Healthcare, Pharma & Life Sciences

SAN DIEGO – October 19, 2026 -- The FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3, with no abstentions, that available evidence did not support the effectiveness of Capricor Therapeutics' Deramiocel for cardiomyopathy in patients with Duchenne muscular dystrophy (DMD), leaving the company's PDUFA target action date of August 22, 2026 as the next decision point.

Non-binding vote addresses narrower indication than Capricor proposed

The committee's vote is non-binding. Capricor (NASDAQ: CAPR) said the voting question covered a narrower indication than the one it had proposed and did not include a vote on Deramiocel's overall benefit-risk profile.

Cardiomyopathy in DMD currently has no approved treatment. Capricor said heart muscle deterioration leads to cardiomyopathy and heart failure, the leading cause of death in DMD, which affects approximately 15,000 people in the United States.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) ended the second quarter with about $237.9 million in cash, cash equivalents and marketable securities, down from about $318.1 million at Dec. 31, 2025. The decline came as an FDA advisory committee voted 9 against and 3 in favor on whether evidence shows Deramiocel is effective for cardiomyopathy in Duchenne muscular dystrophy (DMD) patients.

Advisory panel vote is non-binding and limited to cardiomyopathy

The Cellular, Tissue and Gene Therapies Advisory Committee voted on July 29, 2026. Capricor says the panel was not asked to vote on the HOPE-3 primary endpoint or on overall benefit-risk. In a separate discussion of upper limb function, the committee's feedback was directionally supportive of the HOPE-3 evidence, according to the company. The recommendation is advisory and non-binding, and the Biologics License Application (BLA) remains under active FDA review.

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.

Capricor files 24-month HOPE-3 extension data after July advisory committee

Following the July 2026 Advisory Committee meeting, Capricor submitted a BLA amendment containing 24-month open-label extension data from its pivotal Phase 3 HOPE-3 study. The filing also includes additional robustness analyses.

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.

HOPE-3 24-month cohort reaches 82 of 106 randomized patients

Of the 106 patients randomized in HOPE-3, 82 reached the 24-month time point: 40 originally assigned to Deramiocel and 42 to placebo. The data build on the 12-month results reported previously.

Melbourne – October 19, 2026 -- Helfie AI and UK-based Health Innovation South West have launched a partnership to evaluate smartphone-based hypertension screening in real-world healthcare settings, with a focus on people who face barriers to conventional care.

Partners will test digital screening for earlier detection of high blood pressure

The programme will assess whether smartphone-enabled screening can identify people at risk of high blood pressure and cardiovascular disease earlier. Hypertension remains one of the leading modifiable risk factors for cardiovascular disease, yet many people go undiagnosed until they develop serious health problems.

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.

Crossover analysis shows 76% slower decline on PUL 2.0

The late-breaking poster was presented at the 31st Annual Congress of the World Muscle Society in Hiroshima, Japan. It measured upper limb function with the Performance of Upper Limb (PUL 2.0) scale. Of 106 randomized patients, 98 entered the open-label extension, 49 per arm. At Month 24, 42 patients in the placebo-origin arm and 40 in the Deramiocel arm were assessed.

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.

Lilly reports 81% induction response and 50% remission at one year

In the single-arm, open-label study, 81% of patients achieved clinical response at Week 12. Among the 52 responders, ages 6 to 17, 50% reached clinical remission at Week 52. The results were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.

Secondary outcomes at Week 52 in responders were:

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.

Oral sessions report 76-week outcomes in two rare kidney diseases

The two oral presentations cover 76-week outcomes with Aspaveli/Empaveli in C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). According to Sobi, the data show maintained proteinuria reduction and stabilised eGFR. The package includes a paediatric subgroup analysis from the VALIANT study and its VALE extension.

Seongnam – October 19, 2026 -- NTL HEALTHCARE drew more than 200 representatives of distributors, healthcare institutions and policy organizations to its booth at WHX Johannesburg 2026 (October 6-8) and supplied its CerviCARE AI cervical screening system to Zimbabwe during the show.

South Africa is slated to become the hub for pan-African expansion

The South Korean company met South African policymakers and academic representatives to discuss implementation procedures and possible collaborations. It plans to use South Africa as a strategic base for reaching neighboring countries and other African markets, building on pilot projects in Zambia, Uganda and Tanzania.

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).

ABBV-466 clears the Week 12 primary endpoint at 30.2%

At Week 12, the primary endpoint, 30.2% of ABBV-466 patients achieved endoscopic remission. Patients on anti-IL-23 p19 monotherapy (risankizumab) reached 21.3%, and those on anti-α4β7 monotherapy (trosunilimab) reached 18.0%. The gap to both monotherapy arms widened by Week 24.

ABBV-466 combines risankizumab with trosunilimab. AbbVie said its research found α4β7-driven inflammation persisting despite IL-23 p19 inhibition, which led it to add the α4β7 inhibitor to risankizumab.