Shares of Otonomy Inc. (OTIC) - Get Report fell 83.1% to $3.50 in morning trading on Wednesday, Aug. 30, after the San Diego firm said a Phase 3 study of Otividex in patients with Meniere's disease missed its primary endpoint.
"We are greatly disappointed by these results, and surprised by both the higher placebo response and lower OTIVIDEX improvement than observed in our previous trials," said Otonomy president and CEO David A. Weber, Ph.D., in a statement.
Weber said the firm is undertaking a review of its pipeline and commercial efforts "to identify opportunities to extend its cash runway and build shareholder value."
Otonomy had total cash, cash equivalents, and short-term investments of $150.5 million as of end-June.
Meanwhile, Eli Lilly & Co. (LLY) - Get Report and Incyte Corp. (INCY) - Get Report said they will resubmit their new drug application for rheumatoid arthritis drug baricitinib before the end of January 2018. The companies said the resubmission will include new safety and efficacy data.
Eli Lilly shares rose 1.7% to $79.91 and Incyte shares were up 2.6% to $128.26.
"We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA as we seek to bring baricitinib to people with RA in the U.S," said Christi Shaw, president of Lilly Bio-Medicines, in a statement.
The FDA rejected the drug in April. In July, Eli Lilly and Incyte aid they will be further discussing the path forward with the FDA and considering options for resubmission, including the possibility of an additional study, as the agency had requested. The companies said they anticipate it would take at least 18 months before they resubmit their application.
In other news, The Medicines Co. (MDCO) - Get Report said it has clinched the U.S. Food and Drug Administration's approval for Vabomere as a treatment for adults with complicated urinary tract infections, including pyelonephritis.
The approval triggered a $40 million milestone payment obligation to the former securityholders of Rempex Pharmaceuticals Inc., which Medicines purchased in December 2013.
Medicines said it expects that Vabomere will be available in the fourth quarter. Medicines shares were down 1.4% to $38.21.
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