FDA approval

Argenx's VYVGART achieves Phase 3 success for ocular myasthenia gravis, meeting primary endpoint. Company plans FDA application to expand indication for the rare eye disorder treatment.

ImmunityBio completed Phase 3 cancer trial enrollment ahead of schedule with strong 85% response rates. Anktiva sales surged 750% year-over-year, hitting $38.29M in revenue.

BioCryst achieved historic profitability with ORLADEYO revenue surging 38% to $601.8 million. FDA approval for pediatric formulation and Astria acquisition expand HAE treatment portfolio.

argenx's VYVGART met its primary endpoint in a Phase 3 ocular myasthenia gravis trial, showing significant symptom improvements. The company plans FDA approval for label expansion.

uniQure faces class action lawsuit over failing to disclose FDA rejection of AMT-130 drug candidate, causing 49% stock decline. Lead plaintiff deadline: April 13, 2026.

Class action lawsuit filed against uniQure for allegedly making false statements about FDA approval status and BLA submission timelines, misleading investors.

Arcutis reported 2025 revenue of $372.1M (123% growth) and raised 2026 guidance to $480-495M, driven by strong ZORYVE adoption and positive clinical data.

BVF Partners invests $52M in Disc Medicine despite FDA setbacks, betting on Phase 3 trial data and strong cash reserves through 2029.

Eton Pharma gains FDA approval for DESMODA, the first liquid desmopressin formulation for central diabetes insipidus, launching March 9 with projected peak sales of $30-50 million.

Pfizer's Braftovi receives full FDA approval for treating BRAF-mutated metastatic colorectal cancer when combined with cetuximab and chemotherapy, based on Phase 3 trial data.

Moderna shifts from pandemic revenues toward diversified pipeline including seasonal vaccines and oncology treatments, targeting cash breakeven by 2028 amid FDA progress on flu vaccine candidate.

Grace Therapeutics will present at TD Cowen conference in March 2026. FDA sets April 2026 review date for GTx-104 aneurysmal subarachnoid hemorrhage treatment.

Geron's RYTELO generated $184M in 2025 revenue. The company guides 2026 sales of $220-240M, driven by domestic expansion and international opportunities.

Immuron lifted H1 revenue 5% to AUD$4.2M with strong U.S. growth of 17%. The company secured AUD$7.3M funding and is pursuing partnerships to advance its clinical pipeline.

uniQure faces securities fraud lawsuit after FDA rejected its drug candidate AMT-130, causing a 49% stock plunge. Plaintiffs allege the company failed to disclose material information to investors.

Corcept Therapeutics faces securities fraud lawsuit for failing to disclose FDA setback on relacorilant drug, causing 50% stock decline.

Law firm files securities fraud lawsuit against BellRing after 52% stock plunge, alleging failure to disclose inventory and supply chain issues.

Cytokinetics launches MYQORZO for heart disease post-FDA approval; guides $830-870M spending in 2026 with strong cash position supporting commercial expansion.

FDA approves Dupixent for allergic fungal rhinosinusitis in patients six and older, marking the drug's ninth indication for treating type 2 inflammatory conditions.

Clene outlines 2026 regulatory milestones for ALS drug CNM-Au8, including FDA meeting, NDA submission, and Phase 3 trial, backed by $28 million funding.