BlossomHill Therapeutics (BLSM) FDA Approvals $22.93 +0.92 (+4.18%) As of 04:00 PM Eastern Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartFDA EventsInsider TradesNews and TrendsSEC Filings BlossomHill Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by BlossomHill Therapeutics (BLSM). Over the past two years, BlossomHill Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BH-30643. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. BH-30643 FDA Regulatory Events BH-30643 is a drug developed by BlossomHill Therapeutics for the following indication: Treatment of Advanced EGFR C797S-positive NSCLC. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Updated data - September 1,2026Updated Data Phase 1/2Drug: BH-30643Announced Date: September 1, 2026Indication: Treatment of Advanced EGFR C797S-positive NSCLCAnnouncementBlossomHill Therapeutics, Inc. announced that updated data from the ongoing Phase 1/2 SOLARA trial describing anti-tumor activity of BH-30643 in patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S will be shared as a mini-oral presentation on September 15, 2026 at the 2026 World Conference on Lung Cancer in Seoul, South Korea.Read AnnouncementDesignation Grant - August 18,2026Designation Grant Fast TrackDrug: BH-30643Announced Date: August 18, 2026Indication: Treatment of Advanced EGFR C797S-positive NSCLCAnnouncementBlossomHill Therapeutics, Inc. 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).Read Announcement BlossomHill Therapeutics FDA Events - Frequently Asked Questions Has BlossomHill Therapeutics received FDA approval? As of now, BlossomHill Therapeutics (BLSM) has not received any FDA approvals for its therapy in the last two years. What drugs has BlossomHill Therapeutics submitted to the FDA? In the past two years, BlossomHill Therapeutics (BLSM) has reported FDA regulatory activity for BH-30643. What is the most recent FDA event for BlossomHill Therapeutics? The most recent FDA-related event for BlossomHill Therapeutics occurred on September 1, 2026, involving BH-30643. The update was categorized as "Updated data," with the company reporting: "BlossomHill Therapeutics, Inc. announced that updated data from the ongoing Phase 1/2 SOLARA trial describing anti-tumor activity of BH-30643 in patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S will be shared as a mini-oral presentation on September 15, 2026 at the 2026 World Conference on Lung Cancer in Seoul, South Korea." What conditions do BlossomHill Therapeutics' current drugs treat? Currently, BlossomHill Therapeutics has one therapy (BH-30643) targeting the following condition: Treatment of Advanced EGFR C797S-positive NSCLC. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Artiva Biotherapeutics FDA EventsAvalyn Pharma FDA EventsBriacell Therap FDA EventsBeam Therapeutics FDA EventsBioAge Labs FDA EventsBioVie FDA EventsBelite Bio FDA EventsDefinium Therapeutics FDA EventsDyne Therapeutics FDA EventsMonte Rosa Therapeutics FDA EventsNkarta FDA EventsIntellia Therapeutics FDA EventsQuoin Pharmaceuticals FDA EventsRoivant Sciences FDA EventsUpstream Bio FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:BLSM last updated on 9/1/2026 by MarketBeat.com Staff. 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Updated data - September 1,2026Updated Data Phase 1/2Drug: BH-30643Announced Date: September 1, 2026Indication: Treatment of Advanced EGFR C797S-positive NSCLCAnnouncementBlossomHill Therapeutics, Inc. announced that updated data from the ongoing Phase 1/2 SOLARA trial describing anti-tumor activity of BH-30643 in patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S will be shared as a mini-oral presentation on September 15, 2026 at the 2026 World Conference on Lung Cancer in Seoul, South Korea.Read Announcement
Designation Grant - August 18,2026Designation Grant Fast TrackDrug: BH-30643Announced Date: August 18, 2026Indication: Treatment of Advanced EGFR C797S-positive NSCLCAnnouncementBlossomHill Therapeutics, Inc. 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).Read Announcement
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