KOMO Biosciences Grants Research Evaluation License to Syngenta to Explore Precision Genome Modification in Maize




KOMO Biosciences Grants Research Evaluation License to Syngenta to Explore Precision Genome Modification in Maize

Collaboration brings non-viral, site-specific DNA insertion to crop trait development, intended to accelerate the path to more resilient and sustainable agriculture

CAMBRIDGE, Mass., March 11, 2026 (GLOBE NEWSWIRE) — KOMO Biosciences, a developer of non-viral targeted insertion technologies, today announced that it has granted Syngenta, a world leader in agricultural innovation, a Research Evaluation License to assess aspects of KOMO’s proprietary KOMbine™ platform that is designed for precision genome modification in Zea mays (maize).

Under the agreement, Syngenta will evaluate KOMO’s non-viral, integrase-based genome engineering technology for research applications focused on the controlled and predictable introduction of genetic programs into maize genomes. The evaluation will support early-stage studies exploring how precise genomic integration can enable more advanced crop trait development.

KOMO’s platform addresses a core limitation of existing genetic engineering approaches: the inability to reliably and efficiently introduce large or complex genetic payloads into defined genomic locations without relying on viral delivery or nuclease-induced DNA breaks. This challenge is well recognized in therapeutic development and is increasingly important in agriculture as modern traits require coordinated expression of multiple genes with long-term stability.

Maize remains one of the world’s most critical crops, yet improving traits such as stress tolerance, yield stability, and resource efficiency increasingly depend on precise genomic control rather than single-gene edits. KOMO’s integrase-based approach is designed to enable site-specific, programmable genome modification, supporting predictable expression and durable performance across generations.

“This evaluation reflects a broader shift in how genome engineering is evolving,” said Jennifer Manning, Founder and CEO of KOMO Biosciences. “As biological systems become more complex, the question is no longer just whether a gene can be edited, but whether genetic programs can be reliably installed and controlled. KOMO was built to enable that next layer of genome engineering, and we’re excited to see this capability explored in maize and other agricultural systems.”

“At Syngenta, we’re energized by our collaboration with KOMO Biosciences. By combining our deep expertise in plant genetics and trait introgression with KOMO’s cutting-edge technology, we can accelerate our commitment to bring more precise solutions to farmers around the world.” stated Trevor Hohls, Global Head of R&D, Syngenta Seeds.

About KOMO Biosciences
KOMO Biosciences is a next‑generation precision genome engineering company developing non-viral, large serine integrase-based platforms for precise and scalable genome modification. Its technologies, including its KOMbine™ and KOMbineX™ platforms, are designed to enable the controlled insertion of large genetic payloads into defined genomic loci, supporting applications across therapeutics, biomanufacturing, agriculture, and synthetic biology. KOMO’s platforms are designed to overcome key limitations of existing gene editing approaches, including constraints on payload size, predictability, and durability.

Learn more at www.komobiosciences.com.

About Syngenta
Syngenta is a global leader in agricultural innovation with a presence in more than 90 countries. Syngenta is focused on developing technologies and farming practices that empower farmers, so they can make the transformation required to feed the world’s population while preserving our planet. Its bold scientific discoveries deliver better benefits for farmers and society on a bigger scale than ever before. Guided by its Sustainability Priorities, Syngenta is developing new technologies and solutions that support farmers to grow healthier plants in healthier soil with a higher yield. Syngenta Crop Protection is headquartered in Basel, Switzerland; Syngenta Seeds is headquartered in the United States. Read our stories and follow us on LinkedIn, Instagram & X.

Media Contacts
KOMO Biosciences
Keith Bowermaster, APR, CCMP
keith.bowermaster@genesisbiocapital.com

Syngenta Media Relations
media@syngentagroup.com

This press release contains forward-looking statements regarding potential applications of KOMO’s technologies and the anticipated benefits of the collaboration. Actual results may differ materially from those expressed or implied due to a variety of factors, including scientific, regulatory, and commercial uncertainties.

Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study




Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study

Access the Moleculin CEO Corner here

HOUSTON, March 11, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. The CEO Corner is designed to provide investors and stakeholders with enhanced insight into the Company’s corporate developments, clinical progress and strategic initiatives.

As part of the segment, Mr. Klemp discussed progress on the Company’s pivotal MIRACLE Study evaluating Annamycin in combination with cytarabine (AnnAraC) for patients with relapsed or refractory Acute Myeloid Leukemia. Mr. Klemp explained that the adaptive Phase 3 trial was designed with input from the U.S. Food and Drug Administration and includes an initial cohort of 45 patients. After treatment of these patients is completed, the study will undergo an interim unblinding to evaluate safety and efficacy and help inform the most efficient regulatory path forward. Enrollment and dosing across clinical sites are progressing as planned, with completion of treatment for the first 45 patients expected in the near term. The study builds on encouraging results from the Company’s earlier MB-106 Study, in which AnnAraC demonstrated overall survival outcomes that exceeded historical benchmarks in this difficult-to-treat patient population.

Access the CEO Corner on the Company’s website here.

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding the continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study




Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study

Access the Moleculin CEO Corner here

HOUSTON, March 11, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. The CEO Corner is designed to provide investors and stakeholders with enhanced insight into the Company’s corporate developments, clinical progress and strategic initiatives.

As part of the segment, Mr. Klemp discussed progress on the Company’s pivotal MIRACLE Study evaluating Annamycin in combination with cytarabine (AnnAraC) for patients with relapsed or refractory Acute Myeloid Leukemia. Mr. Klemp explained that the adaptive Phase 3 trial was designed with input from the U.S. Food and Drug Administration and includes an initial cohort of 45 patients. After treatment of these patients is completed, the study will undergo an interim unblinding to evaluate safety and efficacy and help inform the most efficient regulatory path forward. Enrollment and dosing across clinical sites are progressing as planned, with completion of treatment for the first 45 patients expected in the near term. The study builds on encouraging results from the Company’s earlier MB-106 Study, in which AnnAraC demonstrated overall survival outcomes that exceeded historical benchmarks in this difficult-to-treat patient population.

Access the CEO Corner on the Company’s website here.

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding the continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder




New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder

• Patients adherent to SUBLOCADE^® for 12 months had 42% lower adjusted non-MOUD medical costs vs. those adherent to other forms of MOUD
• Patients adherent to SUBLOCADE had the lowest inpatient, emergency department, and detoxification utilization across all treatment groups

RICHMOND, Va., March 11, 2026 (GLOBE NEWSWIRE) — Indivior Pharmaceuticals (Nasdaq: INDV) today announced findings from a new real-world evidence, retrospective observational study published in Frontiers in Public Health showing that adherence to SUBLOCADE^® (extended-release buprenorphine), a monthly injectable, is associated with meaningfully lower healthcare utilization and medical costs among commercially insured patients with opioid use disorder (OUD). These outcomes were more favorable compared to both patients adherent to other medications for OUD (MOUD) and to those who were nonadherent to MOUD.

These findings add to growing evidence that long-acting injectable buprenorphine treatment supports sustained engagement in care and reduces costly acute healthcare use.

To evaluate the relationship between treatment adherence, medication type, healthcare utilization, and costs, patients were grouped based on adherence level and primary MOUD received during follow-up including: those adherent to SUBLOCADE, those not adherent to SUBLOCADE but adherent to other MOUD (e.g., transmucosal buprenorphine), and those who were not adherent to any MOUD.

Patients who were adherent to SUBLOCADE across the 12-month follow-up experienced the lowest rates of inpatient admissions, emergency department visits, and detoxification services across all other groups.

Key findings:

• $15,017 (42%) lower annual non-MOUD medical costs per patient for SUBLOCADE-adherent patients vs other MOUD ($35,761 vs. $50,778).
• Lower adjusted costs observed among MOUD nonadherent patients likely reflect disengagement from routine outpatient care, and greater reliance on acute services.

