Healthcare Business

How Global Blood Therapeutics Is Capitalizing on Its Sickle Cell Disease Approval

Global Blood Therapeutics Inc. (NASDAQ: GBT) shares dipped on Friday after the company announced that it would be conducting a secondary offering. This offering comes on the heels of a key U.S. Food and Drug Administration (FDA) approval.

Note that the stock jumped about 35% on the announcement of the approval, far offsetting any loss that the company is seeing on Friday.

GBT is offering $150 million in stock, with an overallotment option for an additional $22.5 million. Cantor Fitzgerald is the sole book-running manager for the offering. H.C. Wainwright is acting as lead manager.

Earlier this week, the FDA informed GBT that it agrees with the company’s proposal relating to use of an accelerated approval pathway for voxelotor for the treatment of sickle cell disease (SCD). GBT plans to submit a New Drug Application (NDA) for voxelotor for the treatment of SCD under this pathway.

GBT proposed that by raising hemoglobin, voxelotor is reasonably likely to reduce strokes in SCD patients. As part of these discussions, the FDA agreed that transcranial Doppler flow velocity would be an acceptable primary endpoint in a post-approval confirmatory study to demonstrate stroke risk reduction.

The company plans to request a pre-NDA meeting for the first quarter of 2019 and intends to provide further details regarding its plans and timing for an NDA submission as well as additional specifics on the transcranial Doppler confirmatory study following this meeting.

In the release GBT detailed its intentions for the net proceeds:

GBT intends to use the net proceeds from the offering and its existing capital resources to fund its clinical development of voxelotor for the treatment of sickle cell disease, including its ongoing clinical studies, as well as preparation for the potential commercial launch of voxelotor, if approved by the U.S. Food and Drug Administration, future clinical trials of voxelotor and other product candidates that GBT may elect to pursue, including inclacumab, its other research and development activities, and for working capital and general corporate purposes.

Shares of GBT were last seen down over 6% at $43.69, in a 52-week range of $30.15 to $68.05. The stock has a consensus analyst price target of $86.92.