Alkermes (NASDAQ:ALKS) used its presentation at the J.P. Morgan Healthcare Conference to outline its positioning entering 2026, emphasizing a profitable commercial foundation, the advancement of its lead orexin 2 receptor agonist candidate ALKS 2680 into Phase 3 testing, and an expanding pipeline intended to broaden the company’s footprint in neuroscience.
Company overview entering 2026
Chief executive Richard Pops said Alkermes is entering 2026 with what he described as “a very strong foundation for growth and value creation” in both the near and long term. He characterized Alkermes as a profitable neuroscience company with a late-stage candidate and leadership in a new therapeutic category. Pops highlighted three elements of the business: the commercial portfolio, ALKS 2680, and the broader orexin platform.
ALKS 2680: Phase 3 plans and market opportunity
Management centered much of the discussion on ALKS 2680, an orexin 2 receptor agonist being developed for narcolepsy and idiopathic hypersomnia (IH). Pops said the candidate is entering Phase 3 in narcolepsy after completion of what he described as a “vigorous and rigorous” Phase 2 program, and he called ALKS 2680 a potential blockbuster that could advance the standard of care in narcolepsy and IH.
Pops said ALKS 2680 received FDA Breakthrough Therapy designation in late 2025 for narcolepsy type 1 (NT1). In the Q&A, he said Alkermes does not plan to seek separate breakthrough designation for narcolepsy type 2 (NT2), noting the company expects to pursue registration for NT1 and NT2 in the same application.
On market sizing, Pops said Alkermes views the narcolepsy and IH opportunity alone as exceeding $10 billion annually. He cited approximately 200,000 people with narcolepsy in the U.S., with about half diagnosed, and said roughly 80,000 are currently receiving treatment. He added that about 80% of treated patients report residual symptoms. For IH, he referenced claims data suggesting roughly 40,000 diagnosed patients, while also describing a larger undiagnosed population with excessive daytime sleepiness. He pointed to oxybates as the largest branded category, used by about 16,000 to 18,000 patients annually at an average net price of approximately $100,000 per year, generating $1.8 billion in 2024 sales.
Phase 2 Vibrance results and the Phase 3 “Brilliance” program
Pops reviewed the company’s Phase 2 “Vibrance” studies in narcolepsy. He said Vibrance-1 (NT1) and Vibrance-2 (NT2) each enrolled more than 90 patients across more than 40 clinical trial sites worldwide. He said ALKS 2680 demonstrated statistically significant and clinically meaningful improvements in measures of wakefulness and sleepiness, and in NT1, reductions in cataplexy rates. He also highlighted patient-reported outcomes related to fatigue and cognition, which he said were included based on patient input. Pops said ALKS 2680 was generally safe and well tolerated across doses tested, with no safety signals related to adverse cardiovascular events or liver toxicity, and that approximately 95% of patients rolled into a safety extension in both studies.
Addressing market reaction to NT2 data, Pops said some investors misunderstood the Maintenance of Wakefulness Test (MWT) results, describing NT2 as a heterogeneous population in which some patients did not respond on MWT despite improvements on the Epworth Sleepiness Scale (ESS). He said the reported average included both responders and non-responders and did not reflect a single “central tendency” in the way NT1 results do.
Looking ahead, Pops said Alkermes plans to initiate a registrational Phase 3 narcolepsy program in the first quarter of 2026 following an end-of-Phase 2 meeting with the FDA scheduled for the following month. He said the Phase 3 program, branded “Brilliance,” is planned as 12-week randomized, placebo-controlled parallel studies evaluating both once-daily and split-dose regimens. The program is expected to include traditional endpoints such as MWT and ESS, and cataplexy in NT1, along with additional measures intended to capture broader patient experience, including fatigue and cognition.
Pops said the ongoing Vibrance-3 Phase 2 study in IH is enrolling patients and testing three once-daily doses and placebo, and that Alkermes plans to add a split-dose arm and split-dose placebo arm. The primary endpoint is ESS, with IHSS as a key secondary endpoint, and the company expects to complete the IH study in the fourth quarter of 2026.