“These data highlight the potential of long-acting injectable buprenorphine treatment to improve care continuity for people living with OUD and reduce the need for acute, high-cost healthcare services,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior.

Across treatment groups, consistent use of a monthly injectable buprenorphine was associated with lower overall healthcare expenditures compared with adherence to other MOUD. Consistent with other research, this study found that adherence to MOUD remains low overall, underscoring the broader challenges of treatment continuity in OUD care.

“These findings reinforce the importance of evaluating OUD treatment based on total healthcare cost,” said Patrick Barry, Chief Commercial Officer at Indivior. “Sustained engagement with long-acting therapy can reduce costly acute care use, generating meaningful system-wide savings while supporting treatment continuity for patients.”

Study limitations include the retrospective observational design and reliance on administrative claims data, which may be subject to coding inaccuracies and unmeasured confounding. Portions of the study period overlapped with the COVID-19 pandemic, where disruptions in care may have influenced healthcare utilization patterns. At the time the study was conducted, SUBLOCADE was the only extended-release buprenorphine product available in the U.S. market.

The study is available online: Association between extended-release buprenorphine adherence and reduced healthcare costs among insured patients with opioid use disorder

About SUBLOCADE®

SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII

INDICATION AND HIGHLIGHTED SAFETY INFORMATION

INDICATION

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

HIGHLIGHTED SAFETY INFORMATION

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

• Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.

CONTRAINDICATIONS

Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.

Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.

Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.

Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.

Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

ADVERSE REACTIONS

Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. 

About Opioid Use Disorder (OUD) 
Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions.

About Indivior 
As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine, developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities – we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

For Further Information 
Investors: 
Jason Thompson 
Indivior Pharmaceuticals 
Tel: 804-402-7123 
E-mail: jason.thompson@indivior.com 

Media: 
Cassie France-Kelly 
Indivior Pharmaceuticals 
Tel: 804-594-0836 
E-mail: Indiviormediacontacts@indivior.com

New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder




New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder

• Patients adherent to SUBLOCADE^® for 12 months had 42% lower adjusted non-MOUD medical costs vs. those adherent to other forms of MOUD
• Patients adherent to SUBLOCADE had the lowest inpatient, emergency department, and detoxification utilization across all treatment groups

RICHMOND, Va., March 11, 2026 (GLOBE NEWSWIRE) — Indivior Pharmaceuticals (Nasdaq: INDV) today announced findings from a new real-world evidence, retrospective observational study published in Frontiers in Public Health showing that adherence to SUBLOCADE^® (extended-release buprenorphine), a monthly injectable, is associated with meaningfully lower healthcare utilization and medical costs among commercially insured patients with opioid use disorder (OUD). These outcomes were more favorable compared to both patients adherent to other medications for OUD (MOUD) and to those who were nonadherent to MOUD.

These findings add to growing evidence that long-acting injectable buprenorphine treatment supports sustained engagement in care and reduces costly acute healthcare use.

To evaluate the relationship between treatment adherence, medication type, healthcare utilization, and costs, patients were grouped based on adherence level and primary MOUD received during follow-up including: those adherent to SUBLOCADE, those not adherent to SUBLOCADE but adherent to other MOUD (e.g., transmucosal buprenorphine), and those who were not adherent to any MOUD.

Patients who were adherent to SUBLOCADE across the 12-month follow-up experienced the lowest rates of inpatient admissions, emergency department visits, and detoxification services across all other groups.

Key findings:

• $15,017 (42%) lower annual non-MOUD medical costs per patient for SUBLOCADE-adherent patients vs other MOUD ($35,761 vs. $50,778).
• Lower adjusted costs observed among MOUD nonadherent patients likely reflect disengagement from routine outpatient care, and greater reliance on acute services.

