$CABA News
Last published 1d ago
- 1d agoCABAGUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - CABALETTA BIO INCEarnings Call TranscriptsWelcome to third annual Healthcare Innovation Conference. My name is Yatin Suneja, one of the senior biotech analysts here at Guggenheim. It is my pleasure to welcome our next presenting company, Carpaletta. We have a fe
- 3d agoCABACabaletta Bio Presents New Rese-cel Phase 1/2 Clinical Data at ACR Convergence 2026 Featuring Immunomodulator-Free Durability and Favorable Benefit-Risk Profile Across Autoimmune DiseasesGlobeNewswire100% (6 of 6) of dermatomyositis patients maintained immunomodulator-free, moderate-to-major TIS responses through one year, with most patients also free...
- 3d agoCABACabaletta Bio Presents New Rese-cel Phase 1/2 Clinical Data at ACR Convergence 2026 Featuring Immunomodulator-Free Durability and Favorable Benefit-Risk Profile Across Autoimmune DiseasesGlobeNewswire100% (6 of 6) of dermatomyositis patients maintained immunomodulator-free, moderate-to-major TIS responses through one year, with most patients also free of steroids 100% (5 of 5) of lupus nephritis patients with
- 6d agoCABACabaletta Bio, Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 6d agoCABACabaletta Bio Reports Third Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswireRESET-Myositis® registrational adult topline results anticipated in 2H27 with BLA submission in 1Q28, including Phase 1/2 juvenile dermatomyositis data for potential PRV eligibility and Phase 1/2 adult durability data
- 1w agoCABACabaletta Bio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswirePHILADELPHIA, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically
- 1w agoCABACabaletta Bio to Participate in Upcoming Investor ConferencesGlobeNewswirePHILADELPHIA, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically
- 1mo agoCABACabaletta Bio - CABALETTA BIO INCEarnings Call TranscriptsAll right. Hello, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Goltz, one of the biotech analysts here, and it's my pleasure to introduce the team from Cabaletta Bio. O
- 2mo agoCABACabaletta Bio to Participate in Upcoming Investor ConferencesGlobeNewswirePHILADELPHIA, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed
- 3mo agoCABACabaletta Bio Reports Second Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswireRegistrational RESET-Myositis® clinical data on track to be reported in mid-2027 to support 2H27 BLA submission for rese-cel Juvenile myositis Phase 1/2 data expected to be submitted with BLA to support potential FDA
- 5mo agoCABAGoldman Sachs 47th Annual Global Healthcare Conference - CABALETTA BIO INCEarnings Call TranscriptsOkay, good morning. We're happy to be hosting Cavaletta Bio. With us today we have Dr. Steven Nickberger, CEO, Dr. Arun Dutt, the Chief Business Officer, and Steve Cavill, the Chief Commercial Officer. So to start, could
- 5mo agoCABACABALETTA BIO, INC. JEFFERIES GLOBAL HEALTHCARE CONFERENCE IN NEW YORK - CABALETTA BIO INCEarnings Call TranscriptsMy name is Roger Song, one of the senior undercover at Smica Biotech. It's my pleasure to have the next 30 minutes, the five-step chat with company Camerata Bio, and then we have Stephen, CEO, and then Steve, Chief Comme
- 5mo agoCABACabaletta Bio Announces New Rese-cel Data and Development Updates Across Autoimmune Portfolio, Including Encouraging Early PC-Free Lupus Findings, at EULAR 2026 CongressGlobeNewswire83% of dermatomyositis patients in the Phase 1/2 RESET-Myositis study would have met the registrational primary endpoint; all these patients maintained their response off immunomodulators through latest follow-up, as
- 6mo agoCABACabaletta Bio Reports First Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswirePreconditioning-free (PC-free) 6-to-9-month clinical data with a single infusion of the lowest dose of rese-cel in the RESET-PV® study presented today at ASGCT 2026 Annual Meeting along with initial rese-cel
- 6mo agoCABACabaletta Bio Presents Preconditioning-free Clinical Data and Automated Manufacturing Translational Data for Rese-cel at ASGCT 2026 Annual MeetingGlobeNewswireA single infusion of the lowest dose of rese-cel administered without preconditioning, after discontinuation of all immunomodulators, demonstrated compelling drug-free responses for 6 months in 2 of 4 refractory
