Here's What Investors Need to Know About Vertex Pharmaceuticals and CRISPR Therapeutics' Big Day at the FDA
On Oct. 31, Vertex Pharmaceuticals (NASDAQ: VRTX) and its collaborator CRISPR Therapeutics (NASDAQ: CRSP) met with regulators at the Food and Drug Administration (FDA) in a high-stakes meeting about commercializing the pair's gene therapy for sickle cell disease (SCD), exa-cel. The jury hasn't convened yet on the topic of approving exa-cel for sale with a binding ruling, which is scheduled for later this year. But the conference was a critical opportunity for the two companies to talk with decision-makers about any concerns they might have about the already-submitted collection of clinical data and manufacturing methods.
Let's unpack the consequences of the meeting and take a moment to understand the issues regulators were interested in discussing, as they're likely to make a big difference for shareholders over the coming quarters.
Exa-cel is a key program for both Vertex and CRISPR Therapeutics. It aims to treat or functionally cure sickle cell disease, an inherited blood disorder; SCD causes red blood cells to harden and warp into a crescent-moon shape, which is suboptimal for their functioning.
Source Fool.com
Vertex Pharmaceuticals Inc. Aktie
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