Palvella Therapeutics (NASDAQ:PVLA) said the U.S. Food and Drug Administration has granted Fast Track Designation to QTORIN 3.9% rapamycin anhydrous gel for treating angiokeratomas, a dermatologic condition with no currently approved therapies.
Nektar Therapeutics (NASDAQ:NKTR) reported mixed Phase 2b results for rezpegaldesleukin in severe-to-very-severe alopecia areata, showing meaningful clinical activity but narrowly missing the trial’s primary endpoint in the modified intent-to-treat population.
Organigram Global (NASDAQ:OGI), Canada’s leading recreational cannabis producer, reported record fourth-quarter and full-year results for the period ended September 30, 2025.
Bicycle Therapeutics (NASDAQ:BCYC), developer of a novel class of bicyclic peptide-based medicines, has secured a 15-year contract with the UK Nuclear Decommissioning Authority granting access to up to 400 tonnes of reprocessed uranium (RepU)—a resource the company says will underpin long-term production of lead-212 (212Pb) for its emerging cancer radioconjugate programs.
Organogenesis (NASDAQ:ORGO) has secured FDA confirmation to initiate a rolling Biologics License Application for ReNu, its knee osteoarthritis treatment, with submission set to begin before year-end 2025.
Aldeyra Therapeutics (NASDAQ:ALDX) said the U.S. Food and Drug Administration has extended the PDUFA target action date for its reproxalap New Drug Application (NDA) for dry eye disease to March 16, 2026, adding roughly three months to the original timeline.
Palvella’s (NASDAQ:PVLA) topical rapamycin gel improved lesions in most patients and showed a favorable safety profile, supporting upcoming FDA discussions on Breakthrough designation and Phase 3 development.
Greenwich LifeSciences (NASDAQ:GLSI) announced an approximately 80% reduction in recurrence rates from a preliminary analysis of the 250-patient open-label arm of its Phase 3 FLAMINGO-01 breast cancer immunotherapy trial, GLSI-100.
Kyverna’s (NASDAQ:KYTX) miv-cel posts robust efficacy and manageable safety in the KYSA-8 trial, paving the way for a planned 2026 BLA filing.
Argenx (ARGX) announced the discontinuation of its Phase 3 UplighTED studies for efgartigimod SC in Thyroid Eye Disease (TED) after an interim analysis by an Independent Data Monitoring Committee (IDMC) indicated futility.
Royal Philips announced an agreement to acquire SpectraWAVE, a Boston-area medical device company, integrating its advanced HyperVue imaging and AI-enabled FFR technology into Philips’ image-guided therapy suite.
Natera (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, and MEDSIR (Medica Scientia Innovation Research), a global leader in oncology research, today announced their collaboration on the MiRaDoR (NCT05708235) study.