“These data highlight the potential of long-acting injectable buprenorphine treatment to improve care continuity for people living with OUD and reduce the need for acute, high-cost healthcare services,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior.

Across treatment groups, consistent use of a monthly injectable buprenorphine was associated with lower overall healthcare expenditures compared with adherence to other MOUD. Consistent with other research, this study found that adherence to MOUD remains low overall, underscoring the broader challenges of treatment continuity in OUD care.

“These findings reinforce the importance of evaluating OUD treatment based on total healthcare cost,” said Patrick Barry, Chief Commercial Officer at Indivior. “Sustained engagement with long-acting therapy can reduce costly acute care use, generating meaningful system-wide savings while supporting treatment continuity for patients.”

Study limitations include the retrospective observational design and reliance on administrative claims data, which may be subject to coding inaccuracies and unmeasured confounding. Portions of the study period overlapped with the COVID-19 pandemic, where disruptions in care may have influenced healthcare utilization patterns. At the time the study was conducted, SUBLOCADE was the only extended-release buprenorphine product available in the U.S. market.

The study is available online: Association between extended-release buprenorphine adherence and reduced healthcare costs among insured patients with opioid use disorder

About SUBLOCADE®

SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII

INDICATION AND HIGHLIGHTED SAFETY INFORMATION

INDICATION

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

HIGHLIGHTED SAFETY INFORMATION

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

• Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.

CONTRAINDICATIONS

Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.

Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.

Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.

Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.

Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

ADVERSE REACTIONS

Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. 

About Opioid Use Disorder (OUD) 
Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions.

About Indivior 
As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine, developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities – we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

For Further Information 
Investors: 
Jason Thompson 
Indivior Pharmaceuticals 
Tel: 804-402-7123 
E-mail: jason.thompson@indivior.com 

Media: 
Cassie France-Kelly 
Indivior Pharmaceuticals 
Tel: 804-594-0836 
E-mail: Indiviormediacontacts@indivior.com

Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations Following Strong Progress in CGM Program




Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations Following Strong Progress in CGM Program

– Company accelerating partner engagement ahead of pivotal clinical trial to be initiated in 2026

DUBLIN and WILSONVILLE, Ore., March 11, 2026 (GLOBE NEWSWIRE) — Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that senior members of its executive leadership team will attend the ATTD 2026 (Advanced Technologies & Treatments for Diabetes) conference in Barcelona this week to progress strategic collaborations and commercialization plans for the Company’s next‑generation Continuous Glucose Monitoring (“CGM”) platform, CGM+.

The Company’s presence at ATTD follows compelling clinical performance data from its latest CGM technology developments, which formed the basis for Trinity Biotech’s decision to advance the program into a pivotal clinical trial in 2026. These results now provide strong evidence that the upgraded system can meet the industry standards for glucose measurement accuracy of modern CGMs. Ahead of this major development milestone, ATTD 2026 provides an important platform for the Company to accelerate partner engagement and prepare for the next phase of development and commercial readiness.

“Our CGM program has reached a meaningful inflection point, and ATTD is an ideal forum to deepen the partnerships necessary to bring this important innovation to market,” said John Gillard, Trinity Biotech President & Chief Executive Officer. “With pivotal clinical trial preparations underway, our team will be engaging with prospective collaborators across clinical research, technology integration, and commercial distribution as we build momentum with this exciting platform.”

Trinity Biotech’s CGM+ platform is being developed as part of the Company’s broader strategy to create integrated, AI-native healthcare analytics that support data-driven health solutions to enhance the management of diabetes and metabolic health worldwide.

For more information on CGM+ please visit our dedicated website https://cgm.trinitybiotech.com/

Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company’s website: www.trinitybiotech.com.

Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations Following Strong Progress in CGM Program




Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations Following Strong Progress in CGM Program

– Company accelerating partner engagement ahead of pivotal clinical trial to be initiated in 2026

DUBLIN and WILSONVILLE, Ore., March 11, 2026 (GLOBE NEWSWIRE) — Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that senior members of its executive leadership team will attend the ATTD 2026 (Advanced Technologies & Treatments for Diabetes) conference in Barcelona this week to progress strategic collaborations and commercialization plans for the Company’s next‑generation Continuous Glucose Monitoring (“CGM”) platform, CGM+.

