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. (Nasdaq: CABA) is a clinical-stage biotechnology company developing targeted cell therapies for autoimmune diseases, with news flow closely tied to its lead investigational CAR T cell therapy, rese-cel (resecabtagene autoleucel). The company regularly issues updates on clinical data, regulatory interactions, manufacturing progress and corporate developments that are relevant to investors and followers of autoimmune-focused biotechnology.
News about Cabaletta Bio often highlights clinical milestones within its RESET™ (REstoring SElf-Tolerance) development program. These updates include Phase 1/2 data readouts and trial expansions in indications such as myositis, systemic sclerosis, systemic lupus erythematosus, lupus nephritis, generalized myasthenia gravis and pemphigus vulgaris. Press releases have described outcomes from disease-specific cohorts, registrational cohort designs aligned with the U.S. Food and Drug Administration, and emerging data from cohorts evaluating rese-cel without preconditioning regimens.
Regulatory and manufacturing news is another key theme. Cabaletta Bio has reported on FDA designations for rese-cel, including Regenerative Medicine Advanced Therapy and Fast Track designations, as well as PRIME access from the European Medicines Agency. The company also issues announcements regarding chemistry, manufacturing and controls activities and its collaboration with Cellares to use fully automated platforms, such as the Cell Shuttle™ and Cell Q™, for clinical manufacturing and quality control testing of rese-cel.
Corporate and financial updates, including quarterly financial results, public offerings and participation in healthcare and investor conferences, are frequent components of Cabaletta Bio’s news flow. These communications provide context on the company’s cash position, operating plans and engagement with the investment community. For readers tracking CABA, the news stream offers insight into the progress of rese-cel across multiple autoimmune indications, evolving registrational strategies and the company’s preparations for potential future commercialization. Bookmarking the news feed can help users follow ongoing clinical, regulatory and corporate developments related to Cabaletta Bio and its RESET program.
Cabaletta Bio, Inc. (Nasdaq: CABA) has appointed Samik Basu, M.D. as Chief Scientific Officer and Heather Harte-Hall as Chief Compliance Officer. Both executives have extensive experience and will report to Gwendolyn Binder, Ph.D., Executive Vice President of Science & Technology. Dr. Basu, previously Vice President of Preclinical Research, has a background in T-cell immunotherapy, while Ms. Harte-Hall has led compliance at Adaptimmune Therapeutics. These appointments aim to strengthen leadership as the company advances its DSG3-CAART product candidate for mucosal pemphigus vulgaris.
Cabaletta Bio reported promising updates from the DesCAARTes™ Phase 1 trial, highlighting a dose-dependent increase in DSG3-CAART persistence in the third patient cohort. No dose-limiting toxicities or significant adverse events were recorded as of October 31, 2021. The company ended Q3 2021 with $119.3M in cash and expects funding to last through 1Q23. Upcoming milestones include the top-line biologic activity data from the first two low-dose cohorts and an IND submission for MuSK-CAART.
Cabaletta Bio, Inc. (CABA) announced promising results from the DesCAARTes™ Phase 1 clinical trial for DSG3-CAART, targeting mucosal-dominant pemphigus vulgaris (mPV). Data as of October 31, 2021, indicates dose-dependent increases in cell persistence without adverse events across three cohorts. Dosing for the fourth cohort has commenced at 2.5 billion cells, with 28-day safety data expected in Q1 2022, while top-line biologic activity data from earlier cohorts is anticipated in Q4 2021. The trial has successfully increased participant sites to six, enhancing recruitment efforts.
Cabaletta Bio (CABA) announced promising preclinical data supporting its PLA2R-CAART therapy targeting B cells in PLA2R membranous nephropathy. The therapy demonstrated effective cytolysis of anti-PLA2R antibody-expressing B cells with no off-target interactions. An oral presentation will be given at ASN Kidney Week 2021, highlighting the potential for this precise treatment to spare healthy B cells. A pre-IND interaction with the FDA is scheduled for later this year, marking a key step in its development for high unmet medical needs.
Cabaletta Bio (Nasdaq: CABA) announced that its CEO, Steven Nichtberger, M.D., will participate in a fireside chat at the Chardan 5th Annual Genetic Medicines Conference on October 5, 2021, at 8:30 a.m. ET. A live webcast of the event will be available on the company's website, and a replay will be accessible for 90 days post-event. Cabaletta Bio focuses on engineered T cell therapies aimed at treating B cell-mediated autoimmune diseases, with its lead candidate, DSG3-CAART, currently in a phase 1 clinical trial for mucosal pemphigus vulgaris.
Cabaletta Bio (CABA) has appointed Michael Gerard as general counsel, a move intended to bolster its executive team as the company advances its clinical development of engineered T cell therapies for autoimmune diseases. Gerard brings extensive legal experience in life sciences, having previously served at Spark Therapeutics and Sandoz. His addition is expected to support the ongoing DesCAARTes™ trial for DSG3-CAART, which targets mucosal pemphigus vulgaris. The FDA granted Fast Track Designation for this candidate in May 2020, highlighting its potential therapeutic value.
Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company, announced its participation in two investor conferences in September 2021. The Morgan Stanley 19th Annual Global Healthcare Conference will feature a fireside chat with CEO Steven Nichtberger on September 9, while the H.C. Wainwright 23rd Annual Global Investment Conference will include a pre-recorded chat available on September 13. Both presentations will be accessible on Cabaletta's website for 90 days. The company focuses on engineered T cell therapies for B cell-mediated autoimmune diseases, with its lead candidate DSG3-CAART in Phase 1 trials.
Cabaletta Bio reported promising results from its DesCAARTes™ Phase 1 clinical trial regarding DSG3-CAART for treating mucosal pemphigus vulgaris. As of August 17, no dose-limiting toxicities or significant adverse events occurred in the second cohort, which received 100 million cells. DSG3-CAART persistence was confirmed in all three patients during the 28 days post-infusion. The trial has now moved to a third cohort, dosing 500 million cells, with safety and efficacy data expected in Q4 2021. The company aims to develop targeted therapies for autoimmune diseases while avoiding generalized immunosuppression.
Cabaletta Bio, Inc. (Nasdaq: CABA) reported Q2 2021 financial results and updates on its clinical trials. The company is progressing with the DesCAARTes™ trial for DSG3-CAART, expecting to release safety data for additional patient cohorts in Q3 and Q4 2021. They plan to submit an IND for MuSK-CAART in H2 2021 and have requested a pre-IND meeting for PLA2R-CAART. Cash and equivalents stood at $102.8 million as of June 30, 2021. R&D expenses increased to $7.9 million from $5.3 million year-over-year.
Cabaletta Bio, Inc. (CABA) recently appointed Dr. Scott Brun to its Board of Directors. Dr. Brun, with over 20 years in drug development, previously held leadership roles at AbbVie and Abbott Laboratories. His expertise in autoimmune diseases aligns with Cabaletta's goal to advance its lead program, DSG3-CAART, targeting mucosal pemphigus vulgaris. Dr. Brun will also serve on the Audit and Nominating Committees. His appointment follows the resignation of Dr. Brian Daniels, who contributed to the board since 2018. The company aims to enhance shareholder value with this strategic addition.
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