Nuvalent, Inc.
102.97+1.75 (+1.73%)
Oct 29, 4:00:01 PM EDT · NasdaqGS · NUVL · USD
Key Stats
Market Cap
7.42BP/E (TTM)
-Basic EPS (TTM)
-4.92Dividend Yield
0%Recent Filings
8-K
Nuvalent advances NSCLC pipeline
Nuvalent kicked off its rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC patients, targeting completion by Q3 2025, while dosing the first patient in the ALKAZAR Phase 3 trial of neladalkib versus alectinib for front-line ALK-positive NSCLC. Topline pivotal data from ALKOVE-1 for neladalkib in TKI pre-treated ALK-positive NSCLC arrives by year-end, alongside preliminary data for other ALK-positive tumors at ESMO 2025. Cash stands at $1.0 billion, funding operations into 2028. Jason Waters steps up to SVP Commercial. Clinical trials carry enrollment risks.
10-Q
Q2 FY2025 results
Nuvalent's Q2 FY2025 results showed operating expenses climbing 60% y/y to $104.6M, driven by R&D ramp-up for zidesamtinib, neladalkib, and NVL-330 programs, while net loss widened to $99.7M from $57.2M a year earlier, with the gap partly due to a $6.0M fair-value hit on the related-party revenue share liability. Yet interest income rose 36% y/y to $11.1M, buoyed by a hefty $1.0B cash pile. Free cash flow isn't disclosed in the 10-Q. Liquidity stays solid with no debt and ample runway into 2028, but clinical trial delays could strain that buffer. Competition from established TKIs remains a key hurdle.
8-K
Nuvalent starts Phase 3 trial
Nuvalent kicked off its Phase 3 ALKAZAR trial on July 21, 2025, dosing the first patient with neladalkib in TKI-naïve advanced ALK-positive NSCLC patients, pitting it against standard ALECENSA. This head-to-head setup tests neladalkib's potential to disrupt front-line therapy. First patient dosed. The trial advances Nuvalent's oncology pipeline amid rising demand for targeted NSCLC treatments.
8-K
Positive zidesamtinib trial data
Nuvalent announced positive pivotal data from the ARROS-1 trial showing zidesamtinib achieved a 44% ORR in 117 TKI pre-treated ROS1-positive NSCLC patients, with 84% maintaining response at six months and strong intracranial activity, including 48% IC-ORR. The company plans a rolling NDA submission starting July 2025 for this indication, while advancing front-line strategies like preliminary 89% ORR in TKI-naïve patients and ALKAZAR Phase 3 startup for neladalkib. Data mature amid risks of trial delays.
8-K
Nuvalent elects new director
Nuvalent bolstered its board on June 18, 2025, by electing independent director Christy J. Oliger to the Class III seat through 2027 and appointing her to the Audit Committee. She receives standard compensation, including an initial stock option for 6,119 shares at $75.53 and RSUs for 3,971 shares, vesting over three years. At the annual meeting that day, shareholders elected Class I directors Grant Bogle, James R. Porter, and Anna Protopapas; approved executive pay; and ratified KPMG as auditors. Strong attendance signals investor confidence.
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