What is the anticipated timeline for filing a New Drug Application (NDA) or seeking regulatory approval in China and other major markets? | VSTM (Aug 13, 2025) | Candlesense
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What is the anticipated timeline for filing a New Drug Application (NDA) or seeking regulatory approval in China and other major markets?

Anticipated regulatory timeline

The late‑breaking abstract signals that GenFleet’s Phase 1/2 data in China are now mature enough to support a filing in the near term. Given the positive safety and efficacy read‑out, the partner is likely to prepare a China NDA (or its equivalent “Drug Registration Application”) within the next 12‑18 months – i.e., by the second half of 2025 (the study is already being presented at IASLC 2025, so the filing would follow shortly after the conference).

Because the molecule is a KRAS‑G12D “ON/OFF” inhibitor and the data are still early‑stage, filings in the United States, Europe or Japan will come later. Assuming the Chinese filing proceeds on schedule and the company can leverage the data for a global development program, a first‑in‑world NDA submission in the U.S. or a Marketing Authorization Application (MAA) in the EU would be realistic in 2026‑2027, after additional Phase 2/3 data are generated and the regulatory agencies request a complete dossier.

Trading implications

  • Short‑term catalyst: The conference presentation and the imminent China filing are likely to spark a price rally on the news flow, especially if the data confirm a clear efficacy signal. Traders can consider buying on any pull‑back after the initial hype, targeting a 10‑15 % upside as the filing date approaches.
  • Mid‑term risk/reward: The timeline pushes the first major global approval out to 2026‑27, meaning the stock will remain volatile on interim data releases. A tight stop‑loss (≈ 8 % below entry) can protect against any setbacks in the Chinese filing or unexpected safety signals, while the upside remains tied to the potential of a first‑in‑class KRAS‑G12D therapy.

Overall, the market is pricing in a China NDA by H2 2025 and a broader global filing in 2026‑27. The current catalyst offers a near‑term buying opportunity, but position sizing and risk management are essential as the company moves through the longer, more uncertain global approval pathway.

Other Questions About This News

What is the projected market size for KRAS G12D‑mutated NSCLC and how might this affect Verastim's revenue forecasts? What are the expected timelines for regulatory approval of GFH375 (VS-7375) in China and globally? How does the updated safety and efficacy data compare to existing KRAS G12D inhibitors in development? Will the positive Phase 1/2 data trigger any milestone payments or additional funding from GenFleet Therapeutics to Verastim? How might this data release impact Verastim's enrollment and partnership negotiations for future trials? What are the key efficacy endpoints reported in the Phase 1/2 study and how do they compare to historical benchmarks for KRAS G12D NSCLC therapies? What safety signals or adverse event profiles were observed, and could they affect the drug’s regulatory pathway or market acceptance? How will the partnership with GenFleet Therapeutics impact revenue sharing, commercialization rights, and cost structure for Verastim Oncology? What is the projected market size for a KRAS G12D‑targeted oral inhibitor in advanced NSCLC, both in China and worldwide? Will the positive data trigger any changes in the company’s guidance or financial forecasts? What are the potential pricing strategies for GFH375 in China, and how might they differ from pricing in other regions? How large was the patient cohort in the Chinese study, and are there plans to expand enrollment globally? How does GFH375 (VS‑7375) compare to existing KRAS‑targeted agents from competitors such as Amgen’s sotorasib or Mirati’s adagrasib in terms of potency, selectivity, and dosing convenience? Are there any upcoming data readouts, additional trial cohorts, or combination therapy studies that could further de‑risk the commercial potential of GFH375?