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
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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
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News
- Affimed (NASDAQ: AFMD) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald.MarketBeat
- Affimed (NASDAQ: AFMD) had its price target lowered by analysts at Stifel Nicolaus from $5.00 to $4.00. They now have a "hold" rating on the stock.MarketBeat
- Affimed (NASDAQ: AFMD) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
- Affimed Reports Third Quarter 2024 Financial Results & Business UpdateGlobeNewswire
- Affimed to Report Third Quarter 2024 Financial Results & Corporate Update on November 14, 2024GlobeNewswire
AFMD
Earnings
- 11/14/24 - Beat
AFMD
Sec Filings
- 11/14/24 - Form 6-K
- 11/12/24 - Form EFFECT
- 11/8/24 - Form 424B5
- AFMD's page on the SEC website