OPK Opko Health Inc.

3.17
+0.04  (+1%)
Previous Close 3.13
Open 3.16
52 Week Low 1.1171
52 Week High 6.47
Market Cap $2,123,364,346
Shares 669,831,024
Float 400,343,267
Enterprise Value $2,432,814,346
Volume 16,738,214
Av. Daily Volume 18,449,904
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Somatrogon (hGH-CTP)
Children - growth hormone deficiency
BLA Filing
BLA Filing
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
RAYALDEE (REsCue)
Mild-to-moderate COVID-19
Phase 2
Phase 2
Phase 2 trial initiation announced September 15, 2020.
OPK88004
Benign Prostatic Hyperplasia (BPH)
Phase 2b
Phase 2b
Phase 2b trial suspension announced January 31, 2019.
OPK88003
Obesity and diabetes
Phase 2b
Phase 2b
Phase 2b top-line data March 21, 2019 met primary endpoint. Phase 3 trial planned.
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV
Approved
Approved
Approved September 2, 2015.
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4
Approved
Approved
Announced June 21 2016 FDA Approval
hGH-CTP
Adults - growth hormone deficiency
Phase 3
Phase 3
Phase 3 data released December 30, 2016 - primary endpoint not met.

Latest News

  1. MIAMI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announces the initiation of a Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19.  The trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is expected to enroll approximately 160 subjects, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness.

    The trial will be conducted at multiple COVID-19 outpatient clinics in the U.S.  The initial sites are located primarily in South Florida, the Central Gulf coast, the Midwest and the Southwest…

    MIAMI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announces the initiation of a Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19.  The trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is expected to enroll approximately 160 subjects, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness.

    The trial will be conducted at multiple COVID-19 outpatient clinics in the U.S.  The initial sites are located primarily in South Florida, the Central Gulf coast, the Midwest and the Southwest. The first subjects are expected to be enrolled within the next few weeks.

    The REsCue trial will randomize COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up. Dosing with RAYALDEE will commence with 300 mcg per day on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through 27. Primary efficacy endpoints are raising and maintaining serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL and time to resolution of COVID-19 symptoms.  Secondary endpoints include incidence of emergency room or urgent care visits, oxygen saturation below 94%, need for and duration of hospitalizations, requirement for mechanical ventilation, mortality rate, and severity and duration of illness evidenced by quality-of-life measures.  More information about this trial will soon become available on https://clinicaltrials.gov/.

    Numerous independent studies have reported a correlation between vitamin D status and COVID-19 risk and severity.  OPKO expects to report topline results from this Phase 2 trial before year-end.

    About RAYALDEE

    RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.  The product is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH).  RAYALDEE, approved to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in November 2016. 

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements



    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "could," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including product development efforts and the expected benefits of RAYALDEE, whether and when we will initiate and complete the clinical studies contemplated for RAYALDEE and whether final study data will be positive, our ability to develop and commercialize RAYALDEE for COVID-19 patients, whether RAYALDEE is capable of treating  patients with COVID-19 including whether RAYALDEE could impact the SARS-CoV-2 virus or cytokine storm,  or have any impact on the severity of the disease or that it will effectively raise and maintain serum total 25D consistently at or above 50ng/mL, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects.   Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners for RAYALDEE, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    CONTACTS:

    Investors

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  2. MIAMI, Sept. 02, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in two upcoming virtual investor conferences.

    • 13th Annual Barrington Research Fall Conference, September 9, 2020. Management will be available for one-on-one and small group video conference calls with investors during the event.
       
    • H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 14 - 16, 2020. Management will deliver a company presentation on Tuesday, September 15th at 10:00 a.m. ET and will be available for one-on-one meetings. A live webcast of the presentation will be available on the investor section of OPKO's website here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical…

    MIAMI, Sept. 02, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in two upcoming virtual investor conferences.

    • 13th Annual Barrington Research Fall Conference, September 9, 2020. Management will be available for one-on-one and small group video conference calls with investors during the event.

       
    • H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 14 - 16, 2020. Management will deliver a company presentation on Tuesday, September 15th at 10:00 a.m. ET and will be available for one-on-one meetings. A live webcast of the presentation will be available on the investor section of OPKO's website here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

     

    Primary Logo

    View Full Article Hide Full Article
  3. ELMWOOD PARK, N.J., Sept. 2, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today began testing New York City principals, teachers and other staff for COVID-19, across the five boroughs, in preparation for a safer back-to-school environment.

    Through a strategic collaboration with BioReference, New York City, the Department of Health and New York City Health and Hospital Corporation (NYC Health + Hospitals) will collect specimens from principals, teachers and staff members across eight locations. BioReference will then perform COVID-19 PCR tests for the principals, teachers and other school staff at its Elmwood Park, New Jersey laboratory facility. The hours of operation for collection of specimens will be 8:00 a.m. to 8:00 p.m. ET, Monday through Sunday, beginning today and concluding Monday, September 7. Registration and appointment selection is required. To register for collection of a specimen for a COVID-19 test, visit: https://appointments.bioreference.com/nycschools.

    "As NYC schools prepare for the upcoming year, COVID-19 testing will play a pivotal role in supporting a safer overall classroom environment for educators, students and their families," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The systematic measures put in place by New York City reaffirm the dedication to safety and education in New York City."

