BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) Files An 8-K Other Events
Item 8.01. Other Events.
On January 2, 2019, BioCryst Pharmaceuticals, Inc. (the “Company”) announced the dosing of the first subject in a randomized, placebo-controlled phase 1 clinical trial to evaluate intravenous (IV) galidesivir in healthy volunteers.
On January 2, 2019, the Company issued a news release announcing the events described in this Item 8.01. A copy of the news release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
This Current Report on Form 8-K contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that BioCryst or its licensees may not be able to enroll the required number of subjects in planned clinical trials of galidesivir and that such clinical trials may not be successfully completed; that the Company or its licensees may not commence additional pre-clinical studies or human clinical trials may not be commenced as expected; that the FDA may require additional studies beyond those planned for galidesivir, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold on galidesivir, or withhold market approval for product candidates; that the Company may not be able to obtain additional funding for galidesivir; that government funding or other contracts for galidesivir may have certain terms and conditions, including termination provisions, that subject the Company to additional risks; that the Company may lose current funding for the program; that its actual financial results may not be consistent with its expectations, including that operating expenses and cash usage may not be within management’s expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
BIOCRYST PHARMACEUTICALS INC Exhibit
EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1BioCryst Initiates Phase 1 Clinical Trial of Galidesivir RESEARCH TRIANGLE PARK,…
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About BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
BioCryst Pharmaceuticals, Inc. (BioCryst) is a biotechnology company. The Company designs, optimizes and develops small molecule drugs that block enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases. The Company uses X-ray crystallography, computer modeling of molecular structures and chemistry techniques to focus on the three-dimensional molecular structure and active site characteristics of the enzymes that control cellular biology. Its drug candidates include RAPIVAB, RAPIACTA, PERAMIFLU, Avoralstat, BCX7353, other second generation hereditary angioedema (HAE) compounds, BCX4430 and Forodesine. Its product RAPIVAB contains peramivir. Peramivir is an intravenous neuraminidase inhibitor approved in various countries for the treatment of patients with influenza, in the United States as RAPIVAB. RAPIVAB is used for the treatment of acute uncomplicated influenza. Its BCX4430 is a broad-spectrum antiviral (BSAV) research program.