BriaCell (NASDAQ:BCTX) announced that Bria-MEL+ has passed a key genetic engineering milestone, moving the personalized whole-cell melanoma immunotherapy vaccine candidate toward potential clinical development.
Vanda Pharmaceuticals (NASDAQ:VNDA) announced that the European Commission granted orphan designation to imsidolimab for the treatment of generalized pustular psoriasis, following a positive opinion from the EMA Committee for Orphan Medicinal Products.
Scinai Immunotherapeutics (NASDAQ:SCNI) reported first-half 2026 revenue of $949 thousand, up from $773 thousand a year earlier, driven mainly by its acquired Yavne contract development and manufacturing organization operations.
Gilead Sciences (NASDAQ:GILD) announced that the European Commission approved Trodelvy (sacituzumab govitecan-hziy) combined with Keytruda (pembrolizumab) for adults with PD-L1-positive metastatic triple-negative breast cancer.
Precision BioSciences (NASDAQ:DTIL) announced that the first patient has been dosed in the Phase 1/2 FUNCTION-DMD trial evaluating PBGENE-DMD for Duchenne muscular dystrophy.
Oculis (NASDAQ:OCS) announced that the first patient has been treated in PIONEER-1, a registrational trial evaluating Privosegtor for acute optic neuritis in patients with and without multiple sclerosis.
Takeda (NYSE:TAK) announced that Japan’s Ministry of Health, Labour and Welfare approved ORZEYFUL (oveporexton) for adults with narcolepsy type 1, making it the company’s third global approval for the treatment.
Acadia Pharmaceuticals (NASDAQ:ACAD) announced that the European Commission approved DAYBU (trofinetide) for Rett syndrome in adults and pediatric patients aged five years and older, making it the first approved Rett syndrome treatment in the European Union.
Biogen (NASDAQ:BIIB) and Eisai announced that LEQEMBI IQLIK, a once-weekly subcutaneous lecanemab-irmb autoinjector, is now available in the United States for adults with early Alzheimer’s disease.
Scholar Rock (NASDAQ:SRRK) removed Catalent Indiana as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA), with FDA review continuing using an alternate facility.
Alvotech (NASDAQ:ALVO) entered a strategic licensing and commercialization agreement with Lotus Pharmaceutical covering two biosimilar candidates, AVT34 and AVT87, with potential value of approximately $150 million.
Milestone Pharmaceuticals (NASDAQ:MIST) enrolled the first patient in ReVeRA-301, a pivotal Phase 3 trial evaluating etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR).
