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opko.com

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Investments

9

Portfolio Exits

4

Partners & Customers

10

About OPKO Health

OPKO Health, formerly eXegenics, is a multi-national pharmaceutical and diagnostics company that aims to establish industry-leading positions in large and rapidly growing medical markets by leveraging discovery, development, and commercialization expertise. The company intends to leverage global commercialization expertise to pursue acquisitions of commercial businesses that will both drive growth and provide geographically diverse sales and distribution opportunities.

OPKO Health Headquarter Location

4400 Biscayne Blvd.

Miami, Florida, 33137,

United States

305-575-4100

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Expert Collections containing OPKO Health

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Find OPKO Health in 4 Expert Collections, including Vitamin & Supplement Startups.

V

Vitamin & Supplement Startups

237 items

P

Pharma Startups

5,090 items

Pharmaceutical companies working across drug discovery, drug development and drug manufacturing.

M

Medical Devices

295 items

Companies that received PMA from the FDA since 2014. Companies tagged as #FDAPMA

H

Health Monitoring & Diagnostics

701 items

Companies developing technology to facilitate near-patient and point-of-care (POC) in vitro diagnostic testing. Companies tagged as #NearPatient&POCTesting

Latest OPKO Health News

Taysha Gene Therapies : Announces Sponsored Genetic Testing for Giant Axonal Neuropathy (GAN) in Partnership with GeneDx as well as a Collaboration with Hereditary Neuropathy Foundation and Charcot-Marie-Tooth Association Centers of Excellence

