consumers, stewarded with care. Through our acquisitions and technology investments we have developed innovative solutions that extend beyond our strong foundation in core credit into areas such as marketing, fraud, risk and advanced analytics. As a result, consumers and businesses can transact with confidence and achieve great things. We call this Information for Good® — and it leads to economic opportunity, great experiences and personal empowerment for millions of people around the world. http://www.transunion.com/business.

Contact Dave Blumberg
  TransUnion
   
E-mail david.blumberg@transunion.com 
   
Telephone 312-972-6646

Accomplished executive to lead strategy and corporate development function driving TransUnion’s next chapter of global growth and innovation

CHICAGO, Sept. 28, 2026 (GLOBE NEWSWIRE) — Malte Bernholz will join TransUnion (NYSE: TRU) as Executive Vice President, Chief Strategy and Corporate Development Officer, effective today.

In this newly created role, Bernholz will lead TransUnion’s Enterprise Strategy and Corporate Development function, aligning the organization around a long-term strategy to drive global innovation and scale. He will report to TransUnion President and Chief Executive Officer Chris Cartwright and serve on the executive leadership team.

“TransUnion is expanding how we use data, analytics and technology to drive growth from our broader range of solutions across markets globally, building up our leadership in Credit,” said Cartwright. “I’m confident Malte will strengthen our ability to shape strategy, execute enterprise change, monetize our assets and acquire new capabilities.”

Bernholz will join TransUnion with significant experience leading corporate strategy, M&A and large-scale organizational transformation across global software businesses, private equity investments, and top-tier consulting. Most recently at Adobe, he oversaw enterprise-wide growth strategy across the company’s creativity, productivity and customer experience businesses, and founded and scaled its new product incubator. Prior to Adobe, he served as Vice President of Corporate Strategy Consulting at EMC, as well as Chief Operating Officer at iVize and a consultant at McKinsey & Company. He earned an M.S. from Institut Polytechnique de Grenoble.

“Driving growth in the era of agentic AI requires every organization to develop strategy, plan and execute differently to meet customer needs,” said Bernholz. “I’m excited to join TransUnion at the most innovative point in its history and accelerate how we scale that innovation around the world.”
  
About TransUnion (NYSE: TRU)
TransUnion is a global information and insights company with over 13,000 associates operating in more than 30 countries. We make trust possible by ensuring each person is reliably represented in the marketplace. We do this with a Tru™ picture of each person: an actionable view of consumers, stewarded with care. Through our acquisitions and technology investments we have developed innovative solutions that extend beyond our strong foundation in core credit into areas such as marketing, fraud, risk and advanced analytics. As a result, consumers and businesses can transact with confidence and achieve great things. We call this Information for Good® — and it leads to economic opportunity, great experiences and personal empowerment for millions of people around the world. http://www.transunion.com/business.

Contact Dave Blumberg
  TransUnion
   
E-mail david.blumberg@transunion.com 
   
Telephone 312-972-6646

  • Eton Pharmaceuticals now holds exclusive commercialization rights for IMPAVIDO in the United States
  • Eton has integrated full Eton Cares® patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs
  • Centralized distribution through Anovo Specialty Pharmacy is designed to simplify access and therapy initiation for outpatient prescribing, inpatient consignment, and urgent access coordination

DEER PARK, Ill., Sept. 28, 2026 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the Company has launched IMPAVIDO® (miltefosine) capsules.

“We are excited to be relaunching IMPAVIDO and making Eton Cares available to all patients. By bringing IMPAVIDO into Eton’s rare disease commercial infrastructure, we can pair this important therapy with high-touch services designed to help support healthcare providers and expand access for patients. We believe this comprehensive approach will help ensure that patients who need IMPAVIDO can access and initiate treatment without unnecessary delays. We are also working to expand hospital on-site availability across the United States through our consignment inventory stocking program,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Clinicians seeking to prescribe IMPAVIDO can e-prescribe by selecting Anovo #5 (Memphis) or fax a patient referral form to 855-813-2039. Patients with questions regarding their prescription or healthcare providers can call Anovo at the dedicated IMPAVIDO line 877-469-4078.

Hospital pharmacies seeking IMPAVIDO for inpatient use may contact Anovo Specialty Pharmacy to establish access through the hospital network.

For urgent or time-sensitive patient needs, Anovo will coordinate an emergency access pathway with treating clinicians, CDC representatives, and hospital pharmacies. The pathway is designed to evaluate the fastest available source of product and delivery option based on the patient’s need-by time and the treating institution’s location.

Additional product details can be found on the product website, www.impavidous.com.

Important Safety Information for IMPAVIDO

INDICATION

IMPAVIDO® (miltefosine) is an antileishmanial drug indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs) for treatment of:

• Visceral leishmaniasis due to Leishmania donovani.
• Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis.
• Mucosal leishmaniasis due to Leishmania braziliensis.

Limitations of Use: Leishmania species evaluated in clinical trials were based on epidemiologic data. There may be geographic variation in the response of the same Leishmania species to IMPAVIDO. The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.

IMPORTANT SAFETY INFORMATION

Contraindications

IMPAVIDO is contraindicated in pregnancy because it may cause fetal harm; in patients with Sjögren-Larsson syndrome; and in patients with hypersensitivity to miltefosine or any component of the formulation.

Warnings and Precautions

Embryo-Fetal Toxicity: IMPAVIDO may cause fetal harm when administered during pregnancy. Obtain a pregnancy test before initiating therapy in females of reproductive potential. Advise females of reproductive potential to use effective contraception during treatment and for 5 months after completion of therapy. If vomiting or diarrhea occurs during treatment, oral contraceptive effectiveness may be reduced; advise use of an additional non-hormonal contraceptive method.

