September 2026 Catalyst Probability/Move Analysis
We've been working with BPIQ-AI to provide more info about upcoming catalysts to help provide more info for investors to consider in their diligence of smid-cap biopharma companies. The table below shows BPIQ AI's predicted probabilities(FN1) for September 2026 Phase 2 and Phase 3 clinical trial readouts, that an event will readout as a clean positive or negative, or with mixed data. And its predicted magnitude of move for those. Keep in mind of course, that predicting catalysts is moves is very complicated and we are still working with our BPIQ AI to improve its predictions.
Based on those numbers, BPIQ AI expanded the number of suspected big movers (SBMs) identified for the remaining September readouts (compare to the traditional SBM column) and separated up or down move SBM analysis (See Table). Finally, BPIQ AI analyzed options data and upgraded some SBMs to BMs if confirmed by options data, and provides comments re: options data for that ticker.
Please note that we have not independently analyzed these readouts manually. This is NOT investment advice. Please consider it as only part of your diligence before making any investments.
BPIQ-AI: Remaining September 2026 Phase 2/3 Catalyst Forecasts
BPIQ-AI estimates and BPIQ Active MCP options data as of Sept. 16, 2026
Expected Timing | Ticker | Catalyst / Phase | Catalyst Type | BPIQ-AI Probability Clean+ / Mixed / Clean– | Clean+ Move | Up Suspected Big Mover? | Mixed Move | Clean– Move | Down Suspected Big Mover? | BPIQ HFs | BPIQ BM/SBM | Options / AI BM Note | Key Readout Comment | Market Cap | Cash / Liquidity |
September | KOD | DAYBREAK — Zenkuda + KSI-501, wet AMD Ph3 | Pivotal Phase 3; Very High | 45–60 / 25–35 / 15–25% | +12–22% | — | –15 to +5% | –25–40% | YES | 5 | BM | Oct. 16 options implied ~45–50% absolute volatility; fundamentals support Down BM, not Up BM | ~690-patient pivotal study. Ophthalmology Ph3 historical anchor is ~51%; prior Zenkuda successes help, but multiple assets/outcomes create meaningful Mixed risk. | $2.06B | $126M |
September | DMAC | Rinvecalinase alfa, early-onset FGR Ph2 | Small open-label initial cohort; Low | 20–35 / 45–55 / 15–25% | +8–18% | — | –12 to +5% | –15–30% | — | 0 ⚠ | — | Nominal options look large but chain is very wide/illiquid; N/M. Fundamentals do not support ≥20% low-end move. | Only ~6 patients in first cohort. Obstetric/“Other” Ph2 prior is ~38.6%, but tiny open-label sample + 0 HFs substantially increase uncertainty and Mixed risk. | $369M | $43.5M |
Late September | CNTB | Rademikibart SEABREEZE STAT COPD Ph2 | Randomized acute-exacerbation efficacy; High | 15–25 / 30–40 / 40–55% | +35–60% | YES | –20 to +15% | –35–55% | YES | 4 | — | Options N/M because ~$1 stock and coarse strikes. Fundamental magnitude qualifies both directions; therefore AI SBM / SBM rather than BM. | Respiratory Ph2 historical anchor is only ~21.9%. Same treatment-failure architecture as the asthma trial that just missed its primary endpoint. $81M MC also triggers the 50–100M distress weighting. | $81M | $31.5M |
By end Q3 | MIRM | Brelovitug AZURE-1 HDV Ph3 | Registrational pivotal Phase 3; High | 70–82 / 10–18 / 6–12% | +5–10% | — | –8 to +2% | –15–25% | — | 11 | — | Options are confounded by Sept. 26 zilurgisertib PDUFA; no fundamental ≥20% low-end move anyway. | Infectious-disease Ph3 anchor ~64%, with unusually strong same-asset/same-indication Phase 2b evidence supporting an above-base-rate forecast. Market expectations are already high. | $6.42B | $438M |
By end Q3 | ORKA | ORKA-001 EVERLAST-A Week 28 psoriasis Ph2a | Incremental follow-up; Moderate/Low | 72–84 / 12–20 / 4–10% | +3–7% | — | –5 to +2% | –10–18% | — | 10 | — | Oct. options appear to price ~20–25%+ volatility, far more than fundamentals support. No AI BM/SBM because fundamental low ends remain <20%. | Week-16 efficacy is already known and strong. High Clean+ probability is appropriate here because this is follow-up/durability information, not a fresh Phase 2 binary. | $6.47B | $874M |
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BM/SBM legend
BM = the low end of the fundamental move range is at least 20% and usable event-specific options independently imply a ≥20% event move.
SBM = the fundamental low-end magnitude is at least 20%, but options either do not confirm it or cannot cleanly isolate the catalyst.
— = the low end of the fundamental move range is below 20%, so the event does not qualify as BM/SBM regardless of implied volatility.
FN1 The Clean+ probability is a market-outcome probability, not simply the probability that a company calls its press release “positive.”
This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.
Article history:
First published 9/22/26 EJV, RF, AV
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