SEC Filings
4D Molecular Therapeutics Starts Late-Stage DME Trial As Two-Year Data Show 61% Injection Reduction
The 4SIGHT trial targets 514 patients with diabetic macular edema, backed by FDA advanced therapy designation for 4D-150.
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SEC Filings
California's Stem Cell Agency Awards Fate Therapeutics $15 Million To Run A Mid-Stage Lupus Kidney Trial
The CIRM grant funds RECLAIM-LN, a potentially registrational trial of FT819 off-the-shelf CAR T-cell therapy in roughly 53 patients.
SEC Filings
Kodiak Sciences' DAYBREAK Trial Delivers Win For Both Zenkuda And Tabirafusp-Ted, With FDA Filing Due This Quarter
Both drugs hit their primary goals in a pivotal late-stage wet AMD trial, clearing the way for a multi-indication FDA application before year-end.
SEC Filings
Anavex Shareholders Reject Activist Slate — But The Proxy Fight Itself Vested All Unvested Equity Awards
A contested board election at Anavex's annual meeting triggered a change-in-control clause, immediately vesting all outstanding unvested equity grants.
SEC Filings
Keros Therapeutics Doses First Patient In Mid-Stage Rinvatercept Trial For Duchenne Muscular Dystrophy
The clinical-stage biotech expects initial safety and efficacy data from the open-label DMD study in the first half of 2027.
SEC Filings
FDA Clears Mirum's Atebrioz For Rare Bone-Hardening Disease, And A Separate Hepatitis Delta Trial Hits Its Primary Goal
The FDA approved Atebrioz on Friday; the same day, Mirum's late-stage AZURE-1 hepatitis delta study met its primary endpoint at week 24.
SEC Filings
Amprius Technologies Signs Up To $75 Million Pentagon Deal To Build Drone Batteries Domestically
The fixed-price agreement obligates $22.3 million upfront, with the remainder tied to milestone completions and future congressional appropriations.
SEC Filings
Inhibrx's Cancer Drug Hits 80% Response Rate In HPV-Positive Head And Neck Tumors, More Than Double Pembrolizumab Alone
An investor presentation filed Monday shows INBRX-106 combined with pembrolizumab achieved an 80% confirmed response rate versus 33% for the checkpoint inhibitor alone.
SEC Filings
UniQure's Huntington's Gene Therapy Shows 44% Disease Slowing At Four Years, Missing Its Primary Endpoint
Four-year data on AMT-130 fell well short of the 80% slowing reported in the updated three-year analysis, complicating a biologics license application already before the FDA.
SEC Filings
Takeda To Pay Keros Therapeutics $20 Million As Late-Stage Blood Disorder Trial Doses First Patient
Keros plans to pass 25% of the net proceeds to stockholders after the milestone triggers under its Takeda license agreement.
SEC Filings
Iovance Raises Full-Year Revenue Guidance By $55 Million, Citing Record Amtagvi Demand
The biotech lifted its 2026 outlook to $410–$420 million, implying nearly 60% annual revenue growth, in a Tuesday 8-K filing.
SEC Filings
MoonLake Files FDA Approval Application For Skin Disease Drug Sonelokimab
The biologics license application covers moderate-to-severe hidradenitis suppurativa in adults and adolescents as young as 12.