Alixorexton

iStock, siraanamwong Pharma is definitely interested in making more deals. But what biotechs will come under the magnifying glass? BioSpace takes a look at companies that analysts see as near-term targets for buyouts. Where one deal occurs, others follow. That’s the theme emerging as analysts parse potential M&A targets with the biopharma deal environment heating up. With a strong return to M&A in the first half, most experts agree we’re going to see plenty more deals to come. Despite the flood of recent deals, Big Pharmas are still facing tough patent expiries and appear to have a lot of cash to spend, H.C. Wainright wrote in a June 29 note. Buyers are especially seeking companies with assets in MASH, rare disease, immunology, oncology and central nervous system (CNS) disorders, following on other deals in these disease areas. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Wainright flagged Beam Therapeutics, Immunocore and psychedelics drug developer AtaiBekley as potential targets at the time. The latter, of course, went on to be acquired by Eli Lilly for $3.8 billion a few weeks later. Below, BioSpace takes a look at biotechs that analysts see as potential targets for M&A, from sleep disorder biotech Alkermes to CAR T icon Legend Biotech. Psychedelics Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst cautioned, however, that the transaction should not be seen as “supporting a uniform re-rating of every psychedelic developer.” July 20, 2026 · 3 min read · Heather McKenzie Read more Alkermes Thanks to Eli Lilly’s $6.3 billion acquisition of Centessa Pharmaceuticals in March, Alkermes is looking like a strong next bet in the sleep market, according to a July 19 note from Stifel. Centessa’s lead asset was cleminorexton, an oral orexin receptor 2 (OX2R) agonist being trialed for narcolepsy types 1 and 2 as well as idiopathic hypersomnia (IH). Orexin is a key neuropeptide that regulates the sleep-wake cycle; drugs that activate the pathway could help address excessive daytime sleepiness as well as improve attention, cognition and fatigue. The orexin class has pipeline-in-a-product potential that is drawing significant M&A interest, Leerink said in a July 19 note covering other activity in the space. Alkermes is one of the companies on the forefront of the orexin class. The company is expecting a Phase 2 readout for its lead asset, alixorexton, in IH in the fourth quarter. Experts told Stifel that IH could be the next big thing in the insomnia market behind narcolepsy. Layoffs Spurred by deep cuts and M&A activity, H1 layoffs could oust 14,000+ in biopharma Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac. July 16, 2026 · 6 min read · Angela Gabriel Read more A win in these studies could also suggest a future for the drug class in non-sleep indications like attention deficit hyperactivity disorder (ADHD), the firm wrote. “There’s reasons for optimism that this could show real proof-of-concept and increase excitement for the orexin class beyond sleep,” Stifel said. In this vein, Alkermes is also developing the orexin ALKS 7290, with Phase 1b data from 50 patients with ADHD expected in the fourth quarter. A Phase 2 will likely follow in 2027 with 300 adults. After all was said and done, the Centessa deal amounted to a value of just under $8 billion. Alkermes’ current market cap slightly tops that, at $9 billion, according to Stifel. The company has four approved medicines in the neuro space already, Lybalvi, Aristada, Vivitrol and Lumryz. “Alkermes offers an opportunity to participate in the new/exciting OX2R class, but with a meaningful floor value that offers downside protection,” Stifel wrote. Dyne Therapeutics If you ask analysts, Alnylam Pharmaceuticals needs to make an acquisition. The RNAi specialist cut $200 million off its full-year guidance when reporting second quarter earnings last week, losing $10.8 billion in market cap in the process as investors reeled. Oppenheimer believes that neuromuscular disease biotech Dyne Therapeutics could be a natural fit, according to a July 16 note. The company is awaiting a January 2027 decision from the FDA on the approval of exon skipper zeleciment rostudirsen (z-rostudirsen) for Duchenne muscular dystrophy, with a confirmatory Phase 3 trial underway. If approved, the therapy could tap into a $700 million market opportunity, according to Jefferies. The biotech’s pro risen as competitors like Avidity