Every SEC filing and newswire release that matters: FDA decisions, trial readouts, and financing events across the 714-stock universe. Updated as of 2026-09-22.
Positive VK2735 maintenance-study topline: 22% placebo-adjusted weight loss at Week 33 (17.5 mg weekly, no plateau); EOW dosing retained 97% of Week 21 loss, monthly 90% vs 61% placebo; GI AE rates similar to placebo
Positive Ph3 FUSION topline: ulefnersen met primary endpoint (joint-rank functional impairment + survival, p=0.0005) in FUS-ALS; first treatment to target the genetic cause of FUS-ALS and show disease-modifying potential; Ionis/Otsuka to discuss expedited regulatory pathways with FDA
FDA final approval of BRAVNETSA (lutetium Lu 177 dotatate) for SSTR-positive GEP-NETs; first radioligand therapy approved via ANDA pathway; FDA-determined bioequivalent and therapeutically equivalent to LUTATHERA
FDA granted Priority Review to ARIKAYCE sNDA for full approval in MAC lung disease (Ph3b ENCORE met primary RSS + secondary culture conversion endpoints); PDUFA target Jan 28, 2027; Japan PMDA review planned Q4 2026
Positive Phase 2b AMPLIFIED results for inaxaplin 45mg QD in AMKD: -42.7% UACR at Wk13 in modest-proteinuria cohort (N=22), -17.3% in T2D cohort (N=17); safe, no inaxaplin-related SAEs; AMPLITUDE Phase 2/3 fully enrolled, interim analysis data early 2027 (could support accelerated approval)
Positive Ph2 CUE-221 topline in CSU (n=145, China): HSS7=0 at Wk12 met at all doses (54%/53%/43% vs 11% placebo, p<0.005 top two; 41% omalizumab); key secondary UAS7=0 met at 4mg/kg (46% vs 11%); durable benefit 12 weeks off drug; Phase 2b/3 planned
FDA approved sNDA for IBTROZI (taletrectinib) with updated label: TRUST-I TKI-naive median DOR 49.7 months (longest reported for approved ROS1 TKI); approval came ~4 months ahead of PDUFA; no new safety signals
ELPIS II Phase 2b topline missed primary endpoint (RVEF change at Month 12; LS mean diff -0.7 pp, p=0.8336) for laromestrocel in HLHS; exploratory endpoints non-significant; company to explore strategic options + cost containment
ADDRESS-LC Phase 2 topline for bezisterim in Long COVID (signal-finding, n=203): no endpoint stat-sig in overall ITT; statistically significant improvements in pre-specified high-symptom-burden subgroups; safety similar to placebo; confirmatory Phase 3 planned
Mixed Ph2 Seabreeze STAT asthma topline for rademikibart (anti-IL-4Ralpha, n=160): primary treatment-failure rate cut 66% vs placebo but missed significance (p=0.153); key secondary post-BD FEV1 +130mL placebo-adjusted at Day 7, p=0.023; safe; Seabreeze STAT COPD topline later this month; FDA alignment meeting on Ph3 program planned
FDA accepted NDA for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM); PDUFA target action date June 29, 2027; NDAs for NonAdvSM (PDUFA Dec 30, 2026) and GIST (PDUFA Nov 30, 2026) also under review