GSK is in talks to acquire cancer-focused biotech Nuvalent in a deal valued at more than $9 billion

GSK (LSE/NYSE: GSK) is reportedly in advanced discussions to acquire Nuvalent, a clinical-stage biopharmaceutical company focused on developing next-generation tyrosine kinase inhibitors (TKIs) for the treatment of non-small cell lung cancer (NSCLC), in a deal valued at over $9 billion. The potential acquisition would significantly expand GSK’s oncology portfolio, particularly in the area of targeted therapies for genetically defined cancers.

Nuvalent’s lead candidates, neladalkib and zidesamtinib, are being developed for patients with ALK and ROS1 mutation-positive NSCLC, respectively. Both therapies are designed to offer a best-in-class combination of efficacy and tolerability. Neladalkib recently reported positive pivotal results in TKI pre-treated patients, demonstrating durable activity and a favorable safety profile. It is also being evaluated in an ongoing Phase 3 trial in TKI-naïve patients. Zidesamtinib is currently under FDA review, with an action date set for September 18, 2026, and is being studied in a Phase 1/2 trial for TKI-naïve patients.

Analyst consensus projects neladalkib to achieve annual sales of approximately $3.5 billion and zidesamtinib to reach $1.9 billion by 2035. The acquisition would align with GSK’s strategy of acquiring assets with high unmet medical need and the potential for best-in-class profiles. This approach was previously demonstrated in GSK’s $1.15 billion acquisition of IDRx, Inc., which brought the experimental KIT TKI IDRX-42 into GSK’s portfolio for the treatment of gastrointestinal stromal tumors (GIST).

The proposed Nuvalent deal would mark one of the largest acquisitions in GSK’s recent history and reflect the company’s continued focus on expanding its presence in oncology. If finalized, the transaction would be subject to customary regulatory approvals and other standard closing conditions.