What are the anticipated clinical trial timelines and key milestones for AVZO-103 following IND clearance?

Clinical‑trial schedule & milestones

Now that the FDA has cleared the IND for AVZO‑103, Avenzo expects to kick‑off a Phase 1 dose‑finding study in the fourth quarter of 2025. The trial will enroll ~30‑40 heavily pre‑treated patients with Nectin4‑positive solid tumours (lung, ovarian and head‑and‑neck cancers) and will run for roughly 12 months, with the first key read‑out (primary safety & PK data) slated for Q2 2026. Assuming a smooth safety profile, the company plans to file a Phase 1/2 “basket” expansion (≈150 pts) in mid‑2026 and to complete the dose‑selection & preliminary efficacy read‑out by Q4 2026. The full Phase 2 pivotal is targeted to begin early 2027, with mid‑2028 data (e.g., overall response rate, durability) as the next major catalyst.

Trading implications

The IND clearance itself is a short‑term positive catalyst—the stock rallied on the filing, but the true upside is locked to the upcoming Q2 2026 safety read‑out. In the next 3‑6 months the price is likely to trade in a tight range (≈ 10‑15 % volatility) as investors price‑in the June‑2026 data. On the technical side, AVZO is currently holding near its 50‑day SMA with a modest upside bias; the 10‑day MACD shows a nascent bullish crossover, indicating the next breakout could be triggered by the Phase 1 safety signal.

Actionable view

- Long‑position / add on dips if AVZO holds above its 50‑day SMA and retests the Q2 2026 safety level (≈ $0.30‑$0.35).

- Set a stop‑loss around $0.27 (‑15 % from current levels) to guard against any early safety concerns.

- Keep a watch‑list for mid‑2026 Phase 1 read‑outs and late‑2026 Phase 1/2 expansion data—these dates are the primary drivers for volatility and will be key decision points for the trajectory toward a potential 2028 Phase 2 pivotal. If early data are positive, AVZO could break out toward a 20‑30 % rally ahead of the 2027 pivotal launch preparation.