The Company’s presence at ATTD follows compelling clinical performance data from its latest CGM technology developments, which formed the basis for Trinity Biotech’s decision to advance the program into a pivotal clinical trial in 2026. These results now provide strong evidence that the upgraded system can meet the industry standards for glucose measurement accuracy of modern CGMs. Ahead of this major development milestone, ATTD 2026 provides an important platform for the Company to accelerate partner engagement and prepare for the next phase of development and commercial readiness.

“Our CGM program has reached a meaningful inflection point, and ATTD is an ideal forum to deepen the partnerships necessary to bring this important innovation to market,” said John Gillard, Trinity Biotech President & Chief Executive Officer. “With pivotal clinical trial preparations underway, our team will be engaging with prospective collaborators across clinical research, technology integration, and commercial distribution as we build momentum with this exciting platform.”

Trinity Biotech’s CGM+ platform is being developed as part of the Company’s broader strategy to create integrated, AI-native healthcare analytics that support data-driven health solutions to enhance the management of diabetes and metabolic health worldwide.

For more information on CGM+ please visit our dedicated website https://cgm.trinitybiotech.com/

Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company’s website: www.trinitybiotech.com.

Weight Watchers Report Finds Integrated GLP-1 Support Drives Significantly Greater Weight Loss Than Medication Alone




Weight Watchers Report Finds Integrated GLP-1 Support Drives Significantly Greater Weight Loss Than Medication Alone

Weight Watchers’ Med+ members who regularly engaged with their GLP-1 Success Program lost up to 61% more body weight in the first month and 29% more in one year, on average, than those who took medication alone.

Med+ members prescribed medication also reported, on average, over 30% more weight loss than select competitors at 12 months.

NEW YORK, March 11, 2026 (GLOBE NEWSWIRE) — WW International, Inc. (NASDAQ: WW) (“Weight Watchers”), the global leader in science-backed weight health, today released a GLP-1 Results Report which finds that individuals who take GLP-1 medications and regularly engage in the Weight Watchers GLP-1 Success Program achieved significantly greater weight loss and better health outcomes than those using medication alone. The Weight Watchers evidence review builds on a growing body of research on long-term weight management. For example, a recent systematic review published in the British Medical Journal found that weight regain commonly occurs after discontinuation of anti-obesity medications, while guidance from the World Health Organization continues to emphasize the role of nutrition, physical activity, and other lifestyle factors in supporting metabolic health.

“GLP-1 medications are transforming obesity care — but a growing body of research is proving that medication alone is not enough to create lasting results,” said Weight Watchers CEO Tara Comonte. “To maximize the impact of these medical breakthroughs, Weight Watchers has established an integrated weight health platform that combines medication with structured nutritional, behavioral, and lifestyle supports. The results speak for themselves: members who pair weight loss medication with Weight Watchers’ GLP-1 Success Program lose up to 61% more weight in the first month and nearly 30% more weight over a year, on average, compared to those who do not engage with our approach. Clearly, GLP-1s work better with Weight Watchers.”

Weight Watchers’ Med+ platform, combined with the GLP-1 Success Program, offers access to board-certified physicians, FDA-approved prescriptions, and lifestyle support to drive better outcomes and create lasting habits that can sustain results over time. Designed to specifically address side effects, nutrition gaps, muscle loss, and plateaus, the program helps members stay consistent with the tools they need for success throughout their GLP-1 journey.

The GLP-1 Results Report also identified benefits beyond the scale. Additional clinical and real-world evidence cited show that Weight Watchers programs are associated with improvements in important health and behavioral measures — including hemoglobin A1c, blood pressure, diet quality, physical activity, and quality of life — that support long-term health and sustainability.

