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  1. Parabilis Medicines debuted on Nasdaq, achieving IPO haul surpassing Moderna's, while its product received FDA fast-track designation. Regeneron also acquired shares.

Parabilis and FDA Agree on Drug Dose and Regimen for Phase 3 Trial

1 report, 1 independent Updated Oct 24
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What happened

Some supportReported by 1 outlet

Parabilis and the FDA agreed on the dose and regimen for the drug, based on results from an ongoing Phase 1/2 trial. The trial showed an objective response rate of 72.2% among response-evaluable patients who received a starting dose of $\ge$450 mg at 32 weeks. Additionally, a disease control rate of 100% was observed across all response-evaluable patients who received a starting dose of $\ge$450 mg, with no disease progression.

From manilatimes.net

Why it matters

Some supportBrind's analysis of the reports

The agreement informs the selection of a dose and regimen for the upcoming PEDESTAL Phase 3 registrational trial, which is planned to begin in the first half of 2027. The drug previously received FDA fast-track designation, and Parabilis recently debuted on Nasdaq.

Parabilis Medicines debuted on Nasdaq, achieving an IPO haul surpassing Moderna's, while its product received FDA fast-track designation.

From manilatimes.net

Who's involved

  • FDARegulatory agency that aligned on the drug's dose and regimen

Keep exploring

Part of

Parabilis Medicines debuted on Nasdaq, achieving IPO haul surpassing Moderna's, while its product received FDA fast-track designation. Regeneron also acquired shares. All 1 developments

The entities involved

Coverage

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