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Caplyta met the main goal of a Phase 3 trial in bipolar mania, a potential new use for the drug J&J acquired via Intra-Cellular.
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Shionogi to Acquire IntraBio for USD 2.0 Billion, Adding AQNEURSA to Rare Disease Portfolio
Shionogi & Co., Ltd. announced that its Board of Directors approved an agreement to acquire IntraBio Inc., a biopharmaceutical company developing and commercializing therapies for neurodegenerative diseases, for an upfront consideration of USD 2.0 billion payable to IntraBio shareholders. Under the agreement signed on October 5, 2026, IntraBio would become a wholly owned subsidiary of New Jersey-based Shionogi Inc., with the transaction scheduled to close between November 2026 and December 2026, subject to competition-law waiting periods and other customary conditions. The deal would add AQNEURSA (levacetylleucine) to Shionogi's rare disease portfolio; the drug was approved by the FDA in September 2024 for neurological manifestations of Niemann-Pick disease type C and by the European Medicines Agency in January 2026, and on September 18, 2026 it became the first and only FDA-approved treatment for Ataxia in patients with Ataxia-Telangiectasia, for which it is also under EMA review. Shionogi said the acquisition builds on the rare disease foundation it established through its April 2026 acquisition of global rights to edaravone, known as RADICAVA in the U.S. and RADICUT in Japan, and would strengthen its pipeline across Pompe disease, Fragile X syndrome, Jordan's syndrome and early-stage rare neurodegenerative programs. The impact on Shionogi's consolidated financial results for the fiscal year ending March 2027 is currently under review.
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Biotech & Genomic Medicine › Rare Disease ▲Capital
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4507.JP · Capital · Positive Shionogi's board approved a USD 2.0 billion acquisition of IntraBio, adding AQNEURSA and rare-disease pipeline assets to its portfolio.
IntraBio Inc. · Capital · Positive IntraBio is being acquired by Shionogi for USD 2.0 billion upfront, delivering consideration to its shareholders.
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AnnJi Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for SBMA
AnnJi Pharmaceutical announced it is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201, also known as rosolutamide, in patients with spinal and bulbar muscular atrophy, or SBMA, also called Kennedy's disease. The company said it submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now activate U.S. sites for the global trial. The ROMA-KD study is a global, multicenter, randomized, double-blind, placebo-controlled trial expected to enroll approximately 200 ambulatory patients with symptomatic SBMA worldwide, with the United States as a key region, and is intended to support potential global regulatory submissions. AJ201, an investigational oral small molecule and a potential first-in-class treatment for SBMA, has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation in both the United States and the European Union. AnnJi said the Phase 3 program builds on encouraging results from its completed Phase 2 study announced in May 2025, and the company also noted its SBMA Patient and Care Partner Advisory Council, first announced in collaboration with the Kennedy's Disease Association at the 2026 KDA International Patient and Scientific Conference.
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Biotech & Genomic Medicine › Rare Disease ▲Technology
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Technology
7754.TWO · Technology · Positive AnnJi advances AJ201 into pivotal Phase 3 ROMA-KD trial for SBMA after encouraging Phase 2 results
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NeuroSense Regains Nasdaq Bid Price Compliance, Will Appeal MVLS Delisting
NeuroSense Therapeutics said it received a letter from Nasdaq's Listing Qualifications Department on October 1, 2026, stating the company has not regained compliance with Listing Rule 5550(b)(2), which requires a minimum market value of listed securities of $35 million for continued listing on the Nasdaq Capital Market. The company intends to appeal the Staff Determination by timely requesting a hearing before the Nasdaq Hearings Panel and to seek additional time to regain compliance with the MVLS Requirement, which is the only continued listing criterion identified in the determination. Nasdaq had notified NeuroSense on April 2, 2026, that its MVLS had been below $35 million for 30 consecutive trading days, giving it until September 29, 2026, to regain compliance; because it did not, its ordinary shares and warrants face delisting unless it appeals. A timely hearing request stays the suspension of the company's securities and the filing of a Form 25-NSE with the SEC pending the Panel's decision, and the Panel has discretion to grant an exception of up to 180 days from the date of the Staff Determination. Separately, NeuroSense said Nasdaq confirmed it regained compliance with Listing Rule 5550(a)(2), the $1.00 minimum bid price requirement, after its 1-for-20 reverse share split kept the closing bid price at $1.00 or greater for 10 consecutive business days from September 15 through September 28, 2026, closing that matter. Chief Executive Officer Alon Ben-Noon said regaining bid price compliance is an important step and that the company remains focused on advancing PrimeC in ALS, including preparations for its Phase 3 PARAGON trial and a planned New Drug Submission to Health Canada.
