Key Developments: OPKO Health Inc (OPK)

OPK on New York Consolidated

8.30USD
2 Oct 2014
Price Change (% chg)

$-0.09 (-1.07%)
Prev Close
$8.39
Open
$8.42
Day's High
$8.47
Day's Low
$8.24
Volume
909,511
Avg. Vol
2,377,959
52-wk High
$12.95
52-wk Low
$7.32

Search Stocks

Latest Key Developments (Source: Significant Developments)

OPKO Health Inc's second rayaldee phase 3 trial meets primary endpoints
Tuesday, 23 Sep 2014 09:17am EDT 

OPKO Health Inc:Announces successful top-line results from second and final pivotal phase 3 trial of Rayaldee.This trial is second of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish safety and efficacy of Rayaldee as new treatment.Says for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.Both trials are subject of Special Protocol Assessment established with United States (U.S.) Food and Drug Administration (FDA) in Aug 2012.  Full Article

OPKO Health Inc's Rayaldee phase 3 trial meets primary endpoints
Monday, 11 Aug 2014 04:15pm EDT 

OPKO Health Inc:Says top-line results from first pivotal phase 3 trial of Rayaldee.This trial is one of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish safety and efficacy of Rayaldee as new treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.Both trials are the subject of Special Protocol Assessment (SPA) established with United States (U.S.) Food and Drug Administration (FDA) in Aug. 2012.  Full Article

OPKO Health Inc submits IND for Rayaldee as Adjunctive Cancer Therapy
Thursday, 7 Aug 2014 03:35pm EDT 

OPKO Health Inc:Submits Investigational New Drug (IND) Application to the United States (U.S.) Food and Drug Administration (FDA).Under which Rayaldee will begin clinical evaluation as adjunctive therapy for prevention of skeletal-related events (SREs) in patients with bone metastases undergoing anti-resorptive therapy.  Full Article

OPKO Health granted patent from US Patent & Trademark Office for RAYALDEE
Tuesday, 22 Jul 2014 10:41am EDT 

OPKO Health Inc:Announced that the United States Patent and Trademark Office granted OPKO a patent covering Rayaldee.Rayaldee, the company's product to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.The new patent provides OPKO with additional intellectual property protection covering controlled release administration of a vitamin D compound.  Full Article

OPKO Health Inc granted patent from European Patent Office for Lagova
Friday, 27 Jun 2014 09:54am EDT 

OPKO Health Inc:Announced that European Patent Office granted OPKO patent.Patent covering co's long-acting CTP-enhanced human growth hormone product (Lagova), including composition of matter and associated methods.New patent provides OPKO with additional intellectual property protection covering Lagova in Europe, on top of other patents that were previously granted in U.S. by U.S. Patent and Trademark Office.OPKO recently announced strong positive results from Phase 2 study of Lagova in children with growth hormone deficiency.  Full Article

OPKO Health Inc announces positive interim six-month Lagova (hGH-CTP) Phase 2 data in pediatric growth hormone deficiency disorder
Monday, 23 Jun 2014 02:00pm EDT 

OPKO Health Inc:Says six month results of Phase 2 dose-finding study evaluating the safety and efficacy of its long-acting human growth hormone product (Lagova) to treat pediatric growth hormone deficiency disorder (GHD).All three Lagova once-weekly doses demonstrate strong catch-up growth during the six months treatment.Annualized growth rates are above 12 cm in all three doses.Results are supported by excellent dose dependent pharmacokinetics (PK) and pharmacodynamics (PD) profiles.Lagova shows promising safety profile with no serious adverse events reported.Glucose and lipid metabolism markers are within the normal ranges.No lipoatrophy was observed in any patients dosed, and no clinically significant local tolerability issues were identified.  Full Article

OPKO Health Inc announces exchange agreement - Form 8-K
Friday, 20 Jun 2014 05:15pm EDT 

OPKO Health Inc:Enter into an exchange agreement with holder of Company’s 3.00 pct convertible senior notes due 2033 (Notes).Pursuant to which such holder agreed to exchange $70.4 mln in aggregate principal amount of Notes for 10,974,430 shares of Company’s common stock, par value $0.01 per share (Common Stock) and about $0.8 mln in cash representing accrued interest through the date of completion of the exchange.Company expects to complete the exchange on or around June 25, 2014.  Full Article

OPKO Health announces dismissal of PROLOR Biotech Inc class action lawsuit
Thursday, 8 May 2014 09:26am EDT 

OPKO Health Inc:Announced that on May 5, the Eighth Judicial District Court granted the company's motion to dismiss the securities class action lawsuit brought against the company on behalf of the shareholders of PROLOR Biotech Inc in connection with the acquisition of PROLOR.Says Court dismissed all claims as to all defendants including PROLOR and its former officers and directors asserted in the case without prejudice.  Full Article

OPKO acquires dry powder inhaler to treat respiratory disorders
Thursday, 17 Apr 2014 11:22am EDT 

OPKO Health Inc:Acquires Inspiro Medical Ltd.Will add Inspiromatic dry powder inhaler, developed by Inspiro, in its growing product portfolio.  Full Article

OPKO Health Inc announces management changes
Tuesday, 1 Apr 2014 09:28am EDT 

OPKO Health Inc:Appoints Adam Logal as Senior Vice President, Chief Financial Officer.Logal succeeds Juan F. Rodriguez, who will continue to provide services to OPKO as a consultant.  Full Article

Search Stocks