| Cabaletta Bio Announces 2027 Rese-cel BLA Submission Anticipated in Myositis Following Recent FDA Alignment on Registrational Cohorts |
– Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – – RMAT designation granted for rese-cel in myositis, which is a disabling, multi-system autoimmune disease affecting approximately 80,000 U.S. patients with no approved treatments other than monthly IVIg – – Multiple Phase 1/2 disease cohorts fully enrolled across the RESET™ clinical development program; 44 patients enrolled and 23 patients dosed as of May 9, 2025 – – SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 – – New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June – PHILADELPHIA, May 15, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration (FDA) meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel (resecabtagene autoleucel, formerly known as CABA-201). “Myositis is a severe, disabling, and potentially life-threatening multi-system disease that affects approximately 80,000 patients in the U.S. with a three-fold increased mortality risk primarily due to interstitial lung disease, cardiovascular disease and an increased risk of cancer. |
globenewswire.com |
2025-05-15 11:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update |
– FDA meeting to align on myositis registrational trial designs for rese-cel in 1H25 on track – – Enrolling approximately one patient per week across the RESET™ clinical development program since ACR Convergence presentation in November 2024 with 33 patients enrolled across 56 active clinical trial sites in the U.S. & Europe as of March 14, 2025 – – Clinical and translational data on rese-cel to be presented in three oral presentations at the EULAR 2025 Congress in June – – Operational runway into 1H26 with cash and cash equivalents of $164.0 million as of December 31, 2024 – PHILADELPHIA, March 31, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “We are looking forward to meeting with the FDA to align on registrational trial designs in myositis, which affects approximately 70,000 patients in the U.S., by leveraging our emerging clinical data and our efficient development strategy. |
globenewswire.com |
2025-03-31 11:00:00 |
Czytaj oryginał (ang.) |
| Cellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle™ Platform |
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201). Rese-cel is the lead clinical candidate in development by Cabaletta Bio, a biotechnology company focused on developing and launching the first curative targeted cell therapies designed spec. |
businesswire.com |
2025-03-19 09:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in the TD Cowen 45th Annual Health Care Conference |
PHILADELPHIA, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:50 a.m. ET in Boston, MA. |
globenewswire.com |
2025-02-26 10:00:00 |
Czytaj oryginał (ang.) |
| UPDATE - Cabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific Meetings |
– Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off or tapering steroids as of the latest follow-up – |
globenewswire.com |
2025-02-18 12:21:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific Meetings |
– Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off steroids as of the latest follow-up – – Safety profile continues to suggest favorable risk-benefit in the first 10 patients dosed ; 90% of patients experienced either no CRS or Grade 1 CRS (fever) and 90% of patients experienced no ICANS – – Deep B cell depletion observed in all patients after rese-cel infusion with a transitional naïve B cell phenotype upon repopulation; tissue-resident B cell elimination confirmed by a lymph node biopsy in a scleroderma patient – – 50 clinical sites in the U.S. and Europe actively recruiting with 26 patients enrolled across the RESET™ clinical development program as of February 13, 2025 – PHILADELPHIA, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced new and updated clinical data from the first 10 patients dosed with resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) across the RESET clinical development program. These data were presented by Aimee Payne, M.D. |
globenewswire.com |
2025-02-18 09:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Announces Presentations Featuring Updated Clinical Data on Rese-cel at Upcoming Scientific Meetings in February |
PHILADELPHIA, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that updated clinical data on resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) will be featured in presentations at the 2025 American Association for the Advancement of Science Annual Meeting, which is being held at the Hynes Convention Center in Boston, MA from February 13-15, 2025, and the 5th International Conference on Lymphocyte Engineering, which is being held at the Holiday Inn Munich – City Center in Munich, Germany from February 20-22, 2025. The presentations will include safety, translational data and clinical outcomes from the first 10 patients dosed with rese-cel across multiple ongoing clinical trials in the RESET™ clinical development program. |
