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").

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"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])

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])

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.

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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])

On December 23, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads reported the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program.

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Akari has selected WuXi XDC, the world’s leading ADC contract development and manufacturing organization (CDMO), as its partner for this critical and necessary IND-enabling work to support the initiation of clinical trials. WuXi XDC is globally recognized for its end-to-end ADC development and manufacturing capabilities and deep expertise in producing large numbers of ADCs that are currently in clinical development.

The initiation of this key manufacturing activity marks a significant advancement for AKTX-101, which incorporates Akari’s novel proprietary payload PH1 that works through RNA splicing modulation. The PH1 payload represents a differentiated approach to ADC design and brings a 1-2 punch of cytotoxicity and immuno-oncology action that has the potential to significantly increase the therapeutic impact of ADCs beyond today’s current options.

"Initiating GMP manufacturing of AKTX-101 is an important milestone for Akari and for AKTX-101 as we look to demonstrate the potential of our PH1 ADC payload in treating cancer patients," said Abizer Gaslightwala, President and CEO of Akari Therapeutics. "Advancing this critical project with WuXi XDC reflects our confidence in the science behind AKTX-101 and our path to the clinic. To have WuXi XDC as our key partner adds to our confidence of reaching the clinical trials quickly and efficiently and with the highest quality. This key work lays the foundation for our planned Phase 1 first-in-human study in approximately 12 months."

WuXi XDC also highlighted the importance of the collaboration with Akari and the innovative nature of Akari’s ADC payload, PH1:

"We are excited to work with Akari Therapeutics on the manufacturing of AKTX-101," said Dr. Jimmy Li, CEO of WuXi XDC. "The PH1 payload represents a novel and potentially high impact innovation in the ADC field, and we look forward to leveraging our integrated ADC platform to support the production of high-quality GMP material and help advance this promising program toward the clinic. We believe this first project with Akari could lay the groundwork for multiple ADC programs that utilize this novel payload."

Akari and WuXi XDC are building a strategic partnership around AKTX-101, combining Akari’s innovative ADC design and payload technology with WuXi’s global leadership in ADC development and manufacturing. The resulting GMP-grade drug product is intended to support Akari’s planned Phase 1 first-in-human clinical trial, which the Company expects to initiate in late 2026 or early 2027, subject to regulatory clearance.

This manufacturing milestone underscores Akari’s continued progress in advancing its pipeline and executing on its strategy to develop differentiated ADC therapies using novel payloads that have the potential to significantly improve outcomes for cancer patients.

(Press release, Akari Therapeutics, DEC 23, 2025, View Source [SID1234661605])

On December 23, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the 2026 J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PST. A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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(Press release, Bio-Techne, DEC 23, 2025, View Source [SID1234661606])