Pharmaceutical Industry Roundup: AstraZeneca's Pricing Deal, Novo Nordisk's Setbacks, and Novavax's Uncertain Future

AstraZeneca Strikes U.S. Drug Pricing Agreement

AstraZeneca has become the second major pharmaceutical company to reach a drug pricing agreement with the Trump Administration. Following Pfizer's recent deal, AstraZeneca has agreed to sell its drugs to Medicaid at a discount and participate in a new government website offering lower cash prices for medications. The agreement also delays potential tariffs on AstraZeneca drugs by three years. This move, while significant for government programs, does not affect those with commercial insurance or those who don't pay out of pocket.

Novo Nordisk Faces Manufacturing Challenges and Restructuring

Novo Nordisk is grappling with multiple challenges, including regulatory issues and a major restructuring effort. The FDA has issued an "official action indicated" letter for the company's Indiana manufacturing plant, rendering it out of compliance. This development has impacted multiple biotechnology companies using the facility, including Scholar Rock and Regeneron Pharmaceuticals, potentially delaying drug approvals and label expansions.

In a separate development, Novo Nordisk is reportedly shuttering its cell therapy division as part of a larger reorganization under new CEO Maziar Mike Doustdar. This move will result in 250 layoffs and the discontinuation of a high-profile project aimed at curing Type 1 diabetes. The company is now seeking partners to further develop its innovations in this area.

Novavax Under Pressure as Major Shareholder Pushes for Sale

Novavax, a vaccine developer struggling to maintain its market position, is facing pressure from one of its largest shareholders to sell the company. Shah Capital, owning 7.2% of Novavax's stock, has called for an "immediate formal strategic review" and sale, citing a series of missteps leading to "persistent underperformance" and "continued destruction of shareholder value." The firm argues that Novavax's assets would have "far greater upside potential in the hands of a large capable pharma entity." This comes as Novavax shares have plummeted from their pandemic-era peak of nearly $300 to a fraction of that value.

Clinical Trial Setbacks and Regulatory Updates

Tvardi Therapeutics experienced a significant setback as its shares fell more than 80% following negative results from a mid-stage study of its lead drug for idiopathic pulmonary fibrosis (IPF). The study, which tested the drug alone and in combination with the approved medication Ofev, failed to meet its goals. CEO Imran Alibhai cited the "limited data set, high variability within treatment arms, and unexpected performance of the placebo arm" as factors complicating the interpretation of the results.

Meanwhile, Denali Therapeutics faces a potential delay in the FDA's approval decision for its rare disease therapy targeting Hunter syndrome. The agency has requested additional clinical pharmacology information, extending the review process by three months to April 5. Despite this setback, Denali continues to prepare for the potential approval and commercial launch of the therapy.