In the Weight Watchers app, members can track nutrition, follow guided fitness and strength-focused movement sessions, connect with others on GLP-1s, access dietitians, and discover easy recipes and meal plans — supporting sustainable weight loss and maintaining muscle. The membership also offers a variety of workshops led by physicians, registered dietitians, and Weight Watchers-trained coaches to help members maximize the impact of their GLP-1s.

The key findings in the GLP-1 Results Report illustrate:

Clinical and Real-World Findings

• Weight Watchers Med+ members prescribed GLP-1 medications lost 7.4 pounds in the first four weeks, and reached 21% average weight loss at 12 months and 20.5% average weight loss at 24 months.
• Among Weight Watchers Med+ members, those who actively engaged with the GLP-1 Success Program lost 61.3% more body weight after just one month compared with members who did not engage in additional support.
  • The advantage continued over time. Weight Watchers Med+ members who regularly engaged with the GLP-1 Success Program consistently lost more weight than those who did not engage in additional support — with improved outcomes observed at 3, 6, and 12 months, underscoring the value of combining medication with structured lifestyle guidance.
• Weight Watchers Med+ members prescribed GLP-1 medications reported, on average, over 30% more body weight loss than select competitors at 12 months.
• In one comparative analysis, members achieved 72% greater average weight loss than a cohort receiving compounded GLP-1 medications through Hims & Hers.

Reducing Side Effects and Supporting Sustainability

• Nearly 72% of members on the Weight Watchers GLP-1 Success Program reported that the program helped minimize GLP-1 side effects, which can support better adherence and long-term success.
• Among members prescribed obesity medication through the Med+ Program, who began treatment with high blood pressure, 87% had normal blood pressure after 12 months.
• The GLP-1 Success Program also emphasizes evidence-based nutrition targets like protein, fiber, and hydration, helping to preserve muscle mass, reduce gastrointestinal discomfort, and support adequate nutrient intake during weight loss.

Scalable Impact for the Future of Weight Health

• 75% of members report improved confidence and quality of life.
• 71% of members say the program helped them become the healthiest version of themselves.
• 81% say Weight Watchers has changed their life for the better.

ABOUT WEIGHT WATCHERS
Weight Watchers is the global leader in science-backed weight management, offering an integrated support system built for the GLP-1 era that combines scientific expertise, medication, cutting-edge technology, and human connection. With more than 60 years of experience, Weight Watchers is the most studied commercial weight management program in the world, delivered through its No. 1 U.S. doctor-recommended weight-loss program. Its holistic, personalized approach also includes U.S.-based clinical interventions and access to GLP-1 medications when clinically appropriate, and a global network of coaches and community support. Since 1963, the company has led with science to deliver its members the personalized support they need to reach and sustain their goals. Members can access these solutions directly, or through Weight Watchers for Business’ full-spectrum platform for employers, health plans, and payers. In a landscape crowded with contradictory advice, isolating apps, and one-size-fits-all solutions, Weight Watchers offers a proven path forward that is rooted in research, grounded in empathy and designed to help every member feel better in their body and live a longer, healthier life. For more information, visit weightwatchers.com.

For media inquiries, please contact:
Lizzy Levitan
WW@hunt-gather.com 

For investor inquiries, please contact:
John Mills or Anna Kate Heller
WeightWatchers@icrinc.com 

Commit Biologics appoints serial biotech founder as new CEO to take complement-powered immune engagers into the clinic




Commit Biologics appoints serial biotech founder as new CEO to take complement-powered immune engagers into the clinic

• Dr. Thomas L. F. Montgomery Andresen joins from T-Cypher Bio
• Follows breakthrough non-human primate data demonstrating deep B-cell depletion without cytokine release
• Commit is poised to nominate its first two clinical development candidates later in 2026

COPENHAGEN, Denmark, March 11, 2026 (GLOBE NEWSWIRE) — Commit Biologics (“Commit”), a biotechnology company pioneering complement system activation and backed by €21.5 million in seed financing from Novo Holdings, Bioqube Ventures, and Korys, today announces the appointment of seasoned biotech entrepreneur Thomas L. F. Montgomery Andresen, PhD, as Chief Executive Officer. Dr. Andresen joins at a pivotal juncture to accelerate Commit’s transition into a clinical-stage company.

