Shares of Aradigm Corp.
plunged 21% toward a four-month low, after the drug maker said the Food and Drug Administration informed that company that its new drug application (NDA) for its lung infection treatment could not be approved in its current form. The percentage decline was the biggest among stocks listed on the Nasdaq exchange. The FDA’s complete response letter (CRL) for Aradigm’s Linhaliq said the areas of concern included clinical data, human factors validation study and product quality. “We remain confident in the efficacy, safety and quality of Linhaliq and will request a meeting with FDA to discuss the topics covered in the CRL with the view to developing plans to move towards resubmission of the Linhaliq NDA as soon as possible,” said Chief Executive Igor Gonda. The stock plunged 58% over the past three months, while the S&P 500
has climbed 11%.
View more information: https://www.marketwatch.com/story/aradigms-stock-plunges-to-lead-nasdaq-losers-after-linhaliqs-nda-fails-to-get-approved-2018-01-29