Biologics

Viking Reports Mixed Data on Obesity Drug

Viking Therapeutics is reporting mixed data from a Phase 2 study for its oral obesity drug VK2735, with patients losing up to 12.2% of body weight over 13 weeks. Despite the encouraging efficacy, shares of the biotech tumbled more than 35% at one point as investors focused on high discontinuation rates and gastrointestinal side effects, illustrating the competitive pressures in the crowded obesity drug market.

The trial, called VENTURE-Oral Dosing, met its primary and secondary endpoints, according to the company. Patients on VK2735 achieved statistically significant weight loss compared with placebo (1.3%), with up to 97% of treated patients achieving more than 5% weight loss, and 80% saw more than 10% weight loss, it says.

But safety data curbed investor enthusiasm. While most side effects were mild or moderate gastrointestinal events, discontinuation rates were higher than expected, with up to 38% of patients dropping out at the highest dose versus 18% for placebo, the company says. Nausea affected 58% of patients and vomiting 26%, though both declined after the first few weeks of dosing.

“On efficacy, these are among the strongest oral weight-loss data we’ve seen,” said one financial analyst, “but tolerability remains a question, and investors are signaling they want cleaner safety before viewing Viking as competitive with Eli Lilly and Novo Nordisk.” Analysts noted that VK2735’s efficacy compares favorably with other oral agents in development, and Viking says it will continue advancing both oral and injectable versions of the drug.

The results come as the obesity market is increasingly dominated by Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, which have set a high bar for both injectable and oral therapies. Lilly is also advancing an oral GLP-1 candidate, while Novo Nordisk is working on next-generation formulations.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome