Allergan's Nocturia Drug Gets FDA Advisory Committee's Nod

Allergan (NYSE:AGN_pa) plc (NYSE:AGN) and partner Serenity Pharmaceuticals announced that the FDA’s Advisory Committee of Bone, Reproductive and Urologic Drugs recommended approval for its pipeline candidate SER120 (desmopressin nasal spray) for the treatment of nocturia.

Nocturia is a very common yet under-diagnosed urological disorder in adults. Patients suffering from this disease need to wake and empty their bladders at least twice every night. The Committee voted 14-4 in favor of the candidate’s benefit risk profile.

Although the FDA takes the recommendations of its advisory committee into account while reviewing applications, it is not bound to follow the same. A decision from the FDA is expected in the fourth quarter of this year.

Allergan has recently been on an acquisition spree. Last month, it announced a definitive deal to acquire Tobira Therapeutics, Inc. (NASDAQ:TBRA) , a clinical-stage biotechnology company focused on making drugs to treat non-alcoholic steatohepatitis (NASH) and other liver diseases at a massive premium of 500%.The deal is expected to close at 2016 end. On the same day, Allergan also announced that it has bought the privately held Akarna Therapeutics for $50M in upfront cash plus unspecified milestones. Akarna Therapeutics’ lead product candidate AKN-083, a preclinical-stage FXR agonist, is also being evaluated for the treatment of NASH.

In September, Allergan announced that it will be acquiring the clinical-stage biotech company, Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE) , for approximately $639 million. The acquisition, scheduled to close in the fourth quarter of 2016, will boost Allergan’s dermatology pipeline. Allergan also announced the acquisition of RetroSense Therapeutics, a privately held, clinical-stage biotechnology company, which will add the latter’s lead gene therapy development program RST-001 to Allergan’s eye care pipeline.

Meanwhile, the company sold its generics business to Teva Pharmaceutical Industries Ltd (NYSE:TEVA) in August.

Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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