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On April 8, 2022, BioCryst Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the Company has paused enrollment in clinical trials with BCX9930 while it investigates elevated serum creatinine levels seen in some patients. Patients currently enrolled in the trials are continuing on study drug at this time. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
|99.1||Press release dated April 8, 2022 entitled “BioCryst Pauses Enrollment in BCX9930 Clinical Trials”|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|BioCryst Pharmaceuticals, Inc.|
|Date: April 8, 2022||By:||/s/ Alane Barnes|
|Chief Legal Officer|
BioCryst Pauses Enrollment in BCX9930 Clinical Trials
RESEARCH TRIANGLE PARK, N.C., April 08, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company has paused enrollment in clinical trials with BCX9930 while the company investigates elevated serum creatinine levels seen in some patients.
During the investigation, the company will not enroll new patients in the REDEEM-1, REDEEM-2 or RENEW clinical trials. Patients currently enrolled in the trials are continuing on study drug at this time.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO® (berotralstat) is approved in the United States, the European Union, Japan, the United Kingdom and the United Arab Emirates. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection) has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com.
This press release contains forward-looking statements, including statements regarding BioCryst’s plans for its BCX9930 program. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance 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: the results of the investigation described in this press release regarding BCX9930; ongoing and future preclinical and clinical development of BCX9930 may not have positive results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on product candidates, or may impose a clinical hold with respect to product candidates; risks related to the international expansion of BioCryst’s business; the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development and regulatory processes, or have the effect of heightening many of the risks described above or in the documents BioCryst periodically files with the Securities and Exchange Commission. 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, which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements.
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Catherine Collier Kyroulis
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