Stock Watch: Gene Therapy’s Bittersweet Approvals

Two FDA Approvals Could Herald Two Different Financial Outcomes

There are instances where the FDA approval of an unpartnered drug is the worst outcome for a biotech company. We may have just seen the first such gene therapy example.

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

When the FDA approved two gene therapies for sickle cell disease on the same day, adjectives like “momentous” were wheeled out. While the approvals were certainly landmarks, the commercialization that follows may disappoint.

Two weeks before the Christmas holidays, the FDA approved two gene therapies for sickle cell disease (SCD) – an inherited genetic disease for which the only disease-modifying treatment had been a bone marrow transplant. In such a large patient population the approvals were rightly hailed by the US president as a “significant medical advancement

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