BioPharmCatalyst

TL;DR — Biotech News: September 18, 2026 Xenon Pharmaceuticals (XENE): Filed an NDA for azetukalner in focal seizures; psychiatric enrollment remains paused, with X-NOVA2 data expected Q1 2027. Longeveron (LGVN): Phase 2b ELPIS II missed its primary RVEF endpoint and key secondary outcomes, prompting FDA discussions and a strategic review.

TL;DR — Biotech News: September 17, 2026 Xenon (XENE): Filed an NDA for azetukalner in focal onset seizures; psychiatric-trial enrollment was voluntarily paused, delaying X-NOVA2 MDD data to Q1 2027. Nuvation Bio (NUVB): FDA approved an updated IBTROZI label incorporating a 49.7-month median response duration from TRUST-I in TKI-naive ROS1+ NSC...

TL;DR — Biotech Movers: September 16, 2026

Tempest Therapeutics (TPST) +59%: Secured an exclusive option agreement for Senlang's CD7 lentiviral vector platform and Phase 1 BCMA/GPRC5D in vivo CAR-T candidate.

BlossomHill Therapeutics (BLSM) +18%: Phase 1/2 SOLARA study of BH-30643 in EGFR C797S-positive NSCLC yielded a 45% ORR and ...

TL;DR — Biotech News: September 15, 2026

Connect Biopharma (CNTB): Phase 2 Seabreeze STAT asthma trial of rademikibart met key Day 7 post-bronchodilator FEV1 endpoint, but missed statistical significance on 28-day treatment failure reduction.

Radiopharm Theranostics (RADX): Phase 2b trial of 18F-RAD101 in recurrent brain metastases...

TL;DR — Biotech Movers: September 14, 2026 Scinai (SCNI) +47%: Ended its PC111 license and shifted resources toward NanoAbs, IL-17 programs and its growing CDMO business. Cellectis (CLLS) -41%: Pivoted to in vivo gene editing, prioritizing HEAL-101 and HEAL-201 while discontinuing lasme-cel and eti-cel. PDS Biotech (PDSB) +35%:...