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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
2025 performance in the ballpark of +250–270 percent, among the top performers in the defense group.
Growth story tied to autonomous drones and counter-UAS systems in a context of rising defense and security spending.
Very ambitious guidance: management is targeting revenues of at least 36M USD in 2025 and 110M USD in 2026.
Large free float, growing institutional ownership and high volatility: a classic high-beta small cap where newsflow drives big moves.
Bionano Genomics is one of those names where the technology and the share price seem to live in different universes. On the lab side, optical genome mapping (OGM) keeps racking up publications, clinical use-cases and even a Category I CPT code with a 47% reimbursement boost for blood cancers.
Axsome Therapeutics is no longer just “the Auvelity company”. In 2025 it quietly turned into a multi-product CNS platform with three marketed drugs, a late-stage pipeline and, now, a Priority Review from the FDA for AXS-05 in agitation associated with Alzheimer’s disease – with a PDUFA action date set for April 30, 2026.
From going concern to platform story with a cult retail base
For a long stretch of 2023, Novavax was treated as a failed Covid trade. A late vaccine, production issues, a balance sheet that flirted with collapse and a market that moved on to other themes. On paper, the story should have ended there.
CRL in one paragraph:
The FDA acknowledged that one of Corcept’s Phase 3 trials in Cushing was successful, but another failed its primary endpoint. Given this mixed picture, the agency said it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness and therefore rejected the NDA via CRL. No insurmountable safety issues were cited; the focus is efficacy and consistency.
News of the day (REGAL): On 29 December 2025, SELLAS reported that the contract research organization running the Phase 3 REGAL trial notified the company that 72 of the 80 required events (deaths) had occurred as of 26 December 2025. REGAL is an overall survival study; the final analysis will be triggered once 80 events are reached. SELLAS remains fully blinded, and this one-time update does not change the statistical plan. Source: SELLAS REGAL update PR (Dec 29, 2025) .
News of the day: Ironwood maintained FY2025 guidance and issued FY2026 guidance projecting LINZESS U.S. net sales of $1.125–$1.175B, total revenue $450–$475M, and adjusted EBITDA >$300M, citing improved net pricing driven by a January 1, 2026 Linzess list-price reduction. It also reaffirmed that a confirmatory Phase 3 trial for apraglutide is expected to begin in H1 2026, and that the strategic alternatives review is progressing. Source: BusinessWire (Jan 2, 2026).
Oncolytics Biotech (ONCY) — Pelareorep, GI focus, catalysts into Q1–H1 2026 | Oncolytics Biotech (ONCY) — Pelareorep, focus GI, catalyst Q1–H1 2026 EN IT Oncolytics Biotech (ONCY) Panel-style report (EN/IT): news-first, catalyst timelines, fundamentals/cash runway, pipeline, management/ownership, retail sentiment, risk…
The FDA approved NEREUS (tradipitant) for the prevention of vomiting induced by motion in adults — described as the first new FDA-approved pharmacologic treatment in this area in over 40 years. The company expects a commercial launch “in the coming months.”
eep dive on Alpha Tau Medical (DRTS) from a bullish angle: differentiated alpha-radiation platform, multiple late and early-stage trials, solid cash runway and heavy insider ownership. Educational only, not investment advice.
On December 29, 2025, Applied Digital (APLD) and Ekso Bionics (EKSO) announced a non-binding term sheet for a proposed business combination between Applied Digital’s cloud computing arm, Applied Digital Cloud, and EKSO.
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, Mereo BioPharma announced Phase 3 ORBIT and COSMIC results for setrusumab (UX143) in osteogenesis imperfecta. Neither trial met its primary endpoint of reduced annualised clinical fracture rate versus placebo (ORBIT) or bisphosphonates (COSMIC),
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.