FDA approval

Levi & Korsinsky sued $QURE over false FDA statements. Investors who lost money Sept-Oct 2025 can claim damages by April 13, 2026.

Law firm Levi & Korsinsky seeks investors in Inovio Pharmaceuticals securities class action alleging failure to disclose manufacturing delays and FDA's standard review decision.

Cytokinetics insider Andrew Callos sold $929K in stock options weeks after FDA approval of heart drug myqorzo, reducing holdings by 23%.

Dyne Therapeutics initiates Phase 3 HARMONIA trial testing z-basivarsen in approximately 150 DM1 patients, aiming to convert accelerated approval to traditional FDA clearance.

uniQure faces securities lawsuit for allegedly misrepresenting Huntington's study design approval and downplaying BLA delays. Investors must act by April 13, 2026.

Lisata Therapeutics agreed to be acquired by Kuva Labs for $5.00 per share plus up to $1.00 contingent payment, closing expected in Q2 2026.

Lisata Therapeutics agrees to be acquired by Kuva Labs for $5 per share plus up to $1 contingent payment tied to FDA approval, with close expected in Q2 2026.

Savara receives FDA Day 74 Letter for MOLBREEVI with no advisory committee meeting planned. PDUFA target date set for August 2026.

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.