On December 9, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on the announcement by Shanghai Henlius Biotech, Inc. that applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (an antibody-drug conjugate targeting HER2) have been approved by China’s National Medical Products Administration (NMPA). The trials are intended for first-line treatment of HER2-positive breast cancer and for neoadjuvant treatment of HER2-positive breast cancer.

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HLX22 is an anti-HER2 monoclonal antibody being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"Shanghai Henlius regulatory approvals to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer represent continued progress for this programme and broaden its clinical development," said Søren Bregenholt, CEO of Alligator Bioscience. "While Alligator is not directly involved in the development, we follow HLX22 closely as it represents an opportunity for future revenue streams from milestones and royalties upon potential approval."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius. For further information and the latest updates on HLX22’s clinical development, please refer to Henlius’ announcement available on HKEXnews.

(Press release, Alligator Bioscience, DEC 9, 2025, View Source [SID1234661305])

On December 8, 2025 Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, reported its entry into a definitive agreement to acquire Bluejay Therapeutics, a privately held biotechnology company focused on viral and liver diseases. The transaction would add worldwide rights to brelovitug, a late-stage, fully human monoclonal antibody with Breakthrough Therapy and PRIME designations for chronic hepatitis delta virus (HDV) to Mirum’s portfolio of rare liver programs. This acquisition is expected to advance Mirum’s leadership in rare disease, build on its deep expertise in rare liver disorders and add a fourth potential registrational readout for the company over the next 18 months.

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Brelovitug is being evaluated in the AZURE Phase 3 registrational program for HDV, the most severe form of viral hepatitis. HDV occurs in people already infected with hepatitis B; nearly half of those affected progress to liver-related death within 10 years of diagnosis due to rapid progression to fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer. In Phase 2 studies, brelovitug demonstrated strong antiviral activity in HDV, achieving 100% HDV RNA response, along with improvements in liver enzyme levels and a favorable safety profile, with the most common adverse event being injection-site erythema. The ongoing global AZURE Phase 3 program is currently enrolling patients, with top-line data expected in 2H 2026 and potential BLA submission and launch in 2027.

"This acquisition fits squarely with what we do best – advancing high-impact medicines for patients with rare diseases through disciplined development, regulatory innovation, and commercial excellence," said Chris Peetz, Chief Executive Officer of Mirum Pharmaceuticals. "Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and LIVMARLI programs. The Bluejay team has done commendable work advancing brelovitug to this stage and we look forward to building on that progress to bring this important new treatment to people living with HDV."

"Bluejay was founded to develop transformative therapies for people with viral and liver diseases and, working with regulatory agencies, such as the FDA and the European Medicines Agency, the Bluejay team developed brelovitug from clinical development candidate to global Phase 3 trial in four years," said Keting Chu, Founder and CEO of Bluejay Therapeutics. "Brelovitug has the potential to redefine HDV treatment, and Mirum’s rare disease leadership, commitment to rare liver communities and commercialization expertise make it the right company to carry this program forward globally."

Under the terms of the definitive agreement, Mirum has agreed to acquire all outstanding shares of Bluejay for $250 million in cash and $370 million in Mirum common stock, plus potential tiered sales-based milestone payments of up to $200 million in cash. The Mirum common stock issued to the Bluejay security holders at closing will be priced at $71.2085 per share. Mirum has also entered into a definitive agreement with a syndicate of existing and new healthcare investors, for the sale of Mirum common stock and, to certain investors, in lieu of Mirum common stock, pre-funded warrants, in a private placement. The private placement is expected to close concurrently with the acquisition and result in gross proceeds to Mirum of approximately $200 million before deducting placement agent and other offering expenses. The proceeds from the private placement are intended to fund clinical development and commercial activities following the proposed acquisition. The Mirum common stock issued to the private placement investors at closing will be priced at $68.48 per share (or $68.4799 per pre-funded underlying share of Mirum common stock, which equals the purchase price per share of Mirum common stock, less the $0.0001 per share exercise price of each pre-funded warrant). The transaction with Bluejay has been approved by the Boards of Directors of both companies and is expected to close in the first quarter of 2026, subject to regulatory approval and other customary closing conditions.

