FDA slaps a hold on a star Re­gen­eron can­cer drug, paus­ing tri­al en­roll­ment as cy­tokine storms trig­ger new tox tem­pest

Less than two years af­ter one of Re­gen­eron’s star can­cer drugs was in the spot­light fol­low­ing the death of two pa­tients from cy­tokine storms, odronex­tam­ab (REGN1979) is back at cen­ter ring over fresh tox con­cerns. And this time, CRS has brewed back up to force a par­tial hold on fur­ther en­roll­ment for the ear­ly-stage pro­gram.

Ac­cord­ing to Evan Seiger­man at Cred­it Su­isse:

Hold im­pacts on­go­ing ph 1 and 2 tri­als. Co to amend pro­to­cols w/ goal to re­sume pt en­roll­ment in 1Q21. Giv­en the com­pet­i­tive na­ture of the space we are con­cerned but await fur­ther de­tails from the co.

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