Weight loss
Rare disease biotech stocks pop on the news that Vinay Prasad, the FDA’s chief biologics regulator, will depart the FDA at the end of April; Sen. Ron Johnson launches an investigation into recent rare disease drug rejections; and Roche and Zealand’s amylin analog fails to match investor expectations—and Eli Lilly’s rival candidate—in a mid-stage trial.
AbbVie’s foray into the obesity space is successful so far, analysts agree, as amylin analog ABBV-295 elicited as much as 9.73% weight loss at 13 weeks in the multiple ascending dose portion of a Phase 1 trial.
The companies have been embroiled in a row about compounded GLP-1 drugs that escalated to a lawsuit last month. The legal action has now been dropped and the former adversaries have struck a deal that could increase access to Novo’s obesity medicines.
Hansoh’s olatorepatide achieved 19% weight loss at 48 weeks in a Phase 3 trial in China, handing partner Regeneron a glimmer of hope for a pipeline in desperate need of reinvigoration.
Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.
UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
As Novo Nordisk continues to lose ground in the obesity market to rival Eli Lilly, the Danish company has started construction projects to establish the ex-Alkermes plant as a hub for supplying oral GLP-1 products to global markets.
Novo Nordisk reported a loss in a head-to-head trial of CagriSema against Lilly’s Zepbound earlier this week. This time around, Lilly’s orforglipron bested Novo’s oral semaglutide in blood sugar control and weight reduction—albeit with a few extra discontinuations as compared to its rival.
After its next-generation obesity asset CagriSema lost a head-to-head matchup with Eli Lilly’s Zepbound, Novo Nordisk is throwing more money into the obesity space, striking a deal with Vivtex to advance novel weight loss pills.
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