Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

Fi­bro­Gen will like­ly have to de­lay its US roll­out for rox­adu­s­tat once again.

In an un­ex­pect­ed move, the FDA is con­ven­ing its Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee to re­view the NDA in an ad­vi­so­ry com­mit­tee meet­ing. The date is yet to be con­firmed.

Just a few weeks ago, SVB Leerink an­a­lyst Ge­of­frey Porges pre­dict­ed that the roxa ap­proval could come ahead of the PDU­FA date on March 20 — ef­fu­sive de­spite al­ready be­ing let down once by the FDA’s ex­ten­sion of its re­view back in De­cem­ber. As­traZeneca, which is part­nered with Fi­bro­Gen on the chron­ic kid­ney dis­ease-re­lat­ed ane­mia drug, dis­closed reg­u­la­tors had re­quest­ed fur­ther clar­i­fy­ing analy­ses of clin­i­cal da­ta.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER