FDA Pauses Tenaya TN-201 Gene Therapy Trial for Standardization
The FDA placed a clinical hold on Tenaya’s TN-201 trial for MYBPC3-associated HCM to standardize immunosuppression patient management across sites. No delays expected.
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Novo Nordisk Shares Jump 3% After Withdrawing from $10 Billion Metsera Bidding War
Novo Nordisk stock climbed up to 3% after the Danish drugmaker withdrew from its heated bidding war with Pfizer over obesity drug startup Metsera, citing financial discipline concerns.
Gilead’s Trodelvy Fails to Meet Main Goal in Breast Cancer Study but Shows Early Survival Trend
Gilead’s Trodelvy did not significantly improve progression-free survival in a key late-stage study for common breast cancer, though early data hints at a possible survival benefit.
Jefferies Upgrades Aurinia Pharmaceuticals to Buy, Raises Target to $21
Jefferies upgrades Aurinia Pharmaceuticals to Buy, boosting the price target to $21 on strong Lupkynis sales and promising pipeline prospects.
FDA Extends Review for Rhythm’s Obesity Drug Imcivree to March 2026
Rhythm Pharmaceuticals announced that the FDA has extended the review of its obesity drug Imcivree for acquired hypothalamic obesity by three months, moving the decision date to March 20, 2026.
Intellia Therapeutics Shares Plunge 29% After FDA Pauses Key Gene Therapy Trials
Intellia Therapeutics (NTLA) shares fell 29% premarket after the FDA paused two late-stage gene-editing trials following a patient death linked to liver complications.