Brenipatide

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. Replimunes 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 Replimunes application didnt conclusively prove the drug helps patients. RP1s impact on survival wasnt interpretable, and the study didnt tease out RP1s benefits on tumor responses because it didnt have a control group, FDA staff wrote. The most likely outcome is a negative vote, wrote Leerink Partners analyst Daina Graybosch. Ben FidlerShares 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 Alzheimers 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, thats tied to Alzheimers development. The trial enrolled patients with early Alzheimers disease and should produce 12-month data in the first three months of 2027 Jacob BellRA 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 thatll 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 WuAtea Pharmaceuticals said Tuesday a two-drug combination its 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 Ateas 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 its 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 companys defense, given Ateas chance to be the first new entrant in a neglected but still sizable market. Gwendolyn WuA 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. Altimmunes 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 '