TESARO Inc TSRO shares opened 3.25 percent higher after being halted around 3:30 p.m. ET. The company announced FDA approval of niraparib and plans to initiate registration processes for expanded indications of metastatic ovarian, breast and lung cancers.
As of yet, niraparib supports patients with recurrent ovarian, fallopian and peritoneal cancers and is the only PARP inhibitor approved for such treatments in the U.S.
“We plan to expand our first-line ovarian cancer strategy to include a combination study that assesses the potential benefit of niraparib plus an anti-PD-1 antibody in the maintenance setting and initiate a clinical study of niraparib in combination with bevacizumab in patients with a first recurrence of ovarian cancer, with an intent to replace chemotherapy in this setting,” President and COO Mary Lynne Hedley said in a press release.
Tesaro will continue to study the drug’s capabilities for breast cancer treatment while expanding research into other forms of cancer.
Who Feels The Pain?
According to an October report by Barclays, positive Tesaro results and expanded indications for niraparib do not bode well for Myriad Genetics, Inc. MYGN, whose HRD diagnostic technologies are rendered unnecessary.
Tesaro also poses a threat to competitor Clovis Oncology Inc CLVS, which received an accelerated approval from the FDA for its treatment of ovarian cancer in December.
On Tesaro’s news, shares of Myriad plunged 3.5 percent from $19.66 to $19.20 in after-hours trading. Meanwhile, Clovis shares, which initially peaked on the Tesaro halt, fell to trade nearly 3 percent lower at $67.90.
Tesaro shares were valued around $168 in the after-hours session, up 7.5 percent at time of publication.
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