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

Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals Dec. 22, 2025 -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the first patient has

Dec. 22, 2025 -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides and proteins replacement therapies, today announced new validating in vivo pharmacokinetic and pharmacodynamic data that supports further development of a proprietary long-acting parathyroid hormone (PTH) analog using its N-Tab® platform to create the first once-daily tablet treatment for patients with hypoparathyroidism (EB612 program). The positive preclinical findings sh

Dec. 23, 2025 -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track des

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