Re­gen­eron slams the brakes on rare dis­ease tri­al fol­low­ing pa­tient deaths — cast­ing more doubt on a drug with mixed re­sults

Hit with dual set­backs on Fri­day, Re­gen­eron dis­closed that the Covid-19 tri­al wasn’t the on­ly pro­gram where it’s halt­ing en­roll­ment. The New York-based biotech has al­so hit the brakes on a study for fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va af­ter re­ports of pa­tient deaths.

Re­gen­eron didn’t dis­close how many pa­tients died and said they are in­ves­ti­gat­ing whether the deaths are re­lat­ed to gare­tos­mab. But the se­ri­ous ad­verse events that turned fa­tal were re­port­ed dur­ing the open-la­bel ex­ten­sion pe­ri­od, when all pa­tients were on treat­ment.

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