RegulatoryCompany release

Protara pushes STARBORN-1 enrolment into early 2027 and buys TARA-002 manufacturing assets from Novex

🇺🇸 Protara Therapeutics, Inc. (TARA) · Fri 06 Nov 2026

The registrational lymphatic malformations trial is now due to finish enrolling in early Q1 2027, with a rolling BLA planned for the second half of 2027.

Protara Therapeutics has said enrolment in STARBORN-1, the registrational trial of TARA-002 in lymphatic malformations, is now expected to be completed in early Q1 2027. The update came with the company's third-quarter 2026 results, published on 6 November 2026.

The company still plans to start a rolling Biologics License Application (BLA) submission to the US Food and Drug Administration in the second half of 2027. TARA-002 holds Breakthrough Therapy designation, which is intended to speed development and review of drugs for serious conditions. As context, a rolling submission lets a sponsor send completed sections of an application for FDA review before the whole package is ready.

Protara also acquired manufacturing assets for TARA-002 from its supplier, Novex Innovations, for $8.75 million. The company did not provide further detail in the information available to us, so the practical effect on supply arrangements is not clear.

Elsewhere in the pipeline, Protara has finished enrolling the THRIVE-3 Phase 2b cohort of IV Choline Chloride. It reported cash of about $143 million.

What it means for your team

  • Regulatory teams tracking TARA-002 should note that the planned rolling BLA start is the second half of 2027, with enrolment for STARBORN-1 now expected to close in early Q1 2027.
  • Quality and CMC professionals may want to watch how the purchase of manufacturing assets from Novex affects control of the TARA-002 supply chain, as the details have not been given.
  • Market-access teams should treat 2027 as the earliest window for any US filing milestones, given the enrolment delay.

Company's press release (SEC filing): Protara Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Protara Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →