Viatris Acquires Aculys Pharma to Expand Neurology Portfolio in Japan

Viatris VTRS announced the acquisition of Tokyo-based Aculys Pharma, a clinical-stage biopharmaceutical company specializing in neurological therapies. The deal grants Viatris the rights to develop and commercialize pitolisant and Spydia (diazepam nasal spray), two assets in the Central Nervous System (CNS) segment.Under the agreement, Viatris has made an undisclosed upfront payment to Aculys Pharma’s shareholder as consideration for the acquisition. VTRS is also liable to make additional payments tied to the achievement of certain prespecified regulatory and commercial milestones, along with royalties based on net sales.The Rationale Behind VTRS’ Acquisition of Aculys PharmaViatris’ acquisition of Aculys Pharma underscores a strategic move to strengthen its CNS portfolio and deepen its commercial presence in Japan and the broader Asia-Pacific region.A central element of this deal is pitolisant, a selective/inverse agonist of the histamine H3 receptor, for which Viatris has secured exclusive development and commercialization rights in Japan. Based on positive phase III data in Japanese patients demonstrating a favorable global safety and efficacy profile, Viatris plans to file for marketing approval in Japan by the end of 2025 to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and EDS associated with obstructive sleep apnea syndrome (OSAS).Please note that pitolisant is already FDA-approved in the United States and is marketed under the brand name Wakix for EDS or cataplexy associated with narcolepsy. The drug is also approved in the EU for narcolepsy with or without cataplexy and for EDS associated with OSAS.Year to date, VTRS shares have plunged 19.9% compared with no change for the industry.Image Source: Zacks Investment ResearchThe acquisition also provides Viatris with exclusive rights in Japan and select Asia-Pacific markets for Spydia Nasal Spray, which was approved in June 2025 in Japan for the treatment of status epilepticus. This is the first intranasal anti-seizure medication approved in the country for status epilepticus or seizures with potential progression to status epilepticus, marking a significant advancement in acute seizure management. By adding Spydia to its pipeline, Viatris aims to address unmet needs in neurological emergencies with an innovative, patient-friendly formulation.Diazepam nasal spray is also currently approved in the United States, under the brand name Valtoco, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a usual seizure pattern in patients with epilepsy aged six years and older. Earlier this year, the FDA expanded Valtoco’s indication to include patients aged two years and older.Per Viatris, the acquisition leverages the company’s robust commercial infrastructure and deep CNS expertise in Japan. The integration of pitolisant and Spydia is aligned with Viatris’ strategy to grow in areas of high impact, complementing its core strengths and expanding its presence in key global markets.This strategic expansion builds on Viatris’ growing innovative portfolio in Japan, which includes Effexor for generalized anxiety disorder, selatogrel for acute myocardial infarction, Nefecon for IgA nephropathy and cenerimod for systemic lupus erythematosus. While a regulatory application seeking the approval of Effexor is currently under review, selatogrel, Nefecon and cenerimod are all currently undergoing pivotal phase III development. VTRS is also developing Tyrvaya for dry eye disease, with a phase III study expected to begin in 2026. The addition of pitolisant and Spydia strengthens this pipeline with late-stage and already approved assets, positioning Viatris to drive near- and mid-term growth.Viatris Inc. Price and Consensus Viatris Inc. price-consensus-chart | Viatris Inc. QuoteVTRS’ Zacks Rank and Stocks to ConsiderViatris currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall medical sector are ANI Pharmaceuticals ANIP, Chemomab Therapeutics CMMB and Alnylam Pharmaceuticals ALNY. While ANIP currently sports a Zacks Rank #1 (Strong Buy), CMMB and ALNY carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have risen from $7.25 to $7.29. During the same period, earnings per share for 2026 have increased from $7.74 to $7.79. Year to date, ANIP’s shares have rallied 63%.ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with an average surprise of 22.66%.In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 53.3% year to date.Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.In the past 60 days, estimates for Alnylam’s 2025 earnings per share have risen from $3.35 to $3.98. During the same period, earnings per share for 2026 have increased from $8.95 to $9.61. Year to date, ALNY’s shares have surged 99.9%.Alnylam’s earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 348.36%.Free Report: Profiting from the 2nd Wave of AI ExplosionThe next phase of the AI explosion is poised to create significant wealth for investors, especially those who get in early. 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Sponsored ADR (CMMB): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks