Obesity
FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.”
Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
Viking Therapeutics’ VK2735 met Truist’s “best-case scenario,” with robust weight loss that was largely maintained when patients transitioned to less frequent dosing. Viking’s stock popped more than 30% on Tuesday.
With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth.
Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions.
Investors and analysts have been hounding Novo to beef up its pipeline and advance new molecules as a majority of the company’s sales stem from its semaglutide franchise.
Structure Therapeutics’ oral GLP-1 candidate aleniglipron showed 72-week efficacy “in line” with Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote in a note to investors. Meanwhile, Structure’s amylin and calcitonin receptor agonist ACCG-2671 showed “impressive” target engagement in a Phase 1 trial of healthy volunteers, according to Leerink Partners.
Moonwalk Biosciences plans to shepherd its lead obesity asset into first-in-human trials in late 2027. In preclinical studies, MW101 has demonstrated weight loss and fat reduction while maintaining muscle mass.
Efficacy plateaus, muscle loss and weight rebound are testing the limits of GLP-1 success, pushing companies toward new mechanisms and multitarget designs to close the gap. But progress depends on understanding disease biology and selecting the right drug candidates to derisk clinical trials.
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