Cabaletta Bio

Biogen and UCB detailed Phase III PHOENYCS GO trial results for dapirolizumab pegol, showing a 49.5% response rate vs. 34.6% with standard care, significant in lupus. DZP hit key secondary endpoints, improved disease activity scores, and corticosteroid tapering, with a well-tolerated side effect profile. A second Phase III trial is planned.

Cabaletta Bio reports Q3 2024 financials, with $26.3M R&D expenses and $183M cash reserves. Enrolled 16 patients in RESET trials, actively recruiting at 40 U.S. sites and expanding to Europe. CEO highlights clinical progress and potential FDA meeting in 2025. Appoints Gerwin Winter to lead international expansion.

The systemic scleroderma treatment market, valued at USD 1.71 Bn in 2024, is projected to grow to USD 2.39 Bn by 2031, with a CAGR of 4.9%. Growth is driven by rising disease incidence, increased government funding, and awareness. North America leads the market, while Asia Pacific is the fastest-growing region. Challenges include high treatment costs and lack of curative therapies. Innovations in immunosuppressants and oral drugs dominate the market. Emerging economies and startups focusing on innovative treatments and technologies offer significant growth opportunities.

Cabaletta Bio reports Q3 2024 financial results, with $183M in cash, cash equivalents, and short-term investments, supporting operations into H1 2026. Clinical data from RESET-Myositis™, RESET-SLE™, and initial RESET-SSc™ trials to be presented at ACR Convergence 2024. 16 patients enrolled, 10 dosed in the RESET™ program, with 40 U.S. clinical sites actively recruiting. Plans to meet with FDA in 2025 for potential registrational program designs for CABA-201. Clinical development expands into Europe with EMA CTA authorization for CABA-201 in lupus; Gerwin Winter appointed as Senior VP and Head of International.

Cabaletta Bio reported Q3 2024 financial results and business updates, with 40 U.S. clinical sites actively recruiting patients across its RESET clinical trials, 16 enrolled and 10 dosed as of November 12. Clinical data from RESET-Myositis, RESET-SLE, and initial data from RESET-SSc trials will be presented at ACR Convergence 2024. The company received EMA CTA authorization for CABA-201 in lupus, expanding into Europe. Cash position stands at $183.0 million as of September 30, 2024, expected to fund operations into first half of 2026.

Cabaletta Bio (CABA) pioneers CD19 auto-CAR-T therapies for immunology diseases, facing volatility and challenges in manufacturing and patient enrollment. Despite hurdles, CABA's first-mover advantage in CAR-T for immunology could lead to durable drug-free remissions, potentially transforming treatment standards.

Cabaletta Bio to present CABA-201 data at ACR Convergence 2024, showcasing safety and efficacy in autoimmune diseases.

Lupus disproportionately affects racial and ethnic minorities, yet they're underrepresented in clinical trials. LuCIN aims to bridge this gap by enhancing diversity through investigator and research staff engagement, addressing barriers like socioeconomic factors and mistrust, and promoting culturally appropriate communication and education.

Health disparities in lupus among racial and ethnic minorities are addressed through research identifying 33 solutions in categories like Financial Safety Net and Patient Education. High-priority solutions include personalized care and Medicaid expansion to improve healthcare equity and outcomes.

The Systemic Sclerosis Treatment Market is projected to grow significantly by 2034, driven by increasing prevalence, awareness, and FDA approvals like CABA-201's Orphan Drug and Fast Track Designations. Key players include Kyowa Hakko Kirin, AstraZeneca, and others, with therapies such as LUMICEF and SAPHNELO leading the pipeline. The market's expansion is also fueled by ongoing clinical trials and the development of new treatments targeting systemic sclerosis and related conditions.