Milvexian

Data from a closely watched study evaluating Bristol Myers Squibbs mind-stabilizing medicine Cobenfy in patients with Alzheimers disease could now come a year later than expected.In late July, Bristol Myers executives said they were reviewing the companys near-term clinical trials to ensure the timely delivery of results with the highest probability of success. The review included ADEPT-2, a late-stage experiment exploring whether Cobenfy, which is already used to treat schizophrenia, may also have positive effects on the moderate to severe psychosis that often accompanies Alzheimers.On Wednesday, Bristol Myers disclosed that it had identified irregularities in the way the study was conducted at a small number of sites. This discovery prompted the company to not only exclude patient data from those sites for the studys primary analysis, but, after consulting with the Food and Drug Administration, also bring in an independent party to assess the data that had been collected.Based on that partys findings, a data monitoring committee recommended the trial keep going and enroll more participants so as to hit its original target. Bristol Myers is following this advice. ADEPT-2 had recruited around 400 patients across 119 locations, according to its listing on a federal database of clinical trials.The company now expects results to come by the end of 2026.Our decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies, said Laura Gault, head of Bristol Myers neuroscience drug development, in a statement.On Wall Street, the hope was that ADEPT-2 would produce results before the end of this year. The readout is highly anticipated by investors, according to William Blair analyst Matt Phipps, in part because of the size of the market opportunity. Roughly 7 million people in the U.S. have Alzheimers and, though estimates vary widely, its generally thought that between a quarter and a half experience related psychosis.Clinical delays typically lead to stock sell-offs. Shares of Bristol Myers, however, were up almost 5% by mid-morning Wednesday, to trade at $50.60 apiece.To Phipps, investors may be seeing the go-ahead from the FDA and data monitoring committee as a good sign, suggesting the trial data shows at least some positive trends. [I]f there was no signal, why bother increasing enrollment? he wrote in a note to clients.Carter Gould, of the investment firm Cantor Fitzgerald, appears to hold a less-optimistic view. He expects the stock gain is presumably because a no news or delayed news is better than negative results. That may work in the near-term, Gould wrote in his own note, though we would argue this update stops far short of de-risking Cobenfy in Alzheimers psychosis or Bristol Myers broader growth profile.While theres clearly a scenario whereby ADEPT-2 could still [succeed], none of this suggests an overwhelmingly positive result, and all of our past issues with this trial and setting remain, he added.Prior to Wednesday, Bristol Myers shares had fallen 15% from the start of the year. The pharmaceutical giant is set to lose patent protection on its two top-selling drugs the blood thinner Eliquis and the cancer immunotherapy Opdivo over the next couple years. Efforts to offset those looming losses have been mixed.Last month, Bristol Myers stopped early the first of three late-stage studies testing an experimental anticoagulant its been co-developing with Johnson & Johnson. The partners have pegged this drug, milvexian, as a potential multibillion-dollar product. Bristol Myers has also reported stumbles this year in heart disease and a type of anemia.Cobenfy is another growth product for Bristol Myers, though it, too, suffered a recent setback. In April, a 400-person schizophrenia study found it not significantly better than a placebo as an add-on treatment to atypical antipsychotics. Sales of Cobenfy across the first nine months of this year totaled $105 million.Two other large trials, titled ADEPT-1 and ADEPT-4, are appraising the drugs use in Alzheimers psychosis, and should deliver data next year. '

Analysts said new data on Bayer’s oral FXIa inhibitor asundexian “provide new confidence that FXIa inhibition can lead to meaningful improvements.\"\n Bayer’s oral FXIa inhibitor asundexian has significantly reduced the risk of stroke in a phase 3 trial, giving a boost to a potentially blockbuster mechanism that has suffered setbacks over the past two years.Germany’s Bayer stopped a phase 3 trial of asundexian in patients with atrial fibrillation two years ago after an interim look at the data suggested the molecule was less effective than Bristol Myers Squibb and Pfizer’s Eliquis. Earlier this month, BMS and Johnson & Johnson took a similar action, stopping a phase 3 trial of their rival oral FXIa inhibitor in acute coronary syndrome patients early for futility. Bayer broke the losing streak Sunday, reporting that a phase 3 trial of asundexian for secondary stroke prevention (SSP) met its primary efficacy and safety endpoints. The trial randomized patients who had experienced a non-cardioembolic ischemic stroke or high-risk ischemic attack to receive asundexian or placebo, both in combination with antiplatelet therapy.The risk of stroke was significantly lower on asundexian than on placebo, achieving the study’s primary efficacy endpoint. Asundexian reduced the stroke rate without increasing the risk of major bleeding, the trial’s primary safety endpoint. Bayer plans to talk to regulators in preparation for seeking approval of the drug candidate. Shares in Bayer climbed 10% to 30.28 euros ($34.91) in early trading in Germany. The potential for FXIa inhibitors to stop the formation of clots without raising the risk of bleeding is key to the pitch for the mechanism. Bayer and BMS have bet big on the idea that disentangling thrombosis from hemostasis can match or beat the efficacy of existing drugs while improving the safety profile. Delivering that profile could mitigate the arrival of off-patent rivals to Bayer’s Xarelto and BMS’ Eliquis. Guggenheim analysts said in a note to investors early this month that they had “limited enthusiasm” for Bayer’s stroke readout. But, with Bayer bucking the trend and racking up a phase 3 win, BMO Capital Markets analysts said Sunday that the data “provide new confidence that FXIa inhibition can lead to meaningful improvements in anticoagulation without sacrificing safety risks through increased bleeding.”Bayer is yet to share any numbers from the stroke trial. BMO analysts flagged “the relative contribution of treatment and the degree to which treatment benefit is clinically meaningful” as factors to look out for when Bayer presents the full data. The analysts said Bayer’s data are positive for BMS and J&J’s rival FXIa agent milvexian. While milvexian recently failed one trial, BMS and J&J are continuing to study the asset in SSP and afib. BMS has named afib as the big commercial opportunity. While Bayer has already fallen short in afib, the phase 3 SSP win gives it a shot at sparking growth at a pharma unit that currently has stagnant sales.