San Diego – October 19, 2026 -- The U.S. Food and Drug Administration has pushed the decision date for Capricor Therapeutics' Deramiocel Biologics License Application by three months, from August 22, 2026 to November 22, 2026, after classifying the company's latest data submission as a major amendment.

Deramiocel is an investigational cell therapy for Duchenne muscular dystrophy (DMD). Capricor (NASDAQ: CAPR) disclosed the extension of the Prescription Drug User Fee Act (PDUFA) target action date on the day of release.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) will present 24-month skeletal muscle and cardiac data from its Phase 3 HOPE-3 trial of Deramiocel in Duchenne muscular dystrophy (DMD) at the World Muscle Society Congress, weeks ahead of an FDA PDUFA target action date of November 22, 2026.

The 31st Annual Congress (WMS 2026) runs September 29 to October 3, 2026, in Hiroshima, Japan. Capricor will deliver one late-breaking poster and one oral presentation on Deramiocel, plus two preclinical posters from its StealthX exosome platform.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) reported that Duchenne muscular dystrophy patients who switched from placebo to Deramiocel after one year slowed their upper limb decline by 76% compared with their own prior year, according to open-label extension data from the Phase 3 HOPE-3 trial. The U.S. FDA has set a PDUFA target action date of November 22, 2026, for the therapy.

Indianapolis – October 19, 2026 -- Half of pediatric ulcerative colitis (UC) patients who responded to Eli Lilly's Omvoh (mirikizumab-mrkz) were in clinical remission at Week 52, meeting the primary endpoint of the Phase 3 SHINE-2 study. Lilly (NYSE: LLY) says Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric UC, and it plans to submit the data to global regulators for a potential label expansion.

Stockholm – October 19, 2026 -- Sobi will present seven accepted abstracts on Aspaveli/Empaveli (pegcetacoplan) at the American Society of Nephrology (ASN) Kidney Week 2026, running 21–25 October in Denver, Colorado, including two oral and five poster presentations.

New York – October 19, 2026 -- Inspired Entertainment (NASDAQ: INSE) will debut Kora, its next-generation retail cabinet platform, at the Global Gaming Expo at The Venetian in Las Vegas from September 29 to October 1, as it pushes its Interactive, Retail Solutions, Virtual Sports and Hybrid Dealer lines deeper into North America.

North Chicago – October 19, 2026 -- AbbVie's investigational dual-targeting therapy ABBV-466 delivered endoscopic remission in 40.5% of Crohn's disease patients at Week 24, against 22.4% for risankizumab and 20.0% for trosunilimab monotherapy, according to Phase 2a TARGET-CD data (NYSE: ABBV).

Charlotte – October 19, 2026 -- FlowBelow Aero, Inc. has launched a redesigned Trailer AeroSlider System that saves 3.0 gallons of fuel per 1,000 miles, with a payback period the company says can fall below 12 months at current diesel prices. The company unveiled the product at the American Trucking Associations' Management Conference & Exhibition, held Oct. 17-20, 2026, in Charlotte.

Fremont – October 19, 2026 -- Ultima Genomics' UG200 Sequencing Platform has been selected to power a single-cell immune profiling study of 80,000 UK Biobank blood samples, run with IMU Biosciences to produce a foundational dataset for AI.

Boston – October 19, 2026 -- Ascentria Care Alliance is the subject of an upcoming "All Access hosted by Andy Garcia" segment, filmed in Worcester, Massachusetts, that presents workforce development and immigrant integration as a response to a shrinking caregiving workforce and an aging U.S. population.