Biosciences have produced positive data, according to Oppenheimer. Avidity was bought by Novartis last year for $14.6 billion, showing that Big Pharma is willing to spend big cash for neuromuscular disease assets . Dyne recently received the FDA’s go ahead to advance the siRNA therapy DYNE-302 into human trials for facioscapulohumeral muscular dystrophy (FSHD). Avidity’s RNA therapy delpacibart braxlosiran (del-bax) provided early validation for Novartis’ gambit with positive biomarker data in FSHD that was released in June 2026. Both therapies target the DUX4 gene. Mergers & acquisitions ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year. August 3, 2026 · 3 min read · Annalee Armstrong Read more FSHD could be even bigger than DMD. Jefferies predicts the market to be worth about $3 billion, according to a July 30 note. With competitors set to read out trials in the indication in the second half, Jefferies sees this as a key period to “help frame DYN’s differentiation.” “DYN is becoming an attractive platform play,” the firm wrote. First Tracks Biotherapeutics Another company to benefit from deals elsewhere is First Tracks Biotherapeutics, a clinical-stage immunology biotech that is firmly entrenched in a pharma hot spot. Argenyx helped buoy First Tracks with the $2.2 billion takeout of rival Forte Biosciences earlier this month. Argenyx specifically highlighted the early performance of Forte’s CD122 therapy FB102 in vitiligo and celiac disease. But First Tracks has something better, according to Leerink Partners. The biotech’s CD122 candidate ANB033 binds to a different isotope than FB102 does and has shown better potency in animal testing. First Tracks’ asset also offers subcutaneous administration, whereas FB102 is delivered via IV infusion. Forte is also singularly focused on FB102, whereas First Tracks has a small pipeline beyond CD122. It includes ANB101 for inflammatory diseases and rosnilimab, which has shown positive Phase 2 results in rheumatoid arthritis, according to Leerink. “We view IL-15/CD122 antagonism is emerging as a new immunology & inflammation (I&I) class which has the potential to address several diseases with significant unmet need, implying ‘pipeline in a product’ potential,” the firm wrote in a July 27 note. Mergers & acquisitions Biopharma strikes 50+ M&As deals in H1, led by Lilly’s $25B spend The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back. July 1, 2026 · 1 min read · Annalee Armstrong Read more Legend Biotech With Big Pharmas snapping up biotechs in the CAR T space—see Sail Biomedicines below or Gilead Sciences’ $7.8 billion buy of Arcellx —analysts see Legend Biotech as having one of the strongest pipelines in the space. Last month, Legend revealed a readout for the in vivo CAR T therapy LB2501 in non-Hodgkin lymphoma that Oppenheimer analysts called “best case scenario.” The therapy showed a clean safety pro efficacy that “stacked up well” to other modalities currently at use in the disease, the analysts wrote in a June 2 note. Oppenheimer noted that Kelonia Therapeutics was acquired by Eli Lilly for $7 billion just four months after presenting similarly exciting data last year. “Positive in vivo CART data strengthens chances of LEGN acquisition in our view,” Oppenheimer wrote. “LEGN is perhaps (one of) the most advanced-stage in vivo CART companies that is currently available for acquisition/partnership.” Legend is already well known for Carvykti, which it markets with Johnson & Johnson for two types of multiple myeloma. The therapy booked $597 million in sales for the first quarter of the year, a 62% increase over the same period a year before, according to Legend’s first quarter earnings report . Mergers & acquisitions BIO 2026: Forget dual track—biopharma deals are more complex than ever Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire. June 25, 2026 · 5 min read · Annalee Armstrong Read more Others acquired in the space include earlier-stage biotechs Capstan Therapeutics (AbbVie) for $2.1 billion and Orbital Therapeutics (Bristol Myers Squibb) for $1.5 billion. Legend is going through some growing pains at the moment. CEO Ying Huang stepped down last week to be replaced on an interim basis by Alan Bash, who currently leads the company’s Carvykti business unit. Oppenheimer said that Huang has deep experience in the space but investors have nevertheless been dissatisfied. “We believe the new CEO, and their interactions/board