2024-06-14 07:15:55 ET
Summary
- Nuvalent's NVL-655 received FDA Breakthrough Therapy Designation for ALK+ NSCLC, showing potential as a vital therapy.
- Nuvalent's pipeline includes innovative kinase therapies for NSCLC, with NVL-655 and Zidesamtinib showing promise in clinical trials.
- NVL-655 has the potential to become a blockbuster drug, with peak sales estimates supporting a higher share price for Nuvalent in the future.
Nuvalent ( NUVL ) recently publicized that the FDA gave NVL-655 their Breakthrough Therapy Designation (BTD) for locally advanced or metastatic ALK+ non-small cell lung cancer (NSCLC). The BTD press release encouraged me to do some preliminary research on Nuvalent and NVL-655. It didn't take me long to determine that NVL-655 has the potential to be a vital therapy for ALK+ NSCLC patients who often have to deal with multiple lines of therapy after their cancer develops resistance to targeted therapy after secondary mutations in the ALK gene along with the possibility of developing brain metastases. NVL-655 could be a promising agent due to it being a brain-penetrant ALK selective TKI that could avert treatment of some of these resistance mechanisms, as well as avoid CNS adverse events and the development of ALK mutations that are often seen with ALK inhibitors. If successful, NVL-655 could change the treatment paradigm in locally advanced or metastatic ALK-positive NSCLC and provide Nuvalent with a potentially blockbuster product. As a result, NUVL is high on my watchlist for a potential entry in the coming weeks or months....
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Nuvalent: NVL-655 Could Bring Blockbuster Potential