Amylyx Pharmaceuticals Inc earnings date
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Amylyx Pharmaceuticals Inc (AMLX) Q3 2026 Earnings Report
AMLX Q3 2026 EPS Results
- Actual EPS
- -$0.38
- Consensus EPS
- -$0.38
- Beat/Miss
- Beat by +$0.00
- One Year Ago EPS
- -$0.37
AMLX Q3 2026 Revenue Results
- Actual Revenue
- $0
- Expected Revenue
- $59.00K
- Beat/Miss
- Missed by -$59.00K
- YoY Revenue Growth
- ―
Earnings Announcement Details
- Quarter
- Q3 2026
- Date
- 11/05/2026
- Time
- Before Open
- Conference Call
- Thursday, November 5, 2026
Amylyx Pharmaceuticals Inc's next earnings date is estimated for March 9, 2027, based on past reporting schedules.
Q3 2026 Earnings Call Audio
Q3 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q3 2026 Earnings Call Summary
The call was strongly positive, driven by statistically significant and clinically meaningful phase III LUCIDITY results, a planned NDA submission by year-end, substantial funding, and progress toward a potential 2027 launch. The company also reported positive pipeline and commercial developments. The main negatives were higher operating expenses and the early stage of payer, pricing, label, expanded-access, and certain pipeline discussions.
Management remains on track to submit the avexitide NDA to the FDA by the end of this year, with a potential approval and launch in 2027; it is targeting a 2027 IND filing for AMX0318, expects payer information exchanges to begin in the first quarter of the year, and expects a good concentration up front for launch that will build over time as educational efforts expand. The company estimates approximately 160,000 people living with PBH in the U.S., including approximately 118,000 people estimated to have received Roux-en-Y gastric bypass surgery and approximately 48,000 people estimated to have received sleeve gastrectomy; it also said its estimates are that about 120,000 of the 160,000 currently had Roux-en-Y gastric bypass. Management said it will not give interim EAP numbers, it is too early to discuss persistency rates, and it is little bit early to discuss the specifics on pricing.
- Positive Phase III LUCIDITY ResultsAvexitide met the pre-specified primary endpoint in the phase III LUCIDITY trial, demonstrating a 55% reduction in the composite rate of level two and level three hypoglycemic events compared with placebo, with a P-value of 0.000003. The trial also met all secondary endpoints with consistent, highly statistically significant, and clinically meaningful reductions.
- Favorable Avexitide Safety and Trial CompletionAvexitide was generally well tolerated, the majority of adverse events were mild to moderate, and there were no serious adverse events deemed related to treatment. More than 90% of participants completed the 16-week double-blind treatment period, and all eligible participants entered the ongoing open-label extension.
- Consistent Clinical Development Track RecordLUCIDITY was the sixth clinical trial of avexitide in post-bariatric hypoglycemia, and the company stated that all six trials generated statistically significant results. LUCIDITY was also the largest and longest avexitide study conducted to date.
- NDA Submission on TrackAmylyx stated that it remains on track to submit its avexitide NDA to the FDA by the end of 2026. Avexitide has both Breakthrough Therapy and Orphan Drug designations from the FDA.
- Potential First Approved PBH TherapyThe company is preparing for a potential 2027 approval and launch of avexitide as the first-ever approved treatment for post-bariatric hypoglycemia, a condition for which there are currently no FDA-approved therapies.
- Strong Financial Position After Equity OfferingThe oversubscribed equity offering generated net proceeds of $545 million. Cash and cash equivalents totaled $768 million at the end of September, compared with $251 million at the end of the second quarter. Management stated that the company is well-funded to pursue its goals and potentially enter commercialization in 2027 from a position of financial strength.
- Launch Readiness ProgressAmylyx has transitioned from launch planning to executing its launch readiness roadmap, investing in capabilities, infrastructure, supply, and personnel needed for a potential 2027 launch. The full commercial leadership team is in place, with additional hiring underway across marketing, market access, patient services, and commercial operations.
