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.

United Kingdom – October 19, 2026 -- Inspired Entertainment (NASDAQ: INSE) has launched farmyard-themed game Happy Money Hens in the UK B3/LBO market, with a Cat C release scheduled for autumn.

Triple Hit Combo mechanic carries over from Zeus Legends of Olympus

The title uses Inspired's Triple Hit Combo mechanic, with pseudo-persistent bags and dynamic feature combinations. Inspired says it builds on its earlier release Zeus Legends of Olympus.

Three colour-coded hens drive the Win & Spin bonus

The Win & Spin bonus is enhanced by three Feature Pots, each linked to a coloured hen. Every Hen Symbol collected fills its matching pot, and landing multiple symbols raises the chance of triggering several features at once.

New York – October 19, 2026 -- Inspired Entertainment (NASDAQ: INSE) has launched three new slot titles, Piggy Mansion, Golden Winner Bonus Cherries and Wolf It Up! 3 Reeler, across the UK and Malta iGaming markets.

All three games extend established Inspired brands: two build on the Cash Bank series and one on the Golden Winner formula. The source gives no revenue, performance or rollout-volume figures for the releases.

Piggy Mansion adds a pig-themed title to the Cash Bank series

Piggy Mansion features Cash Bank mechanics, including enhanced Collect symbols, expanding reels and stacked Multiplier Collectors. Prize Pots and multipliers sit alongside a Cash Bank Free Spins Bonus with an evolving trail that awards extra free spins and unlocks multiplier opportunities.

United Kingdom – October 19, 2026 -- Inspired Entertainment (NASDAQ: INSE) has launched two Hybrid Dealer titles, Big Piggy Bank Roulette 54 and Big Piggy Bank Big Wheel, to operator partners in the UK and Malta iGaming markets.

Both titles pair the Big Piggy Bank brand with the Cash Bank mechanic

The games combine one of Inspired's best-known game brands, Big Piggy Bank, with the gameplay mechanics of its Cash Bank franchise. Both run on a 54-segment wheel and are available across mobile and online.

Roulette 54 triggers bonuses from highlighted numbers

Big Piggy Bank Roulette 54 blends classic roulette with Cash Bank in a studio-style setting that pairs live-casino atmosphere with RNG-driven gameplay. The Cash Bank Bonus triggers when the ball lands on a randomly highlighted number. The piggy bank character can raise bonus values.

Barcelona – October 19, 2026 -- Inspired Entertainment (NASDAQ: INSE) has signed on as Platinum Impact Partner of Midnight Mayhem, a charity boxing event targeting more than €150,000 in donations during ICE Barcelona 2027.

Behind the Gloves Ltd organises the event, which will take place on January 19, 2027. Eighteen senior leaders from the global gaming industry will fight after months of training. Each participant selects a charity to support.

Inspired sponsors Square in the Air executive Robin Hutchison

As part of the deal, Inspired is backing Robin Hutchison, Chief Commercial Officer at London-based media agency Square in the Air. Hutchison previously held roles at Entain, including at Coral and Ladbrokes. He is raising funds for Parkinson's UK, citing his father and uncle, who live with the condition.