Dr. Andresen is a serial biotech entrepreneur with over 20 years of experience building high-value biotech ventures at the intersection of therapeutic innovation and bioengineering. He brings a proven track record of converting scientific breakthroughs into marketable technologies and has played an instrumental role in securing substantial institutional backing to launch and scale multiple biotechnology companies across Europe and the U.S.

Dr. Andresen will officially assume his role on March 16, 2026.

Anker Lundemose, Chairman of the Board at Commit Biologics, said: “Thomas’ rare combination of deep scientific expertise and strategic leadership as a serial biotech founder makes him exceptionally qualified to lead Commit into its next phase of growth. His appointment is a defining step on our journey to deliver transformative immunotherapies and strengthens our position as a leader in complement-targeting innovation.”

Dr. Andresen, incoming CEO of Commit Biologics, said: “Commit is redefining immunotherapy by activating the complement system – one of the immune system’s most potent, yet untapped weapons. Since the turn of the century, the immunotherapy field has produced a series of breakthrough modalities, from checkpoint inhibitors to CAR-Ts and T-cell engagers. Commit is at the forefront of what I firmly believe to be the next breakthrough modality: complement-powered immune engagers. The Company’s preclinical data is outstanding, and its non-human primate data, in particular, gives me the strong conviction that these positive results will be replicated in the clinic.

“I want to thank Chief Scientific Officer Mikkel Wandahl Pedersen for his steadfast leadership as Interim CEO. Having established strong momentum and a validated platform, I look forward to working with Mikkel and the team to deliver life-changing therapies for patients.”

Commit is currently advancing a pipeline of proprietary therapeutics powered by its Bispecific Complement Engager (BiCE™) technology platform. In November 2025, the Company announced positive proof-of-concept data from a non-human primate (NHP) study, providing critical translational validation of the BiCE™ platform. Results demonstrated rapid, deep, and sustained targeted B-cell depletion without triggering systemic cytokine release – establishing solid safety and efficacy profiles and proof-of-mechanism.

Commit is poised to nominate its first two clinical development candidates (DCs) in 2026, which will address key unmet needs in autoimmune disease and oncology. These DCs lead a broader pipeline targeting strategic clinical entry points, focusing on patients with compromised T-cell function, and indications where the differentiated mechanism of action offers new high-value treatment possibilities.

Prior to joining Commit, Dr. Andresen co-founded several successful biotechs, including Flagship Pioneering-backed Torque Therapeutics, which was acquired by Repertoire Immune Medicines. Most recently, he served as founding CEO of T-Cypher Bio, an Oxford, UK-based immunotherapy company backed by LifeArc, Oxford Science Enterprises (OSE), and Medicxi.

Additionally, he was founding director of DTU Health Tech at the Technical University of Denmark (DTU). He has authored 220+ scientific papers and is a named inventor on 50+ patent families across a diverse range of therapeutic applications.

For more information please contact:

Optimum Strategic Communications
Nick Bastin, Stephen Adams, Aoife Minihan
Tel: +44 (0) 204 566 8543
Email: commit@optimumcomms.com

About Commit Biologics

Commit Biologics is a biotechnology company transforming the treatment of autoimmune diseases and cancer by activating the complement system. The company’s proprietary Bispecific Complement Engager (BiCE™) platform is producing a new class of immune engagers that directly recruit the complement cascade to target cells. BiCE™ antibodies supercharge the innate immune response, rapidly eliminating diseased cells locally without triggering systemic immune activation. With positive NHP proof-of-concept data and €21.5 million in seed financing from Novo Holdings, Bioqube Ventures, and Korys, Commit is advancing toward clinical entry and defining the next era of immune therapeutics.

