Shanghai Fosun Pharmaceutical (Group) Co. Ltd. is paying $60 million up front for an option to secure exclusive rights to Aribio Co. Ltd.’s oral phase III-stage Alzheimer’s disease (AD) therapy, AR-1001. The option fee plus license agreement has the potential to tally $4.7 billion for Aribio, marking the largest deal for an AD asset inked by a Korean biotech company. Through the agreement, Fosun will gain global exclusive rights to AR-1001 excluding South Korea, the Middle East and South America. The agreement expands on Fosun’s existing rights in mainland China, Hong Kong and Macao as well as 10 designated ASEAN countries.

Biogen AD drug shows tau, cognition benefit, despite trial miss

Biogen Inc. has decided to advance diranersen into registrational trials for early Alzheimer’s disease (AD), even though the antisense oligonucleotide therapy, originally discovered by Ionis Pharmaceuticals Inc., missed its phase II primary endpoint. In the Celia trial, diranersen showed a slowing of clinical decline across doses, as well as robust reductions in cerebrospinal fluid tau and tau pathology, but it missed on the primary endpoint assessing dose response for change from baseline on the Clinical Dementia Rating-Sum of Boxes at week 76. While data indicate that diranersen did what no previous tau-targeting agent has done – reducing tau while offering a cognitive benefit – details were scant, and one analyst, Cantor’s Eric Schmidt, worried that by advancing into phase III, the company may be “taking the wrong fork in the road.” Leerink Partners’ Marc Goodman said his team was “not really sure what to make of the data,” other than to say from an investment perspective that it is “relatively disappointing and reminds all of the struggles in AD drug development.” But from a scientific perspective, he said, Celia “was an advancement in the development of tau-targeting AD therapies.”

DMD phase III data send Regenxbio down

Shares of Regenxbio Inc. (NASDAQ:RGNX) were trading at $6.02, down 39%, or $3.98, on top-line and interim functional data in Duchenne muscular dystrophy (DMD) from the pivotal phase III portion of the phase I/II/III Affinity Duchenne trial with gene therapy RGX-202. The study met its primary endpoint with high statistical significance (p<0.0001), as 93% of participants reaching at least 10% microdystrophin expression at week 12 (n=30). Regenxbio said the drug turned up a statistically significant correlation between microdystrophin expression and interim functional improvement. Wall Street watchers of the DMD space apparently balked, though, at two serious adverse events: one case each of subacute myocarditis and asymptomatic liver injury.

ASGCT 2026: Uncovering the mechanisms of AAV toxicity

Gene therapies rely on vectors to reach the target tissue where they act, such as adeno-associated viruses (AAVs) or lipid nanoparticles, among other delivery strategies. Each combination is optimized for a specific cell type and indication, aiming to overcome challenges such as efficacy, specificity and toxicity. On May 13, 2026, two sessions included in the scientific symposia of the 29th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), being held in Boston this week, addressed AAV-related toxicities, which have led to fatal cases in clinical trials and remain an area for improvement in approved therapies.

Andes virus cases rise to 11; Hondius passengers in quarantine to June 21

The number of cases of hantavirus infection has risen from eight to 11, following the repatriation of passengers from the cruise ship MV Hondius, with World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus warning the danger is not over. “In fact, it has entered a new phase as the passengers and crew return home,” he told attendees of a meeting at WHO’s headquarters in Geneva on May 13. The three new cases of Andes virus infection are in repatriated passengers who were asymptomatic when they left the ship. Speaking at a press conference on May 12, Ghebreyesus said, “Given the long incubation period of the virus, it’s possible we might see more cases in the coming weeks.”

Medical devices evolving into intelligent, adaptive systems

The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into their products. And although traditional devices such as screws for orthopedics, or valves for cardiology, remain essential, the shift underway is leading to much more personalized medicine, which is more effective and safer, Eran Lerer, managing partner, at Shoni Health Ventures, told BioWorld.

USPTO doubles down on inconsistencies in dual IPR-court action

The U.S. Patent and Trademark Office (USPTO) is driving home the message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting inconsistent positions as a tactic “to gain an upper hand in the overall litigation.” That message came across loud and clear in three recent decisions by USPTO Director John Squires that the agency designated as “informative” this week. All three decisions denied institution of an IPR, even though the petitioners offered to withdraw their inconsistent court arguments if their IPRs were maintained.

Tracking hantavirus across the globe

The recent hantavirus outbreak aboard the MV Hondius cruise ship has brought increased attention to an infection for which there are no widely available or FDA-approved therapeutics or vaccines, with limited research occurring only at the earliest stages. The rare Andes strain identified in the outbreak is known for human-to-human transmission, although the original infection comes from rodents. While hantavirus does not spread as easily as an infection like COVID-19, the mortality rate, at 30% to 40%, is significantly greater, and serves as another example as to why biopharmas must be at least two steps ahead with technology that can pivot to quickly address the spread of infectious diseases. Read BioWorld’s ongoing coverage of the current hantavirus outbreak.

Also in the news

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