Phase 3 trial

Moleculin Biotech releases CEO update on Phase 3 MIRACLE trial evaluating Annamycin for relapsed/refractory acute myeloid leukemia, with enrollment progressing on schedule.

Minerva Neurosciences reported $293.4M FY2025 net loss, largely from non-cash charges. The biotech secured $80M funding and plans Phase 3 roluperidone trial launch in Q2 2026.

$VERX surges 6.3% after kidney drug povetacicept achieves Phase 3 trial success with 52% proteinuria reduction, positioning FDA approval by year-end.

Celcuity's gedatolisib achieved 76% risk reduction in advanced breast cancer with PIK3CA wild-type mutations; FDA Priority Review decision expected July 2026.

Roche's giredestrant failed to meet primary endpoint in Phase 3 breast cancer trial, causing 5% stock decline. Company plans adjuvant trial readout in 2027.

Dianthus Therapeutics will present interim responder analysis from Phase 3 CAPTIVATE trial of claseprubart for CIDP treatment on March 9, 2026.

MAIA Biotech secures $30M funding and FDA Fast Track designation for ateganosine cancer therapy, with Phase 2 data showing 17.8-month median survival.

Nxera Pharma seeks South Korean approval for insomnia drug daridorexant, already marketed globally, with expected 2027 regulatory decision.

Pomerantz Law Firm investigates Aardvark Therapeutics after Phase 3 trial pause over cardiac safety issues. Stock crashed 56.2% to $5.47.

MAIA Biotechnology launches underwritten public offering of common stock and pre-funded warrants to fund clinical trials for its lead cancer therapy ateganosine.

United Therapeutics ($UTHR) stock rallies 3.98% after Phase 3 trial shows ralinepag reduces PAH worsening 55%, with FDA filing targeted for mid-2026.

Bristol Myers Squibb's experimental breast cancer drug showed survival improvements in advanced patients, though stock declined slightly following the announcement.

argenx's VYVGART met its primary endpoint in a Phase 3 ocular myasthenia gravis trial, showing significant symptom improvements. The company plans FDA approval for label expansion.

Pfizer's Braftovi receives full FDA approval for treating BRAF-mutated metastatic colorectal cancer when combined with cetuximab and chemotherapy, based on Phase 3 trial data.

FDA approves Dupixent for allergic fungal rhinosinusitis in patients six and older, marking the drug's ninth indication for treating type 2 inflammatory conditions.

Viking Therapeutics poised for growth as obesity drug market expands to $100 billion by decade's end. VK2735's Phase 3 success could establish the company as a key competitor.

Takeda stock fell 0.64% despite positive Phase 3 results for Entyvio in pediatric ulcerative colitis, with 47.3% of patients achieving clinical remission.

FDA approves first all-oral combination therapy for untreated chronic lymphocytic leukemia. The fixed-duration treatment showed 35% reduced progression risk versus chemotherapy.

Eli Lilly's Omvoh shows durable three-year remission in Crohn's disease, with 92.4% of patients maintaining clinical remission and reduced hospitalizations compared to placebo.

Merck's RSV antibody Enflonsia shows positive Phase 3 results, supporting FDA expansion plans to protect more at-risk infants from respiratory syncytial virus infection.