Nov 9, 2026: a trial win before dawn, then a miss
ImmunityBio closed Nov 6 at $8.64, up 7.9%. Three releases and three filings came out before the open on Nov 9:
- 6:30am, the trial. ANKTIVA plus BCG met the primary efficacy endpoint in Cohort A of QUILT-2.005, a randomized trial against BCG alone in patients with high-grade non-muscle invasive bladder cancer who had not had BCG. The improvement was statistically significant in patients with carcinoma in situ. There were no treatment-related deaths, and side effects were in line with BCG alone. Global principal investigator Christopher Pieczonka of US Urology Partners described a "meaningful improvement in response rates." The release did not give the rates. Premarket trading reached $9.00 at 6:30am.
- 7am, Israel. Partner Rafa Laboratories received approval in Israel for BCG-unresponsive disease with carcinoma in situ.
- 7:30am, the quarter. Net product revenue was $48.7 million, up 53% from a year earlier, and total revenue $48.8 million. By 7:45am the stock was at $7.20.
- Filings. ImmunityBio filed two 8-Ks and its 10-Q with the SEC the same morning.
The stock opened at $7.23, its high of the session was $7.26 in the first minutes, and it fell to $6.36 at 9:40am before recovering part of the drop. At 11:51am it was $7.05 on about 30.7 million shares.
The fall was ImmunityBio's own. From the Nov 6 close to 11:51am ET:
| Stock or fund | Nov 6 close | Nov 9, 11:51am | Change |
|---|---|---|---|
| ImmunityBio (IBRX) | $8.64 | $7.05 | -18.4% |
| CG Oncology (CGON) | $75.99 | $75.99 | 0.0% |
| UroGen Pharma (URGN) | $24.75 | $25.83 | +4.4% |
| SPDR S&P Biotech (XBI) | $152.21 | $155.80 | +2.4% |
| iShares Biotechnology (IBB) | $213.63 | $218.75 | +2.4% |
After the drop, RSI(14) stood at 38, the shares sat 19% below their 20-day average, 20% below their 50-day average and 12% below their 200-day average, 43% below their 52-week high of $12.43, and volume was already 2.4 times its 20-day average with more than four hours of trading left.
The numbers: growth that stalled
- Revenue. Total revenue rose each quarter from $38.3 million at the end of 2025 to $51.2 million in the second quarter, then fell to $48.8 million. The estimate was about $59.2 million. Over nine months, product revenue was $143.6 million, up 92%.
- Costs. Operating expenses were $126.8 million, up from $87.7 million a year earlier: research and development $71.5 million and selling, general and administrative $54.0 million.
- Loss. The net loss was $184.6 million, or $0.18 a diluted share, including $106.6 million of other expense. The adjusted net loss was $97.9 million.
- Balance sheet. Cash and marketable securities were $334.3 million at Sep 30. The related-party convertible note was carried at $834.9 million and the revenue interest liability at $426.3 million.
At the adjusted loss rate, cash covers a little over three quarters, which is why our guide on how to estimate cash runway matters here, and why a stock sale and dilution is a live question for holders.
The bull case
A randomized Phase 3 win in an earlier, larger group of patients is the kind of result that can change a drug's market. Our explainer on how Phase 3 readouts move stocks notes that a topline release without numbers often gets a cautious first reaction that reverses when the data are strong. The label now covers papillary-only disease, approvals are spreading, with Israel and the UAE and first sales in Europe, and chief executive Richard Adcock said "more physicians" are prescribing ANKTIVA to multiple patients. If the fourth quarter shows the dip was timing, the miss will look small.
The risks
- No numbers yet. Until complete response rates are public, the trial result cannot be compared with BCG alone or with other bladder cancer drugs.
- Demand. A sequential decline right after a label expansion raises the question of whether supply, reimbursement or uptake is the limit. The release did not explain it.
- Funding. About $98 million of adjusted loss a quarter against $334 million of cash, plus large related-party obligations.
- Regulation. Our piece on approvals as catalysts explains why a filing by year end still leaves a review of several months before any new label.
What comes next
ImmunityBio plans to file the BCG-naive application by Dec 31, 2026, and to present the full QUILT-2.005 data at a medical meeting it has not named. The fourth-quarter report will show whether sales return to growth. Biotech had another large drop today, covered in why Ionis fell; for the rest of the session's movers, see today's biggest stock moves.