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Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Category Reports Biotech
Tickers reports and analysis
BNGO Bionano Genomics Inc
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.
AXSM Axsome Therapeutics Inc
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.
NVAX Novavax, Inc
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.
CORT Corcept Therapeutics Inc
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.
SLS http://www.sellaslifesciences.com/
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) .
IRWD Ironwood Pharmaceuticals Inc
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).
VVera Therapeutics (Nasdaq: $VERA): Atacicept’s July 7 FDA Decision, the New eGFR Timeline, and the Real IgAN Competitive Test
VERA Therapeutics is a biopharmaceutical company in advanced clinical stage focused on serious immunological diseases. The company achieved its most important milestone in November 2025 with the submission of a Biologics License Application (BLA) to the FDA for atacicept, its lead candidate for the treatment of IgA Nephropathy (IgAN).