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Neumora Reports NMRA-215 Toxicology Results, Plans IND Submission in 2026
Neumora Therapeutics reported pre-clinical toxicology results from NMRA-215, a highly brain-penetrant, oral NLRP3 inhibitor in development for the treatment of obesity and cardiometabolic disease. Neumora conducted a repeat 13-week toxicology study in rats following results from a prior study in which unexpected in-life adverse findings were observed in 5 of 142 animals. The company opened a for-cause audit of that study which revealed various discrepancies resulting in a number of critical audit observations. In a repeat 13-week rat toxicology study in 162 animals, no instances of unexpected in-life adverse findings were observed. Based on the audit observations, the repeat study data and the results from the previously completed 28-day rat, 28-day dog and 13-week dog toxicology studies, Neumora continues to believe the prior adverse findings were not related to NMRA-215 and plans to submit an IND application for NMRA-215 in the fourth quarter of 2026. "The differentiated properties of NMRA-215 enable it to achieve sustained IC90 coverage in the brain which has resulted in compelling pre-clinical efficacy in the diet induced obesity mouse model. NMRA-215 demonstrated class-leading weight loss as a monotherapy, including incretin-like induction, additive weight loss in the combination setting with semaglutide and potential for use as a switch or maintenance treatment. NMRA-215 also improved peripheral biomarkers related to cardiometabolic risk, which has translated to robust decreases in CV risk factors in clinical studies with other NLRP3 inhibitors," said Nick Brandon, chief scientific officer, Neumora. "These data and the toxicology package to date, support advancing NMRA-215 towards the clinic. We eagerly anticipate initiating a clinical study in 2026."
Neumora Discontinues Navacaprant Development as KOASTAL-2 and -3 Studies Fail to Meet Endpoints
Neumora Therapeutics announced that the Phase 3 KOASTAL-2 and -3 studies of navacaprant for the treatment of major depressive disorder did not achieve statistical significance on the primary or key secondary endpoints. The company is discontinuing development of navacaprant as it continues to focus on advancing the rest of its clinical portfolio. The KOASTAL-2 and -3 studies enrolled 430 and 422 adult patients with MDD, respectively. In addition to these topline results, Neumora today announced results from pre-specified analyses of 426 patients from both studies who were enrolled following study optimizations in early 2025. The primary endpoint of both KOASTAL-2 and -3 was change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale. In the KOASTAL-2 study, patients treated with navacaprant 80 mg demonstrated a similar CFB to those treated with placebo. In the KOASTAL-3 study, patients treated with navacaprant 80 mg demonstrated a numerically lower CFB than those treated with placebo. In patients enrolled after study optimizations, patients treated with navacaprant demonstrated a similar CFB to those treated with placebo. Navacaprant was shown to be safe and generally well tolerated with a safety profile consistent with prior studies.
Neumora Completes Full Enrollment of KOASTAL-2 and -3 Studies
"We focused on steady execution during the first quarter, highlighted by the full enrollment of the navacaprant KOASTAL-2 and -3 studies with more than 400 patients per study. We look forward to the topline readout of these studies this quarter," said Paul L. Berns, chairman and chief executive officer, Neumora. "Additionally, we reported the Phase 1b study with NMRA-511 demonstrating an unsurpassed clinical effect in Alzheimer's disease agitation and we remain on track to report data from the MAD expansion cohort in the second half of 2026, with a Phase 2 study anticipated to begin in the first quarter of 2027."
Major Averages Close Mixed as Oil Prices Continue to Rise
The major averages closed mixed, with the S&P 500 and Nasdaq ending lower despite earlier gains, as oil prices keep rising amid continued conflict in the Middle East. Of note, President Trump said the U.S. is in "serious discussions" with Iran to end its military operations. However, he added that if a peace deal is not reached "shortly" and the Strait of Hormuz is not reopened, the U.S. will "conclude our lovely 'stay' in Iran by blowing up and completely obliterating all of their Electric Generating Plants, Oil Wells and Kharg Island (and possibly all desalinization plants!), which we have purposefully not yet 'touched.'" The comments came after the president stated that Tehran had accepted most of the U.S.'s 15-point plan to end the war.Additionally, Federal Reserve chair Jerome Powell said during a discussion at Harvard University that even with rising energy prices, he views inflation expectations as "well anchored beyond the short term." Powell added that he is "optimistic" about the medium- and long-run outlook for the U.S. economy and that the Fed is watching private credit "super carefully."Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:SyscoJetro Restaurant Depot for a total enterprise value of $29.1BUberglobal chauffeur service leader BlacklaneAuriniaKezar Life Sciencesfor $6.955 per share in cash plus a non-transferable contingent value rightTJX'sboard raised itsand said it plans $2.5B-$2.75B of share repurchases for FY27Apollois near a deal to acquire Atlantic Aviation from KKR,2. WALL STREET CALLS:CrowdStriketo Outperform from Peer Perform at Wolfe ResearchExpediato Buy from Hold at JefferiesInstacartto Buy from Hold at JefferiesDole, Nomad Foodsto Hold at Deutsche BankStarbuckswith an Underperform at BNP Paribas3. AROUND THE WEB:JetBluetold CNBC it is increasing bag fees amid soaring fuel pricesGeneral Motorsis moving to a six days per week production schedule at its Flint plant, Reuters saysBanks led by JPMorganare dealing with pushback related to the terms of a $7.2B debt deal to fund Clayton, Dubilier & Rice's takeover of Sealed Air, Bloomberg reportsYouTubeemployees have admitted their goal was "viewer addiction" and shut down proposed safety tools for kids since they did not provide a sufficient return on investment, NY Post saysAn analysis of billions of anonymized credit card transactions by consumer transaction analysis company Indagari indicates that Claude is seeing record growth in paid subscribers, with subscriptions more than doubling this year according to Anthropic, TechCrunch says4. MOVERS:Compass Diversifiedadvanced after announcing it willto Archer for $292.5MiQiyigained in New York afteron HKEXViridiandeclined after announcing results from itsFermiclosed lower afterBoston Scientificfell after Raymond Jamesits rating on the stock5. EARNINGS/GUIDANCE:Alaska AirprovidedUSA Rare Earth, with CEO Barbara Humpton commenting, "2025 was the year that USA Rare Earth set the foundation to execute our integrated rare earth growth strategy"Spirecut itsNeumora Therapeutics, with EPS missing consensusCBAK Energy Technology, with revenue higher year-over-yearINDEXES:The Dow rose 49.50, or 0.11%, to 45,216.14, the Nasdaq lost 153.72, or 0.73%, to 20,794.64, and the S&P 500 declined 25.13, or 0.39%, to 6,343.72.
Major U.S. Indices Rise as Oil Prices Surpass $100
The major averages were broadly higher near noon to start the week following last week's declines. Amid continued conflict in the Middle East and rising energy prices, President Trump said the U.S. is in "serious discussions" with Iran to end its military operations. However, he added that if a peace deal is not reached "shortly" and the Strait of Hormuz is not reopened, the U.S. will "conclude our lovely 'stay' in Iran by blowing up and completely obliterating all of their Electric Generating Plants, Oil Wells and Kharg Island (and possibly all desalinization plants!), which we have purposefully not yet 'touched.'" Following the comments, oil prices are rising once again past the $100 per barrel mark.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:SyscoJetro Restaurant Depot for a total enterprise value of $29.1BUberglobal chauffeur service leader BlacklaneAuriniaKezar Life Sciencesfor $6.955 per share in cash plus a non-transferable contingent value rightSpirewill sell itsto Boardwalk Pipelines for $215M in cashTJX'sboard raised itsand said it plans $2.5B-$2.75B of share repurchases for FY272. WALL STREET CALLS:CrowdStriketo Outperform from Peer Perform at Wolfe ResearchExpediato Buy from Hold at JefferiesInstacartto Buy from Hold at JefferiesDole, Nomad Foodsto Hold at Deutsche BankStarbuckswith an Underperform at BNP Paribas3. AROUND THE WEB:In a recently published report, Morpheus Research says that MakeMyTrip, a $3.5B online travel agency that is sometimes referred to as the "Booking.com of India" with 50% of the Indian OTA market, "openly defies regulators, scams customers, and pads profits through accounting tricksBanks led by JPMorganare dealing with pushback related to the terms of a $7.2B debt deal to fund Clayton, Dubilier & Rice's takeover of Sealed Air, Bloomberg reportsYouTubeemployees have admitted their goal was "viewer addiction" and shut down proposed safety tools for kids since they did not provide a sufficient return on investment, NY Post saysIQM Quantum Computers has secured $57.64M in venture financing from funds managed by BlackRockto accelerate growth, Reuters saysAn analysis of billions of anonymized credit card transactions by consumer transaction analysis company Indagari indicates that Claude is seeing record growth in paid subscribers, with subscriptions more than doubling this year according to Anthropic, TechCrunch says4. MOVERS:Compass Diversifiedincreases after announcing it willbusiness to Archer for $292.5MiQiyigains in New York afteron HKEXViridiandeclines after announcing results from its REVEAL-1 phase 3Fermilower afterBoston Scientificfalls after Raymond Jamesits rating on the stock to Outperform from Strong Buy5. EARNINGS/GUIDANCE:Alaska AirUSA Rare Earth, with CEO Barbara Humpton commenting, "2025 was the year that USA Rare Earth set the foundation to execute our integrated rare earth growth strategy"Spirefor FY27Neumora Therapeutics, with EPS missing consensusCBAK Energy Technology, with revenue higher year-over-yearINDEXES:Near midday, the Dow was up 0.88%, or 395.42, to 45,562.06, the Nasdaq was up 0.29%, or 60.40, to 21,008.76, and the S&P 500 was up 0.48%, or 30.52, to 6,399.37.
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