Pharmaceuticals & Biopharmaceuticals

Suzhou – October 19, 2026 -- MegaRobo Technologies has launched Poreva Open, a global AI protein design competition that will put more than 10,000 designs through standardized wet-lab experiments and offers US$250,000 in cash prizes.

Megalaxy Lab to run double-blind validation of every submission

Teams from academic institutions, research organizations, university laboratories, and biotech and AI companies can enter. Participants may use any models, algorithms or design methods. All submissions go through double-blind experimental evaluation at MegaRobo's Megalaxy Lab.

Results and experimental data, including data on unsuccessful designs, will be published after the competition. Publication is subject to intellectual property and compliance requirements.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) disputed the post-hoc analyses in the FDA's briefing materials, two days before an advisory committee meets on July 29 to discuss its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).

Capricor says FDA analyses rely on an obsolete draft analysis plan

The company said the FDA's post-hoc analyses use statistical analysis plan (SAP) version 1.1. Capricor described that version as an unsigned, incomplete internal draft that became obsolete when cohort B was added. It also said the draft lacked content the FDA had specifically requested.

Capricor said its results are governed by SAP version 3.0, which was finalized before unblinding.

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 -- 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.

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.

Basel – October 19, 2026 -- WuXi Biologics will expand annual capacity to approximately 300 IND programs and 20 BLA programs by 2027, as bispecific antibodies and ADCs made up 71% of the 169 projects it added in the first half of 2026. More than two-thirds of those new programs originated in the United States and Europe, the company said at its 3rd annual Basel CRDMO+ Day, held alongside Festival of Biologics Basel 2026, which drew more than 3,000 industry professionals.

The company's portfolio stands at 1,064 integrated projects, including 399 first-in-class programs, 732 global IND clearances and more than 90 market authorizations. More than 100 biotech and pharma leaders attended the Basel session.

Shanghai – October 19, 2026 -- Mabwell's Nectin-4-targeting antibody-drug conjugate 9MW2821 (Bulumtatug Fuvedotin, "BFv") achieved a 30.0% objective response rate in 60 efficacy-evaluable triple-negative breast cancer (TNBC) patients previously treated with a topoisomerase I (Topo I) ADC, according to Phase II data to be presented orally at the 2026 European Society for Medical Oncology (ESMO) Congress.

Phase II data show 80% disease control and 8.7-month response duration

The study (CTR20242376) evaluates 9MW2821 as monotherapy or combined with a PD-1 monoclonal antibody in locally advanced or metastatic TNBC. Data are as of October 19, 2026.

North Chicago – October 19, 2026 -- AbbVie will present new and updated data on seven solid tumor assets at the 2026 European Society for Medical Oncology (ESMO) Congress, October 23-27 in Madrid, the company's most expansive ESMO program to date. The data span lung, colorectal, ovarian, prostate and gastric cancers, across antibody-drug conjugates (ADCs), bispecific antibodies and combination regimens.

Temab-A posts 30% response rate in colorectal cancer combination

In a Phase 1 study of previously treated advanced colorectal cancer, Temab-A (telisotuzumab adizutecan) at 2.4 mg/kg plus bevacizumab delivered a 30% overall response rate after a median follow-up of 18.2 months. Median overall survival reached 14.7 months with the combination (n=30), against 10.2 months for standard of care (n=20), regardless of c-Met expression. No new safety signals were observed. The combination is now in the global Phase 3 AndroMETa-CRC-560 study.