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

Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline December 24, 2025. Sanofi announced today that it has entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B®) and differentiated shingles vaccine candidate. The acquisition augments Sanofi’s presence in adult immunization by bringing together Dynavax’s vaccines w

Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year Initiation of RECOVER-2 registrational trial planned in H1 2026, subject to sufficient finan

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

Collaboration aims to accelerate the development of treatments for chronic kidney disease (CKD) and other conditions Rectify has developed oral, small molecules that can potentially reduce calcification by enhancing the activity of the ABCC6 protein, a key disease mechanism in CKD Dec. 22, 2025 -- Rectify Pharmaceuticals, Inc., (“Rectify”) a biotechnology company pioneering positive functional modulators (PFMs) that restore and enhance membrane protein function, has entered a strategic researc