Nuvalent submits NDA to US FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC: Cambridge, Massachusetts Wednesday, April 8, 2026, 13:00 Hrs [IST] Nuvalent, Inc., a ...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the ...

Neladalkib produced a 31% ORR in 253 TKI-pretreated patients and a 46% ORR in lorlatinib-naive patients, supporting utility ...

Nuvalent has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for neladalkib for the ...

Nuvalent seeks FDA approval of neladalkib for TKI-pretreated advanced ALK-positive NSCLC, leveraging ALKOVE-1 results demonstrating activity in extracranial disease and brain metastases. ALKOVE-1 ...

TRIANA Biomedicines, Inc. (TRIANA), a leading biopharmaceutical company focused on advancing a target-first and proximity-first molecular glue discovery platform to address difficult to drug disease ...

The firm submitted data from the ALKOVE-1 trial, in which neladalkib shrunk tumors in 31 percent of patients and showed promising activity against CNS lesions.

FDA fast track designation applies to ALK+ NSCLC progressing after ≥2 ALK TKIs, reflecting limited post-lorlatinib ...

Phase I/II clinical trial results reported at the American Society for Clinical Oncology (ASCO) Annual Meeting 2015 show promising results for investigational drug brigatinib against ALK+ non-small ...

About five percent of lung adenocarcinomas, one of the most common forms of lung cancer, are driven by a faulty fusion of two genes, EML4 and ALK. This fusion results in different variants, and until ...

Drugs that block enzymes called tyrosine kinases are among the most effective targeted therapies for cancer. However, they ...