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- HELP Therapeutics Announces Nature Medicine Has Published HiCM-188 Clinical Trial Data for Advanced Ischemic Heart FailureAug 19, HELP Therapeutics today announced the Nature Medicine publication of 12-month results from the HEAL-CHF clinical trial evaluating HiCM-188, an investigational allogeneic human iPSC-derived cardiomyocyte (hiPSC-CM) therapy for the treatment of severe ischemic heart failure. The randomized controlled trial enrolled 20 patients, assigned 1:1 to receive either coronary artery bypass grafting (CABG) alone or CABG combined with transepicardial HiCM-188 injection. The study achieved both pre-specified primary safety endpoints, demonstrating no treatment-related tumor formation through 12 months and no sustained ventricular tachycardia through 6 months. At 12 months, 90% of patients receiving transepicardial HiCM-188 injection combined with (CABG improved to NYHA Class II, versus 60% of patients in the CABG-only group.. "HEAL-CHF provides the first clinical evidence that delivering HiCM-188 intraoperatively during CABG may combine the benefits of revascularization with myocardial regeneration," said Professor Dongjin Wang, Lead Author and Director of the Department of Cardiothoracic Surgery at Nanjing Drum Tower Hospital. "Over 12 months, we observed no serious cell-related adverse events alongside encouraging signs of reverse cardiac remodeling. Given the substantial global burden of heart failure and the persistent shortage of donor hearts, regenerative approaches like HiCM-188 have the potential to fill a critical unmet need for patients living with end-stage disease." "The publication of the HEAL-CHF study in Nature Medicine reflects years of dedication to advancing breakthrough stem cell technologies into clinically validated therapies," said Dr. Eugene Jiaxian Wang, Chief Executive Officer of HELP Therapeutics. "With our pivotal Phase III trial now enrolling patients in China and our Phase I program initiating in the U.S., we are eager to maintain this momentum as we work toward bringing a new regenerative medicine breakthrough to heart failure patients worldwide." About HiCM-188 HiCM-188 is an investigational allogeneic human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) therapy designed as a standardized, off-the-shelf product for scalable manufacturing and distribution. HiCM-188 is the first iPSC-derived cardiomyocyte therapy worldwide to obtain Investigational New Drug (IND) clearances from both the U.S. FDA and China's NMPA. It is currently being evaluated in a multicenter Phase III trial in China led by TEDA International Cardiovascular Hospital, and a Phase I trial in the United States at the Texas Heart Institute. About HELP Therapeutics Founded in 2016, HELP Therapeutics is a global clinical-stage biopharmaceutical company developing iPSC-based cell therapies for cardiovascular and other degenerative diseases. The company leverages proprietary off-the-shelf cell therapy platforms and national iPSC bank infrastructure to ensure scalable clinical and commercial delivery. HELP Therapeutics has established a commercialization partnership with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (SZSE: 000999) to build out distribution infrastructure in China. For more information, please visit https://en.helptherapeutics.com. Disclosure Notice The information contained in this release is as of August 19, 2026. HiCM-188 is an investigational product and has not been approved for commercial use by the U.S. Food and Drug Administration, China National Medical Products Administration, or any other regulatory authority. This release contains forward-looking statements regarding HiCM-188, including potential clinical benefits and regulatory development timelines, which involve substantial risks and uncertainties that could cause actual results to differ materially. References & Publication Details 1.Journal: Nature Medicine (2026) DOI: 0.1038/s41591-026-04605-1 2.Clinical Trial Registry: ClinicalTrials.gov (NCT03763136) 3.Ethics Approval: Nanjing Drum Tower Hospital IRB (No. SC202000102); National Health Commission of China (MR-32-21-014649)
- Vistin Pharma ASA: Second quarter and YTD 2026 financial resultsOslo, Norway, 20 August 2026
- Curitics Health Solutions Corp.Curitics Health Unveils Next-Generation AI Platform to Transform Clinical WorkflowsNew Curitics Point of Care Solution, Ambient Listening, AI Care Management, and mobile capabilities help reduce administrative burden, strengthen care coordination, and improve patient outcomes. — Curitics Health today announced the expansion of...
