CABALETTA BIO DL -,00001

Cabaletta Bio presented data at the Morgan Stanley Global Healthcare Conference showing that the rese-cel program in the RESET study produced strong response rates of about 80–85% in roughly 100 patients and reported no cases of IEC‑HS; 94% experienced no or only grade‑1 CRS and 97% had no ICANS. Management attributes the favorable safety profile in part to a nine‑day manufacturing process and plans to present approval‑relevant myositis data in Q2–Q3 2025 and to file a BLA by the end of 2025. For commercialization, Cabaletta is building a manufacturing network with Lonza, ElevateBio and Solaris, but still sees the need to demonstrate long‑term durability, scale up production and deliver regulatory data on schedule. » Więcej na de.investing.com

Cabaletta Bio reported a net loss per share of $0.73 for Q2 2026, a deterioration of about 30% year‑over‑year driven by higher spending on late‑stage clinical development. The company holds roughly $225.1 million in cash following a registered direct placement but sees funding secured only through mid‑2027, signaling potential dilution risks ahead of a BLA filing. Clinically, positive Phase‑1/2 data were reported with 80% reaching the primary endpoint in the approval cohort of adult patients with dermatomyositis and antisynthetase syndrome, and ElevateBio was engaged as a second CDMO. Despite operational progress, the stock has come under pressure and is trading intraday weaker than the broader market. » Więcej na de.investing.com

Cabaletta Bio reported positive clinical and translational results from the first four patients in the lowest-dose cohort evaluating preconditioning-free (PC-free) rese-cel, with 50% of patients showing drug-free responses for six months. Manufacturing and translational data from two autoimmune patients treated using the Cellares Cell Shuttle were also presented, and the company found a higher rese-cel dose may be required without preconditioning. Cabaletta has signed a long-term commercial supply agreement to enable large-scale, low-cost production and is preparing initial data from lupus patients dosed with preconditioning while advancing rese-cel toward a BLA and potential commercial launch. » Więcej na finance.yahoo.com