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Cabaletta Bio, Inc. - CABA STOCK NEWS

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.

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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.

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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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Cabaletta Bio, Inc. reports financial results and progress in autoimmune disease treatment trials. The company dosed the first patient with CABA-201 in the RESET clinical trial program, with initial data expected in 2024. FDA grants Rare Pediatric Disease designation for CABA-201. Cash runway into 1H26 with $241.2 million in cash and investments.
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Cabaletta Bio, Inc. receives Orphan Drug Designation from the FDA for CABA-201, a promising therapy for systemic sclerosis. The clinical-stage biotechnology company aims to develop curative targeted cell therapies for autoimmune diseases, focusing on B cell-driven conditions.
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Cabaletta Bio, Inc. (CABA) to participate in two investor conferences in March, showcasing their innovative curative targeted cell therapies for autoimmune diseases. CEO Steven Nichtberger to feature in TD Cowen 44th Annual Health Care Conference and management to attend Jefferies Biotech on the Bay Summit.
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Cabaletta Bio, Inc. receives Orphan Drug Designation from the FDA for CABA-201, a potential curative therapy for autoimmune diseases. The drug is designed to deplete CD19-positive B cells, aiming to provide durable remission off therapy for patients with myositis and other autoimmune diseases. The FDA designation grants Cabaletta certain incentives, including tax credits, waived user fees, and potential marketing exclusivity for seven years.
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Cabaletta Bio, Inc. (Nasdaq: CABA) announced CEO participation in Guggenheim Healthcare Talks 6th Annual Biotechnology Conference. The live webcast will be available on the company's website with replays for 30 days.
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Cabaletta Bio, Inc. (Nasdaq: CABA) has received second and third FDA Fast Track Designations for CABA-201, an investigational 4-1BB-containing fully human CD19-CAR T cell therapy, for the treatment of patients with dermatomyositis and systemic sclerosis. This provides the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune diseases. CABA-201 is designed to deeply and transiently deplete CD19-positive B cells following a one-time infusion, potentially enabling an 'immune system reset' with the potential for durable remission off therapy in patients with autoimmune diseases. The company has received clearance from the FDA for Investigational New Drug (IND) applications for CABA-201 in multiple autoimmune conditions and is conducting four Phase 1/2 clinical trials with a total of nine cohorts that can advance simultaneously.
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Cabaletta Bio, Inc. (Nasdaq: CABA) to present at 42nd Annual J.P. Morgan Healthcare Conference
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Cabaletta Bio, Inc. (Nasdaq: CABA) CEO to participate in fireside chat at Evercore ISI HealthCONx Conference
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FAQ

What is the current stock price of Cabaletta Bio (CABA)?

The current stock price of Cabaletta Bio (CABA) is $2.38 as of December 20, 2024.

What is the market cap of Cabaletta Bio (CABA)?

The market cap of Cabaletta Bio (CABA) is approximately 117.3M.

What is Cabaletta Bio's primary focus?

Cabaletta Bio specializes in developing engineered T cell therapies for B cell-mediated autoimmune diseases.

What are some of Cabaletta Bio's key product candidates?

Key candidates include DSG3-CAART for mucosal pemphigus vulgaris, MuSK-CAART for myasthenia gravis, and CABA-201 for generalized myasthenia gravis.

What is CABA-201 and why is it significant?

CABA-201 is an investigational CD19-CAR T cell therapy designed to offer a one-time dose treatment for autoimmune diseases, recently cleared for trials by the FDA.

Has Cabaletta Bio received any regulatory designations?

Yes, Cabaletta Bio has received multiple Fast Track Designations from the FDA for CABA-201 in treating conditions like dermatomyositis and systemic sclerosis.

Where is Cabaletta Bio headquartered?

Cabaletta Bio is headquartered in Philadelphia, PA.

What is the current financial condition of Cabaletta Bio?

Cabaletta Bio has sufficient funds to support its operating plan into the first half of 2026.

What stages are Cabaletta Bio's clinical trials in?

Cabaletta Bio's lead candidate DSG3-CAART is in Phase I trials, while CABA-201 is preparing for Phase 1/2 trials across multiple autoimmune conditions.

What makes Cabaletta Bio's technology proprietary?

Cabaletta Bio utilizes proprietary CAAR and CARTA technologies to specifically target and eliminate disease-causing B cells while sparing healthy cells.

What recent achievements has Cabaletta Bio made?

Cabaletta Bio recently received FDA approval for multiple IND applications and Fast Track Designations, underscoring its innovative pipeline's potential.

How does Cabaletta Bio aim to impact patient care?

Cabaletta Bio aims to provide deep and durable treatments, potentially offering drug-free remissions and significantly improving patient quality of life.

Cabaletta Bio, Inc.

Nasdaq:CABA

CABA Rankings

CABA Stock Data

117.31M
47.36M
3.1%
100.47%
7.59%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
PHILADELPHIA