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FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

An independent advisory committee will decide on July 29 whether the trial evidence gives regulators enough reason to approve the cell therapy.

Akari’s AKTX-101 Shows Preclinical Synergy With KRAS Inhibitor as Stock Soars

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

CNS Pharmaceuticals Soars 215% on $22.5 Million Oversubscribed Private Placement

Merck and Other Drugmakers Weigh Bids for Inhibrx’s Keytruda-Linked Cancer Drug

CRISPR Therapeutics’ Pipeline Pitched as Path to One-Time Heart Risk Treatments

Serina Therapeutics Shares Jump After Private Placement to Raise Up to $63.3 Million

Xenon to Present Topline X-TOLE2 Phase 3 Results in Focal Onset Seizures at 8 A.M. ET Today

ARK Invest Deepens Pivot to AI With Fresh Buys in Tempus, WeRide and Kodiak, Cuts Twist and 10x

Skye Bioscience Investors Face Friday Deadline in Securities Class Action Over Nimacimab Disclosures

Jan. 16 Deadline Nears in Skye Bioscience Investor Class Actions

Athira Pharma Secures Exclusive Lasofoxifene Rights, Raises $90 Million to Advance Phase 3 Breast Cancer Program

Nektar’s Alopecia Drug Misses Phase 2b Goal as Company Cites Ineligible Patients, Plans Phase 3

MoonLake Immunotherapeutics Investors Face Lead‑Plaintiff Deadline in Securities Fraud Suits

Skye Bioscience Investors Pressed to Seek Lead Role After Class Action Filing

Cathie Wood’s ARK Buys $24 Million of CoreWeave After Guidance Cut

MoonLake Investors Get Deadline Reminder as Securities Suits Mount Over Sonelokimab Trial

ARK Invest Trims Tesla, AMD as It Adds Circle, BitMine and Bullish in Multi‑Day Shift

MoonLake Investors Face Dec. 15 Lead-Plaintiff Deadline in SDNY Securities Case

Novo Nordisk Licenses Omeros’ MASP-3 Drug in Deal Worth Up to $2.1 Billion