What happened
Shares of Nuvalent (NUVL 1.20%) were up more than 27% as of 3:30 p.m. ET on Wednesday after the company reported preliminary phase 1/2 trial data for a therapy to treat advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. The stock reached a 52-week high of $61.70, and so far this year is up more than 93%.
So what
Nuvalent is a clinical-stage biotech that focuses on precise cancer therapies by using proven kinase targets. On Wednesday, the company said that in a trial with 57 subjects, its NVL-655 was generally well tolerated with few adverse effects, and the drug drew at least a partial response in 45% of the ALK-positive NSCLC patients -- that is, patients whose cancer cells have a mutation in the anaplastic lymphoma kinase (ALK) gene.
The drug is developed to overcome the challenges of treatment resistance, brain metastases, and off-target adverse events connected to the central nervous system. In many cases, ALK-type cancers can mutate, making them harder to treat with existing therapies. NVL-655 is able to bypass the brain-blood barrier and can target compound mutations that often occur when a tumor progresses, the company said.
Now what
The company, like many clinical-stage biotechs, could pay off in the long term, but presents plenty of risks in the meantime. It has four programs in its pipeline, but the only one other than NVL-655 that is in clinical trials is NVL-520, in a phase 2 trial to treat NSCLC patients. As of the second quarter, Nuvalent reported it had $431.2 million in cash, enough to fund operations into the second half of 2025.
