Opko Health Inc. (NYSE:OPK) announced the U.S. Food and Drug Administration (FDA) has accepted OPKO’s resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE® (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

OPKO resubmitted the NDA following receipt of a complete response letter (CRL) from the FDA on March 29, 2016, in which the FDA indicated the NDA could not be approved due to deficiencies observed during a facility inspection of OPKO’s third party manufacturer. The observations were not specific to RAYALDEE manufacturing, and the CRL did not cite any safety, efficacy or labeling issues with regard to RAYALDEE, nor did it request any additional studies to be conducted prior to FDA approval.

A six month review period has been assigned for the resubmitted NDA, and the new Prescription Drug User Fee Act (PDUFA) date will be October 22, 2016.

“We have worked closely with our third party manufacturer to ensure the FDA’s inspection observations are promptly and fully addressed, and we believe that our resubmission reflects OPKO’s strong commitment to providing a new treatment for SHPT in CKD patients as soon as possible,” statedPhillip Frost, M.D., Chairman and CEO of OPKO. “If approved, RAYALDEE will be the first drug approved for this important indication.” (Original Source)

Shares of Opko are currently trading at $11.09, down $0.14 or -1.20%. OPK has a 1-year high of $19.20 and a 1-year low of $7.12. The stock’s 50-day moving average is $10.73 and its 200-day moving average is $9.80.

On the ratings front, Opko Health has been the subject of a number of recent research reports. In a report issued on March 31, Barrington Research analyst Michael Petusky maintained a Buy rating on OPK, with a price target of $16, which implies an upside of 44.0% from current levels. Separately, on the same day, Jefferies Co.’s Brandon Couillard reiterated a Hold rating on the stock and has a price target of $11.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Petusky and Brandon Couillard have a total average return of 7.6% and 11.1% respectively. Petusky has a success rate of 73.3% and is ranked #723 out of 3829 analysts, while Couillard has a success rate of 71.6% and is ranked #228.

Overall, 2 research analysts have assigned a Hold rating and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $15.67 which is 41.0% above where the stock opened today.

OPKO Health, Inc. is a multi-national pharmaceutical and diagnostics company. The company is engaged in discovering, developing, commercializing and expertise its novel and proprietary technologies with a focus to provide unmet medical needs through a range of develops solutions to diagnose, treat and prevent various conditions, including molecular diagnostics, point-of-care tests and proprietary pharmaceuticals and vaccines. It operates its business through two segments: Pharmaceutical and Diagnostics. The Pharmaceutical segment consists of pharmaceutical research and development operations in Chile, Mexico, Ireland, Israel and Spain. The Diagnostics segment consists of pathology operations and point-of-care and molecular diagnostics operations. OPKO Health was founded in October 1991 and is headquartered in Miami, FL.