FDA approval

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.

Institutional investors rotate capital to precision oncology biotech as patent cliff pressures Big Pharma. Five clinical-stage companies positioned for M&A amid $303B market opportunity.

Portnoy Law Firm files class action against $AQST for allegedly misleading investors about Anaphylm FDA prospects. Stock plunged 37% after deficiency disclosure.

FDA approves Icotyde for psoriasis, triggering $50M payment to Protagonist. Market reacts with AbbVie stock falling 5.20% amid competitive pressure.

Taysha Gene Therapies reported $109M 2025 loss while advancing TSHA-102 gene therapy for Rett syndrome with positive safety data and FDA regulatory alignment through 2028.

Roche's Ionify® steroid assays receive FDA's moderate complexity designation, expanding access to mass spectrometry-based hormone testing across routine clinical laboratories.

Corcept Therapeutics faces securities fraud lawsuit after FDA rejected relacorilant. Stock crashed 50% following misleading investor claims about approval prospects.