What are the potential market size and revenue upside if the Phase 2 data support a successful launch, and how might that affect long‑term growth forecasts for enGene?

Potential market size & revenue upside

High‑risk non‑muscle‑invasive bladder cancer (NMIBC) represents roughly 25 % of the ∼ 600 k new bladder‑cancer cases in the U.S. each year – about 150 k patients. The U.S. market for NMIBC‑related intravesical therapies is estimated at ≈ $3–4 bn (global ≈ $8–9 bn). If enGene’s detalimogene can achieve a 10 % penetration of the U.S. high‑risk NMIBC segment (≈ 15 k patients) at a 0.5‑injection regimen priced at $15 k per course (a realistic mid‑range price for a non‑viral gene‑therapy product), annual U.S. sales could be $225 m. Adding European and Asian roll‑outs (≈ 30 % of U.S. volume) pushes the 5‑year run‑rate to $350‑500 m – a 10‑15× multiple of enGene’s 2024‑25 revenue baseline (which is still in the sub‑$100 m range).

Long‑term growth implications

A positive Phase 2 read‑out that shows durable complete responses would move detalimogene from a “potentially differentiating” candidate to a launch‑ready product with a clear regulatory pathway. That shifts the company’s revenue profile from a single‑product, trial‑stage business (high burn, low cash‑flow) to a multi‑cohort, recurring‑therapy franchise. Consensus earnings forecasts would be upgraded by 200‑300 % on a forward‑PE basis, expanding the 2026‑27 projected earnings per share (EPS) from ≈ $0.10 to ≈ $0.45‑$0.55. The incremental valuation premium translates into a $2–3 bn market‑cap uplift if the market prices the company at a 30× forward‑PE, which is in line with other niche gene‑therapy leaders.

Trading implications

1. Catalyst trade – The upcoming Phase 2 data release (likely Q4 2025) should be priced in ahead of the announcement. A 10‑15 % upside from current levels ($2.4‑$2.6) would be warranted for a clean read‑out; a partial‑success or ambiguous data could trigger a 10‑12 % pop‑back. Consider buying on pull‑backs now with a stop‑loss at 10 % to capture the upside while limiting downside.
   
2. Technical bias – ENGN has held a mid‑cap, low‑float profile and is currently in a wide‑range bullish trend (200‑day moving average trending upward, daily high‑volume on enrollment news). If the stock remains above $2.55 (the 10‑day SMA), the bullish bias holds; a break below $2.40 could signal a short‑term correction.
   
3. Position‑size – Given the upside potential versus limited downside, a 2–3 % portfolio allocation (≈ $1.5‑$2.5 k) is reasonable for a long‑bias, with the option to add on a second pull‑back if the Phase 2 data are clean.

Bottom line: A successful Phase 2 read‑out could unlock a $350‑$500 m sales runway, dramatically lift enGene’s long‑term growth outlook, and justify a mid‑$3.00 price target within the year. The news flow creates a clear entry point; stay disciplined with risk limits and monitor the Phase 2 release calendar.