fda-and-biotech News

Vaccine Stocks Surge After First Fatal Human H5N5 Case in US
FDA & Biotech
2mo ago

Vaccine Stocks Surge After First Fatal Human H5N5 Case in US

Moderna jumps over 6% as investors speculate on pandemic preparedness, but a shift in U.S. funding strategy presents a complex outlook.

Praxis Insiders Unload $7.5M in Stock After 300% Rally
FDA & Biotech
2mo ago

Praxis Insiders Unload $7.5M in Stock After 300% Rally

Executive profit-taking follows a massive stock surge driven by positive clinical trial data for the company's essential tremor drug, ulixacaltamide.

Pfizer Surges After FDA Approves Key Bladder Cancer Drug Combo
FDA & Biotech
2mo ago

Pfizer Surges After FDA Approves Key Bladder Cancer Drug Combo

The approval for PADCEV with Merck’s Keytruda validates Pfizer's $43 billion Seagen acquisition and establishes a new standard of care in a growing oncology market.

Merck Gains FDA Nod for Keytruda Combo in Bladder Cancer
FDA & Biotech
2mo ago

Merck Gains FDA Nod for Keytruda Combo in Bladder Cancer

Approval for use with Pfizer/Astellas's Padcev establishes a new standard of care for first-line treatment, bolstering the blockbuster drug's market dominance.

Contineum Plunges Over 30% as MS Drug Misses Trial Goals
FDA & Biotech
2mo ago

Contineum Plunges Over 30% as MS Drug Misses Trial Goals

The clinical-stage biotech's lead drug candidate, PIPE-307, failed to meet primary and secondary endpoints in a pivotal Phase 2 study, erasing recent gains.

Pfizer Shares Climb Over 3% on Promising mRNA Flu Vaccine Data
FDA & Biotech
2mo ago

Pfizer Shares Climb Over 3% on Promising mRNA Flu Vaccine Data

Phase 3 trial results show its next-generation vaccine outperforms traditional shots, boosting confidence in the company's post-COVID growth strategy.

SELLAS Director Buys $101K in Stock Amid Share Price Weakness
FDA & Biotech
2mo ago

SELLAS Director Buys $101K in Stock Amid Share Price Weakness

The open-market purchase by board member Katherine Bach Kalin signals insider confidence as the biotech advances its late-stage cancer therapies.

AnaptysBio Stock Slides as GSK Lawsuit Threatens Jemperli Royalties
FDA & Biotech
2mo ago

AnaptysBio Stock Slides as GSK Lawsuit Threatens Jemperli Royalties

Biotech firm and GSK's Tesaro unit file dueling lawsuits over alleged contract breaches, placing a critical cancer drug revenue stream at risk.