Istaroxime has previously completed two positive Phase 2 studies in SCAI Stage B cardiogenic shock; the SEISMiC C study in SCAI Stage C cardiogenic shock is another step progressing to the istaroxime cardiogenic shock Phase 3 program May 22, 2025 -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, today

Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 The Itovebi-based regimen also demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS) in the final OS analysis Final OS data will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting 23 May 2025 - Roche

• Significantly expands IB-Stim’s total addressable market • Clearance covers patients aged 8–21 • Seamless go-to-market strategy with existing reimbursement and provider infrastructure May 20, 2025 -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that it has received FDA 510(k) clearance for IB-Stim™ for the

Positive results show that a single dose of BPL-003, administered adjunctively to SSRIs, produced a rapid and long-lasting antidepressant effect for up to three months after dosing. BPL-003 was well-tolerated and patients were able to be discharged within an average time of less than two hours. Data from the core, randomised stage of Beckley Psytech’s Phase IIb study of BPL-003 for treatment resistant depression is expected in mid-2025. 20 MAY 2025. Beckley Psytech Ltd, a private clinical-stage

These results indicate that EXACT Therapeutics’ Acoustic Cluster Therapy (ACT®) significantly enhances the local effect of chemotherapy In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, pFinal analysis mirrors the excellent safety profile of PS101 seen in the interim read-out and suggests a dose-response relationship The data supports the company’s plans for its Phase 2 trial (EN

--- Ruxoprubart (NM8074) met all clinical endpoints, offering a safe, differentiated treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare hematological (Blood) disorder. Regulatory approval for the Phase II trial in PNH subjects was granted based on the safety profile of healthy subjects in the Phase I trial. Interim results from this 12-subject, three-month, multi-dose Phase II efficacy trial are compelling. The drug was safe and well-to

Preconditioning with lymphodepletion linked to stronger MAR-T cells response and suggests enhanced anti-tumor activity Highest enrollment since study launch underscores momentum and signals a positive trial trajectory Clinical data readout from Phase 1 APOLLO study expected later this year May 20, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of h

-- First ever clinical data supporting safety and efficacy of Prime Editing in humans -- -- Initial data from first patient dosed in Phase 1/2 trial finds single dose of PM359 led to 58% DHR positivity by Day 15 and 66% by Day 30, well above levels believed to be potentially curative -- -- Rapid engraftment observed in both neutrophils and platelets -- -- Encouraging safety profile; no serious adverse events related to PM359 -- -- Initiating efforts to explore continued clinical development oppo

JUV-161 is a first-in-class muscle regenerating biologic that will address myopathies starting with Myotonic Dystrophy Type 1 JUV-161 was discovered using Juvena’s proprietary JuvNET platform, an AI and stem cell secretome-based drug discovery and development platform May 19, 2025 -- Juvena Therapeutics, Inc. (“Juvena”), a clinical-stage biotechnology company pioneering tissue restorative biologics for chronic muscle and metabolic diseases, announced today that it is enrolling participants in

Despite growing recognition of long COVID as a serious condition, diagnosed patients have no approved treatment options, with many suffering from debilitating fatigue and brain fog Evidence suggests sustained inflammation plays a central role in the pathogenesis of long COVID, particularly in the associated cognitive dysfunction and other neurological symptoms1 Bezisterim targets key underlying mechanisms of neuroinflammation, and has demonstrated the potential to reduce chronic symptoms in Alzh