- Essity acquires feminine care business in BrazilHygiene and health company Essity has entered into an agreement to acquire Kenvue's feminine care business in Brazil, including the market-leading brands Carefree, Sempre Livre and o.b. The purchase price amounts to USD 284m (approximately SEK...
- Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Abstract Published by WCLC: Extended Follow‑Up Shows Continued Efficacy ImprovementNanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that the full abstract of the Phase II clinical study evaluating its proprietary drug candidate LBL-024 (Opamtistomig, a PD-L1/4-1BB bispecific antibody) in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (“NSCLC”) has been published on the official website of the World Conference on Lung Cancer (the “WCLC”). Based on data analyzed as of March 6, 2026, LBL-024 in combination with chemotherapy demonstrated an encouraging antitumor activity in the overall population, with robust tumor shrinkage observed in both the squamous and non-squamous NSCLC. The abstract data were based on a median follow‑up of 3.6 months. Updated data with over 7 months of follow‑up will be presented in an oral presentation at WCLC on September 14, 2026.
- Edesa Biotech Announces Pricing of $25.0 Million Public OfferingEdesa Biotech, Inc. (Nasdaq: EDSA) (the “Company” or “Edesa”), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today announced the pricing of an underwritten public offering consisting of (i) 3,870,500 common shares and accompanying common share warrants to purchase an aggregate of 3,870,500 common shares and (ii) in lieu of common shares to investors who so choose, pre-funded warrants to purchase up to 675,000 common shares and accompanying common share warrants to purchase an aggregate of 675,000 common shares, at an exercise price of $0.0001 per pre-funded warrant. Each common share and pre-funded warrant is being sold in combination with an accompanying common share warrant to purchase one common share. The common share warrants will have an exercise price of $7.50 per share, will be immediately exercisable from the date of issuance and will expire on the earlier of (x) the 18-month anniversary of the original issuance date and (y) 30 days following the Company’s public announcement of Phase 2 vitiligo topline data for EB06. The combined public offering price of each common share and accompanying common share warrant is $5.50. The combined public offering price of each pre-funded warrant and accompanying common share warrant is $5.4999, which represents the combined public offering price for the common shares and accompanying common share warrants less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds are expected to be approximately $25.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. In addition, Edesa has granted the underwriters a 30-day option to purchase up to an additional 681,825 common shares and accompanying common share warrants to purchase up to 681,825 common shares at the public offering price, less underwriting discounts and commissions.
- Ascentage Pharma Reports 2026 Interim Unaudited Financial Results and Provides Business UpdatesEarnings release
- Ingenia Therapeutics Nominated for Both the Prix Galien USA and the Inaugural Prix Galien Korea for Best StartupWATERTOWN, Mass., August 19, 2026--Ingenia Therapeutics, a clinical-stage biotechnology company pioneering next-generation vascular-targeted therapies, today announced that it has been nominated for the Prix Galien USA and the inaugural Prix Galien Korea, both in the Best Startup category by The Galien Foundation. The Galien Foundation is the premier global institution recognizing and awarding outstanding achievements of innovators in life sciences.
- Picard Medical Reports Second Quarter 2026 Financial Results-Revenue Increases 39% and Net Loss Decreases 16%-
- Ultragenyx Announces U.S. FDA Approval of GENGLYCOS™ Gene Therapy, the First-Ever FDA-Approved Treatment Designed to Treat the Underlying Cause of Glycogen Storage Disease Type Ia (GSDIa)GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company
- Phibro Animal Health CorporationPhibro Animal Health Corporation to Host Webcast and Conference Call on Fourth Quarter and Fiscal Year 2026 ResultsTEANECK, N.J., August 19, 2026--Phibro Animal Health Corporation (Nasdaq: PAHC) expects to announce its fourth quarter and fiscal year 2026 financial results on Wednesday, August 26, 2026, after the market closes. Phibro management will host a conference call and webcast on Thursday, August 27, 2026, at 9:00 AM Eastern Time.
- Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP)Companies: Regeneron PharmaceuticalsFOP is an ultra-rare genetic disorder characterized by rogue bone formation that infiltrates muscles, tendons, ligaments and other connective tissues, resulting in significant disability