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

WTX-124 initial Phase 1b expansion arm data showed 30% overall response rate as a monotherapy in a defined subset of post-ICI advanced or metastatic cutaneous melanoma patients, with potential best-in-class tolerability profile WTX-330 Phase 1b/2 trial initial data demonstrated additional evidence of antitumor activity and highly favorable tolerability profile, building upon monotherapy activity demonstrated in first-in-human Phase 1 clinical trial Additional Phase 1/1b data update for WTX-124 a

Numab to receive milestone payment Boehringer Ingelheim has advanced its novel multi-specific antibody for retinal diseases resulting from a collaboration with Numab into preclinical development Dec. 18, 2025 -- Numab Therapeutics AG (“Numab”), a biotechnology company advancing a proprietary pipeline of multi-specific antibodies in immunology and oncology, announced today that Boehringer Ingelheim has advanced its novel multi-specific antibody for the treatment of wet age-related macular degen

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

Phase 3 Development Program of Novel Selective Estrogen Receptor Modulator (SERM) Represents Potential Multi-Billion Dollar Opportunity as Treatment Option for Patients with ESR1-Mutations Financing Co-Led by Commodore Capital, Perceptive Advisors and TCGX Supports Development of Lasofoxifene through Phase 3 Clinical Topline Data Readout and Regulatory Milestones Conference Call Today at 8:30 am Eastern Time 18, 2025 -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical-stage biopharmaceutical comp