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Italfarmaco and JCR Pharmaceuticals Announce Commercialisation Agreement for Givinostat in Japan and Strategic Collaboration in Rare Disease

On December 24, 2025 Italfarmaco S.p.A. and JCR Pharmaceuticals Co., Ltd. (TSE 4552; "JCR"), reported an exclusive licensing agreement for the development and commercialisation of givinostat in Japan.

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Under the terms of the agreement, JCR receives exclusive rights to commercialise givinostat for the treatment of Duchenne muscular dystrophy (DMD) in Japan and will be responsible for the local execution of clinical development activities, as well as regulatory submissions.

Givinostat (marketed as Duvyzat in the US, UK and EU) is an orally administered histone deacetylase inhibitor developed by Italfarmaco to treat DMD, regardless of the underlying dystrophin gene mutation. It has obtained regulatory authorisation across several major markets, including the US, EU and the UK; it is currently not approved in Japan.

The agreement also establishes a broader strategic collaboration between the two companies to explore joint opportunities for the treatment of rare diseases.

"This partnership is a key milestone in our global strategy to expand access to givinostat and deepen our impact in rare diseases," said Antonio Nardi, Vice President and Head of Business & Portfolio Development of Italfarmaco. "JCR’s commitment to innovation, strong local expertise, and focus on patient-centred science make them an ideal partner for the expansion of our rare disease portfolios, not only in Japan, but also globally."

"Partnering with Italfarmaco is an important step for JCR as we enter the next phase of our growth and may be the first step in a long-lasting relationship between both companies that may extend into future research and development partnerships and cross-licensing opportunities," said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals. "We remain dedicated to developing therapies for the rare disease community, and givinostat extends this commitment to an even broader group of patients with rare diseases in Japan."

Francesco De Santis, Chairman of Italfarmaco Group, added: "By joining forces with JCR, we are expanding access to an important DMD therapy for the Japanese Duchenne community and also laying the groundwork for future innovations in rare diseases. Together, we are committed to delivering meaningful solutions where they are needed most."

About Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy (DMD) is a rare, progressive neuromuscular disorder caused by mutations in the dystrophin gene. These mutations prevent the production of functional dystrophin, causing the dystrophin-associated protein complex (DAPC) to break down. This makes muscle fibres more vulnerable to damage and increases histone deacetylase (HDAC) levels in the muscle cells, blocking the activation of important genes needed for muscle maintenance and repair. As a result, muscle fibres experience ongoing damage, leading to chronic inflammation and poor regeneration. Over time, muscle cells die and are replaced by scar tissue and fat.1-4 DMD primarily affects males, with symptoms typically appearing between the ages of two and five years. As the condition progresses, muscle weakness worsens, leading to difficulty walking and eventually loss of ambulation. Over time, the heart and respiratory muscles are also affected, which are the leading causes of premature death.5 DMD is one of the most severe and common forms of childhood muscular dystrophy, with a global birth incidence of approximately 1 in 5,050 boys.6 DMD affects an estimated 3,500 patients in Japan.7

About Givinostat
Givinostat (Duvyzat) was discovered through Italfarmaco’s research and development efforts in collaboration with Telethon and Duchenne Parent Project (Italy). Givinostat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. Givinostat’s mechanism of action inhibits HDAC pathological overactivity in an effort to address the cascade of events leading to muscle damage, thereby counteracting the disease pathology and slowing down muscle degeneration.

(Press release, Italfarmaco, DEC 24, 2025, View Source [SID1234661624])

Repare Therapeutics Announces Acquisition of Polθ ATPase Inhibitor, RP-3467, by Gilead Sciences for Up To $30 Million in Total Consideration

On December 24, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported a definitive asset purchase agreement for Gilead Sciences, Inc. to acquire Repare’s polymerase theta (Polθ) ATPase inhibitor, RP-3467 (the "Gilead Agreement").

"We are pleased to announce this transaction which combines Gilead’s leading expertise in oncology research and development with RP-3467, a potential best-in-class Polθ ATPase inhibitor," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "This marks the third and most significant portfolio transaction for Repare this year."

Under the terms of the Gilead Agreement, Repare will receive up to $30 million in total consideration, including a $25 million upfront payment, subject to customary holdbacks and adjustments, and an additional $5 million payment upon completion of specified technology transfer activities.

On November 14, 2025, Repare announced that it had entered into a definitive arrangement agreement (the "Arrangement Agreement") with XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly, "Xeno"), pursuant to which Xeno will acquire (the "Arrangement Transaction") all of the issued and outstanding common shares of Repare (the "Common Shares"). Under the terms of the Arrangement Agreement, Repare shareholders will receive a cash payment per Common Share that will be determined based upon Repare’s cash balance at closing of the Arrangement Transaction (the "Arrangement Closing") after deducting certain transaction costs and the aggregate amount of outstanding liabilities (the "Closing Net Cash Amount").

