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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AFMD
News
- Affimed Announces Acceptance of AFM24 Clinical Abstract at the 2024 Annual Meeting of the American Society of Clinical OncologyGlobeNewswire
- 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 Wells Fargo & Company from $30.00 to $25.00. They now have an "overweight" rating on the stock.MarketBeat
- Affimed (NASDAQ: AFMD) had its price target raised by analysts at Stifel Nicolaus from $1.00 to $5.00. They now have a "hold" rating on the stock.MarketBeat
- Affimed (NASDAQ: AFMD) had its price target raised by analysts at HC Wainwright to $10.00. They now have a "buy" rating on the stock.MarketBeat
AFMD
Earnings
- 11/14/23 - Beat
AFMD
Sec Filings
- 3/28/24 - Form 6-K
- 3/28/24 - Form 20-F
- 3/11/24 - Form 6-K
- AFMD's page on the SEC website