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) has announced its participation in two major investor conferences this December. The company will present a fireside chat at the 7th Annual Evercore HealthCONx Conference on December 4, 2024, at 7:55 a.m. ET in Coral Gables, FL. On the same day, management will be available for one-on-one meetings at Citi's 2024 Global Healthcare Conference in Miami, FL.
The fireside chat will be webcast live and accessible through Cabaletta's website, with replays available for 30 days. The company specializes in developing curative targeted cell therapies for autoimmune diseases.
Cabaletta Bio presented clinical data for CABA-201 at ACR Convergence 2024, showing promising results in treating autoimmune diseases. Eight patients across multiple trials received a single infusion of CABA-201, with follow-up periods up to six months. The therapy demonstrated a favorable safety profile with only three patients experiencing low-grade CRS. Key findings include complete B cell depletion in all patients, early signs of immune system reset, and compelling clinical responses in lupus, myositis, and systemic sclerosis patients. All patients discontinued immunosuppressants prior to treatment. The company has expanded to 40 U.S. clinical sites with 16 patients enrolled and 10 dosed as of November 2024.
Cabaletta Bio (NASDAQ: CABA) reported Q3 2024 financial results and business updates. The company has 40 U.S. clinical sites actively recruiting patients across its RESET clinical trials, with 16 patients 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 (Nasdaq: CABA), a clinical-stage biotechnology company developing curative targeted cell therapies for autoimmune diseases, announced its participation in Guggenheim's Inaugural Healthcare Innovation Conference. The company will engage in a fireside chat on Monday, November 11, 2024, at 10:00 a.m. ET in Boston, MA.
The presentation will be accessible through a live webcast on the News and Events section of Cabaletta's website, with replays available for 30 days following the event.
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.
FAQ
What is the current stock price of Cabaletta Bio (CABA)?
What is the market cap of Cabaletta Bio (CABA)?
What is Cabaletta Bio's primary focus?
What are some of Cabaletta Bio's key product candidates?
What is CABA-201 and why is it significant?
Has Cabaletta Bio received any regulatory designations?
Where is Cabaletta Bio headquartered?
What is the current financial condition of Cabaletta Bio?
What stages are Cabaletta Bio's clinical trials in?
What makes Cabaletta Bio's technology proprietary?
What recent achievements has Cabaletta Bio made?
How does Cabaletta Bio aim to impact patient care?
