This morning after the U.S. markets opened for trading, clinical-stage immuno-oncology company NewLink Genetics Corp. (NLNK:NASDAQ.GM), announced that, "after priority review, the U.S. Food and Drug Administration(FDA) has granted approval of ERVEBO®, or Zaire Ebola virus vaccine V920, (rVSV∆G-ZEBOV-GP), as confirmed by our partner, Merck & Co Inc. (MRK:NYSE)." NewLink indicated that this represents the first vaccine approved by the FDA for the Ebola virus. The company stated that last month the European Commission also granted marketing authorization for ERVEBO across 31 European countries.
NewLink advised that "yesterday's approval comes almost three months prior to the Prescription Drug User Fee Act (PDUFA), or target FDA action date, originally set for March 14, 2020, and that as previously stated by the company, the FDA's approval of this Ebola vaccine will trigger the issuance of a priority review voucher (PRV) owned by Merck and in which NewLink Genetics has a substantial economic interest." The firm noted that after the PRV has been issued it will have the right to monetize its share of interest in the voucher.
Eugene Kennedy, MD, chief medical officer and member of NewLink Genetics' Office of the CEO, commented, "We are delighted by the FDA's decision to approve this Ebola vaccine and by the agency's recognition of the potential this vaccine may offer to protect individuals who may be exposed to Ebola from contracting this deadly disease...We are grateful to our partner Merck, and to the regulatory bodies involved, for their dedication to advancing solutions to combat this deadly illness."
NewLink Genetics is a clinical-stage biopharmaceutical company based in Ames, Iowa. Historically, the firm has focused its efforts on developing novel immunotherapeutic products for treatment of cancer patients. In mid-2020, NewLink is scheduled to merge with private clinical-stage biopharmaceutical company Lumos Pharma, which targets rare and neglected diseases. Upon the close of the proposed merger, the combined company will operate as Lumos Pharma and will focus on Lumos's sole product candidate, LUM-201 (ibutamoren), an oral growth hormone (GH) secretagogue targeting pediatric growth hormone deficiency (PGHD) and other rare endocrine disorders. The company stated, "if approved, LUM-201 has the potential to represent the first orally administered growth hormone stimulating therapy for a subset of PGHD patients."
NewLink Genetics began the day with a market capitalization of about $60.1 million with around 37.31 million shares outstanding and a short interest of approximately 4.40%. NLNK shares opened higher today at $1.69 (+$0.08, +4.97%) over yesterday's $1.61 closing price. The stock has traded today between $1.60 and $2.37 per share and is presently trading at $1.94 (+$0.33, +20.50%).[NLINSERT]
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