Pharmaceutical Industry Update: Key Developments in Drug Development and Corporate Strategy

BioAge Labs Discontinues Obesity Drug, Shifts Focus

BioAge Labs has announced the discontinuation of azelaprag, the obesity drug that was central to its $198 million initial public offering last year. The company halted Phase 2 testing in December due to safety concerns. Originally licensed from Amgen, azelaprag was positioned as a potential solution for preserving muscle mass in patients taking popular weight loss drugs like Zepbound and Wegovy.

In response to this setback, BioAge is pivoting its strategy. The company is now developing new, "structurally distinct" drugs targeting the same pathway as azelaprag, with plans to nominate a candidate for development next year. Additionally, BioAge expects to initiate human trials this year for a drug designed to treat diseases associated with neuroinflammation.

Akero and 89bio Capitalize on Promising MASH Data

Akero Therapeutics and 89bio have successfully raised a combined $600 million in stock offerings following positive study results from Akero. The Phase 2 trial demonstrated that Akero's drug reversed liver damage in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Akero's shares doubled on the news, while 89bio, which is developing a similar drug, saw its stock price climb nearly 40%. Capitalizing on this momentum, Akero secured $350 million in funding, while 89bio raised $250 million.

Roche Reports Positive Survival Data for Breast Cancer Drug

Roche has announced that its breast cancer drug Itovebi, when used in combination with hormone therapy and Pfizer's Ibrance, demonstrated extended survival compared to the latter two drugs alone in a Phase 3 trial. Itovebi received approval in October for treating HR-positive, HER2-negative breast tumors with PIK3CA mutations.

While the initial approval was based on the drug's ability to delay disease progression, these updated results reveal a "statistically significant and clinically meaningful" impact on overall survival. Detailed findings are expected to be presented at an upcoming medical meeting.

Corporate Restructuring and Regulatory Challenges

Allakos has announced a significant workforce reduction, laying off 75% of its employees following the failure of its lead experimental drug, AK006, to show "therapeutic activity" in early testing for chronic urticaria. This marks the second major reset for the company in two years, with only about 15 employees retained to explore "strategic alternatives."

Meanwhile, Vanda Pharmaceuticals is challenging the FDA's rejection of its experimental gastroparesis drug. The company has accepted the agency's offer for a hearing, which it claims must occur within 120 days by law. Vanda has expressed hope that the FDA will adhere to this statutorily mandated timeframe, marking a potential departure from prior practices.