Clene’s FDA update; JCR ends ties with Takeda, partners with AstraZeneca; Gilead ups stake in Hookipa

Plus, news on Lyn­dra Ther­a­peu­tics, Hadean Cap­i­tal, Barinthus Bio, Shat­tuck Labs and In­ven­ti­va.

Clene Nanomed­i­cine’s road­block: The com­pa­ny, which is de­vel­op­ing a gold nanocrys­tal-based drug to treat ALS called CNM-Au8, met with the FDA to dis­cuss the pos­si­bil­i­ty of an ac­cel­er­at­ed ap­proval us­ing bio­mark­er da­ta for neu­ro­fil­a­ment light chain — the same bio­mark­er for which Bio­gen’s Qal­sody won ap­proval ear­li­er this year. But the reg­u­la­tor told Clene that the da­ta from stud­ies com­plet­ed so far are “in­suf­fi­cient to sup­port ac­cel­er­at­ed ap­proval at this time,” per a Clene press re­lease. Clene did not ex­pand on the FDA’s rea­sons, and it’s un­clear if the agency will re­quire Clene to con­duct an ad­di­tion­al study be­fore sub­mit­ting for ap­proval.

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