- Commercial Market OpportunityThe company estimates that approximately 160,000 people in the U.S. are living with post-bariatric hypoglycemia, including approximately 118,000 people who received Roux-en-Y gastric bypass surgery and approximately 48,000 who received sleeve gastrectomy. Repeated claims analyses, survey-based research, and field engagements continued to support these estimates.
- Growing Disease Awareness and Patient IdentificationA dedicated PBH-specific ICD-10 code went into effect in October. Management described this as an important milestone that reflects growing awareness and can support diagnosis and patient tracking over time. The company also reported strong engagement with its Uncover PBH disease-state education campaign among endocrinologists, bariatric surgeons, primary care physicians, patients, and other healthcare professionals.
- Positive Physician and Community ResponseAmylyx reported that physicians reacted positively to the strength of the LUCIDITY data, with endocrinologists describing a significant need for an FDA-approved treatment option. The field medical team has engaged with a substantial number of healthcare professionals, and physicians have proactively sought information about avexitide at conferences and through other interactions.
- Upcoming Medical PresentationThe LUCIDITY results were accepted as a late-breaking oral presentation at the ObesityWeek 2026 annual meeting on November 15. Amylyx also plans to host an in-person and virtual investor event at ObesityWeek focused on the burden of PBH and avexitide data.
- Pipeline Expansion With AMX0318Amylyx is investing in AMX0318, a long-acting GLP-1 receptor antagonist. In preclinical studies, AMX0318 demonstrated strong in vitro potency, evidence of in vivo efficacy and tolerability, and a favorable pharmacokinetic profile consistent with a long-acting peptide. IND-enabling studies are underway and progressing well, with a 2027 IND filing targeted.
- Progress in ALS ProgramThe phase I LUMINA multiple ascending dose trial of AMX0114 in ALS is progressing through dose cohorts. Enrollment in cohort three was completed, cohort four enrollment began at the 100 mg dose level, and data from the initial two cohorts showed that the ASO was well tolerated in people with ALS.
- Additional Research CollaborationAmylyx entered a second research collaboration with Gubra to screen and develop peptide candidates for another rare endocrine disease with high unmet need. The company stated that the program is progressing.
- Positive Data From Other Bariatric Surgery PopulationsAlthough LUCIDITY was conducted in people with PBH following Roux-en-Y gastric bypass surgery, Amylyx stated that a phase IIb study included individuals who had other upper gastrointestinal and bariatric surgeries, and those results were also positive.
AMLX Earnings History
| Report Date | Fiscal Quarter | Forecast / EPS | Last Year's EPS | EPS YoY Change | Press Release |
|---|---|---|---|---|---|
| Mar 09, 2027 | 2026 (Q4) | -0.38- | -0.3 | ― | ― |
| Nov 05, 2026 | 2026 (Q3) | -0.38-0.38 | -0.37 | -2.70% (-0.01) | |
| Aug 06, 2026 | 2026 (Q2) | -0.36-0.39 | -0.46 | 15.22% (+0.07) | |
| May 07, 2026 | 2026 (Q1) | -0.34-0.37 | -0.42 | 11.90% (+0.05) | |
| Mar 03, 2026 | 2025 (Q4) | -0.35-0.30 | -0.55 | 45.45% (+0.25) | |
| Nov 06, 2025 | 2025 (Q3) | -0.44-0.37 | -1.07 | 65.42% (+0.70) | |
| Aug 07, 2025 | 2025 (Q2) | -0.44-0.46 | -1.07 | 57.01% (+0.61) | |
| May 08, 2025 | 2025 (Q1) | -0.47-0.42 | -1.75 | 76.00% (+1.33) | |
| Mar 04, 2025 | 2024 (Q4) | -0.52-0.55 | 0.07 | -885.71% (-0.62) | |
| Nov 07, 2024 | 2024 (Q3) | -0.70-1.07 | 0.3 | -456.67% (-1.37) |
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
