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.
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.
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'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 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.
The SEC has appointed EY veteran Demetrios Logothetis as PCAOB chair, alongside three new board members, as the audit regulator faces a slashed budget and a pivot toward a lighter regulatory touch.
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.
Bank of America Securities has reaffirmed its Buy rating on Hesai Group (HSAI), raising its price target to $32, citing the lidar maker's technological milestones, strategic partnership with NVIDIA, and favorable regulatory developments for autonomous driving.
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.
Goldman Sachs has downgraded MoonLake Immunotherapeutics (MLTX) to Sell, highlighting the failed VELA-2 trial endpoint and persistent approval risks for its key drug, sonelokimab, despite a competing firm's more bullish outlook.
An AI-driven analysis suggests JPMorgan Chase stock could see a slight decline to around $295 by mid-April, as the banking giant contends with rising operational costs and regulatory uncertainty, despite strong fundamentals and shareholder returns.
JPMorgan Chase confronts heightened regulatory and political pressure as a lawsuit from former President Donald Trump alleges biased account closures, while CEO Jamie Dimon's public spat with Coinbase underscores the intensifying battle between traditional banks and crypto platforms for customer funds.
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.
A new report details how Donald Trump's family has amassed a vast cryptocurrency portfolio, coinciding with a regulatory pullback by the SEC and DOJ. The moves raise questions about conflicts of interest as a Trump-backed venture seeks federal banking approval.
While the healthcare sector has surged 17.4% in six months, outpacing the S&P 500, regulatory headwinds and valuation concerns demand a selective approach. We examine one stock with a durable edge and two facing significant challenges.
DoubleVerify's nomination for a Digiday award spotlights its News Accelerator initiative, a strategic push to bolster quality journalism and advertiser confidence in digital news environments. The move comes as the industry grapples with brand safety and seeks more transparent ad placements.
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.
