Nuvalent (NUVL) is a $7.2B Biotech in a very strong trend with shares +40% YTD and recently consolidating a big move in healthy fashion. NUVL gapped through the key $87 level on data which can measure to a $140 target. A trad eon 9/17 sold 1000 January $110 calls to open for $10.50, likely writing against a stock holding implying a ceiling near $120. NUVL has also seen buyers of January $125 calls, a seller of 900 December $90 puts and seller sin Dec. 2025 $75 and $70 puts.

NUVL is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. NUVL develops innovative small molecules that are designed with the aim to overcome the limitations of existing therapies for clinically proven kinase targets. NUVL believes its drug candidates have the potential to overcome resistance, avoid dose-limiting off-target adverse events, address brain metastases, and drive more durable responses.

NUVL’s first lead product candidate, NVL-520, is being developed for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). NVL-520 is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs). NVL-520 has received FDA Breakthrough Therapy designation for the treatment of patients with ROS1-positive NSCLC who have previously been treated with two or more prior ROS1 TKIs, and orphan drug designation for ROS1-positive NSCLC. Its second lead product candidate, NVL-655, is being developed for patients with anaplastic lymphoma kinase (ALK)-positive NSCLC. NVL-655 is a brain-penetrant ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that may limit the use of first-generation (1G; crizotinib), second-generation (2G; ceritinib, alectinib, or brigatinib), and third-generation (3G; lorlatinib) ALK inhibitors. NVL-655 has received orphan drug designation for ALK-positive NSCLC. NUVL’s newest product candidate, NVL-330, is a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed with the aim to address the combined medical need of treating tumors driven by insertions or insertion-deletions in exon 20 of HER2 (collectively, known as HER2 Exon 20 Insertions, or HER2ex20), treating brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type epidermal growth factor receptor (EGFR). Preclinical data have shown that NVL-330 inhibited HER2ex20 in cell-based assays, was brain penetrant, and was selective for HER2ex20 over the structurally related wild-type EGFR.

Analysts forecast up to $1B sales potential for FY29 ($547M average) making NUVL fairly pricey on valuation with high expectations but could also be seen fetching a M&A bid from larger Pharma looking to defend positions in Oncology. NUVL has multiple registrational paths leading to potential product launches for both zidesamtinib and NVL-655 in 2026, and a defined strategy to pursue the significant 1L ALK+ NSCLC market. NVL-655 and zidesamtinib approvals have potential to generate material sales over 2026-2029.Jefferies says the company’s two candidates could generate $1.7B and $2.6B in adjusted peak sales, so $4.3B combined making the $7B market cap feasible for a name with best-in-class drugs.