Orexin platform expansion: ADHD and fatigue programs
Beyond narcolepsy and IH, Pops discussed the company’s view that chronic sleep-wake dysregulation contributes to a range of conditions, including psychiatric disorders, neurologic disease, and cardiometabolic disease, with fatigue as a common symptom across chronic illness.
He outlined a sequencing strategy that begins with ALKS 2680 in narcolepsy and IH and then advances two additional orexin candidates now in Phase 1 studies in healthy volunteers:
- ALKS 7290 (ADHD): Pops said the company plans to advance 7290 into adult ADHD patients in 2026, aiming for proof-of-concept data quickly. He cited preclinical models showing improvements in attention and task engagement and decreased impulsivity. He said single-ascending dose cohorts are underway, multiple-ascending dose cohorts are expected to begin in coming weeks, and a multi-dose Phase 1b study in adult ADHD is expected to yield data in the second half of 2026. He also said Alkermes expects to initiate a larger Phase 2 study in the second half of 2026.
- ALKS 4510 (fatigue in neurodegenerative disease): Pops said Alkermes plans to develop 4510 in fatigue associated with multiple sclerosis and Parkinson’s disease, describing fatigue as a broad opportunity. He cited an estimate that approximately 35 million Americans reported feeling very tired or exhausted every or most days over the prior three months, and he referenced patient populations of approximately 1 million people in the U.S. with MS and another 1 million with Parkinson’s disease. He said 4510 has completed several single- and multiple-ascending dose cohorts in Phase 1 and that Alkermes plans to initiate a Phase 2a study in 2026 in MS and Parkinson’s patients.
In response to questions about class safety, Pops said earlier orexin agonists were not optimized and had issues including cardiovascular liability, and that a liver liability seen in one entrant was molecule-specific. He said ALKS 2680 and Takeda’s compound have generally been safe and well tolerated, with polyuria and transient insomnia described as on-target effects. He also said 7290 and 4510 are “cousins” of ALKS 2680, while noting that any molecule can have idiosyncratic toxicities.
Commercial portfolio and Avidel acquisition plans
Pops reiterated that Alkermes’ commercial business includes proprietary products in addiction and psychiatry: Vivitrol (opioid and alcohol dependence), Lybalvi (schizophrenia and bipolar I disorder), and Aristada (long-acting injectable for schizophrenia). He said Lybalvi is “growing beautifully,” referenced four-year data, and said it is increasingly part of conversations around improving schizophrenia outcomes. For Aristada, he said growth slowed after COVID but has reestablished growth and remains on patent for a long time.
On Vivitrol, Pops said there are “more error bars” as the company moves into 2027 due to an approved Teva ANDA, which he described as the only approved ANDA in that space. He said Alkermes sees Vivitrol persisting into the 2030s with only a single additional player, but expects to evaluate a range of potential outcomes in 2027.
Regarding Avidel, Pops said the planned acquisition would add Lumryz, an FDA-approved narcolepsy medicine approved in 2023 that he described as growing through its launch and as the only once-nightly oxybate in the marketplace. He said the transaction is expected to be accretive and enhance profitability in 2026 and would be financed in part with cash on hand plus new debt, with no Alkermes stock used. Pops said Avidel shareholders approved the transaction earlier in the week and the company expects to close later in the quarter. He also cited Lumryz as having generated $390 million in cumulative sales since launch and approximately $250 million in trailing 12-month sales.
Conference moderators noted that Q&A related to the pending transaction was restricted due to J.P. Morgan’s involvement.
About Alkermes (NASDAQ:ALKS)
Alkermes plc is a biopharmaceutical company focused on developing innovative medicines to address unmet needs in the central nervous system (CNS). The company applies its proprietary drug delivery technologies and therapeutic expertise to advance treatments for addiction, schizophrenia, bipolar I disorder and depression. Alkermes’ portfolio includes both commercial products and a pipeline of investigational therapies designed to improve patient outcomes and support long-term disease management.
Alkermes’ commercial franchise features several approved products.
