- The FDA has signed off an investigational new drug application for Affimed NV (NASDAQ: AFMD) and NKMax America co-sponsored Phase 1/2a dose escalation and expansion study to evaluate AFM24 and SNK-01 in EGFR-expressing solid tumors.
- The Phase 1/2a study will be an open-label, non-randomized, multi-center, US-only, dose-escalation trial to evaluate the combination, with the primary objective to establish the safety and the recommended Phase 2 dose.
- The Phase 1 part will also assess pharmacokinetics, pharmacodynamics, and preliminary activity.
- The Phase 2a portion of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.
- Credit Suisse analyst Brad Canino initiates coverage on Affimed with an Outperform rating and a Price Target of $15.
- Price Action: AFMD shares are up 6.5% at $7.82 in the market trading session on the last check Wednesday.
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