Welcome to our dedicated page for Cabaletta Bio news (Ticker: CABA), a resource for investors and traders seeking the latest updates and insights on Cabaletta Bio stock.
Cabaletta Bio, Inc. (symbol: CABA) is a clinical-stage biotechnology company dedicated to the discovery and development of engineered T cell therapies for patients suffering from B cell-mediated autoimmune diseases. Utilizing its proprietary Chimeric AutoAntibody Receptor (CAAR) and Chimeric Antigen Receptor T cells for autoimmunity (CARTA) technologies, Cabaletta aims to provide targeted, effective, and potentially curative treatments.
The company's flagship product candidate, DSG3-CAART, is in Phase I clinical trials for treating mucosal pemphigus vulgaris, an autoimmune blistering skin disease. Other promising candidates include MuSK-CAART for myasthenia gravis and FVIII-CAART for a subset of patients with hemophilia A. Cabaletta is also actively developing DSG3/1-CAART for mucocutaneous pemphigus vulgaris, with several products in various stages of preclinical and discovery phases.
In recent developments, Cabaletta Bio received approval from the U.S. FDA for its Investigational New Drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy for generalized myasthenia gravis (gMG). This expands their portfolio into neurology, complementing prior clearances for lupus, myositis, and systemic sclerosis. The upcoming Phase 1/2 clinical trial for CABA-201 aims to test its efficacy in treating gMG patients, potentially offering a groundbreaking one-time dose treatment.
Furthermore, Cabaletta has secured multiple Fast Track Designations from the FDA for CABA-201 in conditions like dermatomyositis and systemic sclerosis, facilitating expedited development and review. These designations highlight the critical unmet needs in these patient populations and amplify Cabaletta’s commitment to pioneering advanced therapies.
Based in Philadelphia, PA, Cabaletta Bio continues to advance its innovative pipeline, guided by robust scientific research and strategic collaborations. The company is well-positioned financially, with adequate resources to fund its operations into the first half of 2026. Cabaletta's mission is to harness the power of engineered T cells to unlock transformative therapies, offering patients durable, drug-free remissions and improved quality of life.
Cabaletta Bio (Nasdaq: CABA) announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, featuring new and updated clinical data on CABA-201, their 4-1BB-containing fully human CD19-CAR T cell investigational therapy. The presentations will cover:
1. An oral presentation on the safety and efficacy of CABA-201 in patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical Trials.
2. A poster presentation on correlative studies of CABA-201 in the same patient groups.
The ACR Convergence 2024 will be held from November 14-19, 2024, in Washington, D.C. Presentation materials will be available on Cabaletta Bio's website following the event.
Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases, has announced its participation in four major investor conferences in September 2024:
- Morgan Stanley 22nd Annual Global Healthcare Conference on September 4
- 2024 Wells Fargo Healthcare Conference on September 5
- H.C. Wainwright 26th Annual Global Investment Conference on September 11
- 2024 Cantor Fitzgerald Global Healthcare Conference on September 17
The company will participate in fireside chats at each event. Live webcasts of the presentations will be available on Cabaletta Bio's website, with replays accessible for 30 days after each event.
Cabaletta Bio reported its Q2 2024 financial results and provided a business update. Notable highlights include:
- Enrollment of nine patients as of August 5, 2024, in the RESET™ clinical development program, with 22 U.S. clinical sites now enrolling.
- Upcoming clinical data expected in 2H24 for RESET-Myositis™, RESET-SLE™, RESET-SSc™, and RESET-MG™ trials.
- An LN patient experienced a dose-limiting toxicity which resolved quickly, allowing the study to proceed without delays.
- Agreements with Lonza and Cellares to enhance manufacturing and scalability.
- Cash, cash equivalents, and short-term investments totaling $203.2 million, supporting operations into 1H 2026.
Financially, R&D expenses rose to $23.4M from $11.8M YoY, and G&A expenses increased to $6.9M from $4.1M YoY. The company also welcomed Dr. Sarah Yuan as Chief Technology Officer to advance its manufacturing strategy.
Cabaletta Bio, a clinical-stage biotech firm focusing on curative cell therapies for autoimmune diseases, announced its CEO, Steven Nichtberger, will participate in the Stifel 2024 Virtual Cell Therapy Forum. This event is scheduled for July 9, 2024, at 1:00 p.m. ET. Interested parties can access a live webcast and replay of the fireside chat via the company's website. The webcast will remain available for 30 days.
Cabaletta Bio reported positive initial clinical data from its Phase 1/2 RESET-Myositis and RESET-SLE trials for its investigational therapy, CABA-201.
Key findings include no serious adverse events, no CRS or ICANS, and no infections in either of the first two patients. The therapy showed the expected CAR T cell expansion and contraction with complete B cell depletion by day 15 post-infusion.
Both patients showed improvement in disease measures and were able to discontinue all maintenance therapies, except for a planned steroid taper in one case. The trials indicate a potential immune system reset, with immature, naïve B cell repopulation observed at week 8 in one patient.
The company continues to enroll patients and expects to report more data in the second half of the year. A conference call and webcast are scheduled for June 14, 2024, at 8:00 a.m. ET to discuss these findings.
Cabaletta Bio, a clinical-stage biotech firm specializing in curative targeted cell therapies for autoimmune diseases, announced its CEO, Steven Nichtberger, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2024. The event will be held at 11:00 a.m. ET in New York, NY. A live webcast of the presentation will be accessible on Cabaletta Bio's website, with replays available for 30 days.
Cabaletta Bio (Nasdaq: CABA) announced its Q1 2024 financial results and provided business updates. Key highlights include the absence of CRS or ICANS in the initial patients treated in the RESET-Myositis and RESET-SLE trials, with clinical data expected at the EULAR 2024 Congress. The company is expanding the CABA-201 trial to dermatology with the RESET-PV sub-study and exploring apheresis-free manufacturing methods. Financially, Cabaletta's R&D expenses rose to $22 million, and G&A expenses increased to $6.1 million. The company holds $223.8 million in cash and investments, projected to fund operations into 2026.
Cabaletta Bio, a clinical-stage biotechnology company, will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ. The event is scheduled for May 20, 2024, in New York, NY. The company focuses on developing curative targeted cell therapies for patients with autoimmune diseases.
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