FDA approval

Pomerantz LLP sues Inovio Pharmaceuticals for alleged securities fraud over FDA approval misstatements. Stock fell 3.1% and 24.45% following manufacturing delays and accelerated approval rejection.

Abivax CEO dismisses acquisition rumors, plans equity and debt raise after Phase 3 obefazimod data in Q2 2026. $614.42M cash runway supports strategy.

Class action lawsuit filed against $COPT alleging executives misrepresented relacorilant clinical trial strength and FDA approval prospects, harming investors.

Rosen Law Firm notifies Corcept investors about securities lawsuit alleging misrepresentation of relacorilant clinical data and concealment of FDA concerns during October 2024-December 2025.

Aquestive Therapeutics faces securities fraud lawsuit after FDA rejected Anaphylm drug, contradicting management's prior "on track" statements; $AQST stock fell 37%.

Soligenix's HyBryte™ cutaneous lymphoma therapy shows positive results ahead of 2026 presentation, with FDA awarding $2.6M development grant.

Securities class action filed against uniQure alleging FDA approval misrepresentations. April 13, 2026 deadline for lead plaintiff claims.

Eli Lilly awaits April 10 FDA decision on oral weight loss drug orforglipron, amid $11B quarterly sales from current portfolio. Approval could catalyze gains, but long-term fundamentals matter more than short-term decisions.

RTW Investments purchases $116M stake in Cogent Biosciences, raising position to 2.7% of AUM amid 360% stock surge and anticipated 2026 FDA decision on lead drug.

ENAVATE deepens Zenas BioPharma stake to $142.3M. Key catalyst: obexelimab Phase 2 lupus data and Q2 2026 FDA submission.

Bristol Myers wins FDA approval for Opdivo plus chemotherapy in untreated Hodgkin lymphoma. Stock declined 1.33% despite clinical success in Study CA209-8UT.

Class action lawsuit filed against $CORP alleging false statements about relacorilant clinical trial strength and FDA approval prospects. Investors from Oct 2024-Dec 2025 urged to participate.

Kessler Topaz files class action against $QURE over alleged misleading statements about AMT-130 FDA approval timeline, following 49% stock plunge in November 2025.

UniQure faces securities fraud lawsuit alleging false FDA approval and BLA timeline claims. Investors in stock between September-October 2025 can join class action by April 2026 deadline.

uniQure faces class action lawsuit alleging misleading statements about pivotal study design and FDA approval prospects. Shareholders have until April 13, 2026 to join.

Corcept Therapeutics faces class action lawsuit for allegedly misrepresenting FDA trial data; stock collapsed 50% after regulatory rejection of relacorilant drug.

Rhythm Pharma wins FDA approval for IMCIVREE, the first therapy for acquired hypothalamic obesity, based on 18.4% placebo-adjusted BMI reduction.

Class action lawsuit filed against Inovio Pharmaceuticals ($INO) for allegedly making false statements about INO-3107 treatment and manufacturing capabilities, causing significant stock declines.

Novo Nordisk wins FDA approval for Wegovy HD, a higher-dose version launching in April across 70,000+ U.S. pharmacies, despite modest stock decline.

Class action lawsuit filed against $UQRR alleging materially false statements about FDA approval and BLA timeline delays. Investors urged to join by April 13, 2026 deadline.