This section highlights FDA-related milestones and regulatory updates for drugs developed by OPKO Health (OPK).
Over the past two years, OPKO Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MDX2004, OPK-88006, and MDX2201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
MDX2004 FDA Regulatory Events
MDX2004 is a drug developed by OPKO Health for the following indication: Treatment of Advanced Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MDX2004
- Announced Date:
- October 28, 2025
- Indication:
- Treatment of Advanced Cancers
Announcement
ModeX Therapeutics Inc., an OPKO Health company announced the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune disorders.
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OPK-88006 FDA Regulatory Events
OPK-88006 is a drug developed by OPKO Health for the following indication: for patients with obesity, metabolic and fibrotic disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OPK-88006
- Announced Date:
- June 25, 2025
- Indication:
- for patients with obesity, metabolic and fibrotic disorders.
Announcement
OPKO Health, Inc and Entera Bio Ltd. announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12-15, 2025 in San Francisco, CA, USA.
AI Summary
OPKO Health, Inc. and Entera Bio Ltd. have announced that new in vivo pharmacologic and pharmacokinetic data on their investigational oral OPK-88006 tablet will be presented at the ENDO 2025 annual meeting of the Endocrine Society. The event is scheduled for July 12-15, 2025 in San Francisco, CA, USA. This innovative tablet is being developed as part of a collaboration to treat obesity, metabolic disorders, and fibrotic conditions using a novel dual agonist GLP-1/glucagon peptide. The treatment aims to offer a once-daily dosage as a tablet, complementing an additional weekly injection format. The clinical study results highlight the promising potential of oral peptide therapy, which is rare in metabolic treatment. The ability to tailor therapies could improve patient management by optimizing treatment induction and maintenance regimens for individuals facing related health challenges.
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MDX2201 FDA Regulatory Events
MDX2201 is a drug developed by OPKO Health for the following indication: Epstein-Barr Virus Vaccine Candidate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MDX2201
- Announced Date:
- January 7, 2025
- Indication:
- Epstein-Barr Virus Vaccine Candidate
Announcement
ModeX Therapeutics Inc., an OPKO Health company announces dosing of the first participant in the Phase I study (NCT06655324) of an EBV vaccine candidate being developed in collaboration with Merck, known as MSD outside the United States and Canada.
AI Summary
ModeX Therapeutics Inc., an OPKO Health company, recently announced that it has dosed the first participant in its Phase I trial of a novel Epstein-Barr virus (EBV) vaccine candidate. Developed in collaboration with Merck (known as MSD outside the United States and Canada), the investigational vaccine, MDX2201, targets multiple viral proteins involved in the virus’s entry into cells. The vaccine is being assessed for safety and tolerability in up to 200 healthy adults, marking an important early step in the clinical development of a potential prevention strategy for EBV-related illnesses like infectious mononucleosis, certain cancers, and multiple sclerosis.
This milestone also triggers an undisclosed cash payment from Merck to ModeX, underlining the value of the collaboration as the companies work together to advance a new approach to combat this widespread virus.
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