BlossomHill Therapeutics' Drug in the FDA Approval Process
This 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.
- Drug:
- BH-30643
- Announced Date:
- September 1, 2026
- Indication:
- Treatment of Advanced EGFR C797S-positive NSCLC
Announcement
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.
Read Announcement- Drug:
- BH-30643
- Announced Date:
- August 18, 2026
- Indication:
- Treatment of Advanced EGFR C797S-positive NSCLC
Announcement
BlossomHill 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
As of now, BlossomHill Therapeutics (BLSM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, BlossomHill Therapeutics (BLSM) has reported FDA regulatory activity for BH-30643.
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."
Currently, BlossomHill Therapeutics has one therapy (BH-30643) targeting the following condition: Treatment of Advanced EGFR C797S-positive NSCLC.
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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
FDA progress for NASDAQ:BLSM last updated on 9/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
