FDA approval

Class action lawsuit filed against $ATARA alleging securities fraud over false statements regarding manufacturing issues and ALLELE study deficiencies affecting tabelecleucel approval prospects.

Mesoblast reports Q3 FY2026 Ryoncil revenues of $30.3M, approaching $100M cumulative sales, while reducing operating cash spend and strengthening balance sheet.

Agios Pharmaceuticals surged 13% on strong Q1 earnings, with mitapivat revenue jumping 138% to $20.7M. Company plans supplemental FDA application for sickle cell disease expansion.

Mesoblast completes recruitment of 300+ patients in pivotal Phase 3 trial for chronic back pain therapy, targeting mid-2027 results and Q3 2027 FDA filing.

Portnoy Law Firm files class action against Aquestive Therapeutics for allegedly misleading investors about Anaphylm drug approval prospects, citing undisclosed FDA deficiencies.

Class action lawsuit alleges $ATRA misrepresented manufacturing issues and clinical trial deficiencies for tabelecleucel, obscuring FDA approval challenges between May 2024 and January 2026.

Celcuity rises 4% after Citizens initiates 'market outperform' coverage with $150 price target, citing gedatolisib's breast cancer approval potential within two months and multi-indication opportunity.

PTCL market valued at USD 800 million in 2025 to grow 7% annually through 2036, driven by emerging therapies and rising disease incidence. U.S. represents 68% of market.

Class action lawsuit filed against $AQST alleging securities fraud over false FDA timeline statements and concealed safety risks for Anaphylm drug.

Bronstein, Gewirtz & Grossman files class action against $ATAR, alleging executives misled investors about manufacturing issues and FDA approval prospects for tabelecleucel.

$ADGM surges 11.92% after FULCRUM-VT trial shows 84% shock freedom, 59% arrhythmia freedom, supporting FDA Premarket Approval pathway for vCLAS ablation system.

Wall Street projects 170% upside for Viking Therapeutics' obesity drug candidate VK2735, citing superior weight loss and tolerability versus Novo Nordisk and Eli Lilly rivals.

Securities lawsuit filed against Atara Biotherapeutics over alleged misstatements regarding tabelecleucel manufacturing and failed ALLELE study. Lead plaintiff deadline May 22, 2026.

Eli Lilly's new weight-loss drug Foundayo recorded just 3,707 prescriptions in week two, trailing Novo Nordisk's Wegovy by over 400%, triggering a 4% stock decline.

Regeneron agrees with Trump Administration to lower drug prices via Medicaid benchmarking and free gene therapy access, receiving three years of tariff relief and regulatory certainty.

Schall Law Firm launches securities fraud lawsuit against Atara Biotherapeutics for allegedly misrepresenting manufacturing capabilities and tabelecleucel trial results during May 2024-January 2026 period.

FDA approves $REGN's Otarmeni, first dual AAV gene therapy for genetic hearing loss, in record 61 days under priority voucher program. 80% of patients showed improved hearing.

Class action lawsuit filed against $AQST alleging executives made false statements about Anaphylm FDA approval timeline and concealed human factors risks.

Sanofi's Dupixent gains FDA approval for pediatric urticaria as Q1 earnings beat expectations with 30.8% drug growth at $12.31B sales.

Hagens Berman files securities class action against $SLNO alleging concealed safety risks and inflated metrics for hyperphagia drug VYKAT XR. Stock crashed 27% following August activist report and November earnings miss.