Puma Plummets On Another Neratinib NDA Delay
This article was originally published in Scrip
Executive Summary
Puma Biotechnology Inc. fell 21.1% to close at $27.92 per share on March 29 after it revealed a second major delay for the company's new drug application (NDA) submission to the US FDA for neratinib as an extended adjuvant treatment for early-stage HER2-positive breast cancer.
You may also be interested in...
Puma's Neratinib SUMMIT Study Shows Potential & Pitfalls Of Precision Medicine
"Basket trial" design allowed Puma to identify certain cohorts for further study, but also missed in areas where neratinib was expected to work.
Keeping Track: Approval Elusive For Biosimilar Neulasta; Valeant Gets A Nod And A No From FDA; Submissions From Amgen, Puma, Bristol
The latest drug development news and highlights from our FDA Performance Tracker
First Lumakras Combo Data Show Boosted Efficacy For Amgen Drug In CRC
Amgen’s KRAS G12C inhibitor in combination with the company’s Vectibix generated a 27% overall response rate, nearly tripling the responses seen with Lumakras monotherapy in colorectal cancer.