- 6mo agoCABACabaletta Bio Announces Pricing of $150 Million Underwritten OfferingGlobeNewswirePHILADELPHIA, May 04, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. ("Cabaletta" or the "Company") (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching curative targeted cell
- 6mo agoCABACabaletta Bio and Cellares Announce 10-Year Commercial Supply Agreement for Rese-celGlobeNewswireAgreement facilitates flexible, scalable automated industrialized production of rese-cel for many thousands of patients per year at a cost per batch that is among the lowest in the industry Initial translational data
- 6mo agoCABACellares and Cabaletta Bio Sign 10-Year Commercial Supply Agreement to Scale Rese-celBusiness WireAgreement positions Cellares as a long-term commercial manufacturing partner for rese-cel, enabling thousands of batches per year at a cost per batch that is among the lowest in the industry Cellares' Cell
- 6mo agoCABACabaletta Bio Announces Multiple Upcoming Presentations, Including Data on Rese-cel without Preconditioning and Rese-cel with Automated Manufacturing, at the ASGCT 2026 Annual MeetingGlobeNewswirePHILADELPHIA, April 27, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching targeted cell therapies designed specifically for
- 7mo agoCABAFirst Patients Dosed with Cabaletta Bio's Rese-cel Manufactured on Cellares' Automated Cell Shuttle™ PlatformBusiness WireFirst two GMP doses of rese-cel manufactured on the Cell Shuttle™ met all release specifications, were delivered on time, and have been infused into patients within Cabaletta Bio's RESET™ clinical
- 7mo agoCABACabaletta Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business UpdateGlobeNewswireRese-cel myositis BLA submission on track for 2027 based on a 17-patient, single arm registrational cohort design, including an outpatient dosing option No-preconditioning program enrolling in lupus and PV; anticipating
- 8mo agoCABACabaletta Bio to Participate in the TD Cowen 46th Annual Health Care ConferenceGlobeNewswirePHILADELPHIA, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed
- 9mo agoCABACabaletta Bio to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026GlobeNewswirePHILADELPHIA, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed
- 10mo agoCABACabaletta Bio Announces 2026 Strategic PrioritiesGlobeNewswireRegistrational myositis trial actively enrolling with planned 17-patient cohort and 2027 rese-cel BLA submission – including an outpatient dosing option using a single weight-based dose IND amendment cleared to
- 1y agoCABACabaletta Bio Reports Third Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswireRese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis
- 1y agoCABACabaletta Bio to Participate in Upcoming Investor Conferences in November and DecemberGlobeNewswirePHILADELPHIA, Nov. 04, 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
- 1y agoCABACabaletta Bio Presents Positive Clinical Data and Development Updates for Rese-cel at ACR Convergence 2025GlobeNewswire– All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who met key registrational inclusion criteria exceeded the registrational primary endpoint, demonstrating major TIS responses with no
- 1y agoCABACabaletta Bio Announces Appointment of Steve Gavel as Chief Commercial Officer and Award of Inducement GrantGlobeNewswire– Gavel brings highly relevant CAR T experience from Legend Biotech where he led the launch and commercialization of CARVYKTI® from 2018 until 2025 – PHILADELPHIA, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio,
- 1y agoCABACabaletta Bio Presents First Rese-cel Data with No Preconditioning Demonstrating Biologic Activity and Early Clinical Responses at the 2025 ESGCT Annual CongressGlobeNewswire– Complete B cell depletion, rapid reduction in autoantibodies and near-complete resolution of clinical symptoms in two of three refractory patients; all three patients remained off immunomodulators since infusion and
- 1y agoCABACabaletta Bio to Participate in Upcoming Investor Conferences in SeptemberGlobeNewswirePHILADELPHIA, Aug. 27, 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
- 1y agoCABACabaletta Bio Reports Second Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswire– Registrational cohort enrollment in RESET-Myositis™ trial on track to start in 2H25 with anticipated 2027 BLA submission for rese-cel in myositis – – Five disease-specific cohorts fully enrolled in the
