FDA approval

Class action lawsuit filed against Corcept Therapeutics for allegedly making false claims about relacorilant drug's clinical strength while concealing FDA regulatory concerns.

Class action lawsuit filed against $QURE over alleged misstatements about AMT-130 gene therapy FDA approval status. Stock plunged 49% after FDA reversed position on Phase I/II data adequacy.

Schall Law Firm files securities fraud class action against $INO for allegedly making false statements about manufacturing deficiencies and regulatory filing timelines.

FDA approves J&J's Tecvayli plus Darzalex Faspro for multiple myeloma with 83.3% three-year survival rate, expanding drug's label.

Allarity Therapeutics secures $20M non-dilutive debt financing to complete stenoparib Phase 2 trial and advance toward FDA approval, extending runway to mid-2028.

Catheter Precision ($VTAK) will showcase its FDA-approved LockeT suture retention device at ISLAA 2026, demonstrating cost-saving wound closure technology to electrophysiology fellows.

AtaiBeckley advances psychedelic depression treatment to Phase 3 with $220.7M cash runway through early 2029, plus positive anxiety trial data.

Iovance shows 60.6% fiscal 2025 revenue growth for its personalized cancer therapy Amtagvi, but faces manufacturing complexity and profitability challenges ahead.

uniQure faces shareholder lawsuit alleging false statements on FDA approval and study design. Lead plaintiff deadline: April 13, 2026.

uniQure faces securities class action lawsuit alleging misstatements about Pivotal Study design and FDA approval. Lead plaintiff deadline: April 13, 2026.

$QURE plunged 49% after FDA rejected AMT-130 Phase I/II data for accelerated approval. Securities lawsuit filed; lead plaintiff deadline April 13, 2026.

Class action lawsuit filed against $INO for allegedly false statements about INO-3107 treatment and CELLECTRA device. Lead plaintiff deadline is April 7, 2026.

Grabar Law Office investigates shareholder claims against $CORT, $ITGR, $KD, and $MOH for alleged disclosure failures and fiduciary breaches spanning clinical trials, sales concealment, and cost trend non-disclosure.

Pomerantz files class action against Inovio Pharmaceuticals for alleged securities fraud related to false FDA approval statements and concealed manufacturing deficiencies.

Law firm files securities lawsuit against $CORT alleging false statements about FDA interactions regarding relacorilant drug approval prospects.

United Therapeutics ($UTHR) stock rallies 3.98% after Phase 3 trial shows ralinepag reduces PAH worsening 55%, with FDA filing targeted for mid-2026.

uniQure's $QURE stock crashes 49% after FDA rejects Huntington's gene therapy approval pathway; securities fraud lawsuit filed alleging misleading statements about regulatory expectations.

Rhythm Pharmaceuticals reports positive Phase 3 data for setmelanotide treating acquired hypothalamic obesity, with FDA decision expected March 2026.

uniQure faces securities class action over alleged misrepresentations regarding FDA approval status of Huntington's Disease trial design and regulatory timeline delays. Lead plaintiff deadline April 13, 2026.

Medtronic ($MDT) wins FDA approval for Hugo surgical robot, trading at 27x P/E versus competitor Intuitive Surgical ($ISRG) at 64x, offering potential upside with 2.9% dividend yield.