Beyond brelovitug for HDV, Mirum will evaluate strategic options for Bluejay’s additional investigational programs after close.

Morgan Stanley & Co. LLC acted as exclusive financial advisor to Mirum, and Cooley LLP served as legal counsel. Centerview Partners LLC acted as financial advisor to Bluejay, and Latham & Watkins LLP served as legal counsel. J.P. Morgan Securities LLC also provided financial advice to Bluejay. Mirum has engaged Morgan Stanley & Co. LLC, Leerink Partners LLC, Cantor Fitzgerald & Co., Raymond James & Associates, Inc. and Citizens JMP Securities, LLC as placement agents for the private placement.

Mirum to Host Conference Call

Mirum will host a conference call today, December 8, 2025 at 8:30 a.m. ET/5:30 a.m. PT, to provide further details on the transaction. Join the call using the following information:

United States/Toll-free: +1 833 470 1428
International: +1 646 844 6383
Access code: 490519
You may also access the call via webcast by visiting the Events & Presentations section on Mirum’s website. A replay of this webcast will be available for 30 days.

(Press release, Mirum Pharmaceuticals, DEC 8, 2025, View Source [SID1234661303])

On December 8, 2025 Agora Open Science Trust reported the nomination of M4K2009 as the lead development candidate for its M4K Pharma program, which applies open science to drive the development of an affordable treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare and devastating pediatric brain cancer. Nominating a lead development candidate marks the point where a discovery program selects a single molecule with the highest potential to advance further towards human clinical trials. The selection of M4K2009 represents a significant scientific and organizational milestone.

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The nomination follows an extensive, multi-year research collaboration with several academic and industry partners worldwide. Among the hundreds of compounds designed and evaluated, M4K2009 demonstrated excellent potency, selectivity, brain penetration, and tolerability in preclinical models, establishing it as a strong candidate for further development.

"Our nomination of M4K2009 represents an important milestone for open science drug discovery," said Max Morgan, CEO of Agora Open Science Trust. "By pooling resources, foregoing patents and secrecy, and instead working openly and collaboratively across institutions with complementary capabilities and expertise, our team has now shown that open science is capable of delivering high-quality, clinically viable candidates, particularly in areas of market failure underserved by traditional proprietary approaches."

With financial and in-kind support from the Krembil Foundation, Conscience’s Developing Medicines through Open Science (DMOS) program, OICR’s Cancer Therapeutics Innovation Pipeline (CTIP), Charles River Laboratories, Structural Genomics Consortium, Institute of Cancer Research, University of Pennsylvania, Montreal Children’s Hospital/McGill University, CAMH, Children’s Cancer Institute, Sant Joan de Deu Hospital, Reaction Biology, GL Chemtec and The Brain Tumour Charity, M4K Pharma has made critical strides toward realizing an affordable, first-in-class therapy for children affected by DIPG.

Conscience’s DMOS program, which is supported by a grant from the Government of Canada’s Strategic Innovation Fund, enables collaborative preclinical drug discovery in areas where open sharing and collaboration are key to advancement towards accessible treatments, such as rare and neglected diseases. Participating projects which include at least one Canadian SME, use an open science approach as they foster collaboration for pre-clinical work, demonstrate early proof-of-concept research, and ultimately translate innovation into affordable medicine and better health outcomes globally. The inaugural round of the program launched in February 2025, with the Agora Open Science Trust as one of the recipients.

"M4K Pharma’s lead development candidate nomination represents a significant step in advancing the program toward the clinical stage and demonstrates that an open science approach can bring us closer to meaningful treatments for rare diseases like DIPG," says Anne Fortier, VP drug discovery and development at Conscience. "Through the DMOS program, we’re proud to support rigorous, collaborative work that helps make therapies more accessible and affordable, particularly in areas where few solutions currently exist."

"Canada is proud to support open science collaborations that deliver real hope for children and families facing rare diseases like DIPG. The nomination of M4K2009 as a lead candidate reflects the power of Canadian innovation and partnership. By accelerating the development of affordable and accessible therapies, we are not only advancing research, but strengthening our position as a global leader in health innovation for the benefit of all Canadians," said The Honourable Mélanie Joly, Minister of Industry and Minister responsible for Canada Economic Development for Quebec Regions.

