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Unknown (Nasdaq: Unknown) is an oncology drug developer. Its lead program, BH-30643, is in Phase 2 for EGFR-mutant non-small cell lung cancer (NSCLC). Its next catalyst on record is BH-30643: End-of-Phase 1 meeting with FDA regarding recommended Phase 2 dose and potential accelerated approval pathway (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: BH-30643 — End-of-Phase 1 meeting with FDA regarding recommended Phase 2 dose and potential accelerated approval pathway (Q4 2026). 7 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| BH-30643 | EGFR-mutant NSCLC | small molecule | Phase 2 |
| BH-30236 | Relapsed/refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS) | small molecule | Phase 1 |
| BH-501284 | Pan-KRAS mutations | small molecule | Pre-clinical |
Recent results and decisions
- Sep 18, 2026n/a FDA granted Fast Track designation to BH-30643 for treatment of advanced or metastatic EGFR C797S-positive NSCLC after prior third-generation EGFR TKI.
Announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BH-30643, a macrocyclic OMNI-EGFR™ inhibitor, 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
Filing - Sep 18, 2026positive BH-30643 showed 45% objective response rate and 88% disease control rate in C797S-positive patients with or without T790M mutation.
highlighted a 45% objective response rate and 88% disease control rate observed in patients with C797S resistance to prior TKIs, with or without concurrent T790M mutation
Filing - Sep 15, 2026positive Phase 1/2 SOLARA: 45% ORR (18/40) and 88% DCR (35/40) in EGFR C797S-positive NSCLC, favorable safety; 63% still on treatment at 6.9 months median follow-up.
BH-30643 demonstrated a 45% objective response rate (ORR; 18/40) and an 88% disease control rate (DCR; 35/40).
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.