Metabolic disorders
H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health Secretary Robert F. Kennedy Jr. and a plea from patients with ALS for access to BrainStorm’s NurOwn.
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies.
With PN-477, Protagonist is directly going up against Eli Lilly, which is advancing retatrutide, also a triple-G agonist, in a Phase II trial.
Altimmune’s pemvidutide failed to significantly improve fibrosis in MASH patients in a Phase IIb study. The biotech crashed 53% in the aftermath of the readout.
In the race to make the most tolerable obesity drug, there seems to be no clear winner—at least not according to analysts parsing the data presented at the American Diabetes Association annual meeting this week.
Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved.
Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the mass leadership exodus at the FDA continues as CDER and CBER shed key staff; Kennedy’s revamped CDC vaccine advisors convene for their first meeting; Novo and Lilly present new data at the American Diabetes Association’s annual meeting; and BioSpace recaps BIO2025.
Eli Lilly’s bimagrumab led to weight loss that was due almost entirely to fat reduction when combined with semaglutide, marketed by rival Novo Nordisk as Wegovy. BMO Capital Markets called the data “impressive” while raising concerns about the antibody’s safety profile.
While Eli Lilly brushed off concerns about gastrointestinal side effects for oral weight loss candidate orforglipron, analysts from William Blair worried that adverse events are not tapering off as expected.
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