BCRX » Topics » Item 8.01 Other Events.

This excerpt taken from the BCRX 8-K filed Jan 17, 2006.

Item 8.01 Other Events.

     On January 17, 2006, Registrant issued a press release announcing the U.S. Food and Drug Administration has granted “fast track” designation for peramivir injection in the treatment of influenza infections. The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

     Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Dec 22, 2005.

Item 8.01 Other Events.

          On December 22, 2005, Registrant issued a press release announcing the FDA has given approval to begin clinical studies with intravenous peramivir, the Company’s neuraminidase inhibitor. The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Dec 22, 2005.

Item 8.01 Other Events.

          On December 22, 2005, Registrant issued a press release announcing the initiation of a Phase I/II clinical trial with intravenous Fodosine™ in patients with B-cell acute lymphoblastic leukemia (B-ALL). The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Dec 21, 2005.

Item 8.01 Other Events.

          On December 21, 2005, Registrant issued a press release announcing it had received early termination by the United States Federal Trade Commission of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to the licensing agreement announced on November 30, 2005, granting Roche exclusive worldwide rights to develop and commercialize BioCryst’s Phase I compound, BCX-4208. The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Aug 31, 2005.

Item 8.01 Other Events.

          On August 31, 2005, Registrant issued a press release announcing the initiation of a Phase II clinical trial with oral Fodosine™ in patients with advanced, refractory chronic lymphocytic leukemia (CLL). The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Aug 9, 2005.

Item 8.01 Other Events.

          On August 9, 2005, Registrant issued a press release announcing the initiation of a Phase Ib clinical trial with oral BCX-4208 in healthy volunteers. The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Aug 9, 2005.

Item 8.01 Other Events.

          On August 9, 2005, Registrant issued a press release announcing the initiation of a Phase I pharmacokinetic clinical trial with intravenous/oral Fodosine™ in healthy volunteers. The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Jul 1, 2005.

Item 8.01 Other Events.

          BioCryst is providing an update on the status of its influenza neuraminidase inhibitor, peramivir. BioCryst possesses exclusive rights to peramivir and maintains the patents covering the compound.  BioCryst announced in June 2002 it was discontinuing development of peramivir following a Phase III clinical trial that yielded results that were not statistically significant.  Given international health concerns regarding avian flu, the Company has explored possible additional development of the drug candidate.  Peramivir has shown activity against avian (bird) flu in cell culture and in animals in pre-clinical testing.  The Company is considering various options for the development of peramivir, including whether to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to conduct clinical trials in humans for avian and other viral strains of influenza.  BioCryst intends to announce when appropriate its decision on possible future development of peramivir.

          Neither the filing of this Current Report on Form 8-K nor the inclusion in such 8-K of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.


SIGNATURES

          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.

Dated: July 1, 2005

BIOCRYST PHARMACEUTICALS, INC.

 

 

 

 

By:

/s/ MICHAEL A. DARWIN

 

 


 

 

Michael A. Darwin

 

 

Chief Financial Officer and Chief

 

 

Accounting Officer

This excerpt taken from the BCRX 8-K filed Jun 20, 2005.

Item 8.01 Other Events.

          On June 20, 2005, Registrant issued a press release announcing FDA approval of fast track status for Fodosine™ in the treatment of relapsed or refractory T-cell leukemia. The press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Mar 21, 2005.

Item 8.01 Other Events.

          On March 21, 2005, Registrant issued a press release announcing the presentation of clinical data at the 6th International Symposium in Leukemia and Lymphoma in Amsterdam, Netherlands. The press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the furnishing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

This excerpt taken from the BCRX 8-K filed Mar 15, 2005.

Item 8.01 Other Events.

          On March 15, 2005, Registrant issued a press release announcing the successful completion of a Phase I clinical trial with oral BCX-4208 for psoriasis. The press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

          Neither the furnishing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in such press release of a reference to Registrant’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet address into this Current Report on Form 8-K.  The information available at Registrant’s Internet address is not part of this Current Report on Form 8-K or any other report filed by Registrant with the Securities and Exchange Commission.

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