globenewswire.com |
2025-02-11 10:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in Guggenheim's SMID Cap Biotech Conference |
PHILADELPHIA, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at Guggenheim's SMID Cap Biotech Conference on Wednesday, February 5, 2025, at 10:30 a.m. ET in New York, NY. |
globenewswire.com |
2025-01-29 10:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio: Finding Optimism In Dire Straits |
Cabaletta Bio, Inc.'s CD19-directed CAR T-cell therapy shows early promise in treating autoimmune diseases, despite limited patient numbers and follow-up time. Financially, Cabaletta Bio has enough cash to operate for 5–6 quarters, assuming no further expense growth or additional financing. Risks include the aggressive nature of CAR T-cell therapy for non-life-threatening diseases and competition from other cell therapy approaches. |
seekingalpha.com |
2025-01-06 16:28:04 |
Czytaj oryginał (ang.) |
| Cabaletta: Biotech With Large Potential, Interesting Bottom Pattern, Plenty Of Cash |
I am buying Cabaletta Bio shares as a speculative play on upcoming clinical trial updates for innovative CAR-T therapies. Despite high volatility in 2024 and the potential for total investment loss, the company's strong cash position and lack of recent selling point to a bullish outlook. Super-positive testing results announced in mid-November would trigger significant stock gains, with the possibility of oversized returns on investment similar to 2022-23. |
seekingalpha.com |
2024-10-22 15:41:17 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Present New and Updated Clinical Data on CABA-201 in Oral and Poster Presentations at ACR Convergence 2024 |
PHILADELPHIA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington Convention Center in Washington, D.C. from November 14-19, 2024. The presentations will feature new and updated clinical data on CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, which is being evaluated in multiple ongoing clinical trials in the RESET™ clinical development program. |
globenewswire.com |
2024-09-25 20:30:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in Upcoming Investor Conferences in September |
PHILADELPHIA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following investor conferences in September: |
globenewswire.com |
2024-08-28 12:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Reports Second Quarter 2024 Financial Results and Provides Business Update |
– Nine patients enrolled as of August 5, 2024 across the RESET™ clinical development program, including four since EULAR in June, with 22 U.S. clinical sites now enrolling – |
globenewswire.com |
2024-08-08 11:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in the Stifel 2024 Virtual Cell Therapy Forum |
PHILADELPHIA, July 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Stifel 2024 Virtual Cell Therapy Forum on Tuesday, July 9, 2024, at 1:00 p.m. ET. |
globenewswire.com |
2024-07-02 12:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio: Next Data Readout Needs To Be Mic Drop Moment |
Cabaletta Bio focuses on autoimmune diseases with a potential best-in-class cell therapy, CABA-201, showing promise in early studies. It's stock price rose >$25 due to positive data produced by a drug with the same MoA as CABA-201, showing remarkable results with many patients experiencing full recoveries. Cabaletta stock has been sinking in 2024 however due to slow progress, manufacturing concerns, and disappointing recent data release. |
seekingalpha.com |
2024-06-28 17:42:28 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Reports Positive Initial Clinical Data from Phase 1/2 RESET-Myositis™ and RESET-SLE™ Trials of CABA-201 |
– No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 – |
globenewswire.com |
2024-06-14 06:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Reports First Quarter 2024 Financial Results and Provides Business Update |
– No CRS or ICANS of any grade observed during the 28-day DLT observation window for either of the first patients dosed with CABA-201 in the RESET-Myositis™ and RESET-SLE™ trials – |
globenewswire.com |
2024-05-15 11:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ |
PHILADELPHIA, May 13, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ on Monday, May 20, 2024 at 9:30 a.m. ET in New York, NY. |
globenewswire.com |
2024-05-13 12:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update |
