Zymeworks: Citi Flags Major Upside Catalyst Ahead of August 25 FDA Decision
Citi places Zymeworks on 90-day upside watch with Buy rating and $37 target ahead of the Aug 25 FDA decision on zanidatamab for HER2+ GEA.
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Evercore Upgrades Intellia After New Hypothesis Explains Nex-z Liver Safety Signal
Intellia stock upgraded after solving liver risk issue; trials resume, new safety steps added, and another drug shows strong results.
Why Replimune Shares Dropped Despite FDA Nod for Melanoma Drug TUDRIQEV
Investors reacted to the 24.2% ORR on the official label.
FDA to Review GRAIL’s Galleri Multi-Cancer Blood Test at September Advisory Meeting
GRAIL’s Galleri cancer blood test will be reviewed by FDA experts as the company seeks full approval for early cancer detection.
Halozyme Delivers Record Quarter, Raises Outlook, and Wins Wall Street Praise
Strong Q2 for Halozyme: Revenue $481M (+48% YoY), royalties +50%. Raises 2026 guidance. H.C. Wainwright, Leerink, Morgan Stanley upgrade.
FDA Completes First-Cycle Review of NRx’s Ketamine ANDA with No Drug-Related Issues
FDA clears path for NRx’s preservative-free ketamine: no major drug issues found, only packaging certification remains.