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Investing.com - H.C. Wainwright maintained its Buy rating and $138.00 price target on BioNTech (NASDAQ:BNTX) stock after the company received Orphan Drug Designation from the FDA.
The designation was granted for BioNTech’s bispecific antibody treatment for small cell lung cancer (SCLC), which appears to be BNT327, also known as PM8002, according to the FDA’s Orphan Drug product website.
BNT327 was acquired through BioNTech’s Biotheus acquisition last year and is central to the global agreement formed at the beginning of June between BioNTech and Bristol-Myers Squibb (NYSE:BMY) for co-development of the anti-PD-L1/VEGF bispecific antibody.
The Orphan Drug Designation provides BioNTech with seven years of market exclusivity for the designated product following approval, regardless of patent protection status at that time.
FDA grants this designation primarily to drugs targeting diseases affecting fewer than 200,000 U.S. patients, though in some cases drugs for larger patient populations can receive the designation when the FDA determines that costs could not otherwise be recovered.
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