Free­line Ther­a­peu­tics slams the brakes on gene ther­a­py tri­al plans as FDA seeks more clar­i­ty on man­u­fac­tur­ing

Free­line Ther­a­peu­tics is join­ing a grow­ing line­up of com­pa­nies called to ac­count for CMC is­sues while walk­ing its gene ther­a­py can­di­date through clin­i­cal tri­als.

The UK-based biotech’s stock $FRLN slipped near­ly 2% on Mon­day morn­ing af­ter the com­pa­ny an­nounced it’s de­lay­ing plans for a piv­otal tri­al by two years in or­der to work on CMC feed­back from the FDA. The he­mo­phil­ia B pro­gram, dubbed FLT180a, was ini­tial­ly slat­ed to en­ter a piv­otal Phase IIb/III study in the sec­ond half of this year.

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