Sanofi, Innate Pharma win FDA Fast Track tag for blood cancer drug

Sarah Silbiger
- Innate Pharma (NASDAQ:IPHA) added ~8% pre-market Thursday on the news that the FDA granted Fast Track Designation for SAR’579 / IPH6101, a candidate developed by the French biotech in partnership with Sanofi (NASDAQ:SNY).
- The agency has issued Fast Track Designation for SAR’579 / IPH6101 as a treatment for hematological malignancies.
- SAR’579 / IPH6101 is an antibody-based natural killer cell engager jointly developed by the two French companies under a 2016 research collaboration. According to its terms, Innate Pharma (IPHA) will receive €400m in milestone payments and royalties on net sales from drugs under the partnership.
- The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows frequent communications between the regulator and developers on plans for clinical studies.