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Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.
Novartis plans to build seven new facilities in the U.S., touting the creation of up to 1,000 new jobs at the company. The new facilities will include a biomedical research hub in California, two radioligand plants, and four manufacturing sites.
Analysts at William Blair expect drug developers will continue to perform “at least some animal testing” on their investigational products. Though the process to phase out animal testing will begin “immediately,” no specific timetable was given.
Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
According to Tempest, its options include a partnership or licensing deal, as well as a merger or an acquisition.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses the underrepresentation of women in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming.
Jefferies analysts predict Annexon’s tanruprubart could be approved by mid-2026.
Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be competitors in generalized myasthenia gravis.