Nuvalent Inc. surged 17.46% in after-hours trading following the announcement that it will present topline pivotal data for its ALK-selective inhibitor neladalkib in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer on November 17, 2025. The data, from the global ALKOVE-1 Phase 1/2 trial, positions neladalkib as a potential treatment for tumors resistant to existing ALK inhibitors and brain metastases, supported by FDA Breakthrough Therapy and Orphan Drug designations. Analyst optimism, including Stifel’s initiation of coverage with a $115 price target and UBS/Piper Sandler raising their targets to $132 and $128, respectively, further fueled the rally. The drug’s CNS penetrance and registrational intent for Phase 2 trials highlight its therapeutic differentiation, aligning with the stock’s sharp post-market gains.
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