Oct 13, 2021

03:01a 10/12 10/13/2021 | 07:04am EDT Message : *Required fields GeneDx’s Hereditary Neuropathy Panel will be available free of charge to individuals at risk for or suspected of having GAN Taysha will collaborate with Hereditary Neuropathy Foundation and Charcot-Marie-Tooth Association Centers of Excellence to increase disease awareness and access to testing TSHA-120 is the first and only gene therapy to demonstrate clinical-stage arrest of disease progression at the 1.2x1014 and 1.8x1014 total vg dose Clinical data for high dose 3.5x1014 total vg cohort expected in the second half of 2021 with regulatory feedback by year-end 2021 Estimated prevalence of patients with GAN is 2,400 in United States and Europe Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced sponsored genetic testing for giant axonal neuropathy (GAN) in partnership with GeneDx, Inc., a leader in genomic analysis and a wholly owned subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK). Under the partnership, Taysha will sponsor the inclusion of a genetic marker to test for GAN in the GeneDx hereditary neuropathy panel free of charge to individuals at risk for or suspected of having GAN. GAN is a progressive neurodegenerative disease that affects both the central and peripheral nervous systems leading to motor weakness, sensory impairment, and cognitive dysfunction. Currently, there are no approved treatments for GAN, which results in death for patients often in their late teens or early twenties. Although no symptoms are present in the first few months of life, many children with early onset GAN develop symptoms and features before the age of three. A more recently identified later onset phenotype of GAN is often mischaracterized as Charcot-Marie-Tooth. The estimated prevalence for GAN is 2,400 patients, but the GAN population is anticipated to be larger than previously appreciated. In the natural history study, Motor Function Measure 32 (MFM32), a validated and well-known scale to measure strength and motor function, is the primary endpoint. A four-point change on the MFM32 score is considered clinically meaningful, which has been validated across numerous similar neuropathies. Natural history decline in patients with GAN is eight points per year. Treatment with TSHA-120, Taysha’s intrathecally dosed AAV9 gene therapy currently being evaluated in a Phase 1/2 clinical trial led by Carsten Bönnemann, M.D., Chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section and Senior Investigator, Neurogenetics Branch of the National Institute of Neurological Disorders and Stroke (NINDS), U.S. National Institutes of Health (NIH). Data demonstrate a statistically significant halt in decline as measured by the MFM32 at therapeutic doses. All GAN natural history data was generated and supported by the NINDS, NIH under umbrella protocol NCT01568658. “Rare diseases like GAN are often mischaracterized, particularly when there are overlapping symptoms with other diseases with higher awareness,” said Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha. “Early diagnosis can dramatically improve the lives of patients and we are very excited to work with GeneDx, a global leader in genetic testing, to have GAN included in its routine hereditary neuropathy screening panel. Ultimately, this can help address current treatment barriers by raising disease awareness, making diagnostic tools more accessible and facilitating earlier intervention for patients suffering from GAN. We are also excited to collaborate with the Hereditary Neuropathy Foundation and the Charcot-Marie-Tooth Association Centers of Excellence, healthcare professionals, and patient advocacy groups to increase access to genetic testing. In the meantime, we look forward to reporting Phase 1/2 clinical data for TSHA-120 from the high dose cohort in the second half of this year. We have submitted a request for scientific advice from a regulatory agency and look forward to next steps.” Paul Kruszka, M.D., F.A.C.M.G., chief medical officer of GeneDx added, “Earlier access to genetic testing can take years off the diagnostic journey for patients facing rare diseases like GAN. By ensuring patients and clinicians no longer have to rely on solely clinical criteria and symptom presentation to get to an accurate diagnosis, we can help clinicians turn their attention to effective treatment plans earlier in the course of the disease. We look forward to partnering with Taysha on this important effort to improve diagnosis of neurodegenerative diseases like GAN.” Taysha will sponsor the new initiative which will make genetic testing available free of charge to individuals at risk for or suspected of having GAN. The initiative is designed to increase access to genetic testing for patients. GeneDx will provide analysis of genes on the Hereditary Neuropathy Panel by next-generation sequencing with deletion/duplication detection. As the later onset phenotype of GAN is sometimes miscategorized as Charcot-Marie-Tooth or Charcot-Marie-Tooth Type 2, Taysha plans to collaborate with the Hereditary Neuropathy Foundation (HNF) and the Charcot-Marie Tooth Association (CMTA) by engaging their Centers of Excellence to administer genetic tests to appropriate patients and by creating awareness among patients and families about this new initiative. Allison Moore, Founder and Chief Executive Officer (CEO) of the HNF said, “We believe all patients at risk for or suspected to have GAN should have access to receive genetic testing in order to confirm a potential GAN diagnosis and to be made aware of opportunities to participate in clinical trials for investigational treatments. This initiative aligns with HNF’s mission to accelerate and help facilitate an accurate diagnosis for patients and families worldwide.” “Through this initiative, patients will have access to no-charge genetic testing, eliminating one of the biggest barriers,” said Amy Gray, CEO of the CMTA. “The CMTA’s support of this initiative is part of our broader commitment to accelerate research and empower patients and families living with GAN and other forms of CMT, including the most vulnerable, by giving them access to resources that may help improve outcomes and quality of life.” All testing will be ordered through a clinician. Sponsored testing programs have previously been shown to increase access to genetic testing, confirm diagnosis and enable participation in clinical trials for patients. About Taysha Gene Therapies Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com . About GeneDx, Inc. GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families worldwide. Originally founded by scientists from the National Institutes of Health, GeneDx offers a world-renowned clinical genomics program with particular expertise in rare and ultra-rare genetic disorders. In addition to its market-leading exome sequencing service, 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 http://www.genedx.com . About OPKO Health OPKO Health, Inc. (NASDAQ:OPK) 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 . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of our product candidates, including TSHA-120, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, TSHA-120’s eligibility for accelerated approval in the United States and Europe, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, and the potential market opportunity for these product candidates. Forward-looking statements also include statements as to the accuracy of GeneDx testing and the impact of testing on treatment paths and outcomes. Forward-looking statements are based on current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in the respective Annual Report on Form 10-K for the full-year ended December 31, 2020, and our Quarterly Reports on Form 10-Q for us and OPKO, all of which are available on the SEC’s website at www.sec.gov . Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we and OPKO disclaim any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20211013005395/en/ © Business Wire 2021

OPKO Health Investments

9 Investments

OPKO Health has made 9 investments. Their latest investment was in Eloxx Pharmaceuticals as part of their Series C on August 8, 2017.

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OPKO Health Investments Activity

investments chart

Date

Round

Company

Amount

New?

Co-Investors

Sources

8/2/2017

Series C

Eloxx Pharmaceuticals

$8M

No

2

6/26/2017

Series B - II

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$99M

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10

8/23/2016

Corporate Minority

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$99M

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10

10/10/2013

Corporate Minority

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$99M

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10

10/14/2011

Series B

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$99M

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10

Date

8/2/2017

6/26/2017

8/23/2016

10/10/2013

10/14/2011

Round

Series C

Series B - II

Corporate Minority

Corporate Minority

Series B

Company

Eloxx Pharmaceuticals

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Amount

$8M

$99M

$99M

$99M

$99M

New?