alignment, will be critical to turning the story around ahead of Anito-cel market entry in December and potential M&A discussions,” the firm said on July 27. Sail Biomedicines We know that Johnson & Johnson wants to buy Sail Biomedicines. The healthcare giant secured the right to acquire the Flagship Pioneering biotech for $2.58 billion down the line as part of a larger immunology research partnership that was revealed last week . The research portion of the deal involved $785 million in initial payments, including a $465 million equity investment. But the big question is when. Leerink Partners pointed out on July 29 that the deal could happen soon, since J&J’s press release noted that the agreement could dilute its shares this year or early next. In the meantime, the new partners will work on Sail’s lead program SAIL-0839, an in vivo CAR T cell therapy that targets CD4+ and CD8+. Sail emerged in October 2023 when Flagship folded two of its entities —Laronde and Senda Biosciences— into one company to work on programmable medicines. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

— First Long-Term Study of an Orexin 2 Receptor Agonist to Demonstrate Sustained Clinically Meaningful Improvements in Wakefulness and Excessive Daytime Sleepiness for Up to Nine Months in Narcolepsy Type 1 and Type 2 — — Improvements in Patient-Reported Cognition and Fatigue Were Also Sustained — — Alixorexton Was Generally Well Tolerated at All Doses Tested — DUBLIN--(BUSINESS WIRE)-- Alkermes plc (Nasdaq: ALKS) today announced results from a planned interim analysis of the ongoing long-term extension (LTE) study evaluating alixorexton in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Across all dose groups in both NT1 and NT2 participants, alixorexton demonstrated sustained clinically meaningful improvement from baseline 1 on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week 24 of the LTE, approximately nine months after the first dose for participants treated with alixorexton in the randomized double-blind period of the Vibrance-1 and Vibrance-2 phase 2 studies. Alixorexton also demonstrated sustained and clinically meaningful improvement from baseline across patient-reported outcomes (PROs) evaluating cognition and fatigue at week 24. Alixorexton was generally safe and well tolerated at all doses tested. Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, NT2 and idiopathic hypersomnia (IH). “For people living with narcolepsy, symptom burden extends beyond excessive daytime sleepiness and can affect cognitive function and fatigue. It is exciting to see clinically meaningful improvements sustained across these important measures in this analysis of the long-term extension study of alixorexton in patients with narcolepsy type 1 and type 2. The consistency of the data in up to nine months of treatment provides further evidence that alixorexton, across a range of doses, has the potential to address important aspects of disease burden of narcolepsy regardless of narcolepsy type 1 or type 2 diagnosis,” said Yves Dauvilliers, M.D., Ph.D., Professor of Neurology and Physiology, and Director of the Sleep-Wake Disorders Center at the University of Montpellier, France, and Coordinator of the French National Reference Center for Rare Diseases dedicated to narcolepsy and hypersomnias. This ongoing open-label extension study is designed to evaluate the long-term safety, tolerability and durability of treatment effect of alixorexton. This interim analysis reflects safety and tolerability data as of the May 12, 2026 data cutoff and efficacy measures collected at week 24 of the LTE for participants who enrolled in the LTE after completing Vibrance-1 (NT1) or Vibrance-2 (NT2), reflecting treatment with alixorexton for up to nine months. The LTE remains ongoing and is open for enrollment for participants who complete ongoing phase 2 and phase 3 studies of alixorexton. Narcolepsy Type 1 As previously announced , in the Vibrance-1 phase 2 parent study, alixorexton demonstrated statistically significant and clinically meaningful improvements in wakefulness and cataplexy in participants with NT1 (n=92) randomized to receive a once-daily dose of alixorexton (4 mg, 6 mg or 8 mg) or placebo. Approximately 85% of Vibrance-1 participants (n=78) enrolled in the LTE. Dose adjustment was allowed during the first four weeks of the LTE, with most participants receiving 6 or 8 mg as their most frequent