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Form SCHEDULE 13D BlossomHill Therapeutics Filed by: ORBIMED ADVISORS LLC

Tue, 18 Aug 2026 16:53:00 -0400

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FDA grants fast track status to BlossomHill's lung cancer drug BH-30643

Tue, 18 Aug 2026 07:00:15 -0400

BlossomHill Therapeutics, Inc. (Nasdaq: BLSM) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational drug BH-30643 for the treatment of adult patients with advanced or metastatic EGFR C797S-positive non-small cell lung cancer (NSCLC) following prior treatment with a third-generation EGFR tyrosine kinase inhibitor.

BH-30643 is an orally administered, non-covalent, macrocyclic, mutant-selective EGFR inhibitor. The company states there are currently no approved oral targeted therapies for this molecularly defined patient population.

"Fast Track designation is an important regulatory milestone and reflects FDA's recognition, based on its review of our preliminary data, of the potential for BH-30643

BlossomHill Therapeutics Announces FDA Fast Track Designation for BH-30643, a Macrocyclic OMNI-EGFR™ Inhibitor for the Treatment of Advanced EGFR C797S-positive NSCLC

Tue, 18 Aug 2026 07:00:00 -0400

SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). BH-30643 is being evaluated in SOLARA, a global Phase 1/2, first-in-human

BlossomHill Therapeutics Announces FDA Fast Track Designation for BH-30643, a Macrocyclic OMNI-EGFR™ Inhibitor for the Treatment of Advanced EGFR C797S-positive NSCLC

Tue, 18 Aug 2026 07:00:00 -0400

Form SCHEDULE 13G BlossomHill Therapeutics Filed by: Vivo Innovation Fund II Holdings, L.P.

Mon, 17 Aug 2026 15:47:00 -0400

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Form SCHEDULE 13G BlossomHill Therapeutics Filed by: PERCEPTIVE ADVISORS LLC

Fri, 14 Aug 2026 17:21:00 -0400

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Form SCHEDULE 13D BlossomHill Therapeutics Filed by: Cormorant Asset Management, LP

Thu, 13 Aug 2026 16:13:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 10 Filed by: GORDON CARL L

Wed, 12 Aug 2026 16:46:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 10 Filed by: ORBIMED ADVISORS LLC

Wed, 12 Aug 2026 16:44:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 10 Filed by: Schmid John P.

Mon, 10 Aug 2026 18:35:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: GORDON CARL L

Mon, 10 Aug 2026 18:34:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Cormorant Asset Management, LP

Mon, 10 Aug 2026 18:32:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Agrawal Sundeep

Mon, 10 Aug 2026 18:29:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Keyes Jason A

Mon, 10 Aug 2026 18:27:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Liptak Vincent Paul

Mon, 10 Aug 2026 18:26:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Oxnard Geoffrey Raymond

Mon, 10 Aug 2026 18:25:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Li Yishan

Mon, 10 Aug 2026 18:23:00 -0400

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Form 4 BlossomHill Therapeutics For: Aug 06 Filed by: Cui Jingrong Jean

Mon, 10 Aug 2026 18:22:00 -0400

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Form S-8 BlossomHill Therapeutics

Mon, 10 Aug 2026 16:49:00 -0400

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Form 8-K BlossomHill Therapeutics For: Aug 10

Mon, 10 Aug 2026 16:02:00 -0400

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Form 3 BlossomHill Therapeutics For: Aug 06 Filed by: ORBIMED ADVISORS LLC

Thu, 06 Aug 2026 21:09:00 -0400

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Form 3 BlossomHill Therapeutics For: Aug 06 Filed by: Schmid John P.

Thu, 06 Aug 2026 20:48:00 -0400

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Form 3 BlossomHill Therapeutics For: Aug 06 Filed by: GUJRATHI SHEILA

Thu, 06 Aug 2026 20:47:00 -0400

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Form 3 BlossomHill Therapeutics For: Aug 06 Filed by: Agrawal Sundeep

Thu, 06 Aug 2026 20:46:00 -0400

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Form 3 BlossomHill Therapeutics For: Aug 06 Filed by: GORDON CARL L

Thu, 06 Aug 2026 20:43:00 -0400

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