Category Reports Biotech

The Japan Patent Office has granted a patent titled “Gut Microbiota-Activated PDE4 Inhibitor Prodrug” covering the composition of matter for PALI-2108, Palisade Bio’s lead gut-restricted PDE4 B/D inhibitor for moderate-to-severe ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD). The base patent term runs into 2041 and is eligible for extension based on regulatory review timelines.

Q3 2025: revenue beat, IBSRELA guidance raised, Street now models ARDX turning profitable in 2026
October–December 2025 – Q3 revenue beat, IBSRELA guidance increased to $270–275M for 2025, XPHOZAH absorbs Medicare shock, analysts talk about 2026 breakeven.

FLAMINGO-01 open-label arm shows ~80% reduction in breast cancer recurrences; Fast Track in place and lock-up extended to 2026
December 2025 – GLSI reports preliminary ~80% recurrence rate reduction in the 250-patient open-label arm of FLAMINGO-01, completes enrollment, and extends insider/pre-IPO lock-up to September 30, 2026, while the stock breaks to new 52-week highs.

n March 3, 2025, the FDA filed Corcept’s NDA for relacorilant as a treatment for adult patients with endogenous hypercortisolism (Cushing’s syndrome), assigning a PDUFA target action date of December 30, 2025. The NDA is based on the pivotal Phase 3 GRACE study, confirmatory evidence from Phase 3 GRADIENT, long-term extension data and a Phase 2 study in hypercortisolism.

FDA accepts INO-3107 BLA, Standard Review, PDUFA October 30, 2026
On December 29, 2025 the FDA accepted Inovio’s Biologics License Application for INO-3107 as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The review classification is Standard and the agency set a PDUFA target action date of October 30, 2026. The FDA also indicated that it is currently not planning to hold an Advisory Committee for this dossier.

On 12 December 2025 BioXcel held its virtual Annual Meeting. Shareholders approved all proposals, including a flexible reverse stock split authorization (from 1-for-5 up to 1-for-30) that the Board may implement within 12 months if needed to keep Nasdaq listing compliance. The company is currently compliant, but this vote gives management an emergency tool in case of further price pressure

On 29 December 2025 Ultragenyx announced that the Phase 3 ORBIT and COSMIC studies of setrusumab (UX143) in osteogenesis imperfecta did not meet their primary endpoints of reducing annualized clinical fracture rate versus placebo (ORBIT) or bisphosphonates (COSMIC).

16 December 2025: Lipocine reports that its Phase 3 trial of LPCN 1154 (oral brexanolone) in postpartum depression has reached 80% enrollment (66 of 80 planned participants). The second independent Data Safety Monitoring Board (DSMB) review is scheduled for mid-January 2026 and topline results are still guided for the second quarter of 2026. The study is intended to support a 505(b)(2) NDA submission referencing IV brexanolone.

Tango Therapeutics (TNGX) – PRMT5, CoREST and a crowded short base into 2026 | Tango Therapeutics (TNGX) – PRMT5, CoREST e una base short affollata verso il 2026 English Italiano Ticker: TNGX (NASDAQ) Tango Therapeutics (TNGX) – PRMT5, CoREST and…