Cogent Biosciences secures FDA Breakthrough Therapy Designation and enters the Real-Time Oncology Review program for its lead drug candidate bezuclastinib in gastrointestinal stromal tumors (GIST), marking significant regulatory momentum for the biotech firm.
Following the FDA's decision to remove the clinical hold on Intellia's Nex-Z hATTR-PN trial, analysts at Baird and H.C. Wainwright have significantly raised their price targets for the CRISPR gene-editing pioneer, citing reduced regulatory risk and a clearer path forward.
Cogent Biosciences secures a key FDA Breakthrough Therapy Designation for its bezuclastinib-sunitinib combination in advanced GIST, following promising Phase 3 data that showed a halving of disease progression risk.
The FDA has cleared Intuitive Surgical's latest robotic system for use in certain heart surgeries, marking a strategic expansion into one of healthcare's largest and most complex service lines and potentially reshaping hospital capital planning for robotics.
Glaukos Corporation secures a significant FDA nod allowing repeated administration of its sustained-release iDose TR implant, broadening treatment options for patients with glaucoma and potentially reshaping long-term care paradigms.
Glaukos Corporation's iDose TR glaucoma therapy receives a key FDA labeling update, permitting repeat administration. While the news bolsters the company's growth narrative, analysts are divided on whether its current stock price already reflects future potential amid rich valuation metrics.
The FDA's approval of a repeat treatment protocol for Glaukos's iDose TR implant transforms it from a one-time procedure into a potential chronic therapy platform, reshaping its commercial narrative and investor calculus in the competitive glaucoma market.
The FDA's Priority Review for Vyvgart's label expansion in myasthenia gravis accelerates Argenx's growth strategy, while investors weigh the company's broader pipeline against its current valuation.
The FDA clearance of Spectrum Dynamics' Veritas.AI platform marks a significant step forward for nuclear imaging, promising to cut scan times in half and enhance image clarity for critical applications like cancer theranostics.
Shares of Corcept Therapeutics plunged 16% after a corrected FDA letter disclosed the agency had repeatedly cautioned the company against filing its application for a Cushing's syndrome drug, which was later rejected over efficacy and safety concerns.
Barclays initiates coverage of 4D Molecular Therapeutics with an Overweight rating and a $33 price target, citing a favorable industry backdrop with potential M&A tailwinds and shifting focus away from drug pricing pressures. The gene therapy developer also outlined key clinical milestones expected through 2026.
The U.S. Food and Drug Administration has issued a complete response letter for Aquestive Therapeutics' oral film drug designed to treat severe allergic reactions, the company announced Monday, delaying a potential new option for millions at risk.
After a stellar 365% surge in the past three years, XRP faces a challenging horizon. Economic uncertainty, shifting investor sentiment, and the maturation of key growth drivers suggest a potentially turbulent period ahead for the digital asset.
Exelixis has filed its next-generation therapy zanzalintinib with U.S. regulators for metastatic colorectal cancer, marking a significant step in its clinical development and potentially enhancing its competitive position in the targeted oncology space.
Wells Fargo boosts its price target for Taysha Gene Therapies (TSHA), citing strong progress in its pivotal Rett syndrome gene therapy program. The company has dosed the first patient in a key trial phase and received FDA alignment on its regulatory pathway.
While investors chase AI and big tech, a niche biotech firm focused on rare genetic obesity disorders has quietly delivered staggering returns, with Wall Street seeing further 40% upside. Rhythm Pharmaceuticals' targeted approach and upcoming catalysts have analysts bullish, despite its relative anonymity.
Despite underperforming the broader market since August 2025, insurance marketplace platform MediaAlpha (MAX) exhibits robust fundamentals—including sustained sales growth, expanding cash flow margins, and rising returns on capital—that could signal significant upside potential for patient investors.
Despite recent price pressures, Ethereum is positioned for a potential surge, driven by impending U.S. crypto legislation and its dominant role in the booming tokenization of real-world assets. Analysts see a pivotal window opening before mid-2026.
Fractyl Health's Revita procedure shows promise in maintaining weight after stopping GLP-1 drugs, with new six-month data prompting the company to seek a streamlined FDA pathway. A packed 2026 roadmap aims for a U.S. submission, but financial pressures loom.
As the wearables market surges, Biolinq CEO Richard Yang positions smart patches as the next evolution, capable of tracking deep biochemical data where watches track surface metrics, with his company's FDA-cleared glucose sensor leading the charge.
