RegulatoryCompany release

BlossomHill agrees 50 mg twice-daily dose of BH-30643 with FDA ahead of pivotal trial

🇺🇸 BlossomHill Therapeutics, Inc. (BLSM) · Thu 12 Nov 2026

The US biotech says SOLARA-2, a single-arm study in EGFR C797S-positive NSCLC, should dose its first patient in Q1 2027 and could support an accelerated approval filing.

BlossomHill Therapeutics has aligned with the US Food and Drug Administration on 50 mg twice daily as the recommended Phase 2 dose of BH-30643, its candidate for EGFR C797S-positive non-small cell lung cancer. The company announced the agreement on 12 November 2026 alongside its third-quarter results.

The dose decision clears the way for SOLARA-2, a single-arm pivotal trial that BlossomHill says could support an application for accelerated approval. The company expects to dose the first patient in the first quarter of 2027.

BlossomHill is also working with Foundation Medicine on a companion diagnostic. The programme targets a biomarker-defined population, so a test to identify EGFR C797S-positive patients will be part of the development path.

On finances, the company reported cash of $224.9 million. That follows an initial public offering in August 2026 that raised $168.3 million gross. BlossomHill expects its resources to fund operations into the second quarter of 2028.

For context, accelerated approval is an FDA pathway that allows a medicine for a serious condition to be authorised on the basis of a surrogate or intermediate endpoint, usually with confirmatory evidence required after approval.

What it means for your team

  • Regulatory teams tracking EGFR-targeted lung cancer therapies should note that the FDA has aligned on the Phase 2 dose, a step before the pivotal study begins.
  • A single-arm pivotal design aimed at accelerated approval points to a possible filing route, though the source does not say the FDA has agreed to it as a basis for approval.
  • The Foundation Medicine collaboration signals that a companion diagnostic will be developed in parallel, which diagnostics and market-access teams may need to follow.
  • The funding runway into Q2 2028 covers the planned start of SOLARA-2 in Q1 2027.

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

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

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