FDA Approves Myriad's MyChoice CDx as Sole Companion Diagnostic for Zejula in Ovarian Cancer
MYGN sits 31% above its 52-week low of $3.76.
Summary
Myriad Genetics has received FDA approval for its MyChoice CDx Test as the companion diagnostic for GSK's Zejula (niraparib) in advanced ovarian cancer. This approval is highly significant as MyChoice CDx is now the only FDA-approved companion diagnostic for Zejula in the United States, reinforcing Myriad's leadership in comprehensive HRD testing. This regulatory and commercial win provides a much-needed positive catalyst for Myriad, especially following its reported net loss and revenue decline in the last fiscal year. The exclusivity in identifying HRD-positive patients eligible for Zejula could materially boost Myriad's revenue and market position. Traders should monitor the commercial rollout and adoption rates of the MyChoice CDx test, as well as any revised financial guidance from the company.
At the time of this announcement, MYGN was trading at $4.92 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $447M. The 52-week trading range was $3.76 to $10.32. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.