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.
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.
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.
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.
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.
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.
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 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.
PGIM India Asset Management, the underperforming local arm of the U.S. financial giant, has drawn acquisition interest from domestic rivals Groww and Edelweiss as its parent considers an exit from the competitive market.
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.
As Skyworks Solutions prepares to report Q4 earnings, investors are weighing its track record of beating estimates against a backdrop of expected revenue decline and mixed semiconductor sector performance.
Enphase Energy, a key player in the home energy management sector, is set to release its quarterly earnings after the bell on Tuesday. Investors are watching closely as the company navigates a shifting market landscape.
As Artisan Partners prepares to report fourth-quarter results, investors are weighing its recent track record against a backdrop of mixed signals from peers. Will this earnings release mark a turning point?
As Zurn Elkay Water Solutions prepares to report its quarterly results, investors are watching to see if the company can extend its impressive track record of exceeding revenue forecasts. We break down the key figures, peer performance, and market sentiment heading into the announcement.
Varonis Systems (VRNS) is set to report Q4 earnings after the bell Tuesday, with investors watching closely for signs of resilience after recent revenue misses and a broader sell-off in cybersecurity stocks.
As IAC prepares to report quarterly results, investors are bracing for another potential revenue decline. We examine the key metrics, peer performance, and what the numbers could mean for the company's turnaround strategy.
Sonos (SONO) is set to report its fiscal fourth-quarter earnings after Tuesday's market close. Investors are watching closely to see if the audio specialist can maintain its track record of outperformance in a challenging consumer spending environment.
As Illinois Tool Works prepares to report its fourth-quarter results, investors are weighing steady growth forecasts against a history of revenue misses. The report comes amid a mixed performance for the industrial machinery sector.
