Tue, Jun. 21, 9:12 AM
Mon, Jun. 20, 5:36 PM
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)
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.
Nov. 10, 2015, 9:13 AM
Sep. 2, 2015, 9:17 AM
Aug. 25, 2015, 9:19 AM| Aug. 25, 2015, 9:19 AM | 7 Comments
Jun. 4, 2015, 9:14 AM
Jun. 4, 2015, 8:24 AM
- In a all-stock deal, OPKO Health (NYSE:OPK) acquires Bio-Reference Laboratories (NASDAQ:BRLI) for $52.58 per share or ~$1.47B. BRLI shareholders will receive 2.75 shares of OPK for each BRLI share.
- OPKO intends to leverage BRLI's commercial organization to enhance sales of its diagnostic tests, including 4Kscore, a blood test for prostate cancer.
- OPK is down 7% premarket on increased volume. BRLI is up 43% premarket on robust volume.
Apr. 6, 2015, 11:04 AM
- MabVax Therapeutics Holdings (OTCQB:MBVX +28.3%) closes $11.6M in new financing via a private placement led by OPKO Health (OPK -0.2%) and its Chairman & CEO Dr. Philip Frost. The company issued 15,486,001 units at $0.75 per unit for net proceeds of ~$11.1M. Each unit consists of one share of common stock and a 30-month warrant to purchase one-half share of common stock at $1.50.
- Net proceeds will fund the advancement of novel human antibodies in its pipeline, including the initiation of a Phase 1 trial of its lead antibody, HuMab 5B1.
Mar. 5, 2015, 4:35 PM
- Thinly-traded small cap Heron Therapeutics (NASDAQ:HRTX) heads north again delivering another 10% on an 8x surge in volume. Shares have more than doubled since the intermediate low of $7.09 on January 22.
- The party kicked into high gear in early February when the company announced the initiation of a Phase 1 trial evaluating the safety, pharmacokinetics and pharmacodynamics of HTX-011, an investigational pain medicine the utilizes the company's Biochronomer polymer-based drug delivery platform to release the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam over an extended period. HTX-011 has previously shown to significantly reduce pain in a validated animal model for up to 72 hours following surgery, although exactly how this was measured is unclear. The company expects to report the results this quarter. A series of Phase 1b/2 trials is on tap to begin in Q2 assessing HTX-011 in a post-surgical pain setting with results expected before the end of the year.
- The company's lead product candidate is the Phase 3-stage Sustol (granisetron injection, extended release) for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). Granisetron is a 5-HT3 receptor antagonist also formulated in the Biochronomer drug delivery platform. The FDA has approved only one 5-HT3 receptor antagonist to date, GlaxoSmithKline's Zofran (ondansetron hydrochloride) injection in 1991.
- CINV-related tickers: (NYSE:OPK) (NASDAQ:INSY) (NASDAQ:TSRO)
Feb. 5, 2015, 3:23 PM
- The resignation of prominent healthcare investor/entrepreneur Dr. Phillip Frost, M.D., from Teva Pharmaceutical Industries' (TEVA +1.8%) Board of Directors prompts aggressive buying from speculators who think a potential deal is afoot with Opko Health (OPK +4.6%). Teva is up on 50% higher volume while Opko's turnover is 3x average.
Dec. 15, 2014, 9:12 AM
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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