What are the expected timelines for Phase 3 enrollment and potential FDA approval compared to Shingrix's pathway?
Timeline Outlook vs. Shingrix
Dynavax’s press‑release indicates that Phase 1/2 data are already “supporting a best‑in‑class” profile, and the company has signaled an intention to move into Phase 3 “later this year.” In practice, a typical shingles‑vaccine program allocates 6‑9 months to fully enroll the pivotal cohort once the protocol is finalized. Assuming the enrollment window opens in Q4 2025, we can expect the 1,800‑plus‑patient Phase 3 study to be completed by mid‑2026, with an interim immunogenicity read‑out around Q1 2026 and a final data package by the end of 2026. A U.S. filing would then be realistic in early‑to‑mid 2027, putting the earliest FDA approval window in late 2027 or early 2028, barring any regulatory surprises.
For context, GSK’s Shingrix entered Phase 3 in early 2015, completed enrollment by the end of that year, and received FDA approval in October 2017—a roughly 2‑year path from pivotal start to market. Dynavax’s timeline is therefore roughly 3‑4 years longer than Shingrix’s historic pathway, reflecting the added time needed to build a Phase 3 program from scratch and the current competitive landscape.
Trading Implications
The upcoming Q4 2025 enrollment kickoff is the next material catalyst; a clear enrollment start date and patient accrual metrics should drive short‑term volatility. Positive Phase 3 data (especially if the tolerability edge over Shingrix holds) could trigger a 30‑50 % upside in DNVX, as investors price in a differentiated product and potential pricing power in the $5‑6 bn shingles market. Conversely, delays in enrollment or a muted immunogenicity signal would likely erode the premium built into the stock. Keep an eye on partnership announcements (e.g., with a large vaccine commercializer) and any FDA “fast‑track” or “breakthrough‑therapy” designations that could compress the timeline and materially alter the risk‑reward profile. In the meantime, the stock remains in a consolidation phase; a breakout above the 20‑day EMA on strong enrollment news would be a practical entry point, while a break below the 50‑day SMA would suggest re‑evaluating exposure.