No

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Co-Investors

Sources

2

10

10

10

10

OPKO Health Portfolio Exits

4 Portfolio Exits

OPKO Health has 4 portfolio exits. Their latest portfolio exit was Eloxx Pharmaceuticals on December 22, 2017.

Date

Exit

Companies

Valuation
Valuations are submitted by companies, mined from state filings or news, provided by VentureSource, or based on a comparables valuation model.

Acquirer

Sources

12/22/2017

Reverse Merger

2

00/00/0000

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10

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10

00/00/0000

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10

Date

12/22/2017

00/00/0000

00/00/0000

00/00/0000

Exit

Reverse Merger

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Companies

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Valuation

Acquirer

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Sources

2

10

10

10

OPKO Health Acquisitions

15 Acquisitions

OPKO Health acquired 15 companies. Their latest acquisition was Transition Therapeutics on June 30, 2016.

Date

Investment Stage

Companies

Valuation
Valuations are submitted by companies, mined from state filings or news, provided by VentureSource, or based on a comparables valuation model.

Total Funding

Note

Sources

6/30/2016

$991

Acquired

1

5/5/2015

$991

Acquired

2

5/22/2014

$991

Acquired

3

1/8/2014

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$99M

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10

8/29/2013

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$99M

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10

Date

6/30/2016

5/5/2015

5/22/2014

1/8/2014

8/29/2013

Investment Stage

Companies

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Valuation

$991

$991

$991

Total Funding

$99M

$99M

Note

Acquired

Acquired

Acquired

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Sources

1

2

3

10

10

OPKO Health Partners & Customers

10 Partners and customers

OPKO Health has 10 strategic partners and customers. OPKO Health recently partnered with Pfizer on September 9, 2021.

Date

Type

Business Partner

Country

News Snippet

Sources

9/24/2021

Licensee

Pfizer

United States

News / Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency.

In 2014 , Pfizer and OPKO Health , Inc. entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD .

1

8/12/2020

Client

Pediatrix Medical Group

United States

OPKO Health inks deal with Pediatrix to offer neonatal genomic testing services

OPKO Health enters into an agreement with Pediatrix Medical Group to offer next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units .

1

6/24/2020

Client

Centers for Disease Control and Prevention

United States

The Daily Biotech Pulse: Opko Wins CDC Contract, Novartis Lowers Guidance, Pieris Study Placed On Partial Clinical Hold

The contract calls for BioReference performing antibody testing to determine COVID-19 seroprevalence , providing results with key demographic information and analysis in collaboration with the CDC .

2

3/16/2020

Partner

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10

10/21/2019

Partner

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10

Date

9/24/2021

8/12/2020

6/24/2020

3/16/2020

10/21/2019

Type

Licensee

Client

Client

Partner

Partner

Business Partner

Pfizer

Pediatrix Medical Group

Centers for Disease Control and Prevention

Country

United States

United States

United States

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News Snippet

News / Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency.

In 2014 , Pfizer and OPKO Health , Inc. entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD .

OPKO Health inks deal with Pediatrix to offer neonatal genomic testing services

OPKO Health enters into an agreement with Pediatrix Medical Group to offer next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units .

The Daily Biotech Pulse: Opko Wins CDC Contract, Novartis Lowers Guidance, Pieris Study Placed On Partial Clinical Hold

The contract calls for BioReference performing antibody testing to determine COVID-19 seroprevalence , providing results with key demographic information and analysis in collaboration with the CDC .

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Sources

1

1

2

10

10

OPKO Health Team

9 Team Members

OPKO Health has 9 team members, including former President, Dave Okrongly.

Name

Work History

Title

Status

Bruce Meyers

Founder

Former

Michael Tolentino

Founder

Former

Dave Okrongly

President

Former

David Steinmiller

Chief Operating Officer

Former

Tom Brennan

Chief Technology Officer

Former

Name

Bruce Meyers

Michael Tolentino

Dave Okrongly

David Steinmiller

Tom Brennan

Work History

Title

Founder

Founder

President

Chief Operating Officer

Chief Technology Officer

Status

Former

Former

Former

Former

Former

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