Clinical Trials

Holon, Israel – September 22, 2026 -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) will host a virtual key opinion leader event on October 5, 2026 at 8:00 AM ET, presenting new detail on COM701, its anti-PVRIG antibody candidate for relapsed platinum-sensitive ovarian cancer (PSOC).

Harvard oncologist to preview MAIA-ovarian trial design and timeline

Oladapo Yeku, M.D., Ph.D., FACP, of Harvard Medical School and Massachusetts General Hospital, will join Compugen management to discuss the randomized MAIA-ovarian adaptive platform trial. The study evaluates COM701 as a maintenance therapy in relapsed PSOC patients, with median progression-free survival data from the interim analysis expected by Q1 2027. COM701 has already shown initial anti-tumor activity and a favorable safety and tolerability profile in Phase 1 studies as monotherapy and in combination regimens.

Redmond – September 22, 2026 -- SystImmune Inc. has secured U.S. Food and Drug Administration clearance for its Investigational New Drug application for SI-B037, a bispecific antibody, marking the first time the company has built a regulatory submission entirely on New Approach Methodologies (NAMs) rather than traditional animal toxicology studies.

SystImmune replaces animal testing with human organ-on-chip models

The IND package for SI-B037 relied on human organ-on-chip systems and primary human tissue models instead of conventional animal studies to assess nonclinical safety. Dr. Jahan Khalili, Senior Vice President of Research at SystImmune, said the human-relevant models provided a more direct read on a molecule engineered to engage multiple human pathways simultaneously.

Taipei – September 22, 2026 -- Merry Life Biomedical has advanced TML-6, a Taiwan-developed oral therapy for early Alzheimer's disease, into a global Phase 2 trial spanning 20 clinical sites across Taiwan, Sweden, and the United States, targeting approximately 210 participants.

Twenty sites across three countries anchor the trial's design

The study includes nine medical centers in Taiwan, seven sites in Sweden, and four centers in the United States, with Taiwan forming the largest single group of participating sites. The randomized, double-blind, placebo-controlled trial will assign patients to TML-6 100 mg, TML-6 200 mg, or placebo, administered once daily for 52 weeks.

Waltham, Mass. – September 22, 2026 -- The U.S. Food and Drug Administration has approved Mercy BioAnalytics' Investigational Device Exemption application for its Evident Ovarian Cancer Screening Test, clearing the way for the company's pivotal SOARA Clinical Validation Study pending Institutional Review Board sign-off.

FDA clears IDE application for Mercy's Evident Ovarian Cancer Screening Test

The approval permits Mercy to launch the prospective SOARA study -- Safety in Ovarian Cancer for Average-Risk Women, Analysis -- to evaluate the safety of the blood-based test in average-risk women. The IDE clearance does not constitute FDA approval or clearance of the Evident test itself, but authorizes the specified clinical investigation to proceed.

Shanghai – September 21, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) has dosed the first patient in China in its pivotal Phase III CLINCH-3 study evaluating ATG-022, a CLDN18.2 antibody-drug conjugate, as monotherapy for CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Breakthrough Therapy Designation accelerated the trial's launch

China's National Medical Products Administration granted ATG-022 Breakthrough Therapy Designation, which the company says streamlined regulatory communications and enabled the rapid start of CLINCH-3. The randomized, controlled, open-label multicenter study is initiated in China and planned for expansion into a multi-regional clinical trial, with Professor Lin Shen of Peking University Cancer Hospital serving as principal investigator. The study compares ATG-022 against treatment of investigator's choice, targeting a future marketing approval application.

Las Vegas – September 20, 2026 -- The paroxysmal nocturnal hemoglobinuria (PNH) market across the seven major markets was valued at approximately $1.5 billion in 2025 and is projected to grow at a compound annual growth rate of 7.1% through 2036, according to DelveInsight.

Regeneron's pozelimab-cemdisiran combination leads next wave of PNH therapies

Pozelimab, a fully human anti-C5 monoclonal antibody developed on Regeneron's VelocImmune platform, is expected to generate the highest revenue among emerging PNH therapies in the seven major markets. The drug is being tested in combination with Alnylam's siRNA therapy cemdisiran; Regeneron has said Phase III results in PNH are anticipated in the fourth quarter of 2026 or the first quarter of 2027.

Jupiter, Florida – September 19, 2026 -- Myosin Therapeutics, Inc. has been selected as one of just 30 companies for the National Cancer Institute's 2026–2027 Investor Initiatives Showcase, a distinction drawn from NCI's full portfolio of funded companies following a competitive review by more than 70 third-party investors and strategic partners.

NCI selects Myosin from a competitive field of oncology innovators

The 2026–2027 cohort spans biopharmaceuticals, medical devices, diagnostics and digital health, covering first-in-class therapeutics, cell and immune therapies, radioligand therapies, antibody-drug conjugates, RNA medicines, precision drug delivery, AI-enabled cancer technologies, liquid biopsy and multi-omics platforms. Myosin enters this group with a mechanics-based approach that targets molecular nanomotors underlying cancer cell growth, invasion and survival.

San Jose, Calif. – September 19, 2026 -- Anixa Biosciences (NASDAQ: ANIX) has appointed Carmen Guerra, M.D., M.S.C.E., F.A.C.P., to its Cancer Business Advisory Board as the company prepares to advance its breast cancer vaccine into a Phase 2 clinical trial and continues its ovarian cancer CAR-T therapy Phase 1 trial.

Atlanta – – September 19, 2026 -- Alzamend Neuro, Inc. (Nasdaq: ALZN) has regained compliance with Nasdaq's minimum stockholders' equity rule, ending a listing threat that began in March 2026.

Nasdaq confirms Alzamend's equity now exceeds required threshold

Nasdaq's Listing Qualifications Staff issued a notification letter dated September 19, 2026, confirming Alzamend satisfies Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2.5 million. Alzamend's Quarterly Report on Form 10-Q for the quarter ended September 19, 2026, filed with the SEC on September 19, 2026, showed stockholders' equity of $5,802,680, more than double the required minimum.

Tel Aviv, Israel – September 19, 2026 -- Lutris Pharma will present updated phase 2 clinical data for its topical B-Raf inhibitor LUT014 at the 35th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, running September 30 through October 3.

Oral presentation scheduled for October 2 at EADV Congress in Vienna

The randomized, double-blind, placebo-controlled trial results will be delivered in an oral presentation titled 'Acneiform Rash from EGFR Inhibitor Therapy: Durable, Mechanism-Directed Reduction with Topical LUT014 (B-Raf Inhibitor) in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.' The session, Free Communication 6: Pruritus/Adverse Drug Reactions, is set for Friday, September 19, 2026, from 11:25 to 11:35 am CET in Hall N. Anisha Patel, MD, professor of Dermatology at The University of Texas MD Anderson Cancer Center in Houston, will present the data under Abstract ID AS-1328.