Shares of Onyx Pharmaceuticals jumped by more than 40% on Thursday as its multiple myeloma drug gained the advisory board's unanimous approval.
Shares of Onyx Pharmaceuticals jumped by more than 40% on Thursday as the company announced good news for its multiple myeloma drug candidate. Even more impressive, the company managed to maintain its high all throughout the day.
The stock far surpassed its 52-week high of $47.80 when an advisory panel recommended the approval of Onyx’s Kyprolis for blood cancer patients who did not respond to other medicines. The U.S. Food and Drug Administration had previously expressed concern about the drug’s side effects and will make a decision by July 27.
While the FDA mentioned concern since the drug had serious heart, lung and liver side effects, the positive vote from the board caused analysts to increase their expectation of Kyprolis’ approval. While the FDA doesn’t have to agree with the board’s vote, it often does.
The vote of confidence caused Onyx’s shares to shoot up in what is the company’s largest single-day percentage gain in more than five years. It closed at $63.78, up 43.07% over the previous day’s close of $44.58.
Kyprolis shrunk tumors in 22% of multiple myeloma patients. According to , if the drug is approved, annual sales for Kyprolis may be $523 million in 2016, which would more than double the revenue Onyx had in 2011.
However, the side effects can’t be overlooked. During trials, five patients died from heart ailments and more than 70% had lung complications.
Still, the advisory board voted 11-0 (with one abstention) that the benefit-risk assessment is favorable. The drug would be a tertiary treatment, though. The advisory board voted in favor of it when it is used in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.
"Today's ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma," Ted W. Love, MD, executive vice president of Research and Development and Technical Operations, said in a statement. "Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."
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