Compared with tirzepatide, Wegovy® (semaglutide 2.4 mg) showed a significant 57% greater reduction in the risk of heart attack, stroke or death from any cause, in people with overweight or obesity and cardiovascular disease (CVD) who stayed on treatment1 Similarly, the study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy® users compared with tirzepatide users in all treated people, regardless of any gaps in their treatment1 This stu

TT125-802 is a small molecule CBP/p300 bromodomain inhibitor that shows clinical activity as single agent in solid tumors, including advanced EGFR-mutated and KRAS-G12C-mutated non-small cell lung cancer (NSCLC) 1 in 5 cancer-related deaths in the US are due to lung cancer, with NSCLC representing 87% of all lung cancer cases; 30% of all NSCLC have an EGFR or KRAS-G12C mutation August 28, 2025 – TOLREMO therapeutics AG (TOLREMO), today announced that their lead candidate, TT125-802, received tw

Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference Aug. 27, 2025 -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN)

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA Outlook Therapeutics plans to work with FDA to address the Agency’s issues Company to host a conference call and webcast today, August 28th at 8:30 AM ET Aug. 28, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete re

FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Supported by Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 Aug. 27, 2025 -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine bein

PannTheraPi prepares plans to conduct its first Phase IIa clinical trial with PTI5803 in patients with resistant epilepsy and accelerate the development of its proprietary pipeline Pre-submission file completed with French regulatory agency (ANSM) to discuss clinical trial protocol Phase IIa clinical trial planned to start in 2026 once fund raising is closed Strategic evolution of PannTheraPi’s management to drive upcoming milestones 26th August, 2025 - PannTheraPi, a company developing innovat

Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphoma showed 66% of Non-Hodgkin Lymphoma (NHL) patients achieving objective response rates, with 50% demonstrating complete response (CR) Favorable safety profile observed in study participants with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) in the dose escalation cohort Dose expansion phase of study will investigate MT-601 at pre-specified maximum dose

Aug. 26, 2025 -- PolarityBio, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the completion of patient enrollment in COVER DFUS II, a Pivotal Phase III Multicenter Randomized Controlled Trial (RCT) investigating SkinTE® in the treatment of Wagner 1 Diabetic Foot Ulcers (DFUs). Final trial results are anticipated in the first quarter of 2026. The trial has enrolle

First iadademstat clinical trial in non-malignant hematological indications Aug. 25, 2025 -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA), the European equivalent to an IND, to initiate a Phase Ib trial of iadademstat in sickle cell disease (SCD). This will be the first clinical trial investi

August 26, 2025 Breakthrough Therapy Designation granted to Rina-S for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy Regulatory decision supported by data from the Phase 1/2 RAINFOL™-01 trial showing encouraging responses in heavily pretreated EC patientsi Rina-S continues to be evaluated as a single-agent in patients with advanced EC in th