Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)
Affimed N.V. (AFMD)
Last affimed n.v. earnings: 11/19 07:30 am
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Source: GlobeNewswire
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients MANNHEIM, Germany, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic’s AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL). The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial. RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening condi
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News
- Affimed Reports Positive Clinical Update on AFM24/Atezolizumab Combination Therapy in Non-Small Cell Lung Cancer (NSCLC)GlobeNewswire
- Affimed (NASDAQ: AFMD) had its price target lowered by analysts at Wells Fargo & Company from $20.00 to $15.00. They now have an "overweight" 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 Promising Phase 1 Efficacy and Safety Data for AFM28 in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)GlobeNewswire
- Affimed to Host Investor Conference Call Highlighting Clinical Data from AFM24 in Combination with Atezolizumab in Non-Small Cell Lung CancerGlobeNewswire
AFMD
Earnings
- 11/14/24 - Beat
AFMD
Sec Filings
- 12/17/24 - Form 6-K
- 11/14/24 - Form 6-K
- 11/12/24 - Form EFFECT
- AFMD's page on the SEC website