Clinical Trials

NEW YORK – October 29, 2026 -- Breakthrough T1D, the global type 1 diabetes (T1D) research and advocacy organization, has presented four awards to researchers whose work spans disease prevention, insulin pump therapy, beta cell biology and large-scale clinical trials. The recipients were recognized at a ceremony in Philadelphia earlier in October 2026.

Chief Scientific Officer Sanjoy Dutta, Ph.D., said the honorees embody the organization's mission "to accelerate research toward cures for type 1 diabetes while improving the lives of those who live with it."

Chanhassen – October 28, 2026 -- Every patient with investigator-assessed clinical deterioration in an exploratory 15-patient glioblastoma analysis showed sustained increases in lactate dehydrogenase (LDH) during treatment, Alpheus Medical, Inc. reported at the ESMO Congress 2026 in Madrid.

Poster 4289P tracks LDH trajectories in 15 recurrent glioblastoma patients

The clinical-stage oncology company presented the data from its first-in-human study of Porphyrin Metabolite Activation (PoMA). The cohort comprised 15 patients with MGMT-unmethylated recurrent glioblastoma. Instead of relying on a single LDH value, the analysis examined how LDH changed over time and how those trajectories related to clinical and radiographic disease status.

Danbury – October 28, 2026 -- CellsBin has received a Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) to advance CB-Insight, its blood-based test for multiple myeloma, a cancer of plasma cells in the bone marrow.

Federal award follows 108 BioCapital-led Series A

The NCI funding comes after CellsBin's Series A financing, announced in September and led by 108 BioCapital. Together, the private and federal money moves the myeloma program beyond early proof-of-concept work and into formal patient testing and development of a test that can be offered to doctors.

CellsBin first presented early myeloma results at the 2024 American Society of Hematology Annual Meeting. Privately funded work since then made the company eligible for the Direct-to-Phase II track, which lets small businesses that have already shown feasibility skip the Phase I stage.

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 -- 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.

Indianapolis – October 19, 2026 -- Eli Lilly and Company (NYSE: LLY) will present first Phase 1 data for its investigational FRα-targeting antibody-drug conjugate sofetabart mipitecan (Sofe-M) in platinum-sensitive ovarian cancer (PSOC) at the European Society for Medical Oncology (ESMO) Congress, October 23–27 in Madrid, alongside updated data across lung, thyroid and breast cancer programs.

Sofe-M plus bevacizumab data in PSOC backs ongoing Phase 3 trial

Lilly will give a rapid oral presentation on the first Phase 1 results for Sofe-M combined with bevacizumab in PSOC. The company says the data support the ongoing Phase 3 clinical trial of Sofe-M in PSOC.

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.