Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis
Cabaletta Bio, Inc. (CABA)
Company Research
Source: GlobeNewswire
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. “Myositis, believed to be driven by B cells, is a severe and potentially fatal autoimmune disease for which no curative therapy exists. Current treatment options provide modest efficacy, with a significant
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News
- Cabaletta Bio, Inc. (NASDAQ: CABA) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $50.00 price target on the stock.MarketBeat
- Cabaletta Bio, Inc. (NASDAQ: CABA) had its price target raised by analysts at Citigroup Inc. from $26.00 to $30.00. They now have a "buy" rating on the stock.MarketBeat
- Cabaletta Bio, Inc. (NASDAQ: CABA) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $50.00 price target on the stock.MarketBeat
- Cabaletta Bio, Inc. (NASDAQ: CABA) had its price target raised by analysts at Wells Fargo & Company from $34.00 to $35.00. They now have an "overweight" rating on the stock.MarketBeat
- Cabaletta Bio, Inc. (NASDAQ: CABA) had its price target raised by analysts at HC Wainwright from $25.00 to $30.00. They now have a "buy" rating on the stock.MarketBeat
CABA
Earnings
- 3/21/24 - Miss
CABA
Sec Filings
- 4/23/24 - Form ARS
- 4/23/24 - Form DEFA14A
- 4/23/24 - Form DEF
- CABA's page on the SEC website