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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.
FROM OUR EDITORS
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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Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.
The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment.
Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.
ImmunityBio will lay off 16 employees in California and said it expects to need more funding to commercialize Anktiva, approved in April for non-muscle invasive bladder cancer.
Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions.
Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.
BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial.
The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.
Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Pfizer are leading the way.