The upfront portion of the consideration payable under the Gilead Agreement has increased Repare’s cash balance and, therefore, has also increased the estimated Closing Net Cash Amount. Based on Repare’s revised estimate of the Closing Net Cash Amount, it is now currently estimated that each Repare shareholder will receive a cash payment of approximately US$2.20 per Common Share at the Arrangement Closing.

About RP-3467.

RP-3467 is a highly potent, small molecule inhibitor of Polθ that is a synthetic lethality target associated with BRCA mutations and other genomic alterations. RP-3467 is being evaluated in the POLAR Phase 1 clinical trial to evaluate its safety, pharmacokinetics, pharmacodynamics and preliminary activity alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer or pancreatic adenocarcinoma.

(Press release, Repare Therapeutics, DEC 24, 2025, View Source [SID1234661623])

Sanofi to Acquire Dynavax, Adding a Marketed Adult Hepatitis B Vaccine and Phase 1/2 Shingles Candidate to the Pipeline

On December 24, 2025 Sanofi reported that it has entered into an agreement to acquire Dynavax Technologies Corporation (Nasdaq: DVAX), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B) and a differentiated shingles vaccine candidate. The acquisition augments Sanofi’s presence in adult immunization by bringing together Dynavax’s vaccines with Sanofi’s global scale, development capabilities and commercial reach.

Dynavax’s adult hepatitis B vaccine HEPLISAV-B is currently marketed in the US and is differentiated by its two-dose regimen over one month, which enables high levels of seroprotection faster than other hepatitis B vaccines, which are given in three doses over six months.

The acquisition also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in phase 1/2 clinical development, and additional vaccine pipeline projects.

"Dynavax enhances Sanofi’s adult immunization presence by adding differentiated vaccines that complement Sanofi’s expertise," said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. "Its marketed adult hepatitis B vaccine and shingles candidate bring new options to our portfolio and underscore our commitment to providing vaccine protection across the lifespan."

"Joining Sanofi will provide the global scale and expertise needed to maximize the impact of our vaccine portfolio," said Ryan Spencer, Chief Executive Officer, Dynavax. "We believe Sanofi’s commercial reach, development capabilities and commitment to evidence-based immunization will amplify the opportunity for HEPLISAV-B and our innovative pipeline to address important public health needs, further advancing our mission to help protect the world against infectious disease. We are confident that this transaction – and the compelling value it provides – is in the best interests of the Company and its stockholders."

Dynavax believes hepatitis B and shingles represent a significant public unmet health need and adult vaccination opportunities. In the US alone, nearly 100 million adults born before 1991 remain unvaccinated, with many potentially at risk for infection. Chronic infection with the hepatitis B virus can cause liver damage and lead to cirrhosis and liver cancer. Shingles, which is caused by the varicella zoster virus, affects one in three adults over their lifetime, according to the World Health Organization. In most people shingles causes a painful, itchy rash, but in some cases it can lead to long-term nerve pain, serious eye infections that can damage the vision and, rarely, dangerous inflammation of the brain.

Financial considerations
Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax for $15.50 per share in cash, reflecting a total equity value of approximately $2.2 billion.

The offer price represents a premium of approximately 39% over the closing price of Dynavax on December 23, 2025 and a premium of approximately 46% over the 3-month volume-weighted average price (VWAP) of Dynavax as of December 23, 2025.

The transaction has been unanimously approved by the Dynavax board of directors. The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Dynavax common stock that represent at least a majority of the outstanding shares of Dynavax common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, certain foreign regulatory filings and clearances and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer.

Sanofi plans to fund the acquisition with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close in the first quarter of 2026.

Centerview Partners LLC and Goldman Sachs & Co. LLC are acting as financial advisors to Dynavax, and Cooley LLP is acting as its legal counsel.

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s vaccine adjuvant, a toll-like receptor (TLR) 9 agonist, to enhance the immune response.

HEPLISAV-B is a shot given to adults 18 years of age and older to help prevent infection caused by the hepatitis B virus. HEPLISAV-B is usually given in the arm muscle. HEPLISAV-B is given in two doses, one month apart, by a healthcare provider.

IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).

There are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals. Available data, primarily in individuals who received one dose of HEPLISAV-B in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage.

It is not known whether HEPLISAV-B is excreted in human milk.

Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.

Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients.

