Drug Development
Pent-up demand for the new pancreatic cancer therapy Rasonque helped RevMed soar past analysts’ sales expectations and reach 5,000 patients in the third quarter.
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BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
A fresh FDA review for Biohaven’s embattled ataxia drug lifted the biotech’s shares, while a late-stage lung cancer miss battered ArriVent, which failed to rebound even after encouraging early ADC data.
With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ Akeso-partnered PD-1xVEGF antibody, one analyst calls the asset “the next major backbone” of cancer treatment.
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With the first Phase 3 data expected for Amgen’s MariTide next year, analysts are looking for evidence that the GLP-1 candidate is tolerable. Meanwhile, the company has begun testing an autoinjector formulation.
Sanofi has discontinued an early-stage STAT6 degrader program licensed from Nurix Therapeutics, a decision analysts say is related to the asset itself or Sanofi’s strategic reprioritization rather than the drug class more broadly.
The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.
Compass Pathways revealed that an FDA filing for COMP360 will be complete “in the next two weeks,” with an expected drug launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression on Monday.
Novartis is discontinuing a neurodegeneration alliance with BioArctic in which the companies aimed to develop a drug candidate that could cross the blood-brain barrier.
The cessation of manufacturing activities follows a Sun Pharma recall and reports that regulators found fault with the company’s quality system.
In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after the higher dose failed to deliver the same benefit.
Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ecosystem, despite regional political instability. Whether it can produce sustainable biotech companies and a resilient manufacturing base for global production remains an open question, but the future looks bright.
If approved, BridgeBio Pharma’s BBP-418—which, according to one Jefferies analyst, boasts “pretty darn compelling” data—would be the first therapy for limb-girdle muscular dystrophy. The FDA has an action date of Nov. 27.
Strong immunology and neuroscience sales fueled AbbVie’s latest quarterly beat as the pharma’s stock continues to hit all-time highs.