fda-and-biotech News
Sangamo Shares Surge on FDA Fast-Track for Fabry Disease Gene Therapy
The U.S. regulator's acceptance of a rolling submission for ST-920 could accelerate the approval timeline for the one-time treatment, positioning it against established therapies.
Inhibikase Surges After FDA Allows Key Lung Drug to Skip Phase 2b Trial
Company to advance IKT-001 for Pulmonary Arterial Hypertension directly to a pivotal Phase 3 study, accelerating its potential path to market by three years.
Jazz Pharma Executives Sell Stock Into 25% Rally
Insider sales totaling over $1.2 million were executed as the company's shares hit a 52-week high following positive oncology drug trial results.
Mesoblast Expands Ryoncil Ambitions with Pivotal Adult GVHD Trial
Company initiates late-stage study for its cell therapy as a first-line treatment in adults, targeting a larger market beyond its pediatric approval.
Amgen Gains on Full FDA Approval for Lung Cancer Drug Imdelltra
Pivotal data shows the first-in-class therapy reduced the risk of death by 40%, cementing its role in treating an aggressive form of lung cancer.
AstraZeneca Shares Climb on FDA Nod for Rare Disease Drug Koselugo
The regulator approved an expanded use for the drug to treat adults with a rare genetic disorder, bolstering the company's lucrative rare disease portfolio.
Alumis Insiders Buy Millions in Stock, Signaling Strong Conviction
Key directors and 10% owners accumulate a significant stake in the biopharma firm, aligning with a bullish Wall Street outlook and a $19 price target.
Alumis Insiders Signal Confidence With Coordinated Stock Purchases
Multiple directors at the clinical-stage biopharmaceutical firm have acquired millions in company stock on the open market, signaling strong internal conviction.