- Trial Phase
- Phase 2/3 (ASPEN-06 in HER2+ gastric cancer); Phase 2 (ASPEN-09-Breast in HER2+ breast cancer)
- Time to Market
- Unknown; earliest potential FDA submission would likely be 2027-2028, assuming Phase 3 data from ASPEN-06 supports a BLA filing.
- Why 4/10
- No hard dated binary catalyst within ~12 months. The next major milestone for evorpacept is the ASPEN-09-Breast Phase 2 interim topline readout anticipated in mid-2027. ALX2004 safety data (2H 2026) is for a separate drug, not evorpacept. Without a near-term PDUFA or pivotal readout, share-price impact from the drug alone is muted in the next year, though the drug is ALXO's primary value driver.
Watch for ASPEN-06 Phase 3 enrollment completion and any FDA interaction updates — the company earned Fast Track designation for HER2+ gastric cancer in Jan 2025 and plans to discuss the path forward with FDA. The ALX2004 safety readout in 2H 2026 could move shares indirectly by validating the pipeline beyond evorpacept. The stock has strong institutional backing (RA Capital, Blackstone, Driehaus) but is still clinical-stage with no revenue and the CD47 class carries a high failure rate.
Price Chart
Executive Summary
Evorpacept is ALX Oncology's lead investigational CD47-blocking fusion protein, positioned as a potentially safer alternative in a drug class that has seen major setbacks (Gilead's magrolimab partial clinical hold, AbbVie/I-Mab termination). Phase 2 data in HER2+ gastric cancer showed a meaningful benefit over standard of care, earning FDA Fast Track designation. The drug is now in a Phase 2/3 registrational trial (ASPEN-06) with the Phase 3 portion still enrolling. A second Phase 2 trial (ASPEN-09-Breast) targets HER2+ breast cancer with interim data due mid-2027. The stock trades near $2.07 with a mean analyst target of $4.60 (~152% upside), and the company has ~$169M cash funding operations through 1H 2028. Strong institutional buyers entered in Q1 2026 (RA Capital, Blackstone, Driehaus). However, the CD47 field carries a history of clinical failures, and evorpacept remains years from potential commercialization with no near-term binary catalyst.
How It Works
Evorpacept is a SIRPα-Fc fusion protein that blocks the CD47 "don't eat me" signal on cancer cells. CD47 is a protein cancer cells use to evade the immune system — it tells macrophages (a type of immune cell) not to eat them. By blocking this signal, evorpacept "reveals" cancer cells to macrophages, which then engulf and destroy them. Unlike older CD47-targeting drugs (like Gilead's magrolimab), evorpacept uses an inactive Fc domain designed to minimize anemia and other side effects from attacking healthy blood cells.
Trial Status
The Phase 2 part of ASPEN-06 (HER2+ gastric/GEJ cancer) completed with positive final data presented at ASCO GI Jan 2025, showing evorpacept + trastuzumab/ramucirumab/paclitaxel improved outcomes vs. standard of care. The Phase 3 portion of ASPEN-06 is ongoing. ASPEN-09-Breast (HER2+ metastatic breast cancer) began enrollment Jan 2026 with interim topline data expected mid-2027. A Phase 1b/2 trial with zanidatamab in breast cancer showed a 100% confirmed ORR in the small CD47-high subgroup (n=5).
The Two-Sided Case
Upcoming Catalysts
- ASPEN-09-Breast Phase 2 interim topline data — anticipated mid-2027 (main evorpacept catalyst, but >12 months away)
- ASPEN-06 Phase 3 enrollment completion and potential interim analysis — no specific date announced
- FDA interaction outcomes following Fast Track discussions — the company is discussing the regulatory path for evorpacept in HER2+ gastric cancer
- ALX2004 (separate pipeline drug) Phase 1 safety data expected 2H 2026 — could impact ALXO sentiment indirectly
Source Filing
The SecBot filing or press-release report that triggered this drug report:
ALX ONCOLOGY HOLDINGS INC 8-K ALXO ·Originating report