As Q1 earnings roll in, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
While Big Pharma earnings from Eli Lilly, Bristol Myers Squibb and AbbVie have dominated analyst attention for the past few weeks, small- to medium-sized biotechs will begin reporting first quarter earnings in the next week—many with pivotal quarters ahead.
Sarepta Therapeutics, Amylyx and Neumora Therapeutics have all made headlines the past couple of years—for undesirable reasons. All are attempting to right the ship, with Amylyx and Neumora banking at least partly on a pivot to biopharma’s hottest space: obesity. As these three biotechs prepare to report earnings over the next week, analysts are focused on near-term readouts that could make or break a comeback.
Sarepta under pressure but ‘key milestones’ ahead
As Sarepta Therapeutics gears up to report first quarter earnings on Wednesday, the company is “still under pressure” from the deaths of two nonambulatory teenage patients with Duchenne muscular dystrophy (DMD) who were treated with the biotech’s gene therapy Elevidys, Kostas Biliouris, managing director, biotech equity research at Oppenheimer, told BioSpace. However, the company has a few key upcoming milestones “that can help the situation.”
The first, he said, is that Sarepta was expected to file for full FDA approval of DMD exon skippers Amondys 45 and Vyondys 53 by the end of April. The review is expected to take 12 months. The drugs, which Biliouris said generate about 50% of Sarepta’s total sales, are currently marketed under the FDA’s accelerated approval pathway but failed a confirmatory study in November 2025. The company is banking on real-world and safety data from the confirmatory study, suggesting both therapies have a favorable profile, according to a March press release.
The second catalyst, according to Biliouris, is the upcoming readout of a Phase 1b study testing the immunosuppressive regimen sirolimus during Elevidys treatment in 25 patients with DMD who are unable to walk, which he expects to read out in the fourth quarter. After the deaths last year, both linked to liver failure associated with the therapy’s delivery mechanism, Elevidys is no longer indicated for this patient population. The sirolimus regimen is designed to mitigate the risk of acute liver injury and acute liver failure associated with AAV gene therapy.
As nonambulatory patients account for half of all patients with DMD, a return to the market “could potentially double the revenue of Elevidys,” Biliouris said.
Also on the Elevidys front, Sarepta’s partner Roche—which owns the rights to the gene therapy outside the U.S.—announced last month that it will launch a pivotal trial in Europe. This follows a negative recommendation for Elevidys from the European Medicines Agency in July 2025. This decision by Roche is a “very positive signal” for Sarepta, Biliouris said.
“Roche will spend a lot of money and a lot of resources to run a pivotal trial,” he continued, “which means two things. Number one, Roche believes this trial will be positive, otherwise they wouldn’t do it. Number two, importantly, Roche believes that if this trial is positive, physicians will take it, patients will take it.”
Sarepta is set to report first quarter earnings on Wednesday.
Amylyx’s next act
May 7
Amylyx took a seismic hit when amyotrophic lateral sclerosis drug Relyvrio was pulled from U.S. and Canadian markets in April 2024 after it failed a Phase 3 trial. The move—which honored a pledge co-CEOs Josh Cohen and Justin Klee had made to an advisory committee—sent Amylyx’s stock tumbling and around 70% of the company’s employees out the door.
Three months later, Amylyx rebounded in a somewhat surprising pivot. The neurodegenerative-focused biotech announced in July 2024 the acquisition of a Phase 3-ready glucagon-like peptide-1 receptor antagonist, avexitide, from Eiger BioPharmaceuticals. This summer, Amylyx will learn if the diversification gamble was worth it. Pivotal topline data from the Phase 3 LUCIDITY study, which is testing the asset in post-bariatric hypoglycemia, are due in the third quarter, according to Mizuho. Primary completion of LUCIDITY was estimated to be in March, per ClinicalTrials.gov, with study completion expected in October. Mizuho expects “granularity” on the timing of this readout in the company’s Q1 earnings report on May 7, according to an April 29 note to investors.
“We remain bullish on the prospects of AMLX’s lead asset, avexitide,” the analysts wrote.
The firm will also be watching for updates on next steps for Amylyx’s Phase 3 study of AMX0035 in Wolfram syndrome and expectations ahead of biomarker data from a Phase 1 study of AMX0114 in ALS, which Mizuho expects in the first half of this year. The company announced positive long-term results from the Phase 2 open-label Helios trial of AMX0035 in Wolfram in May 2025.
Neumora Therapeutics
May 11 (estimated)
Another neuro-focused biotech aiming to take a bite of the obesity market, Neumora Therapeutics is expecting a couple of key readouts in the second quarter for its lead asset. Topline data from two Phase 3 studies of kappa opioid receptor navacaprant in major depressive disorder, KOASTAL -2 and KOASTAL-3, are expected “likely in mid-to-late June,” according to Mizuho.
“We favor NMRA for its novel pipeline that addresses both neuropsychiatric and neurodegenerative diseases of high unmet need and large commercial opportunity,” the analysts wrote on April 29 ahead of the company’s first quarter results, which Mizuho expects on May 11. “That said, negative first Phase 3 data (from the KOASTAL-1 study) for lead asset navacaprant has re-set expectations (and the stock price).”
In January 2025, navacaprant failed to demonstrate a statistically significant improvement on KOASTAL-1’s primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at 6 weeks. The asset also missed the trial’s secondary endpoint of a change from baseline on the Snaith-Hamilton Pleasure Scale. Neumora’s stock fell from $11 to just over $2 in the aftermath.
Mizuho will be looking for updates on the navacaprant program during Neumora’s Q1 call, which the firm predicts will take place on May 11.
However, Mizuho highlighted “upcoming news flow through 2026 & 2027 for pipeline opportunities” that could “provide opportunities for stock inflection.” The analysts specifically pointed to Phase 1 data for NMRA-215 in obesity. With this asset, Neumora is “proceeding cautiously following a review of preclinical toxicology results,” Mizuho wrote. In October 2025, the biotech reported preclinical data for the asset showing “class-leading weight loss of up to 19% as a monotherapy with semaglutide-like induction and 26% in combination with semaglutide.”
Neumora is developing NMRA-215, a NLRP3 inhibitor that targets neuroinflammation mediated by this inflammasome, for both obesity and Parkinson’s disease.
