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Stock impact report

Affimed Announces FDA Granted Orphan Drug Designation for Lead Innate Cell Engager AFM13 for the Treatment of T-cell Lymphoma

Affimed N.V. (AFMD) 
Last affimed n.v. earnings: 11/19 07:30 am Check Earnings Report
US:NASDAQ Investor Relations: affimed.com/investor-relations.php
Company Research Source: GlobeNewswire
Heidelberg, Germany, April 1, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma. The granted designation includes peripheral T cell lymphoma (pTCL), a subtype of T-cell lymphoma. AFM13 is being investigated as a monotherapy for the treatment of relapsed or refractory CD30-positive pTCL in a Phase 2 registration-directed study. The FDA may grant orphan designation to drugs and biologics intended to treat a rare disease or condition affecting fewer than 200,000 persons in the U.S. The designation qualifies a company for certain benefits, including financial incentives to support clinical development and the potential for seven years of market exclusivity in the U.S. upon regul Show less Read more
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