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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).
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).
Complete Verastem Oncology VSTM Stock Hub updated through Q2 2026 earnings: AVMAPKI FAKZYNJA launch, VS-7375, RAMP 301, RAMP 205, cash, dilution, risks and future catalysts.
