The FDA has issued a complete response letter for Aquestive Therapeutics' sublingual epinephrine film Anaphylm, citing concerns over packaging and user instructions. The company aims to address the issues and resubmit its application by the third quarter of this year.
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.
Jefferies has downgraded Amicus Therapeutics to 'Buy' from 'Hold' and trimmed its price target to $14.50, aligning it with BioMarin's pending $4.8 billion acquisition offer. The move reflects analyst skepticism about competing bids emerging for the rare disease biotech firm.
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.
Identifying companies with sustainable growth engines is a perennial challenge for investors. We analyze three firms—Vertiv, Ares Management, and Halozyme Therapeutics—that are expanding their competitive moats and delivering robust revenue growth, offering potential shelter in uncertain times.
Merck & Co. shifts its cancer drug development playbook, opting for targeted collaborations with Guardant Health and Eikon Therapeutics after walking away from a major acquisition. Analysts debate whether the stock's current price fully reflects its long-term pipeline potential.
GSK makes a dual strategic move, acquiring RAPT Therapeutics for its food allergy portfolio and securing broader European approval for its RSV vaccine Arexvy, reinforcing its focus on immunology and respiratory health.
AbbVie's stock presents a complex picture for investors, with recent mixed performance contrasting sharply with its robust multi-year returns. As shares trade below consensus targets, the market weighs near-term headwinds against the pharmaceutical giant's proven track record and pipeline potential.
Synthetic biology leader Twist Bioscience reported strong Q1 FY2026 results, with revenue climbing 17% year-over-year to $103.7 million. Management highlighted accelerating demand from AI-powered drug discovery and reiterated its path to adjusted EBITDA breakeven by Q4 FY2026.
Amid a backdrop of cautious market optimism, companies with significant insider ownership are drawing investor attention. We examine three firms where those closest to the business are putting their money, spanning biotech, advanced semiconductors, and regional banking.
As Amgen prepares to report earnings, analysts are divided on the stock's trajectory. While strategic acquisitions and a solid track record fuel optimism, looming competitive pressures and a key pipeline wait temper expectations.
Shares of clinical-stage biotech Scholar Rock (NASDAQ: SRRK) have surged nearly 60% in three months, closing at $44.34. This rally, backed by promising clinical progress, has investors weighing its premium valuation against its long-term potential in treating serious diseases.
Barclays initiates coverage with an Overweight rating and $20 price target on Altimmune, citing strong fundamentals and pipeline potential. The biotech firm prepares to channel recent offering proceeds toward its pivotal Phase 3 development for metabolic liver disease treatment pemvidutide.
Twist Bioscience kicks off fiscal 2026 with robust growth, reporting a 17% year-over-year revenue increase to $103.7 million. The company credits its semiconductor-based DNA synthesis platform and surging demand from AI-enabled drug discovery programs as key drivers, while reiterating its path to adjusted EBITDA breakeven within the year.
Sanofi reports a pivotal Phase 3 win for its investigational therapy venglustat in a rare neurological disorder, alongside positive EU regulatory news for Rezurock and progress for amlitelimab, signaling a strategic shift toward high-value specialty medicines.
Chinese biotech firm Arctic Vision moves to create an integrated ophthalmology powerhouse by acquiring MDCO Technology's device business, combining drug and device expertise to address unmet needs in eye care.
With a cash reserve that could last just over a year at its current burn rate, InflaRx faces a critical period to prove its clinical pipeline's value. While management has reined in spending, the company's financial strategy is now under the microscope.
Amidst a cautious market climate, companies with substantial insider ownership often signal strong internal conviction. We examine three such firms—spanning South Korean tourism, Chinese sensors, and Taiwanese biopharma—where executives and directors have significant skin in the game.
Pharmaceutical giant Eli Lilly announces a major $3.5 billion manufacturing expansion for its weight-loss drugs and enters two strategic research collaborations in gene editing and immunology, signaling aggressive growth plans amid a recent stock valuation dip.
As Amgen prepares to release its fourth-quarter results, investors are watching for signs of sustained momentum in its key drug portfolios and the impact of recent acquisitions.
