In a rare event for the European biotech sector, Dutch/Belgian immunology specialist Argenx SE is to acquire a U.S. counterpart, Forte Biosciences Inc., in an all cash deal valued at $2.2 billion. The price of $77 per share is a premium of about 86% to Forte’s volume-weighted average price since it reported positive phase Ib data for the lead program FB-102 in vitiligo on July 9. That news sent the share price (NASDAQ:FBRX) soaring by 78% to close at $36.70. Forte shares closed at $50 on July 24 before the sale was announced. At that price, the market capitalization was about $1.1 billion. Argenx laid the ground for the acquisition in April 2026, buying Forte shares in a rights issue when the Dallas-based company raised $150 million at $26.27 per share.

Capricor pushes against FDA’s negativity ahead of adcom

With its stock price falling as much as 70% this morning, Capricor Therapeutics Inc. (NASDAQ:CAPR) took the rare step of issuing a news release to explain the negative tone of the U.S. FDA’s briefing document for Wednesday’s Cellular, Tissue and Gene Therapies (CTGT) Advisory Committee meeting to discuss the company’s BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy. Capricor linked the FDA’s concerns to the agency basing its post-hoc analyses on the statistical analysis plan (SAP) 1.1, which was an unsigned incomplete internal draft that had become obsolete. The company’s positive analysis is based on SAP 3.0, which was finalized prior to unblinding. Meanwhile, the stock price of Replimune Group Inc. (NASDAQ:REPL) took a 24% tumble this morning ahead of a Thursday meeting with the CTGT adcom to discuss vusolimogene oderparepvec as a second-line treatment in advanced melanoma. The FDA will post the briefing docs for that meeting tomorrow.

FDA clears Otsuka’s triple-acting Simtriyo in ADHD

Otsuka Pharmaceutical Co. Ltd. gained U.S. FDA approval of Simtriyo (centanafadine), a once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) in adults as well as pediatric patients age 6 years and older weighing at least 20 kg (about 44 lbs.). Simtriyo is the first and only approved norepinephrine, dopamine, and serotonin reuptake inhibitor, functioning also as a central nervous system stimulant in ADHD. Tokyo-based Otsuka said the drug will be available this year after DEA scheduling.

Maplight aims to differentiate muscarinic agonist from competitors

Maplight Therapeutics Inc. is betting that the next competitive battleground in schizophrenia will not be simply proving muscarinic agonists work but demonstrating they are easier for patients to stay on while offering benefits beyond psychosis. Positive top-line results from the company's registrational phase II Zephyr study of ML-007C-MA moved the program one step closer to phase III. But during a July 27 conference call, executives spent as much time discussing cognition, tolerability and real-world adherence as they did the primary efficacy endpoint, laying out what they see as the drug's differentiation strategy in an increasingly competitive muscarinic landscape dominated by Bristol Myers Squibb Co.'s Cobenfy.

Tidalsense raises $19M for AI-powered COPD diagnostic platform

Tidalsense Ltd. raised $19 million in a funding round for N-Tidal Diagnose, its AI-based diagnostic platform which can identify chronic obstructive pulmonary disease (COPD) in as little as five minutes. The test requires an individual to breathe normally into a handheld device for 75 seconds and it captures a carbon dioxide breath waveform, which is analyzed by AI to detect COPD. The funds will be used to support commercialization in the U.K., Ireland and Europe, preparations for U.S. market entry and expansion of the platform into additional respiratory conditions, including asthma.

Taiwan biotech looks outward in next phase of growth

Taiwan’s biotechnology sector was built around domestic health needs, including vaccines and drug manufacturing, but it is increasingly looking outward – to international partnerships, licensing, clinical development and a bigger role in the global biomedical ecosystem. Lee-Cheng Liu, chairman of the Taiwan Bio Industry Organization opened BIO Asia-Taiwan in Taipei by bringing to light “a period of intense transformation” in biotechnology, driven by rapid technological progress and convergence of bioengineering, digital technologies, manufacturing and global collaboration. Amid seismic shifts, Taiwan’s government is seeking to connect the local life sciences sector with global capital, supply chains and pharmaceutical partners, serving as a key hub in Asia.

Also in the news

Abbvie, Abivax, Alfasigma, Astrazeneca, Codexis, Daiichi, Dyne, GE, Genmab, Gilead, Ipsen, Magnendo, Mannkind, Menarini, Merck, Minoryx, Neuraxpharm, Neurocrine, Newamsterdam, Organon, Par, Roche, Tessera, Thyora, Vir, Zevra