- 1y agoCABACabaletta Bio Announces Pricing of Public Offering of SecuritiesGlobeNewswirePHILADELPHIA, June 11, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. ("Cabaletta" or the "Company") (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted
- 1y agoCABACabaletta Bio Announces Proposed Public Offering of SecuritiesGlobeNewswirePHILADELPHIA, June 11, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. ("Cabaletta" or the "Company") (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted
- 1y agoCABACabaletta Bio Announces New Rese-cel Safety and Efficacy Data in Patients with Myositis, Lupus and Scleroderma to Be Presented at the EULAR 2025 CongressGlobeNewswire– 7 of 8 myositis patients achieved clinically meaningful TIS responses after discontinuation of all immunomodulators, while off or actively tapering steroids; responses were sustained throughout the follow-up period in
- 1y agoCABACabaletta Bio to Participate in the Jefferies Global Healthcare ConferenceGlobeNewswirePHILADELPHIA, May 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
- 1y agoCABACabaletta Bio Announces 2027 Rese-cel BLA Submission Anticipated in Myositis Following Recent FDA Alignment on Registrational CohortsGlobeNewswire– 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
- 1y agoCABACabaletta Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business UpdateGlobeNewswire– 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
- 1y agoCABACellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle™ PlatformBusiness WireTechnology Adoption Program (TAP) program success demonstrates the ability of Cellares' IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio's clinical-stage CAR T program to treat
- 1y agoCABACabaletta Bio to Participate in the TD Cowen 45th Annual Health Care ConferenceGlobeNewswirePHILADELPHIA, 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
- 1y agoCABAUPDATE - Cabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific MeetingsGlobeNewswire– 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
- 1y agoCABACabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific MeetingsGlobeNewswire– 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
- 1y agoCABACabaletta Bio Announces Presentations Featuring Updated Clinical Data on Rese-cel at Upcoming Scientific Meetings in FebruaryGlobeNewswirePHILADELPHIA, 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
- 1y agoCABACabaletta Bio to Participate in Guggenheim's SMID Cap Biotech ConferenceGlobeNewswirePHILADELPHIA, 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
- 1y agoCABACabaletta Bio Outlines Strategic Priorities and Anticipated Key Milestones for 2025GlobeNewswire– Company plans to meet with the FDA to align on registrational trial designs in 1H25 based on emerging clinical profile of resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) and increased pace of
- 1y agoCABACabaletta Bio to Participate in Upcoming Investor Conferences in DecemberGlobeNewswirePHILADELPHIA, Nov. 26, 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
- 1y agoCABACabaletta Bio Presents Positive Clinical Safety and Efficacy Data on CABA-201 at ACR Convergence 2024GlobeNewswire– CABA-201 safety profile suggests favorable risk-benefit with no CRS or ICANS in the majority of patients; low-grade CRS in three of eight patients and one previously reported ICANS event – – Compelling clinical
- 1y agoCABACabaletta Bio Reports Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire– Clinical data from the RESET-Myositis™ and RESET-SLE™ trials, along with initial clinical data from the RESET-SSc™ trial, to be presented this weekend in oral and poster presentations at ACR
- 2y agoCABACabaletta Bio to Participate in Guggenheim's Inaugural Healthcare Innovation ConferenceGlobeNewswirePHILADELPHIA, Nov. 06, 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
- 2y agoCABACabaletta Bio to Present New and Updated Clinical Data on CABA-201 in Oral and Poster Presentations at ACR Convergence 2024GlobeNewswirePHILADELPHIA, 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
- 2y agoCABACabaletta Bio to Participate in Upcoming Investor Conferences in SeptemberGlobeNewswirePHILADELPHIA, 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