By sharing data and results with the research community and firmly committing to Agora’s charitable mission of achieving affordable access for affected children, the M4K Pharma program has been successful in motivating and aligning a broad range of contributors. The program has crowdsourced inputs from leading experts and reduced costs and duplication of effort across ALK2 drug discovery research for DIPG, and demonstrated that open science can achieve breakthroughs in areas that traditional, closed models often overlook.

(Press release, M4K Pharma, DEC 8, 2025, View Source [SID1234661302])

On December 8, 2025 Abcuro, Inc., a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic, reported interim data from the ongoing Phase 1/2 clinical trial evaluating ulviprubart (ABC008) in patients with T cell large granular lymphocytic leukemia (T-LGLL) with anemia and/or neutropenia, in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025 in Orlando, Florida.

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Ulviprubart is a potentially first-in-class, potent, monoclonal antibody targeting KLRG1, a novel mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. Ulviprubart was designed to target KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

"The data presented at ASH (Free ASH Whitepaper) continue to support the potential of ulviprubart to selectively target and deplete highly differentiated T cells that drive debilitating diseases like T-LGLL. At the interim analysis, ulviprubart had an acceptable safety profile and was generally well tolerated across ascending doses, further supporting ulviprubart’s potential in treating patients with T-LGLL," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro.

T-LGLL is a hematological cancer driven by pathogenic expansion of immune cells that are frequently KLRG1+, resulting in neutropenia and anemia. Neutropenia can lead to frequent infections, a major cause of premature death in patients with T-LGLL, while anemia results in transfusion dependence in approximately one-third of patients.

Key Highlights from Oral Presentation:

The Phase 1/2 clinical trial (NCT05532722) is an open label, ascending dose study of ulviprubart patients with T-LGLL. The primary objective is to evaluate safety and tolerability. Secondary objectives include evaluating initial efficacy and pharmacokinetic/pharmacodynamic (PK/PD) profile of ulviprubart.

As of the data cut-off date of November 15, 2025:

21 patients were enrolled and evaluable for safety. 95% (n=20) of patients had neutropenia and 57% (n=12) of patients had anemia at baseline.
62% (n=13) of patients achieved >12 weeks of Q4W dosing on ulviprubart.
Among evaluable patients, seven experienced sustained depletions of >50% of CD8+ CD57+ KLRG1+ T cells at two or more consecutive visits. Three patients experienced sustained depletions of >90% of both CD8+ CD57+ KLRG1+ T cells and the CD8+ CD57+ parent population.
Among evaluable patients, all had neutropenia and nine patients had anemia at baseline.
With treatment, seven patients had a neutropenia response, defined as an absolute neutrophil count (ANC) increase of ≥50% from baseline for ≥4 weeks or ANC levels ≥1000 cells/µL for ≥4 weeks.
With treatment, two patients had an anemia response, defined as hemoglobin increased ≥1 g/dL for ≥4 weeks and not attributable to transfusion or growth factor.
Overall, ulviprubart was well tolerated at increasing doses and had an acceptable safety profile. Most treatment-related treatment-emergent adverse events (TEAE) were mild or moderate in severity. One patient experienced a Grade 3 infusion-related reaction, the only serious treatment-related TEAE observed on therapy.

About Ulviprubart
Ulviprubart (ABC008) is potentially a first-in-class, potent, monoclonal antibody targeting KLRG1, a novel proposed mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. KLRG1 is a cell surface receptor predominantly expressed on highly differentiated T cells, while moderately or minimally expressed on other immune cells. Ulviprubart was designed to selectively deplete KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

(Press release, Abcuro, DEC 8, 2025, View Source [SID1234661301])

On December 8, 2025 Cellarity, a clinical-stage biotechnology company developing Cell State-Correcting therapies through integrated multi-omics and AI modeling, reported the presentation of new preclinical data on investigational programs for sickle cell disease (SCD) and myelofibrosis (MF) during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Cellarity has created a novel approach to drug discovery that focuses on understanding the holistic cell state. The Company’s advanced platform leverages high-dimensional transcriptomics and AI predictive algorithms to discover new biological pathways and to create novel, oral therapeutics that can effectively and safely switch disease mechanisms to healthy cell function, termed as "Cell State-Correcting." This has resulted in a growing pipeline of differentiated drug candidates, with the first now in clinical development for sickle cell disease.

