When are the expected key regulatory and clinical milestones for the combination trial and IND‑enabling studies, and how might they drive stock volatility?

Key milestones & timing

• Combination Phase‑2 trial of the ANGPTL3 siRNA – Novartis expects to launch the dyslipidemia study in the mid‑2025 window (the agreement was signed in early 2024 and the IND‑enabling package is already in hand). The first interim efficacy read‑out is slated for Q4 2025, with a complete topline data set expected by Q2 2026. Because the trial is a “proof‑of‑concept” for a novel lipid‑lowering mechanism, any positive signal at the interim point would be viewed as a catalyst for both the partner (NVS) and the underlying asset (Argo).

• IND‑enabling program for the second‑generation siRNA candidate – The candidate currently in IND‑enabling studies is on track for an IND filing in H1 2026. Assuming a standard 12‑month pre‑IND work‑stream, the filing window is projected for June‑July 2026, with the first Phase‑1 safety read‑out anticipated late‑2026 (around Q4). The IND submission itself is a regulatory milestone that tends to generate a short‑term “announcement‑driven” swing.

Impact on volatility & trading take‑aways

• Novartis (NVS): The stock historically spikes on early‑stage data that validates a novel modality, especially in the high‑interest dyslipidemia space. Traders should watch the mid‑2025 trial‑start press release (likely a modest uptick) and the Q4‑2025 interim read‑out (potential 4‑7 % swing). The Q2‑2026 topline data could be the biggest move—a clear “binary” catalyst that could push the share price higher on positive results or pull it down on a neutral/negative read‑out. Positioning could be a long‑call spread or buy‑the‑rumor/sell‑the‑news play ahead of the Q4‑2025 interim, scaling out before the Q2‑2026 data release.

• Argo Biopharma (private, but its valuation is reflected in the partnership premium): The June‑July 2026 IND filing is another volatility event. Even though the filing itself is a regulatory step rather than a data point, the market often reacts to the “milestone achievement” narrative, especially given the $160 million upfront and option structure. Hedge funds that have exposure to the private round may see a 10‑15 % re‑rating in secondary‑market transactions around the filing date.

In practice, a tight‑range breakout strategy around the Q4‑2025 interim press release (buy on a break above the pre‑announcement high, sell on a break below the low) can capture the expected volatility without over‑exposing to the binary outcome of the final Phase‑2 read‑out. Keep an eye on FDA/EMA meeting minutes for lipid‑lowering therapies; any favorable guidance will amplify the move.