PIRS - Pieris Pharmaceuticals shares rise after FDA orphan drug status for cinrebafusp

Pieris Pharmaceuticals shares rise ([[PIRS]] +8.5%) after the U.S. FDA granted orphan drug designation to cinrebafusp alfa (PRS-343) for the treatment of HER2-high and HER2-low expressing gastric cancers.FDA grants orphan drug designation to promote the development of a drug that targets a condition affecting 200K or fewer U.S. patients annually.The status provides qualifying therapies with development and commercial incentives, including market exclusivity for seven years following FDA approval, among other things.The company hinted at initiating a phase 2 trial of cinrebafusp alfa later this summer.

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Pieris Pharmaceuticals shares rise after FDA orphan drug status for cinrebafusp