FDA re­ject­ed Out­look Ther­a­peu­tic­s' Lu­cen­tis ri­val, and the com­pa­ny's stock plunged

The FDA has re­ject­ed Out­look Ther­a­peu­tics’ oph­thalmic for­mu­la­tion of be­va­cizum­ab for wet AMD, an eye dis­or­der that can cause blurred vi­sion or blind spots.

In their com­plete re­sponse let­ter, reg­u­la­tors not­ed “sev­er­al CMC is­sues, open ob­ser­va­tions from pre-ap­proval man­u­fac­tur­ing in­spec­tions, and a lack of sub­stan­tial ev­i­dence,” Out­look said Wednes­day.

The com­pa­ny’s stock $OTLK plunged more than 83% Wednes­day morn­ing to $0.23 per share.

Endpoints News

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.