Ipsen giv­en an ad­comm date for palo­varotene; Am­brx Bio­phar­ma looks to se­cure $75M in lat­est se­cu­ri­ties of­fer­ing

Ipsen has been giv­en an ad­vi­so­ry com­mit­tee date of June 28 for its re­sub­mit­ted NDA for palo­varotene as a po­ten­tial treat­ment for fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va (FOP).

In De­cem­ber of last year, the FDA re­ject­ed the drug, ask­ing for more da­ta from its ex­ist­ing stud­ies. But the agency is giv­ing the French phar­ma an­oth­er shot, set­ting a PDU­FA date for Aug. 16, 2023, as more in­for­ma­tion on palo­varotene’s clin­i­cal tri­al will be in­clud­ed in the re­sub­mis­sion. This com­pris­es more analy­ses across the clin­i­cal tri­al pro­gram, in­clud­ing the first Phase III study that was car­ried out in pa­tients.

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