In back-to-back dis­as­ters, the FDA spurns In­no­coll’s NDA and shares plunge (again)

Shares of In­no­coll tum­bled in­to pen­ny stock ter­ri­to­ry Thurs­day evening af­ter the biotech re­port­ed that the FDA had spurned its ap­pli­ca­tion for a new pain ther­a­py called Xara­coll.

In­no­coll re­port­ed that the FDA had re­turned a “refuse-to-file” let­ter for their ap­pli­ca­tion, say­ing it would need to be re­vised for a drug/de­vice com­bi­na­tion be­fore reg­u­la­tors could con­sid­er a mar­ket­ing ap­proval.

In­no­coll’s stock $INNL plunged about 50% on the RTF re­port, which leaves the com­pa­ny in a tough spot. The biotech had a lit­tle more than $30 mil­lion in cash on hand at the end of the third quar­ter af­ter burn­ing through $53 mil­lion in the first 9 months of the year. Now it will have to turn to in­vestors af­ter an em­bar­rass­ing about-face; its sec­ond in two months.

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