(Press release, Sanofi, DEC 24, 2025, View Source [SID1234661622])

Nona Biosciences Expands Integrated Discovery-to-Clinical Capabilities Through Strategic Platform Growth

On December 23, 2025 Nona Biosciences, a global biotechnology company advancing biotherapeutic discovery through innovative technology platforms, reported the expansion of its integrated discovery and development framework to support early clinical development and Investigator-Initiated Trials (IITs). This expansion extends Nona’s capabilities beyond discovery and IND-enabling activities to further strengthen CMC development, toxicology, and GMP manufacturing capabilities. Through strategic partnerships, platform acquisitions, and internal technology innovations, Nona will enable global biopharmaceutical companies to accelerate the clinical trial initiation with rigorous scientific and quality standards.

The expanded framework builds upon Nona’s proprietary platforms, including Harbour Mice, HBICE, Hu-mAtrIx, NonaCarFx, and Modalities-on-Demand and integrates strengthened preclinical and early clinical development capabilities across CMC development, toxicology, and clinical operation. By leveraging extensive partnerships in China and advancing of IITs, Nona enables global biopharmaceutical partners to access established infrastructure and operational efficiency. This approach facilities faster clinical trial initiation while maintaining high standards of global development and regulatory compliance.

"Expanding Nona’s technology platforms and capabilities from antibody discovery to early clinic development represents a natural progression of our strategic vision," said Dr. Di Hong, Chief Executive Officer of Nona Biosciences. "By combining our proprietary platforms with strategic external collaborations and internal development efforts, we are strengthening our ability to enable efficient clinical translation while remaining focused on building differentiated, scalable technologies."

With extensive experience spanning more than 300 discovery programs and a growing portfolio of clinically validated platforms, Nona Biosciences continues to advance the future of biologic innovation as a technology-centric company—empowering partners to progress efficiently from discovery through early clinical development using integrated, high-performance platforms.

(Press release, Nona Biosciences, DEC 24, 2025, View Source [SID1234661621])

Co-PSMA abstract accepted for oral presentation at EAU Annual Congress 2026

On December 24, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the acceptance of an abstract on the Co-PSMA (NCT06907641)1 Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent’s Hospital Sydney, for oral presentation at the upcoming European Association of Urology (EAU) Congress 2026, Europe’s biggest urological conference, to be held 13-16 March 2026 in London, UK2.

Co-PSMA’s official study title is "Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". This Phase II IIT evaluated the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to standard-of-care (SOC) 68Ga-PSMA-11 in 50 patients with low prostate-specific antigen (PSA) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.

The results to be presented by Prof Emmett at the EAU Congress 2026 will expand on the earlier findings that the trial met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) detected significantly more lesions per patient than the SOC, 68Ga-PSMA-11 PET/CT3. These results further build on the growing body of evidence showing that 64Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, especially in patients with low PSA levels4,5.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "64Cu-SAR-bisPSMA has been purposely developed at the benchtop to overcome the many shortfalls of the current SOC PSMA imaging agents. With the molecule only being invented some 7 years ago, we have already demonstrated at the cellular level, in animal models and now in multiple clinical trials, that 64Cu-SAR-bisPSMA is clearly differentiated from the competitors. In a very short amount of time, we have moved from invention to two registrational Phase III trials, both to complete recruitment next year, continuing to build on strong evidence generated to date of the improved diagnostic performance of our product through various clinical trials and real-world evidence (compassionate use supply). We reported earlier that our optimised agent detects more lesions in this IIT head-to-head comparison against the SOC product3. We also know that 64Cu-SAR-bisPSMA identifies more as well as smaller lesions and was able to do so earlier than SOC PSMA PET agents in our Phase II COBRA trial6. The full results from Co-PSMA will again reinforce the mounting data showing how 64Cu-SAR-bisPSMA can outperform SOC PSMA PET products.

"We are committed to a rigorous scientific and clinical development process, which has delivered exceptional results to date. The acceptance of the Co-PSMA data by this world-leading urology conference for an oral presentation is a testament to its strength and quality. This recognition not only highlights the impact of this research but also underscores the significant potential of 64Cu-SAR-bisPSMA to advance PSMA imaging and improve prostate cancer management. The abstract summary will be announced in mid-February, followed by the oral presentation in mid-March 2026.

"Prof Emmett is a global key opinion leader in the field of urologic nuclear medicine, with a strong track record of highly regarded scientific publications as well as extensive clinical experience. We are honoured to continue working together on our registrational AMPLIFY7 and CLARIFY8 trials and trust that her unique expertise and commitment to providing the best available patient care will help us to get closer to our mutual goal of improving detection and treatment paradigm for prostate cancer patients.

"With two US Food and Drug Administration (FDA) Fast Track Designations for 64Cu-SAR-bisPSMA and two ongoing registrational trials, we are extremely excited to enter the USD 2 billion PSMA PET imaging market as it is further expected to grow to over USD 3 billion by 2029 with not only a clearly differentiated agent, but also a product with substantial logistical benefits over the current competitors."

(Press release, Clarity Pharmaceuticals, DEC 24, 2025, View Source [SID1234661608])