Today, a brief rundown of news involving Summit Therapeutics and Esperion Therapeutics, as well as updates from Axsome Therapeutics and AstraZeneca that you may have missed.
Summit Therapeutics shares fell by 27% Thursday evening on news that its cancer immunotherapy ivonescimab missed statistical significance at an interim check of a closely watched late-stage trial. Last year, Summit revealed plans to conduct an interim analysis in a particular subgroup of patients in that study, a global trial called HARMONi-3 that’s testing ivonescimab and chemotherapy against Merck & Co.’s Keytruda in front-line non-small cell lung cancer. Summit did so to potentially enable a faster path to regulatory approval if the results were clearly positive. On Thursday, though, Summit said ivonescimab missed that mark, and a final analysis will be conducted in the second half of the year. The disclosure amounts to a “self-inflicted narrative complication” leaving some investors to wonder why Summit created a situation that offered “more risk than regulatory upside” in the first place, wrote Stifel analyst Dara Azar.
Esperion Therapeutics is being acquired by healthcare investment firm Archimed in a deal worth up to $1.1 billion. Archimed is paying $3.16 per share in cash, and could add up to $100 million more if certain sales targets are met. The acquisition ends a difficult run in the public markets for Esperion, which brought a cholesterol-lowering pill to market in 2020 but has since struggled to significantly grow sales. Shares once worth over $115 in 2015 closed at $2 on their last trading day before the Archimed deal was announced.
The Food and Drug Administration has expanded use of Axsome Therapeutics' Auvelity, clearing it as a treatment for the agitation that can accompany Alzheimer’s disease. Auvelity was first approved four years ago for major depressive disorder and, since then, sales have steadily climbed to eventually reach $507 million in 2025. Investors were uncertain about a potential clearance in Alzheimer's agitation, though, as Axsome had reported mixed results in testing. Thursday’s approval alleviated those concerns and unlocks a sizable market opportunity. In a note to clients, Mizuho Securities’ Graig Suvannavejh estimated that around 6.5 million people with Alzheimer's in the U.S. experience some form of disease-related agitation and, given a launch price of around $15,000 per patient, Auvelity could reach peak sales of $1.2 billion in that indication in 2038. Axsome shares climbed by double digits on the news.
An FDA advisory committee sided against AstraZeneca’s experimental drug camizestrant in what would be a new kind of treatment setting in breast cancer. AstraZeneca is seeking an OK to administer camizestrant to patients with HR-positive HER2-negative breast cancer once an ESR1 mutation — an alteration that can drive cancer growth — is detected. But the majority of panelists at a Thursday meeting found the evidence supporting camizestrant’s benefits in that setting inconclusive, and weren’t convinced that the findings merited a “change in the treatment paradigm,” wrote Leerink Partners’ Andrew Berens. The FDA usually, but not always, follows the guidance of its advisory panels. AstraZeneca said in a statement that it will “continue to work with the FDA” during the agency’s review. Regulatory filings are also still being evaluated in the Europe, Japan and elsewhere. Camizestrant is part of a new class of oral “SERD” medicines aiming to supplant a widely used, injectable type of hormone therapy.