"Cellarity’s novel platform is fueling meaningful progress, enabling us to explore a broad set of indications across several therapeutic areas. We are advancing our lead asset in sickle cell disease, CLY-124, currently in phase 1 clinical development, while also progressing a second hematology program focused on myelofibrosis in the preclinical stage," said Ted Myles, Chief Executive Officer of Cellarity. "Together, these efforts reinforce the strength of our platform approach and commitment to delivering highly innovative, novel therapies to patients."

"The presentations at ASH (Free ASH Whitepaper) underscore the power of Cellarity’s novel pipeline of potentially transformative programs in hematology, addressing significant unmet medical need in sickle cell disease and myelofibrosis. CLY-124 has the potential to transform the standard of care in sickle cell disease, as we believe it may induce fetal hemoglobin through a pathway that avoids cytotoxicity that limits other approaches," said Cameron Trenor, M.D., Chief Medical Officer of Cellarity. "In myelofibrosis, we have identified new candidates that are highly selective in targeting pathways implicated in mutant JAK2 signaling, which may result in the avoidance of anemia that is a common side effect associated with other therapies."

CLY-124: A first-in-class, oral globin-switching therapy for sickle cell disease
SCD is a devastating inherited disease involving sickle-shaped red blood cells that block blood vessels. Research has demonstrated that increasing fetal hemoglobin (HbF) reduces vaso-occlusive crises (VOCs), pain and organ damage, yet most compounds that increase HbF are limited by cytotoxicity and highly variable patient response. Using its integrated discovery platform, Cellarity evaluated hemoglobin regulation through erythropoiesis to predict chemical compounds that could enrich fetal hemoglobin, identifying high levels of HbF induction associated with neddylation inhibition. This led to the identification of Defective in Cullin Neddylation 1 (DCN1) – a previously unexplored target for globin gene switching. Knockout of DCN1 in vitro led to increased expression of gamma globin genes (HBG1/2) and a higher ratio of fetal vs total globin gene expression with no evidence of cytotoxicity, illustrating a potentially safer globin-switching mechanism.

CLY-124 is being developed as a potent DCN1 inhibitor with optimized pharmacology and pharmacokinetic properties. Preclinical evaluation of CLY-124 demonstrated superiority to hydroxyurea in both fetal hemoglobin protein and globin gene ratios (HBG1/2 over total beta-like globin transcripts), approaching levels reported for recent gene therapy programs. Further, pre-clinical combination studies demonstrated robust synergistic effects when combining CLY-124 with hydroxyurea and with no dose-limiting toxicities. CLY-124 is currently progressing through a phase 1 dose escalating study in healthy volunteers and adults with sickle cell disease.

Selective targeting of mutant JAK2 to address myelofibrosis
Myelofibrosis is a blood cancer caused by mutated gene called JAK2V617F (JAK2) in stem cells within the bone marrow, causing fibrosis, inflammation, and dysfunctional blood cells that lead to anemia, enlargement of the spleen and eventual bone marrow failure. Current JAK2 inhibitor therapies like ruxolitinib manage disease symptoms but are limited by dose because they inhibit both healthy and mutant JAK2 signaling resulting in cytopenias.

Cellarity leveraged high-dimensional transcriptomics from patient samples to map gene signatures uniquely associated with JAK2-mutant hematopoietic stem cells. Through its AI-powered, transcriptomic-driven discovery platform and iPSC (induced pluripotent stem cell)-based disease models, the company identified a novel, druggable biological target and small molecule interventions that selectively suppress the JAK2-mutant clone while sparing normal hematopoiesis.

(Press release, Cellarity, DEC 8, 2025, View Source [SID1234661300])