After Abeona Therapeutics received a Complete Response Letter, or CRL, from the FDA for pz-cel in recessive dystrophic epidermolysis bullosa, or RDEB, Cantor Fitzgerald analyst Kristen Kluska called the news “a punch to the gut,” but added that it is “not the end of the road,” telling investors that it was known that manufacturing was the biggest risk heading into this FDA decision. The firm, which says its initial worst-case scenario was that there would be a PDUFA delay versus an outright CRL, still sees a path towards approval for pz-cel and contends that the 50% stock move after markets suggesting a valuation of about $100M was “overdone.” The firm has an Overweight rating and $36 price target on Abeona shares.
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