FDA approval

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.

DBV Technologies announced strong Phase 3 data for VIASKIN® Peanut patch, with 82.8% of treated children showing improved tolerance. FDA submission planned for H1 2026.

DBV Technologies' peanut allergy patch met Phase 3 goals with 46.6% responder rate versus 14.8% placebo, supporting planned 2026 FDA submission.

Medtronic gains FDA approval for Hugo robotic surgery system and spins off diabetes division, strengthening market position while reporting 8.7% revenue growth and maintaining 48-year dividend streak.

Exelixis secures FDA approval for zanzalintinib and expands beyond cabozantinib with robust pipeline, posting 57.9% EPS growth while advancing multiple Phase 3 trials.

Ascendis Pharma wins FDA approval for YUVIWEL, the first once-weekly treatment for pediatric achondroplasia. The therapy offers improved dosing convenience over existing options.

Rosen Law Firm sues Corcept Therapeutics for allegedly making misleading statements about clinical trial data and FDA approval prospects for its relacorilant drug candidate.

BMS's Sotyktu shows promise for psoriatic arthritis among one-third of surveyed rheumatologists, but analysts expect modest market capture ahead of March 2026 FDA decision.

Corcept Therapeutics faces securities lawsuit alleging misrepresentation of relacorilant clinical data and FDA approval prospects, while withholding known regulatory risks from investors.

Mesoblast reports strong H1 results with Ryoncil® revenue of $51.3M and narrowed net losses. Commercial expansion underway with 49 transplant centers operational and FY2026 guidance of $110-120M revenue.

UniQure faces securities lawsuit alleging material misrepresentations about its Huntington's Disease trial design and FDA approval status. Lead plaintiff deadline is April 13, 2026.

Anteris secures $320M funding to advance DurAVR heart valve through global trials, with FDA approval and increased clinical development spending.

Psilocybin gains regulatory momentum with first Phase 3 success in treatment-resistant depression. DEA increases production quota 67%, while five pharma companies advance psychedelic programs across multiple CNS indications.