- Trial Phase
- Phase 2b (registrational-intent)
- Time to Market
- Unknown — no approval filing or PDUFA is scheduled. If the Phase 2b interim is positive, an FDA submission would still be a later, undated step; realistic commercialization would be several years out.
- Why 7/10
- Next hard catalyst is the prespecified interim analysis of the registrational-intent Phase 2b plus the all-comer serous endometrial cancer arm data, which Acrivon reconfirmed (Aug 12, 2026 earnings) is on track for 2H 2026 — a high-stakes binary on the lead asset within roughly 4 months at a micro-cap trading near $2.20; scored 7 (not 8) because the date is a window rather than a firm date and the company also has earlier-stage programs (ACR-2316, ACR-6840).
The stock is a pure binary bet on the 2H 2026 Phase 2b interim readout in serous endometrial cancer — a positive result could drive a large move toward the $11.50 mean analyst target (implied upside ~377% from the $2.20 close), while a miss would likely be severe for a company whose cash only runs into Q2 2027. Watch company guidance for a firm interim date, and treat the 52% cORR maturing data and Fast Track designation as encouraging but not de-risked; note the Breakthrough designation was for the OncoSignature diagnostic assay, not the drug itself.
Price Chart
Executive Summary
ACR-368 is Acrivon Therapeutics' (NASDAQ: ACRV) lead asset — a dual CHK1/2 inhibitor in a registrational-intent Phase 2b study for serous endometrial cancer, with maturing data showing a 52% confirmed overall response rate. FDA granted Fast Track for the drug and Breakthrough Device designation for its companion OncoSignature assay in March 2026. The key near-term event is the Phase 2b prespecified interim analysis plus all-comer arm data, on track for 2H 2026. The stock closed around $2.20 (52-week range $1.27–$3.56) against a $11.50 mean analyst price target with 13 of 14 ratings at Buy/Strong Buy, and cash runway into Q2 2027.
How It Works
ACR-368 is a pill that blocks two enzymes called CHK1 and CHK2 — "checkpoint" proteins cancer cells use to repair DNA damage. Blocking them makes tumor cells that rely on that repair machinery die when DNA damage builds up. Acrivon pairs the drug with its OncoSignature test, which aims to pick patients whose tumors are predicted to be sensitive to the drug.
Trial Status
Ongoing registrational-intent Phase 2b in serous endometrial cancer. Maturing data reported with the Q4/FY2025 results (March 19, 2026) showed a 52% confirmed overall response rate (cORR). A prespecified simultaneous interim analysis and data update for both all-comer (biopsy-independent) serous endometrial cancer arms is guided for 2H 2026, reaffirmed with Q2 2026 results (Aug 12, 2026). FDA granted Fast Track designation for ACR-368 monotherapy in endometrial cancer and Breakthrough Device designation for the ACR-368 OncoSignature assay (March 2026, per 8-K filed 2026-03-19).
The Two-Sided Case
Upcoming Catalysts
- Phase 2b prespecified interim analysis + all-comer serous endometrial cancer arm data — guided for 2H 2026 (the next hard binary; company said 'on track' as of Aug 12, 2026).
- Any announcement of a firm interim data date — watch Q3 2026 earnings (roughly Nov 2026) for timing updates.
- Planned FDA IND submission for next program ACR-6840 in Q4 2026 (minor, different drug).
- Continued maturing of ACR-368 data and any new trial arms in endometrial cancer per Q4/FY2025 commentary.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Acrivon Therapeutics, Inc Press Release ACRV ·Originating report