What is the expected timeline for FDA acceptance of the INO-3107 BLA and how might that affect the stock in the short term?

Timeline:

In the Q2‑2025 results Inovio disclosed that the Biologics License Application (BLA) for INO‑3107 will be submitted in the second half of 2025 and the company is targeting FDA acceptance of the filing by the end of calendar‑2025 (i.e., the “year‑end” deadline mentioned in the release). Assuming a standard 15‑day filing‑acceptance window, the acceptance date is likely to fall somewhere between mid‑December 2025 and early January 2026.

Short‑term market impact:

1. Catalyst‑driven upside: The explicit acceptance target creates a clear, near‑term catalyst. As the market digests the “year‑end” deadline, the stock typically experiences a pre‑catalyst rally in the weeks leading up to the filing window—especially if the price is currently in a consolidation phase. Traders will price‑in the probability of a clean acceptance; a higher perceived likelihood translates into buying pressure now.

2. Volatility & risk: The acceptance window is still 6‑9 months away, so the short‑term price action will be dominated by technical momentum and broader market sentiment rather than the FDA decision itself. Any news of a filing delay, additional data requests, or a missed acceptance deadline would trigger a sharp sell‑off, so the trade is exposed to “event‑risk” volatility.

3. Actionable set‑up: If INO is trading near a key support level (e.g., a recent swing low or a 20‑day moving‑average bounce) with modest volume, a small‑position long on a pull‑back could capture the anticipated pre‑catalyst rally. Tight a stop just below the support zone (5‑7 % downside) to protect against a potential FDA‑related setback. Conversely, if the stock has already surged on the filing‑timeline news, consider taking partial profits and holding a modest “catalyst‑play” position for the actual acceptance announcement in Q4 2025.

In short, the market is likely to price in a modest upside now as investors position for the year‑end acceptance, but the trade remains vulnerable to FDA timing risk and broader market dynamics until the filing window actually opens.