The U.S. FDA approved the oral peptide Icotyde (icotrokinra), an IL-23 receptor antagonist, for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy. Partnered between Johnson & Johnson and Protagonist Therapeutics Inc., Icotyde met all primary efficacy endpoints and turned up a favorable safety profile across four phase III studies that included 2,500 patients. The approval is based on an unprecedented body of evidence from the Iconic clinical development program, which tested the drug in adults and adolescents at high-impact disease sites such as the scalp and genitals, as well as in duplicate head-to-head trials vs. an active comparator. Shares of Protagonist (NASDAQ:PTGX) were trading at $97.24, up 1 cent.

340B provider finds new way into court over price disputes

Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act (FCA). A lower court had locked that door, saying the provider could only pursue its claims against Abbvie Inc., Astrazeneca plc, Novartis AG and Sanofi SA through the 340B administrative dispute resolution process. But the U.S. Court of Appeals for the Ninth Circuit not only unlocked the FCA door yesterday for alleged 340B pricing abuses, but welcomed Adventist through it.

Excalipoint closes $68.7M seed round for cancer T-cell engagers

Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history. “I still remember we were at a hot pot dinner in Shanghai in October 2024 when [Lei Fang and I] started sketching the next steps,” Chief Financial Officer and Chief Business Officer Jielun Zhu told BioWorld. Within six months, Fang and Zhu formed Excalipoint in Shanghai and closed two transactions, including a $857.5 million deal with Lepu Biopharma Co. Ltd. for two TCE candidates, CTM-012 (EXP-011) and CTM-013 (EXP-012), as well as IP rights to Lepu’s Topabody platform.

Imperative secures $100M for thromboembolic technologies

Imperative Care Inc. secured $100 million through an oversubscribed convertible note financing round to support commercialization of its stroke and vascular thrombectomy technologies. The round was co-led by new investors Elevage Medical Technologies and Perceptive Advisors alongside existing investor Catalio Capital Management LP. Also participating were new backers Longaeva Partners LP and Brown Advisory, with continued support from existing investors, including Ally Bridge Group and Bain Capital Life Sciences.

Promise of exercise in a pill as Atrogi pivots from type 2 diabetes to obesity

Atrogi AB is making a bid for a slice of the obesity market and has dosed the first overweight subjects with ATR-258, an oral therapy it says mimics the effects of exercise, driving loss of fat whilst sparing muscle. The study aims to demonstrate that ATR-258, a modified beta-2 agonist, mimics the muscle building seen with traditional beta-2 agonists, such as clenbuterol, but does not have the associated adverse cardiovascular effects that make these earlier counterparts unsuitable for chronic use. ATR-258, taken once daily, binds beta-2 receptors, activating glucose transporter-4 that moves glucose from the bloodstream into skeletal muscle cells for storage as glycogen.

Pharma USA: Folding AI into the gameplan to speed research, adoption

As AI continues to storm into global life, biopharma companies are figuring out ways to incorporate it into their operations, all with the goal of bringing better therapies to patients faster. At Pharma USA, a Reuters Events meeting in Philadelphia March 16-17, numerous AI companies presented their offerings to attendees, driving interest and partnerships. AI tools are seeping into every aspect of drug discovery and development, from isolating promising targets and enabling faster clinical trial enrollment to streamlining the regulatory process and accessing networks for commercialization. Some are exploring its use with patient education and adoption or with helping to speed a physician’s capabilities where volumes of information are available at the touch of a keystroke.

Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer

Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. As of the data cut-off date (Nov. 28, 2025), 49 patients had received intravesical instillation of SIM-0237 monotherapy. Among patients with carcinoma in situ who had at least one post-baseline tumor assessment, 80% achieved a complete response. Among patients with papillary-only disease, the 12-month disease-free survival rate was 65.8%.

ADPD 2026: Can we prevent dementia? Scientists quantify it

Neurodegenerative disease and cognitive decline cannot be explained by a single process. Beta-amyloid plaques, hyperphosphorylated tau, alpha-synuclein, activated microglia and astrocytes, altered receptors such as TREM2, mitochondrial dysfunction, epigenetic changes and cerebrovascular alterations all seem to contribute to the development of dementia in Alzheimer’s disease. While scientists attempt to address each of these elements, prevention is growing as a primary goal.

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