FDA approval

Deerfield Management increases Vera Therapeutics stake to $205.58M as kidney drug atacicept approaches July 7 FDA decision. Stock up 50% annually.

Deerfield Management increased its Celcuity stake by $80.6M in Q4, bringing total position to $170.95M. Stock surged 1,040% amid FDA review of breast cancer drug gedatolisib.

Deerfield Management boosts $PRAX stake to $266M as biotech stock surges 685% annually. Company eyes $20B+ pipeline revenue potential with two FDA applications pending.

Picard Medical's SynCardia Systems showcases its Total Artificial Heart technology on FOX Business, highlighting over 2,100 implants worldwide.

Class action lawsuit filed against Inovio Pharmaceuticals for allegedly making false statements about CELLECTRA device manufacturing and INO-3107 FDA submission timeline between October 2023 and December 2025.

uniQure faces securities lawsuit after FDA rejected AMT-130 approval pathway. Stock plummeted 49% following disclosure. Lead plaintiff deadline: April 13, 2026.

Rosen Law Firm notifies $CORT investors of securities class action alleging misrepresentation of clinical trial data for relacorilant drug and undisclosed FDA concerns.

BridgeBio reports positive Phase 3 results for BBP-418, showing 31-second improvement in walking tests. FDA submission expected H1 2026, potential U.S. launch late 2026/early 2027.

Law firm Bragar Eagel & Squire files class action lawsuits against $NAVAN and $COPT alleging material misstatements, citing 60%+ and 50%+ stock declines respectively.

Schall Law Firm seeks investors in $COPT securities class action, alleging false statements about relacorilant FDA approval prospects between October 2024 and December 2025.

$VERX surges 6.3% after kidney drug povetacicept achieves Phase 3 trial success with 52% proteinuria reduction, positioning FDA approval by year-end.

Telix Pharmaceuticals' TLX591-Tx meets Phase 3 safety objectives in prostate cancer trial, advancing toward U.S. expansion with FDA.

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.