Thu, Jun. 30, 7:20 AM
- OPKO Health (NYSE:OPK) inks an agreement to acquire Transition Therapeutics (NASDAQ:TTHI) for ~6.4M shares of OPKO common stock. Based on the average price of OPKO shares over the five days preceding the signing of the contract, the transaction is valued at ~$60M or $1.55 per TTHI share. The deal should close in H2.
- Transition's three top product candidates are Phase 3-stage TT401 for type 2 diabetes and obesity, Phase 3-stage ELND005 for Alzheimer's disease and Down syndrome and Phase 2-stage TT701 for androgen deficiency.
- TTHI closed yesterday at $0.70, OPK at $9.30.
Tue, Jun. 21, 9:12 AM
Tue, Jun. 21, 7:03 AM
- The FDA approves Opko Health's (NYSE:OPK) RAYALDEE (calcifediol) extended release capsules for the treatment of patients with secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Market launch will commence later this year.
- Opko received a Complete Response Letter (CRL) in late March after its first NDA filing citing 14 deficiencies at third party manufacturer Catalent's (NYSE:CTLT) St. Petersburg, FL facility. The agency accepted its resubmitted NDA for review in late April and established an action date (PDUFA) of October 22.
- Rayaldee's proprietary modified-release formulation is designed to gradually raise serum vitamin D prohormone levels while avoiding upregulating CYP24A1, an enzyme which reduces vitamin D's parathyroid hormone-lowering efficacy. Gradually increasing the level of vitamin D prohormone, called 25-hydroxyvitamin D, prevents excessive elevation of serum calcium and related vascular and renal calcification.
- Shares are up 7% premarket on increased volume.
Mon, Jun. 20, 5:36 PM
Mon, Jun. 13, 10:38 AM
Thu, May 26, 5:09 PM
- The FDA approves CSL Behring's AFSTYLA [Antihemophilic Factor (Recombinant) Single Chain], its long-acting recombinant factor VIII single-chain therapy for the treatment of adults and children with hemophilia A.
- AFSTYLA is indicated for routine prophylaxis to reduce the frequency of bleeding episodes with dosing of two-to-three times per week, on-demand treatment and control of bleeding episodes and the perioperative management of bleeding.
- Market launch will commence this summer.
- Hemophilia A-related tickers: (NYSE:BXLT)(OTCPK:BAYRY)(NASDAQ:BMRN)(NYSE:OPK)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:BIIB)(NASDAQ:SGMO)(OTCQX:RHHBY)(NASDAQ:CBIO)
Mon, May 9, 5:40 PM
Mon, May 9, 4:38 PM
Mon, May 9, 9:10 AM
- Fresenius Medical Care's (NYSE:FMS) Vifor Fresenius Medical Care Renal Pharma (VFMCRP) enters into an agreement with OPKO Health (NYSE:OPK) to develop and commercialize RAYALDEE (calcifediol) in Europe, Canada, Mexico, Australia, South Korea and certain other international markets for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease and vitamin D insufficiency. OPKO retains the rights in the U.S., Latin America (excluding Mexico), Russia, China, Taiwan and Japan. The companies will collaborate to prepare the Marketing Authorization Application (MAA) in Europe.
- Under the terms of the agreement, OPKO will receive an upfront payment of $50M, up to $52M in regulatory and launch milestones, up to $180M in sales-based milestones and double-digit royalties. VFMCRP has the option to acquire the U.S. rights for dialysis patients. If it exercises the option, it will pay OPKO commercial-based milestones and double-digit royalties.
- In the U.S., the FDA's action date for its review of OPKO's resubmitted NDA for RAYALDEE is October 22.
- OPK is up 4% premarket on increased volume.
