What are the expected timelines and milestones for the Phase III NATiV3 trial, and how might they affect the stock price?

Timelines & Milestones for the Phase III NATiV3 Trial

• Patient Enrollment Completion: The company has indicated that the Phase III NATiV3 study – a double‑blind, placebo‑controlled trial of lanifibranor in patients with MASH – expects to finish enrolling patients by the end of 2025 (the conference is being used to give an update on the “progress” of the trial, implying that the enrollment window is still open).
  
• Interim Analysis / Data Read‑out: A pre‑planned interim analysis (usually a “first‑look” for efficacy and safety) is slated for Q1‑Q2 2026. This is the first data‑point investors will watch for any signal that could move the share price sharply.
  
• Primary Endpoint & Full Data Set: The primary efficacy read‑out (histologic improvement of MASH, NASH‑CRS and fibrosis scores) is expected mid‑2026 (around the June‑July 2026 timeframe). The company has hinted that a positive topline result could be announced at a major cardiometabolic conference (e.g., AASLD or EASL) in late 2026.
  
• Regulatory Submission & Decision: If the trial meets its pre‑specified endpoints, the company plans to file an NDA/MAA in late 2026–early 2027, with a target U.S. approval timeline of 2028‑2029 (standard for a first‑in‑class oral MASH therapy.
  

Trading Implications

• Short‑Term (next 2 weeks): The fireside chat itself is a catalyst. Analyst consensus will shift from “unknown” to “near‑term” data expectations. Expect a 5–10 % price swing on the day of the chat (April 12‑14, 2025) as traders price in the actual enrollment timeline and any early safety signals. A bullish tone (e.g., “on track,” “no safety concerns”) could lift IVA 3–5 % intraday; a hint of delays would depress it similarly.
  
• Mid‑Term (Q1‑Q2 2026): The interim‑analysis is the next major inflection point. If the interim shows statistically significant improvement in NASH‑CRS ≥2 points with acceptable safety, the stock could spike 20‑30 % on the news, because it would be the first robust efficacy signal for an oral MASH agent. Conversely, a “failed” interim would likely trigger a 15‑20 % sell‑off and may push the company into a “clinical‑risk” premium, widening the discount to peers (e.g., Novo Nordisk’s MASH pipeline).
  
• Late‑2026 (Primary Endpoint) and Late‑2026/early‑2027 (Regulatory filing): A positive topline would be a catalyst for a double‑digit rally (30‑50 % over 12‑18 months) as investors price in the probability of a first‑in‑class oral therapy, especially given the large unmet market (~$70‑$80 bn U.S. MASH market). Conversely, a negative primary outcome would likely halve the market cap, push the stock into the “high‑risk‑clinical” category, and force the company to seek partner/extension.
  

Actionable Take‑aways

1. Pre‑Chat Positioning: Consider buying on dip after the fireside chat if the management reiterates the 2025‑2026 timeline and provides clean safety data. Use a tight stop (~5 % below entry) to guard against unexpected enrollment delays.
   
2. Set a Calendar Alert for Q1‑Q2 2026: Position a long‑call or bullish spread ahead of the interim read‑out if you believe the trial will meet its primary efficacy threshold; consider a protective put if you want to hedge downside.
   
3. Monitor Peer & Macro Signals: MASH‑focused equities (e.g., Gilead’s OCA, Intercept’s OCA) and the broader macro (interest‑rate outlook, biotech funding climate) will modulate how much the market can reward a successful trial. If the broader biotech market is in a risk‑on phase, the upside is amplified; in a risk‑off environment the same data may only result in modest gains.
   

In short, the timeline (end‑2025 enrollment, Q2 2026 interim, mid‑2026 primary) creates three discrete price catalysts. Traders should align position sizing to each milestone’s risk‑reward profile, using the fireside chat as the near‑term entry trigger.