Global Blood Therapeutics, Inc. (NASDAQ:GBT) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure.
On December 3, 2018, Global Blood Therapeutics, Inc. issued a press release titled “GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)” (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 to this report on Form 8-K.
The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Press release, dated December 3, 2018 |
Global Blood Therapeutics, Inc. ExhibitEX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA) Pre-NDA Meeting to be Requested for First Quarter of 2019 Company to Host Conference Call and Webcast Today,…To view the full exhibit click here
About Global Blood Therapeutics, Inc. (NASDAQ:GBT)
Global Blood Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in discovering, developing and commercializing therapeutics to treat blood-based disorders. The Company’s segment is engaged in discovering, developing and commercializing therapeutics to treat blood-based disorders. It is developing its initial product candidate, GBT440, as an oral, once-daily therapy for sickle cell disease (SCD) and is evaluating GBT440 in SCD subjects in an ongoing Phase I/II clinical trial. SCD is a genetic disease marked by red blood cell (RBC) destruction and occluded blood flow and hypoxia, leading to anemia, stroke, multi-organ failure, severe pain crises, and shortened patient life span. GBT440 inhibits abnormal hemoglobin polymerization, the underlying mechanism of RBC sickling. It is also engaged in other research and development activities targeted towards hereditary angioedema (HAE).