Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Fi­nal­ly freed from the re­straints of a par­tial FDA clin­i­cal hold on its lead HER2-pos­i­tive sol­id tu­mor can­di­date, Pieris Phar­ma­ceu­ti­cals is now rac­ing to­ward Phase II.

The FDA slapped a par­tial hold on Pieris’ PRS-343 back in Ju­ly, re­strict­ing the biotech from en­rolling new pa­tients in a Phase I tri­al. While Pieris was al­lowed to con­tin­ue dos­ing pa­tients who were al­ready en­rolled, the agency re­quest­ed they con­duct an ad­di­tion­al “in-use and com­pat­i­bil­i­ty study” be­fore re­cruit­ing any more.

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