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NRSN · Regulation · Negative Nasdaq determined NeuroSense failed to regain the $35M minimum market value of listed securities requirement, leaving its shares and warrants facing delisting unless its appeal succeeds.
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Wells Fargo Starts Design Therapeutics at Overweight on Friedreich Ataxia Program
Wells Fargo initiated coverage of Design Therapeutics with an overweight rating, citing the company's Friedreich ataxia candidate DT-216P2 as having potentially best-in-disease functional improvement based on results from the RESTORE-FA study released in May. The bank set a $26 price target, implying roughly 112% upside based on the October 1 close. Analyst TianQi Hang wrote that the May update showed pharmacokinetics look good, and that blood-FXN protein, muscle-mRNA data, plus an early mFARS signal further de-risk the platform. Hang estimates that the blood FXN protein increase seen after 6 weeks can translate to at least a 2-point mFARS change, and said that if the drug kinetics sustain for 12 weeks, which he believes they will, DT-216P2 could deliver best-in-disease functional benefits. He assigns DT-216P2 a 60% probability of success, with peak sales of approximately $600M in the US and approximately $900M outside it. If approved, DT-216P2 would compete against Biogen's Skyclarys, also known as omaveloxolone, and Hang sees it gaining a peak share of the FA treatment market of 30% in the US and 20% ex-US.
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Biotech & Genomic Medicine › RNA Therapeutics ▲Competition
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AbbVie Wins FDA Approval for Juvmo, First Selective D1/D5 Parkinson's Pill
AbbVie has secured FDA approval for Juvmo, a once-daily oral treatment for Parkinson's disease, with a commercial launch targeted for October 2026. Juvmo is the first selective D1/D5 dopamine receptor agonist that can be used both as a standalone treatment and in combination with levodopa, the current standard of care for Parkinson's symptoms. The approval expands AbbVie's Parkinson's portfolio, which already includes Vyalev and Duopa, and management expects the three therapies to collectively represent a peak-sales opportunity of more than $5 billion. Neuroscience now accounts for nearly a fifth of AbbVie's overall topline and generated $6.1 billion in revenues in the first half of 2026, up 22% year over year, with the company expecting approximately $12.7 billion in neuroscience revenues for the full year. The approval could also deliver a commercial payoff from AbbVie's approximately $8.7 billion acquisition of Cerevel Therapeutics in 2024, a deal that came under pressure after emraclidine failed in two registration-enabling phase II studies in schizophrenia and prompted a $3.5 billion impairment charge. AbbVie competes in neuroscience with Biogen, which markets Leqembi with Eisai and Zurzuvae, and Johnson & Johnson, whose portfolio is anchored by Spravato and Invega Sustenna and was strengthened by last year's acquisition of Intra-Cellular Therapies, adding Caplyta.
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ABBV · Regulation · Positive FDA approval of Juvmo, a first-in-class selective D1/D5 Parkinson's pill, expands AbbVie's neuroscience portfolio toward a >$5B peak-sales opportunity.
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Roche Wins FDA Priority Review for Fenebrutinib in Multiple Sclerosis
Roche Holding received FDA acceptance of its New Drug Application for fenebrutinib in multiple sclerosis under priority review. The filing covers fenebrutinib as an oral BTK inhibitor for both relapsing and primary progressive forms of multiple sclerosis. If approved, fenebrutinib could become the first high efficacy oral BTK inhibitor targeting both relapse control and disability progression in MS, adding an oral, CNS penetrant option alongside Ocrevus in Roche's neurology offering. Roche Holding is a CHF279.4 billion pharmaceuticals and diagnostics group, and the milestone reinforces the view that late stage assets like fenebrutinib can help offset ongoing loss of exclusivity and pricing pressure. The key signpost now is the FDA's priority review timeline for fenebrutinib, including the final decision date and any label details regulators set, with three Phase III trials supporting the filing.
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ROP.SW · Regulation · Positive FDA accepted Roche's fenebrutinib NDA for multiple sclerosis under priority review, advancing a potential first-in-class oral BTK inhibitor.