dose. As of the data cutoff, approximately 90% (n=70) of these participants remained on treatment. Endpoints Evaluating Durability of Effect in NT1 Participants 3, 4 All alixorexton dose groups for NT1 achieved normative wakefulness on the MWT (mean sleep latency (MSL) ≥20 minutes) at week 24 of the LTE, with a mean observed MSL of approximately 29 minutes across LTE participants. Improvements in ESS 2 from baseline were sustained in the normal range (a score of ≤10) for all doses tested throughout the LTE, with a mean observed ESS of 7.5 at week 24 across LTE participants. Alixorexton demonstrated improvements from baseline on weekly cataplexy rate (WCR) at all LTE assessment timepoints. At week 24, the median WCR across LTE participants was 2. Durability of Effect in NT1 Participants 4 mg 6 mg 8 mg Most frequent dose in the LTE n=4 n=24 n=50 Mean Observed MSL on MWT 3 (minutes) At Baseline 1 1.7 2.2 3.4 At Week 24 of LTE 35.3 30.7 28.1 Mean Observed ESS 4 At Baseline 1 19.0 19.0 18.4 At Week 24 of LTE 4.3 7.0 8.1 Median WCR 4 At Baseline 1 19.8 18.2 15.8 At Week 24 of LTE 6.0 1.2 4.0 Exploratory Endpoints in NT1 Participants: Cognition and Fatigue Improvements from baseline in exploratory PROs evaluating cognition and fatigue were generally maintained across dose groups in the LTE. At week 24, most NT1 participants across all doses had cognitive functioning scores within the normal range, as measured by the British Columbia – Cognitive Complaints Inventory (BC-CCI) 5 , and mean fatigue scores were within the normal range, as measured by PROMIS-Fatigue 6 , across all doses. Prior to treatment with alixorexton in the parent study, participants reported mean scores of moderate cognitive impairment and fatigue. Safety in NT1 Participants Alixorexton was generally safe and well tolerated across all doses tested in the LTE. No serious treatment-emergent adverse events (TEAEs) were reported. Most TEAEs were mild to moderate in severity. The most common TEAEs 7 in the LTE were headache, micturition urgency, pollakiuria, and nasopharyngitis. Narcolepsy Type 2 As previously announced , in the Vibrance-2 phase 2 parent study, alixorexton demonstrated statistically significant and clinically meaningful improvements in wakefulness in participants with NT2 (n=93) randomized to receive a once-daily dose of alixorexton (10 mg, 14 mg or 18 mg) or placebo. Approximately 70% of Vibrance-2 participants (n=63) enrolled in the LTE. Dose adjustment was allowed during the first four weeks of the LTE, with most participants receiving 14 or 18 mg as their most frequent dose. As of the data cutoff, approximately 80% (n=51) of these participants remained on treatment. Endpoints Evaluating Durability of Effect in NT2 Participants 3,4 All alixorexton dose groups for NT2 demonstrated further improvement on the MWT at week 24 of the LTE, with mean observed MSL of approximately 18 minutes across LTE participants. Improvements in ESS were sustained in the normal range (a score of ≤10) for the 14 mg and 18 mg dose groups throughout the LTE. Across LTE participants, the mean observed ESS was 8.9 at week 24. Durability of Effect in NT2 Participants 10 mg 14 mg 18 mg Most frequent dose in the LTE n=3 n=25 n=34 Mean Observed MSL on MWT 3 (minutes) At Baseline 1 2.0 4.8 5.2 At Week 24 of LTE 8 21.1 18.0 17.3 Mean Observed ESS 4 At Baseline 1 16.7 16.8 18.1 At Week 24 of LTE 12.5 8.1 9.3 Exploratory Endpoints in NT2 Participants: Cognition and Fatigue Improvements from baseline in exploratory PROs evaluating cognition and fatigue were generally maintained in NT2 participants across dose groups in the LTE. At week 24, most NT2 participants across all doses had cognitive functioning scores within the normal or mild range, as measured by the BC-CCI 5 , and mean fatigue scores were within the normal range, as measured by PROMIS-Fatigue 6 , across all doses. Prior to treatment with alixorexton in the parent study, participants reported overall mean scores of moderate cognitive impairment and fatigue. Safety in NT2 Participants Alixorexton was generally safe and well tolerated across all doses tested in the LTE. No serious TEAEs were reported. Most TEAEs were mild to moderate in severity. The most common TEAEs 7 in the LTE were insomnia, headache, pollakiuria, and upper respiratory tract infection. “These long-term results represent a significant contribution to our understanding of alixorexton as a potential new treatment option for patients with narcolepsy. We are particularly encouraged by the durability of effect observed across multiple dimensions of the disease, including wakefulness, cognition and fatigue, together with a safety pro continued to be generally well tolerated. These data also underscore the importance of dosing flexibility to meet individual needs across narcolepsy patients with known orexin deficiency as well as patients with normal orexin tone,” said Craig Hopkinson, M.D., (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “We are excited to continue advancing enrollment in the phase 3 Brilliance Studies and work toward completing the Vibrance-3 phase 2 study in IH later this year.” Alkermes plans to present these results at an upcoming medical meeting. Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in adults with NT1 and NT2, and in the phase 2 Vibrance-3 study in adults with IH (Brilliance NT1 – Study 302: NCT07455383; Brilliance NT2 – Study 303: NCT07502443; Brilliance NT1 – Study 304: NCT07540897; Vibrance-3: NCT06843590). About Alixorexton Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. 9 Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. 10 Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. The U.S. Food and Drug Administration (FDA) has granted alixorexton Breakthrough Therapy designation for the treatment of NT1 and Orphan Drug Designation (ODD) for the treatment of IH. The European Commission has granted ODD to alixorexton for the treatment of narcolepsy. About Alkermes plc Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at . Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of alixorexton, and the company’s expectations, including timelines, related to the alixorexton development program. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: clinical study results for alixorexton may not be predictive of results of future stages of ongoing clinical studies, future clinical studies or real-world results; clinical studies for alixorexton may not be initiated or completed on expected timelines or at all; alixorexton may be shown to be ineffective or unsafe; the FDA may not agree with the company’s regulatory strategies or components of its development program for alixorexton, including clinical trial designs, conduct and methodologies; potential changes in the cost, scope and duration of the alixorexton development program; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2025 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. 1 For efficacy/durability endpoints and disease characteristics, baseline values are defined as the parent study baseline. For safety endpoints, baseline values are defined as end of treatment in the parent study (rollover), or prior to the first dose of LTE (re-entry). 2 ESS: Self-administered, 8-item questionnaire (score range: 0-24) that measures severity of excessive daytime sleepiness over the past 7 days (score ≤10 = normative; 11-12 = mild; 13-15 = moderate; 16-24 = severe). 3 For MSL on MWT, results are summarized by the dose that participants received on the day of the MWT assessment at week 24. 4 For ESS and WCR, results are summarized by the most frequent dose participants received during the LTE. 5 BC-CCI: 6-item self-administered questionnaire (score: 0-18) assessing perceived problems with concentration, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems over the past 7 days (≤4 = normative; 5-8 = mild; 9-14 = moderate; 15-18 = severe). 6 PROMIS-Fatigue: 6-item self-administered questionnaire assessing the severity of a patient’s fatigue over the past 7 days. Items are scored and transformed to T-scores (<55 = normative; 55-<60 = mild; 60-<70 = moderate; ≥70 = severe). 7 TEAEs in ≥10% of all alixorexton-treated patients with symptom onset during the LTE. 8 MWT data for four NT2 participants that had completed 24 weeks of treatment was outstanding at the time of, and therefore not included in, the data analysis. 9 Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders. Journal of Psychiatric Practice . 2005; 11(2):102-115. 10 Ten-Blanco M, Flores A, Cristino L, Pereda-Perez I. Targeting the orexin/hypocretin system for the treatment of neuropsychiatric and neurodegenerative diseases: From animal to clinical studies. Frontiers in Neuroendocrinology. 2023;69(101066). . Contacts Alkermes Contacts: For Investors: Sandy Coombs, +1 781 609 6377 For Media: Gretchen Murphy, +1 781 609 6419