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the role COVID-19 testing will play in supporting a safer classroom environment, the accuracy and availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of educators, students and their families, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-announces-new-york-city-schools-covid-19-testing-program-301122624.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  4. ELMWOOD PARK, N.J., Sept. 1, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), along with its specialty oncology division, GenPath, today announced the launch of OnkoSight AdvancedTM, a next-generation sequencing (NGS) assay that enables revolutionary deoxyribonucleic acid (DNA) mutational profiling of tumor samples.

    OnkoSight Advanced NGS testing provides targeted gene content that is aligned with the latest National Comprehensive Cancer Network (NCCN) and World Health Organization (WHO) guideline recommendations, to provide critical insights into many of the most common cancer types. Additionally, OnkoSight Advanced panels each include key biomarkers: Tumor Mutation Burden (TMB) and Tumor-Only Microsatellite (MSI), which are critical when profiling advanced stage tumor malignancies to guide potential immunotherapy.

    "OnkoSight Advanced NGS panels are tumor-type specific and optimized to exclude extraneous gene content, significantly improving clinical actionability and relevance of the data to effectively guide real-world oncology patient management," said Bevan Tandon, M.D., Hematopathologist and Molecular Pathologist, Director of Cancer Genomics at BioReference Laboratories. "Coupled with BioReference and GenPath's comprehensive oncology test menu, OnkoSight Advanced empowers physicians to make informed decisions effectively and efficiently."

    "A cancer diagnosis and treatment path are difficult to address with patients and their families, which drives the importance of understanding a patient's risk group and accurately diagnosing the type of cancer, to result in a targeted treatment strategy and prognosis assessment," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The latest advancement from BioReference's oncology division underscores the commitment to patient-centric care through our industry-leading result turnaround time with enhanced accuracy."

    For more information about OnkoSight Advanced, visit: https://www.genpathdiagnostics.com/hcp/onkosight-advanced-tm-next-generation-sequencing/.

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding our NGS assay, whether it will prove to be best-in-class or revolutionary, whether the test will perform or be as accurate as anticipated,  the role and value of the information provided and its impact on decisions to be made by physicians, and statements about our result turnaround time and accuracy, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-launches-best-in-class-next-generation-sequencing-ngs-assay-301122384.html

    SOURCE BioReference Laboratories, Inc.

    View Full Article Hide Full Article
  5. GAITHERSBURG, Md., Aug. 12, 2020 /PRNewswire/ -- GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), the global leader in neonatal and pediatric genetic testing, announced the entrance into an agreement with Pediatrix Medical Group ("Pediatrix"), the nation's leading provider of maternal-fetal, and pediatric medical and surgical subspecialty physician services, to offer state-of-the-art, next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units ("NICUs") staffed by Pediatrix's affiliated neonatologists. The sequencing is designed to enhance diagnostic capabilities in order to lessen the impact of disease and facilitate the development of novel precision medicine…

    GAITHERSBURG, Md., Aug. 12, 2020 /PRNewswire/ -- GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), the global leader in neonatal and pediatric genetic testing, announced the entrance into an agreement with Pediatrix Medical Group ("Pediatrix"), the nation's leading provider of maternal-fetal, and pediatric medical and surgical subspecialty physician services, to offer state-of-the-art, next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units ("NICUs") staffed by Pediatrix's affiliated neonatologists. The sequencing is designed to enhance diagnostic capabilities in order to lessen the impact of disease and facilitate the development of novel precision medicine solutions for pediatric care. The initial offering will include whole exome and whole genome sequencing and genomic support services under the brand Detect Genomix and the initial clinical diagnostic support services will be made available to hospitals and patients across the country.

    "Our innovative technology, advanced analytics, customized genomic reports and genetic counseling offerings coupled with Pediatrix's vast neonatal clinical experience and expansive coverage across the country set the stage for this arrangement to provide the first comprehensive offering of this type to hospitals and health systems nationwide," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories and GeneDx. 

    "Our combined network of more than 2,200 affiliated physicians and GeneDx's more than 100 genetic counselors will make Detect Genomix one of the nation's largest neonatal genomics platforms," said Ingrid Vasiliu-Feltes, M.D., MBA, Chief Quality and Innovation Officer at Pediatrix. "Genetic disorders and congenital anomalies are a leading cause of neonatal morbidity and mortality, and time to diagnosis is a crucial factor in the treatment of the patient. This arrangement is designed to provide Pediatrix-affiliated neonatologists with access to the latest sequencing technology."

    About GeneDx, Inc.

    GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned clinical genomics program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.  

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the strengths and resources of GeneDx and its counterparty, the role and value of genomic sequencing and whether such sequencing will significantly enhance diagnostic capabilities or lessen the impact of disease or facilitate the development of novel precision medicine solutions for pediatric care; rapid whole exome and genome sequencing in neonatal intensive care units; statements about the experience and technology of each of GeneDx and its counterparty; statements about the uniqueness of the proposed offerings of Detect Genomix; as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product and service development, federal and state regulations and legislation, and the regulatory process for testing and services, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-genedx-enters-into-agreement-with-pediatrix-medical-group-to-offer-neonatal-genomic-services-301110912.html

    SOURCE GeneDx, Inc.

    View Full Article Hide Full Article
View All Opko Health Inc. News