fda-and-biotech News
Soleno Buys Back $100M in Shares, Citing 'Underappreciated' Drug Launch
The biopharmaceutical company signals strong confidence in its newly approved PWS drug, VYKAT XR, following a recent stock price decline.
iRhythm Surges After Study Shows Zio Superiority in Arrhythmia Detection
Shares climb as new data published in a leading medical journal finds traditional monitors miss actionable arrhythmias in 64% of symptomatic patients.
Intellia Stock Hit by Evercore Downgrade, Target Slashed to $8
Analyst cites uncertain timelines and competitive hurdles for the gene-editing firm's key therapy following a recent clinical hold.
Vor Biopharma Shares Plunge After Pricing $100M Stock Offering
The capital raise, representing nearly 78% of its market value, was priced at a 47% discount, sparking concerns of massive shareholder dilution.
Stereotaxis Shares Jump on FDA Clearance for GenesisX Robotic System
The approval opens the U.S. market for the company's next-generation cardiac navigation platform, a key step in its commercial strategy.
AstraZeneca Shares Hit 52-Week High on Hypertension Drug Success
Pivotal Phase 3 trial for Baxdrostat shows a significant reduction in blood pressure, positioning the drug as a potential blockbuster for treatment-resistant patients.
Ionis Pharma Posts Strong Phase 3 Data for Cholesterol Drug
Olezarsen shows an 85% reduction in acute pancreatitis events, a critical complication of severe hypertriglyceridemia, paving the way for a regulatory filing.
HHS Lifts Decades-Old Warning on Hormone Therapy, Boosting Drugmakers
The decision to remove a contentious 'black box' warning could reinvigorate the multi-billion dollar market for women's health treatments, benefiting both pharma giants and specialized firms.