- Previously: FDA accepts OPKO's resubmitted NDA for RAYALDEE (April 27)
Sun, May 8, 5:35 PM
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Fri, Apr. 29, 10:37 AM
- In a regulatory filing, Catalent (CTLT -0.7%) reports that the French drugs regulator, l'Agence National de Securite du Medicament et des produits de sante (ANSM), has lifted its suspension on the operations at its Beinheim, France softgel facility. ANSM notified the company in November 2015 that it had to suspend operations to address quality issues, specifically the misplacement of softgel capsules in several batches that appeared to be intentional. The company has been working with law enforcement and regulators to investigate. The suspension trimmed $21M off the company's top line.
- Catalent is the third party manufacturer for OPKO Health (OPK +0.4%) that was the source of the Complete Response Letter OPKO received from the FDA regarding its RAYALDEE New Drug Application. An on-site inspection at its St. Petersburg, FL location resulted in the citing of 14 deficiencies which need to be resolved before approval.
Wed, Apr. 27, 1:12 PM
- The FDA accepts for review the resubmitted New Drug Application (NDA) from OPKO Health (OPK -2.2%) seeking approval of RAYALDEE (calcifediol) for the treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The agency's action date (PDUFA) is October 22.
- The company received a Complete Response Letter in late March citing deficiencies observed during an on-site inspection of a third-party manufacturer. The issues did not pertain to the safety, efficacy or labeling of RAYALDEE.
- Previously: FDA rejects OPKO's RAYALDEE NDA; shares down 9% premarket (March 30)
- Read now OPKO: The FDA Decision Provides An Opportunity
Wed, Mar. 30, 9:21 AM
Wed, Mar. 30, 7:30 AM
- OPKO Health (NYSE:OPK) is off 9% premarket on robust volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of RAYALDEE (calcifediol) for the treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.
- The CRL cited deficiencies observed during an on-site inspection initiated at OPKO's third-party manufacturer on March 14. The observations were not specific to RAYALDEE manufacturing. The manufacturer has committed to respond promptly to the FDA's observations.
- OPKO will host a conference call this morning at 8:30 am ET to discuss the situation.
- Update: There were 14 deficiencies cited during an on-site FDA inspection of Catalent's (CTLT -0.3%) St. Petersburg, FL facility. The report, called a Form 483, noted that the company failed to inspect earlier batches of a gel for possible contamination after finding a contaminated gel receiver in its operation and it failed to follow its own standard operating procedure by waiting 11 days after the incident before the investigation was opened. Other deficiencies included improper documentation related to a malfunctioning refrigerator and failure to adequately respond to six complaints of blue spots on finished valporic acid capsules. Two other Catalent sites, Morrisville, NC and Beinheim, France, were cited for deficiencies last year.
Thu, Mar. 17, 6:27 AM
- The FDA approves Bayer's (OTCPK:BAYRY) KOVALTRY Antihemophilic Factor (Recombinant), an unmodified full-length factor VIII compound for the treatment of children and adults with hemophilia A. KOVALTRY can be used two to three times per week in adolescents and adults and up to every other day in children.
- Hemophilia A, or factor VIII deficiency, affects 16,000 Americans.
- KOVALTRY was cleared in the EU and Canada in February.
- Related tickers: (NYSE:BXLT)(NYSE:BAX)(OTCQX:RHHBY)(NASDAQ:DMTX)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:BIIB)(NYSE:OPK)(NASDAQ:SGMO)
Tue, Mar. 1, 9:22 AM
- OPKO Health (OPK) Q4 results: Revenues: $276.2M (983.1%); Costs & Expenses: $284.1M (+389.8%); Operating Loss: ($7.9M) (+75.7%); Net Income: $1.6M (+103.0%); EPS: $0.00.
- FY2015 results: Revenues: $491.7M (+439.7%); Costs & Expenses: $590.2M (+149.1%); Operating Loss: ($98.5M) (+32.4%); Net Loss: ($30M) (+82.5%); Loss Per Share: ($0.06) (+85.4%); Quick Assets: $193.6M (+99.8%).
- No guidance given.
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,... More
Industry: Medical Appliances & Equipment
Country: United States
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