Monitor the PDUFA date of December 30, 2026 for bezuclastinib in NonAdvSM and the upcoming ASCO oral presentation on May 30, 2026. The APEX NDA submission for AdvSM in 1H 2026 is the next major catalyst. The stock is a binary event play on FDA approvals — position accordingly with defined risk.
Price Chart
Executive Summary
Cogent Biosciences reported Q1 2026 net loss of $97.4M, wider than the $72.0M loss in Q1 2025, driven by increased R&D and G&A spending ahead of planned bezuclastinib launches. The company ended the quarter with $866.4M in cash, with two NDAs under FDA review and a PDUFA date of December 30, 2026 for NonAdvSM. The wider loss and lack of revenue are consistent with a pre-commercial biotech, but the stock will trade on regulatory catalysts, not quarterly financials.
Key Facts
- Net loss of $97.4M in Q1 2026 vs $72.0M in Q1 2025
- Cash, cash equivalents and marketable securities of $866.4M as of March 31, 2026
- FDA accepted NDA for bezuclastinib in NonAdvSM with PDUFA date of December 30, 2026
- NDA for bezuclastinib in GIST submitted under RTOR program; APEX NDA for AdvSM expected in 1H 2026
- R&D expenses of $75.4M in Q1 2026 vs $63.0M in Q1 2025
- G&A expenses of $28.2M in Q1 2026 vs $11.9M in Q1 2025
- Cash includes $45.7M net proceeds from ATM stock offering
Financial Impact
Net loss widened by $25.4M YoY to $97.4M; cash burn of ~$34.4M in Q1 2026 (excluding $45.7M ATM proceeds)
Risk Factors
- FDA non-approval or delayed review for bezuclastinib NDAs
- Cash burn rate may require additional financing before reaching profitability
- Competitive landscape in KIT-mutant driven diseases
- Clinical trial failures in pipeline candidates
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-205124 |
| Document: cogt-20260505.htm | 0001193125-26-205124 |
| Document: 0001193125-26-205124-index-headers.html | 0001193125-26-205124 |
| Document: 0001193125-26-205124-index.html | 0001193125-26-205124 |
| Document: 0001193125-26-205124.txt | 0001193125-26-205124 |
| 8-K Data (Synthetic) | 0001193125-26-205124 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 10, 2026 7w ago | 8-K | $41.53 $35.28 | ▼ −15.05% | ▼ −14.13% | $31.02 (−25.31%) |
Aug 10, 2026 7w ago | Press Release | $41.53 $35.28 | ▼ −15.05% | ▼ −14.13% | $31.02 (−25.31%) |
Aug 9, 2026 7w ago | Institutional Cluster | $41.53 $35.28 | ▼ −15.05% | ▼ −14.13% | $31.02 (−25.31%) |
Jun 12, 2026 16w ago | Press Release | $33.10 $38.87 | ▲ +17.43% | ▲ +15.65% | $31.02 (−6.28%) |
Jun 12, 2026 16w ago | Press Release | $33.10 $38.87 | ▲ +17.43% | ▲ +15.65% | $31.02 (−6.28%) |
May 30, 2026 17w ago | Press Release | $34.81 $38.70 | ▲ +11.18% | ▲ +12.47% | $31.02 (−10.89%) |
May 28, 2026 18w ago | Press Release | $35.38 $38.10 | ▲ +7.69% | ▲ +10.83% | $31.02 (−12.32%) |
May 5, 2026 21w ago | 8-K | $36.98 $32.76 | ▼ −11.41% | ▼ −16.37% | $31.02 (−16.12%) |
Apr 17, 2026 24w ago | Press Release | $37.25 $34.19 | ▼ −8.21% | ▼ −13.59% | $31.02 (−16.72%) |
Apr 1, 2026 26w ago | Press Release | $35.24 $35.87 | ▲ +1.79% | ▼ −7.93% | $31.02 (−11.98%) |
US Market Status
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