Clinical Trial News

InspireMD submitted a PMA application to the FDA for its CGuard Prime carotid stent system, based on positive C-GUARDIANS trial results. The trial showed a 1.95% major adverse event rate, the lowest for any carotid stent trial. U.S. commercial launch is anticipated in H1 2025, if approved.

TransCon CNP demonstrated superior annualized growth velocity (AGV) to placebo in children with achondroplasia, with LS mean treatment differences of 1.49 cm/year at Week 52 (p<0.0001) for ages 2-11 and 1.78 cm/year for ages 5-11 (p<0.0001). TransCon CNP was well-tolerated, with low frequency of mild injection site reactions. Ascendis plans to submit a New Drug Application (NDA) for TransCon CNP in Q1 2025.

AstraZeneca's Imfinzi shows benefits in event-free and overall survival in muscle-invasive bladder cancer, but faces FDA scrutiny over treatment phase contributions. The NIAGARA study results, published in NEJM, suggest a 32% EFS improvement and 25% reduced risk of death. Despite concerns, the FDA approved Imfinzi for lung cancer, raising questions about its decision-making process for NIAGARA.

InspireMD submitted a PMA application to the FDA for its CGuard Prime carotid stent system, based on the C-GUARDIANS trial's low major adverse event rate. The company prepares for a potential U.S. launch in H1 2025, aiming to establish CGuard Prime as the industry standard. InspireMD reported a 5.4% revenue increase in Q2 2024 but also a net loss of $7.9 million, highlighting financial challenges. Investors monitor the company's financial health and market performance, noting its expanding market presence and potential growth opportunities.

Evaxion Biotech's phase 2 trial of EVX-01, a personalized cancer vaccine, showed a 69% Overall Response Rate in advanced melanoma patients. The AI-Immunology™ platform-designed vaccine targets neoantigens, triggering a targeted immune response in 79% of cases. With melanoma cases projected to reach 510,000 by 2040, EVX-01's potential market value is significant. Final trial results are expected in Q3 2025.

Medexus Pharmaceuticals has been informed by medac that the FDA extended the treosulfan NDA review period by three months to January 30, 2025, due to additional data analysis required. Medexus remains prepared for a potential US approval and commercial launch in H1 2025.

Eli Lilly's targeted IL-13 inhibitor Ebglyss (lebrikizumab-lbkz) approved by FDA for moderate-to-severe atopic dermatitis in adults and adolescents aged 12+ with at least 40kg body weight, not well controlled by topical therapies. Ebglyss, effective with or without topical corticosteroids, showed 38% of patients achieving clear or almost-clear skin at week 16 in ADvocate trials, compared to 12% with placebo.

NMPA grants Breakthrough Therapy Designation to Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone for relapsed or refractory multiple myeloma, based on phase III DREAMM-7 trial results showing significant PFS improvements. A positive OS trend was observed but not statistically significant at interim analysis.

BioNTech to present clinical trial data on mRNA-based cancer vaccines, next-gen immunomodulators, and targeted therapies at ESMO Congress 2024 in Barcelona.

FDA lifts partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing resumption of enrollment in ongoing clinical trials without changes to the development plan. Zentalis remains confident in azenosertib's therapeutic potential for gynecologic malignancies and plans to present monotherapy data later this year.