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BlossomHill advances BH-30643 to Phase 2 for EGFR C797S-positive NSCLC after FDA dose approval

Market News
09 Nov 2026, 14:00 WIB
GlobeNewsWire
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Bullish
BlossomHill advances BH-30643 to Phase 2 for EGFR C797S-positive NSCLC after FDA dose approval

BlossomHill Therapeutics announced FDA alignment on a 50 mg twice daily dose for BH-30643, an investigational drug targeting EGFR C797S-positive non-small cell lung cancer (NSCLC). The company plans to start the pivotal Phase 2 SOLARA-2 trial in early 2027, aiming to support accelerated approval for patients with limited treatment options. BH-30643 has shown promising anti-tumor activity and received Fast Track designation, with the trial including both chemotherapy-naive and pretreated patients. This development marks a significant step toward addressing resistance in EGFR-mutant NSCLC.

BlossomHill Therapeutics' recent FDA meeting and trial plans provide context for health sector activity. For readers following health stocks, 108 of 150 US health-sector stocks rose while 26 fell on Pluang. Notable movers included CTXR at USD 0.54 (-2.98%), HIMS at USD 25.29 (-2.73%), and MRVI at USD 7.35 (-2.26%). Data is as of Nov 09, 2026 18:41 WIB.

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