FDA Lifts Hold on Intellia’s Phase 3 Gene-Editing Trial for Deadly Heart Disease
Intellia Therapeutics gets FDA approval to resume its Phase 3 trial for nexiguran ziclumeran, a gene-editing treatment for ATTR-CM heart disease, boosting shares by 6%.
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FDA Rejects UniQure’s Huntington’s Gene Therapy Path – Shares Plunge
UniQure's stock falls sharply in premarket trading after the FDA says early data for AMT-130 isn't enough for approval. The company plans more talks for a Phase III trial on this Huntington's disease treatment.
Eikon Therapeutics Draws Buy Ratings from Morgan Stanley, JPMorgan, and Mizuho
Wall Street initiates coverage on Eikon Therapeutics with Overweight/Outperform ratings and price targets of $26–$32 (vs ~$13.78 current price). Bullish on oncology pipeline, innovative microscopy tech, and 2026 data catalysts.
Ascendis Pharma Scores FDA Approval for Yuviwel – Weekly Injection to Boost Growth in Achondroplasia
FDA approves Ascendis Pharma's Yuviwel, the first once-weekly injection to boost growth in children 2+ with achondroplasia. Launch expected Q2 2026.
Aardvark Therapeutics Pauses Phase 3 HERO Trial for PWS Hunger Drug ARD-101 Over Safety Signals
Aardvark Therapeutics voluntarily pauses Phase 3 HERO trial of ARD-101 for Prader-Willi hyperphagia after reversible cardiac signals in high-dose study. Updates expected Q2 2026.
Analyst Bullish on Pelthos Therapeutics: Big Potential in Skin Treatment
Piper Sandler starts coverage on Pelthos Therapeutics with Overweight rating and $48 price target, highlighting ZELSUVMI as a promising new treatment for common viral skin infection molluscum contagiosum with peak U.S. sales potentially over $200M.