News brief­ing: Mar­ius sub­mits NDA for oral hy­pog­o­nadism ther­a­py; Cell­tri­on's bil­lion­aire founder steps down

US reg­u­la­tors will soon be look­ing at a new testos­terone re­place­ment ther­a­py, if Mar­ius Phar­ma­ceu­ti­cals has its way.

The Raleigh, North Car­oli­na-based biotech sub­mit­ted on Tues­day an NDA for Kyza­trex, an oral testos­terone un­de­canoate soft gelatin cap­sule aim­ing to treat both pri­ma­ry and sec­ondary hy­pog­o­nadism in men. Should the FDA ac­cept the ap­pli­ca­tion for pri­or­i­ty re­view, Mar­ius ex­pects a PDU­FA date to fol­low rough­ly six months lat­er.

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