– First patient dosed with CABA-201 in the RESET™ (REstoring SElf-Tolerance) clinical trial program – – Initial clinical data from each of the first patients in the RESET-Myositis™ and RESET-SLE™ trials anticipated in 1H24; longer term follow-up on these and additional patients to be reported in 2H24 – – RESET-SSc™ (systemic sclerosis) and RESET-MG™ trials initial clinical data anticipated to be reported in 2H24 – – Rare Pediatric Disease designation granted by FDA for CABA-201 in juvenile dermatomyositis – – Cash runway into 1H26 with cash, cash equivalents and short-term investments of $241.2 million as of December 31, 2023 – PHILADELPHIA, March 21, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update. “Throughout the past year, we set the foundation to enable an efficient development strategy for CABA-201 across a broad range of autoimmune diseases. |
globenewswire.com |
2024-03-21 09:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in Upcoming Investor Conferences in March |
PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in two upcoming investor conferences in March: |
globenewswire.com |
2024-02-27 10:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis |
PHILADELPHIA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of idiopathic inflammatory myopathies (IIM, or myositis). CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells. Four RESET™ (REstoring SElf-Tolerance) Phase 1/2 trials are advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-Myositis™ trial. |
globenewswire.com |
2024-02-01 18:30:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference |
PHILADELPHIA, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 10:00 a.m. ET in New York, NY. |
globenewswire.com |
2024-01-31 10:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio: Two Differentiated CAR-T Platforms To Carry It Forward |
Initial data from the phase 1/2 study, using CABA-201 for the treatment of patients with systemic lupus erythematosus [both renal and non-renal], is expected in the 1st half of 2024. Initial data from the phase 1/2 study, using CABA-201 for the treatment of patients with myositis, is expected in the 1st half of 2024. Initial data from the phase 1/2 study, using CABA-201 for the treatment of patients with generalized myasthenia gravis, is expected in the 2nd half of 2024. |
seekingalpha.com |
2024-01-31 04:53:09 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Present at the 42nd Annual J.P. Morgan Healthcare Conference |
PHILADELPHIA, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 5:15 p.m. PT (8:15 p.m. ET) in San Francisco, CA. |
globenewswire.com |
2024-01-02 10:00:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio: Expanding The Success Of CAR-T Beyond Oncology |
Cabaletta Bio is developing targeted cellular therapies for autoimmune diseases, including systemic lupus erythematous and myositis. Their lead program, CABA-201, is a CD19 chimeric antigen receptor (CAR) T cell therapy currently in phase 1/2 clinical trials. Academic studies have shown the efficacy of CD19 CAR T cell therapy in treating autoimmune diseases, supporting Cabaletta's approach. |
seekingalpha.com |
2023-12-11 07:58:05 |
Czytaj oryginał (ang.) |
| Buy Cabaletta Bio's Promising SLE Treatment |
Cabaletta Bio is a biotech company with promising CARTA and CAART therapies for autoimmune diseases. Their main research project, CABA-201, targets patients suffering from SLE, opening up a huge market with significant revenue potential. The company is well-capitalized and has a cash runway that extends beyond 2025, making it a good long-term investment. |
seekingalpha.com |
2023-12-10 04:44:26 |
Czytaj oryginał (ang.) |
| Cabaletta Bio to Participate in the 6th Annual Evercore ISI HealthCONx Conference |
PHILADELPHIA, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Wednesday, November 29, 2023 at 8:20 a.m. ET in Miami, FL. |
globenewswire.com |
2023-11-28 18:30:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio's and Gracell's stock falls sharply as FDA investigates risks of CAR-T therapy |
Shares of Cabaletta Bio Inc. CABA, Gracell Biotechnologies Inc. GRCL and other smaller biotech companies involved in developing CAR-T cell therapies plunged Tuesday after the Food and Drug Administration said it was investigating cancer risks potentially associated with all currently approved products in the class. |
marketwatch.com |
2023-11-28 17:55:00 |
Czytaj oryginał (ang.) |
| Cabaletta Bio Reports Third Quarter 2023 Financial Results and Provides Business Update |
– Initial clinical data from CABA-201 treated patients in Phase 1/2 trials for lupus and/or myositis expected in the first half of 2024, with the first lupus clinical site actively recruiting patients – |
globenewswire.com |
2023-11-09 09:00:00 |
Czytaj oryginał (ang.) |