When is the data expected to be presented and what is the timeline for potential FDA filing or approval? | NUVL (Aug 13, 2025) | Candlesense
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When is the data expected to be presented and what is the timeline for potential FDA filing or approval?

When the data will be shown

Nuvalent says the pivotal ARROS‑1 data for zidesamtinib will be unveiled at the World Conference on Lung Cancer (WCLC) 2025 Presidential Symposium. The press release is dated 13 August 2025, and the WCLC symposium is scheduled for mid‑September 2025 (around Sept 15‑17). Expect the data package to be released in the first week of the symposium, with a full slide deck and a press‑release the same day.

FDA filing & approval timeline

If the ARROS‑1 read‑out is positive, Nuvalent will likely prepare a sponsored‑type New Drug Application (sNDA) or a Biologics License Application (BLA) for a oncology‑focused, accelerated‑approval pathway. Historically, companies in this space file within 3–4 months of a positive pivotal read‑out to keep momentum and to meet the FDA’s 12‑month review clock for accelerated‑approval products. Consequently, a Q4 2025 filing (October‑December) is realistic. Assuming the agency grants priority review and the drug qualifies for the FDA’s Oncology Fast Track/Breakthrough Therapy designations, the earliest possible approval would be mid‑2026 (≈ June‑July 2026), with a typical review time of 6–8 months under priority review.

Trading implications

- Short‑term catalyst: The September data release is a high‑volatility event. A clear efficacy signal (e.g., ≥ 30 % ORR in a TKI‑pre‑treated ROS1‑positive NSCLC cohort) could spark a 20‑30 % rally in Nuvalent’s stock as investors price in the near‑term filing potential.

- Risk: A modest or ambiguous read‑out may trigger a 10‑15 % pull‑back and push the stock back toward its pre‑data level, especially if the company signals a delayed filing.

- Positioning: Consider a buy‑on‑breakout strategy ahead of the symposium (e.g., buying on a 5‑% dip if the market under‑reacts to the data release) with a stop just below the pre‑data support zone (≈ $2.00). If the data are robust, look to scale in as the filing window opens in Q4 2025, while keeping an eye on any FDA guidance that could accelerate the timeline further.

In short, expect the pivotal data in mid‑September 2025, a Q4 2025 FDA filing, and potential approval by mid‑2026 if the trial meets its primary endpoints. The window from the symposium to the filing is the most actionable period for traders.

Other Questions About This News

How will the pivotal ARROS-1 data impact Nuvalent's stock price in the short term? What are the efficacy and safety results compared to existing ROS1 inhibitors like crizotinib and entrectinib? How does this trial position Nuvalent against competitors targeting ROS1-positive NSCLC? What is the estimated market size for ROS1‑positive NSCLC and the potential revenue upside for zidesamtinib? Will the results trigger any partnership, licensing, or co‑development deals with larger pharma companies? How might the data affect Nuvalent's cash runway and future financing needs? What are the key regulatory or clinical milestones following the ARROS-1 data release? Could the trial outcomes lead to a re‑rating of the company's valuation by analysts? What is the expected reaction from institutional investors and analyst coverage after the data is presented?