Reproductive Effects: Miltefosine caused impaired fertility in animal studies. The potential effects on human fertility have not been adequately evaluated.

Renal Effects: Monitor serum creatinine during treatment and for 4 weeks after completion of therapy.

Hepatic Effects: Monitor liver transaminases and bilirubin during treatment.

Gastrointestinal Effects: Vomiting and diarrhea are common and may result in dehydration. Encourage adequate fluid intake during treatment.

Thrombocytopenia: Monitor platelet counts during therapy in patients treated for visceral leishmaniasis.

Stevens-Johnson Syndrome: Stevens-Johnson syndrome has been reported. Discontinue IMPAVIDO if an exfoliative or bullous rash develops.

Adverse Reactions

The most common adverse reactions (≥2%) are nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, and elevated serum creatinine.

To report a suspected adverse event related to IMPAVIDO, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/MedWatch or call 1-800-FDA-1088.

Please see Full Prescribing Information, including Boxed Warning regarding Embryo-Fetal Toxicity.

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eleven commercial rare disease products: KHINDIVI® (hydrocortisone), INCRELEX® (mecasermin), ALKINDI SPRINKLE® (hydrocortisone), DESMODA™ (desmopressin acetate), GALZIN® (zinc acetate), HEMANGEOL® (propranolol hydrochloride), PKU GOLIKE®, IMPAVIDO® (miltefosine), Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: AMGLIDIA® (glyburide), ASN-001, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

  • Eton Pharmaceuticals now holds exclusive commercialization rights for IMPAVIDO in the United States
  • Eton has integrated full Eton Cares® patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs
  • Centralized distribution through Anovo Specialty Pharmacy is designed to simplify access and therapy initiation for outpatient prescribing, inpatient consignment, and urgent access coordination

DEER PARK, Ill., Sept. 28, 2026 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the Company has launched IMPAVIDO® (miltefosine) capsules.

“We are excited to be relaunching IMPAVIDO and making Eton Cares available to all patients. By bringing IMPAVIDO into Eton’s rare disease commercial infrastructure, we can pair this important therapy with high-touch services designed to help support healthcare providers and expand access for patients. We believe this comprehensive approach will help ensure that patients who need IMPAVIDO can access and initiate treatment without unnecessary delays. We are also working to expand hospital on-site availability across the United States through our consignment inventory stocking program,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Clinicians seeking to prescribe IMPAVIDO can e-prescribe by selecting Anovo #5 (Memphis) or fax a patient referral form to 855-813-2039. Patients with questions regarding their prescription or healthcare providers can call Anovo at the dedicated IMPAVIDO line 877-469-4078.

Hospital pharmacies seeking IMPAVIDO for inpatient use may contact Anovo Specialty Pharmacy to establish access through the hospital network.

For urgent or time-sensitive patient needs, Anovo will coordinate an emergency access pathway with treating clinicians, CDC representatives, and hospital pharmacies. The pathway is designed to evaluate the fastest available source of product and delivery option based on the patient’s need-by time and the treating institution’s location.

Additional product details can be found on the product website, www.impavidous.com.

Important Safety Information for IMPAVIDO

INDICATION

IMPAVIDO® (miltefosine) is an antileishmanial drug indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs) for treatment of:

• Visceral leishmaniasis due to Leishmania donovani.
• Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis.
• Mucosal leishmaniasis due to Leishmania braziliensis.

Limitations of Use: Leishmania species evaluated in clinical trials were based on epidemiologic data. There may be geographic variation in the response of the same Leishmania species to IMPAVIDO. The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.

IMPORTANT SAFETY INFORMATION

Contraindications

IMPAVIDO is contraindicated in pregnancy because it may cause fetal harm; in patients with Sjögren-Larsson syndrome; and in patients with hypersensitivity to miltefosine or any component of the formulation.

Warnings and Precautions

Embryo-Fetal Toxicity: IMPAVIDO may cause fetal harm when administered during pregnancy. Obtain a pregnancy test before initiating therapy in females of reproductive potential. Advise females of reproductive potential to use effective contraception during treatment and for 5 months after completion of therapy. If vomiting or diarrhea occurs during treatment, oral contraceptive effectiveness may be reduced; advise use of an additional non-hormonal contraceptive method.

Reproductive Effects: Miltefosine caused impaired fertility in animal studies. The potential effects on human fertility have not been adequately evaluated.

Renal Effects: Monitor serum creatinine during treatment and for 4 weeks after completion of therapy.

Hepatic Effects: Monitor liver transaminases and bilirubin during treatment.

Gastrointestinal Effects: Vomiting and diarrhea are common and may result in dehydration. Encourage adequate fluid intake during treatment.

Thrombocytopenia: Monitor platelet counts during therapy in patients treated for visceral leishmaniasis.

Stevens-Johnson Syndrome: Stevens-Johnson syndrome has been reported. Discontinue IMPAVIDO if an exfoliative or bullous rash develops.

Adverse Reactions

The most common adverse reactions (≥2%) are nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, and elevated serum creatinine.

To report a suspected adverse event related to IMPAVIDO, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/MedWatch or call 1-800-FDA-1088.

Please see Full Prescribing Information, including Boxed Warning regarding Embryo-Fetal Toxicity.

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eleven commercial rare disease products: KHINDIVI® (hydrocortisone), INCRELEX® (mecasermin), ALKINDI SPRINKLE® (hydrocortisone), DESMODA™ (desmopressin acetate), GALZIN® (zinc acetate), HEMANGEOL® (propranolol hydrochloride), PKU GOLIKE®, IMPAVIDO® (miltefosine), Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: AMGLIDIA® (glyburide), ASN-001, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

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