BlossomHill Therapeutics (BLSM) has upcoming FDA regulatory milestones for BH-501284. The table below outlines estimated target dates and event types for these pending regulatory actions.
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 and BH-501284. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BH-30643 FDA Regulatory Timeline and 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:
- November 9, 2026
- Indication:
- Treatment of Advanced EGFR C797S-positive NSCLC
Announcement
BlossomHill Therapeutics, Inc. announced the outcome of its End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) regarding BH-30643 for the treatment of patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC).
Read Announcement- Drug:
- BH-30643
- Announced Date:
- September 15, 2026
- Indication:
- Treatment of Advanced EGFR C797S-positive NSCLC
Announcement
BlossomHill Therapeutics, Inc. announced updated data from the ongoing Phase 1/2 SOLARA trial of BH-30643 in non-small cell lung cancer (NSCLC) patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S.
Read Announcement- 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
BH-501284 FDA Regulatory Events
BH-501284 is a drug developed by BlossomHill Therapeutics for the following indication: Novel Pan-KRAS Inhibitor.
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-501284
- Announced Date:
- September 28, 2026
- Target Action Date:
- Q1 2027
- Estimated Target Date Range:
- January 1, 2027 - March 31, 2027
- Indication:
- Novel Pan-KRAS Inhibitor
Announcement
BlossomHill Therapeutics, Inc. announced that the IND submission in Q1 2027
Read Announcement- Drug:
- BH-501284
- Announced Date:
- September 28, 2026
- Indication:
- Novel Pan-KRAS Inhibitor
Announcement
BlossomHill Therapeutics, Inc announced the presentation of preclinical data on BH-501284 at the American Association for Cancer Research (AACR) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development, taking place September 25-28, 2026, in San Diego, CA..
Read Announcement
