Protara Therapeutics Receives Both FDA Breakthrough Therapy and Fast Track Designations for TARA-002 in Pediatric Patients with Lymphatic Malformations
Protara Therapeutics, Inc. (TARA)
Company Research
Source: GlobeNewswire
NEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the Company’s investigational cell-based therapy, for the treatment of pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs). In addition, the FDA has selected TARA-002 to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program, which aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access. “Receiving these important FDA designations and invitation to participate in the CDRP program highlights the significant unmet need among pediatric patients with LMs and underscores our belief that TARA-0
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TARA
News
- Protara Therapeutics Highlights Recent Updates and Anticipated 2026 MilestonesGlobeNewswire
- Protara Therapeutics (NASDAQ:TARA) was upgraded by analysts at Piper Sandler to a "strong-buy" rating.MarketBeat
- Protara Therapeutics Announces Dosing of First Patient in Phase 3 Registrational THRIVE-3 Trial of IV Choline Chloride in Patients on Long-Term Parenteral Support [Yahoo! Finance]Yahoo! Finance
- Protara Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare ConferenceGlobeNewswire
- Protara Therapeutics Announces Dosing of First Patient in Phase 3 Registrational THRIVE-3 Trial of IV Choline Chloride in Patients on Long-Term Parenteral SupportGlobeNewswire
TARA
Earnings
- 11/10/25 - Beat
TARA
Sec Filings
- 12/15/25 - Form 8-K
- 12/9/25 - Form 424B7
- 12/8/25 - Form 8-K
- TARA's page on the SEC website