About the complement system

The complement system is a powerful pillar of the innate immune system, acting as a first line of defense to identify and eliminate pathogens or damaged cells. While it is one of the body’s most effective killing mechanisms, harnessing its potential for targeted therapy represents a major frontier in immuno-engineering. Controlling this activation offers a novel therapeutic approach across autoimmune, inflammatory, and malignant diseases.

Bavarian Nordic and Serum Institute of India Expand Strategic Partnership with Chikungunya Vaccine Manufacturing Agreement




Bavarian Nordic and Serum Institute of India Expand Strategic Partnership with Chikungunya Vaccine Manufacturing Agreement

• The agreement enables a full tech transfer of the chikungunya vaccine for future supply to low- and middle-income countries.
• Expanded collaboration provides future co-development opportunities.

COPENHAGEN, Denmark, March 11, 2026 – Bavarian Nordic A/S (OMX: BAVA) today announced an expansion of the strategic partnership with Serum Institute of India Pvt. Ltd. (SII) to include a contract manufacturing agreement covering a full tech transfer of the manufacturing process for the chikungunya vaccine (CHIKV VLP) from Bavarian Nordic to SII to allow for scaling of capacity to enable future supply to endemic low- and middle-income countries (LMICs). This agreement builds on the existing mpox vaccine license and manufacturing agreement with SII, and replaces the agreement previously entered with Biological E. Limited.

In addition, through this expanded collaboration, the parties will explore potential future co-development opportunities.

“We are pleased to strengthen our strategic partnership with Serum Institute of India. By leveraging the strengths of both organizations, we can scale manufacturing of our chikungunya vaccine to expand global supply and improve access for populations around the globe,” said Paul Chaplin, President & CEO of Bavarian Nordic.

About CHIKV VLP
CHIKV VLP is a single dose, prefilled, adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination.

The vaccine does not contain viral genetic material and is therefore non-infectious and unable to cause disease, ensuring a broad range of people can benefit from vaccination.

CHIKV VLP (marketed as Vimkunya^®) has been approved by the U.S. Food and Drug Administration, the European Commission and the U.K. Medicines & Healthcare products Regulatory Agency in 2025. Regulatory review of the vaccine is ongoing in Switzerland and Canada.

About chikungunya
Chikungunya is a mosquito-borne disease caused by the chikungunya virus. In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, chikungunya has been identified in more than 110 countries¹. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years². In 2025, as of December, nearly 500,000 cases of chikungunya and over 200 associated deaths were reported worldwide³. More than half of the reported cases and associated deaths were reported from Brazil⁴. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile⁵.

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com.

About Serum Institute of India
Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer, developing life-saving vaccines against diseases including polio, measles, meningitis, rotavirus, diphtheria, tetanus, malaria, HPV, pneumonia, and COVID-19, with a mission to make affordable vaccines accessible worldwide. Present across 170+ countries, including the U.S., the UK, and Europe, SII operates one of the largest multifunctional vaccine production facilities in Manjri, Pune, with an annual capacity of 4 billion doses, contributing to saving over 30 million lives over the years. For more information, visit www.seruminstitute.com.

Contact investors:
Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com
US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03

¹ World Health Organization (WHO). Chikungunya.https://www.who.int/news-room/fact-sheets/detail/chikungunya   

² European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease.

³ European Centre for Disease Prevention and Control. Chikungunya virus disease worldwide overview. https://www.ecdc.europa.eu/en/chikungunya-monthly.

⁴ Pan American Health Organization (PAHO). Chikungunya: analysis by country.  https://www.paho.org/en/arbo-portal/chikungunya-data-and-analysis/chikungunya-analysis-country

⁵ Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701.

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• Bavarian Nordic and Serum Institute of India Expand Strategic Partnership with Chikungunya Vaccine Manufacturing Agreement