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vTv Therapeutics Completes Phase 3 Trial Enrollment and Gains FDA Orphan Status

BullishMedium impact
VTVT$31.18 3.66%

vTv Therapeutics, Inc. Class A (NASDAQ:VTVT) reached two clinical milestones, finishing patient enrollment for its Phase 3 CATT1 study of cadisegliatin in type 1 diabetes while securing FDA orphan drug status for HPPD, an investigational sickle cell treatment. The stock rose 3.66% to $31.18 following the updates.

Completing enrollment in the CATT1 trial with 166 patients brings the company closer to evaluating cadisegliatin in late-stage testing for type 1 diabetes. Meanwhile, orphan drug designation for HPPD provides regulatory incentives for the oral Nrf2/Bach1 modulator, which showed positive preclinical results including increased fetal hemoglobin and reduced cell sickling.

Investors will look ahead to mid-2027, when the company expects to release topline data from the Phase 3 CATT1 trial. Further updates on the clinical development path for HPPD will also be key monitoring points.

Key points

  • vTv Therapeutics completed enrollment of 166 patients in its Phase 3 CATT1 study evaluating cadisegliatin for type 1 diabetes.
  • Topline results from the Phase 3 CATT1 trial are expected in mid-2027.
  • The FDA granted orphan drug designation to HPPD, an oral Nrf2/Bach1 modulator targeting sickle cell disease.
  • Preclinical data for HPPD demonstrated oral activity, good tolerability, higher fetal hemoglobin, and reduced sickling.
  • Shares of vTv Therapeutics, Inc. Class A (NASDAQ:VTVT) gained 3.66% to close at $31.18.

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Questions and answers

When will vTv Therapeutics release Phase 3 CATT1 trial results?

vTv Therapeutics expects to report topline data from the Phase 3 CATT1 trial of cadisegliatin in mid-2027.

What status did the FDA grant to vTv Therapeutics HPPD?

The FDA granted orphan drug status to HPPD, an oral Nrf2/Bach1 modulator being developed for sickle cell disease.

How many patients were enrolled in the CATT1 study?

The Phase 3 CATT1 trial completed enrollment with 166 type 1 diabetes patients.