Based on the positive global Phase III MANEUVER study, the National Medical Products Administration (NMPA) has granted the world’s first regulatory approval for pimicotinib, the first domestically developed systemic therapy for the treatment of Tenosynovial Giant Cell Tumor (TGCT), to our partner Merck KGaA, Darmstadt, Germany, which holds worldwide commercialization rights Pimicotinib, a Class 1 innovative drug discovered and developed by Abbisko Therapeutics, received zero-deficiency approval

Subject enrollment expected to begin in Q1 2026 CDI-988 is the first oral broad-spectrum antiviral drug candidate for potential prevention of norovirus outbreaks and treatment of acute viral gastroenteritis caused by norovirus infection There are no approved treatments or vaccines currently available for norovirus infection Dec. 18, 2025 -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the approval from the Institutional Review Board (IRB) at Emory University S

Dec. 22, 2025 -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced the successful dosing of the first patient in the United States in the TENACITY-01 clinical trial (NCT07070219). The TENACITY-01 trial is evaluating CTD402, Imviva’s investigational allogeneic anti-CD7 CAR-T cell therapy, for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). This miles

Large, well-powered Phase 1b study, designed to generate clinically and biologically meaningful insights in early Alzheimer’s disease Clear and near-term value inflection points, with blinded 6-month interim data expected in Q2 2026 and final unblinded top-line results anticipated in Q4 2026 Dec. 18, 2025 -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics and vaccines targeting toxic misfolded p

Memo Therapeutics AG’s Potravitug Granted Orphan Designation in the European Union Orphan designation confers market exclusivity, regulatory and financial benefits for medicines intended to treat rare diseases Recognizes both medical plausibility of the initial clinical data and that potravitug targets a life-threatening or chronically debilitating condition, BKPyV infection, which affects fewer than 5 in 10,000 people 18 December, 2025 – Memo Therapeutics AG (“MTx”), a late-stage biotech compa

- Data expected in Q2 2026 - Dec. 18, 2025 -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 trial designed to evaluate th

Dec. 18, 2025 -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in the randomized, placebo-controlled Phase 2 clinical trial, the OXTOX study (Oxaliplatin Neurotoxicity study in patients with metastatic colorectal cancer). This study, an investigator-initiated clinical trial led by Dr. Janette Vardy and Dr. Harya

Dec. 19, 2025 -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary trac

The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses Dec. 19, 2025 -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal product designed to reduce exposure to airborne respiratory viruses, including influenza and cold vir

Dec. 19, 2025 -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced that the Bellberry Human Research Ethics Committee (HREC) has formally approved the use of PsyLabs’ psilocybin product (NPX5) in the Company’s ongoing Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer. Th