Today, a brief rundown of news involving Replimune and ProMIS Neuroscience, as well as updates from RA Capital, Atea Pharmaceuticals and Altimmune that you may have missed.
Replimune shares plummeted nearly 40% after the publication of documents suggesting that Food and Drug Administration scientists are still skeptical of the data supporting its experimental melanoma treatment. Replimune’s therapy, “RP1,” has twice been rejected by U.S. regulators. But the company in late May forged ahead with a third approval attempt following what it claimed to be “productive” talks with the agency — and, reportedly, White House intervention. An advisory panel will evaluate RP1 at a meeting on Thursday, and ahead of it, FDA reviewers claimed in briefing documents that the key study supporting Replimune’s application didn’t conclusively prove the drug helps patients. RP1’s impact on survival wasn’t “interpretable,” and the study didn’t tease out RP1’s benefits on tumor responses because it didn’t have a control group, FDA staff wrote. The “most likely outcome” is a negative vote, wrote Leerink Partners analyst Daina Graybosch.— Ben Fidler
Shares of ProMIS Neuroscience were up as much as 47% Tuesday as early clinical trial results hinted that the Boston-area biotechnology company may have a promising drug for Alzheimer’s disease. According to ProMIS, a six-month interim look at data from 136 participants in the Phase 1 study showed no cases of a type of brain swelling known as ARIA-E. This swelling is a major concern for drugs like ProMIS’, which are designed to bind to and neutralize toxic forms of a protein, “amyloid beta,” that’s tied to Alzheimer’s development. The trial enrolled patients with early Alzheimer’s disease and should produce 12-month data in the first three months of 2027 — Jacob Bell
RA Capital Management has found a target for its third “SPAC” deal. On Monday, its latest blank-check company announced a deal to merge with, and take public, biotech startup Oak Hill Bio. Oak Hill is developing an antisense oligonucleotide drug, rugonersen, for the rare genetic disorder Angelman syndrome — the target of Ultragenyx and Ionis Pharmaceuticals treatments that are nearing pivotal study readouts. Oak Hill licensed the therapy from Roche and has since brought it to a late-stage trial that’ll be funded by the SPAC merger and a concurrent $100 million private funding deal. Once the merger closes, Oak Hill will begin trading on the Nasdaq stock exchange under the ticker symbol “OAKH.” — Gwendolyn Wu
Atea Pharmaceuticals said Tuesday a two-drug combination it’s been developing was statistically non-inferior to Epclusa, a medicine for chronic hepatitis C infections, in a Phase 3 trial. According to Atea, 93.9% of patients on Atea’s regimen of bemnifosbuvir and ruzasvir had no detectable virus in their blood after six months, versus 94.8% of patients on Epclusa. That result marks the first success for any company in a head-to-head trial in hepatitis C, and proves “not only that it’s possible” to run such a trial, but get “strong” results even in “challenging modern populations,” wrote Evercore ISI analyst Jonathan Miller in a client note. Shares of Atea, which is pitching its regimen as an easier-to-take alternative to existing medications, fell by about 6%. But Miller rushed to the company’s defense, given Atea’s chance to be the first new entrant in a “neglected but still sizable market.” — Gwendolyn Wu
A dual-acting cardiometabolic drug from Altimmune showed promise treating people with alcohol use disorder, according to study results unveiled Tuesday. After six months, trial participants taking 2.4 milligrams of pemvidutide reported a mean reduction of 4.2 heavy drinking days per week, compared to a 2.8 day-reduction for those on placebo. Altimmune’s drug showed “unequivocal clinical benefits” and a potentially “more robust clinical profile” than a short course of low-dose semaglutide, wrote William Blair analyst Andy Hsieh. But Altimmune is also well behind Eli Lilly, which is testing its experimental medicine brenipatide in two late-stage studies in the same indication. Hsieh believes Altimmune will “require additional capital” to fund such trials of pemvidutide. — Gwendolyn Wu