Crispr Therapeutics (CRSP) has disclosed a new risk, in the Innovation / R&D category.
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Crispr Therapeutics faces a significant business risk due to potential early competition arising from the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The BPCIA provides a regulatory framework for the approval of biosimilar and interchangeable biological products, potentially impacting the exclusivity period of Crispr’s product candidates. Although they anticipate a 12-year exclusivity for their biologics, any changes in legislation or FDA interpretation might allow for biosimilars to enter the market sooner, thereby affecting their market share and pricing power. The uncertainty surrounding the FDA’s implementation of the BPCIA and the dynamics of biosimilar substitution further compound the risk, posing a threat to the company’s future commercial prospects.
Overall, Wall Street has a Moderate Buy consensus rating on CRSP stock based on 9 Buys, 1 Sell and 7 Holds.
To learn more about Crispr Therapeutics’ risk factors, click here.
