Okpo Health - Früherkennung bei Prostatakrebs ?
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http://www.nasdaq.com/symbol/opk/insider-trades
Summary
OPKO has achieved several important pipeline and commercial milestones over the last few quarters.
The 4Kscore test has grown to 5,300 a month in June.
The company is preparing for the Rayaldee launch in Q4 and for two important data readouts for two pipeline candidates.
The early/mid-stage pipeline has been expanded by the acquisition of Transition Diagnostics.
Several value-creating events ahead for OPKO.
OPKO Health (NASDAQ:OPK) has achieved a lot over the last few quarters and yet the company's share price is still stuck slightly below $10. The approval of Rayaldee marks a significant milestone for OPKO and the company is preparing for a launch in Q4 2016. The 4Kscore test has grown to 5,300 in the month of June and the broadening reimbursement should help accelerate its growth in 2017. The company also stands to start collecting more meaningful royalties from Varubi, which is marketed by Tesaro (NASDAQ:TSRO). There are also several catalysts that should drive OPKO higher over the next 12-18 months.
Opko Health Inc (OPK) : The short interest in Opko Health Inc (OPK) has increased from 68,462,042 to 70,451,570 from Jul 29, 2016, to August 15, 2016, indicating that the traders are bearish on the stock.
Transition Therapeutics kündigt Sonder-Hauptversammlung Abstimmungsergebnisse einschließlich Zustimmung der Aktionäre des Plan of Arrangement mit OPKO Health, Inc.
https://translate.google.de/...600312.html&edit-text=&act=url
http://www.aktiencheck.de/exklusiv/...erweigert_Aktienanalyse-7379673
Auf Grund von positiv ausgefallenen Phase 3-Daten von Parsabiv sei eine Zulassung durch die FDA zur Behandlung von sekundärem Hyperparathyreoidismus erwartet worden. Überraschend habe die FDA aber nun den Zulassungsantrag abgelehnt.
Die Umsatzprognose für 2022 werde mit rund 500 Mio. USD beibehalten, auch wenn der Zeitpunkt einer möglichen Zulassung noch unbekannt sei. Der Markt gehe im Durchschnitt von 575 Mio. USD aus. Parsabiv repräsentiere nur einen kleinen Teil des Bewertungsmodells (Barwert von rund 2 USD bei einer 50% Erfolgswahrscheinlichkeit).
http://www.aktiencheck.de/exklusiv/...en_werden_Aktienanalyse-7381628
Amgen Inc. habe mitgeteilt, dass die FDA einen Completre Response Letter für Parsabiv zur Behandlung einer eingeschränkten Nierenfunktion ausgestellt habe. Die Analysten von Piper Jaffray weisen darauf hin, dass Parsabiv im Vergleich zur zugelassenen Therapie mit Sansipar im Rahmen einer Phase 3-Studie besser abgeschnitten habe.
Nach Angaben von Analyst Joshua E. Schimmer ist es unklar, warum die FDA in der Art reagiert habe. Allerdings habe das Mittel von Amgen eine höhere Rate von Nebenwirkungen. Amgen wolle nun mit FDA gemeinsam an einer Problemlösung arbeiten. Amgen könnte den Rückschlag mit der Übernahme von Biotechfirmen ausgleichen, die kein allzu hohes Risikoprofil aufweisen würden.
http://...-response-letter-for-amgens-nda-for-parsabiv-260816-4989866
Hatte mir jetzt länger keine News mehr angesehen von OKPO, der Kursverlauf war ja auch mehr als langweilig ;)
https://translate.google.de/translate?sl=en&tl=de&js=y&prev=_t&hl=de&ie=UTF-8&u=http%3A%2F%2Fwww.fiercebiotech.com%2Fspecial-report%2Fdr-phillip-frost&edit-text=&act=url
Was mir noch Gedanken macht ist ein Gap (Kurslücke) bei 9$ und natürlich die Pdufa nächsten Monat ....
Results from a late stage trial of Opko Health Inc.'s long-lasting human growth hormone are expected later this year.
Opko Health, Inc. (NASDAQ:OPK) has shown a 805.92% year-over-year revenue change and 1,124.72% two-year change. When a company grows revenue this quickly, shows positive two-year revenue growth and is trending consecutively higher, top line growth may supersede earnings and free cash flow in the short to intermediate term. If revenue stays trending, Opko Health, Inc. could find net income and cash from operations growing rapidly in the near future.
https://translate.google.de/...decision%2F&edit-text=&act=url
Products in the Pipeline for OPK
Point-of-Care Diagnostics
Point-of-Care Diagnostics
Opko Health develops, manufactures, and distributes an extensive array of diagnostics and therapeutics for a wide range of indications and conditions.
Point-of-Care Diagnostics includes OPKO’s breakthrough point-of-care platform and a pipeline of novel diagnostic tests, including those for prostate cancer, total PSA, and Vitamin D.
OPKO LAB: At OPKO Lab, we combine expert professional judgment with the most cutting-edge technology in the market in order to give urologists accurate results that guide patient care. OPKO Lab gives you more than just laboratory services – you get access to a one-stop solution for all your urologic pathology needs.
4Kscore Test: The 4Kscore Test is a new tool for Urologists to help clarify the prostate cancer biopsy decision.
OPKO Chile markets and distributes a line of pharmaceuticals, nutraceuticals, and topicals for a wide variety of conditions.
OPKO EU develops, manufactures, markets, and sells a line of pharmaceutical, nutraceutical, and veterinary products throughout Europe.
OPKO FineTech manufactures numerous high-value, complex APIs (active pharmaceutical ingredients), such as latanoprost, bimatoprost, and melatonin.The 4Kscore Test is a new tool for Urologists to help clarify the prostate cancer biopsy decision.
OPKO Mexico maintains a line of pharmaceuticals, nutraceuticals, and topicals focused on ocular medicine. It is also conducting research on influenza, uterine cancer, and cervical cancer.
Cytochroma: OPKO has gained access to a suite of products for treatment of secondary hyperparathyroidism and hyperphosphatemia in chronic kidney disease patients through its recently announced agreement to acquire all of the assets.
Collectively, I think this pipeline and laundry list of products makes Opko Health very diversified, and the losses in OPK stock make it an attractive investment. With a market capitalization of only $5 billion, it is not so large that a company like Medtronic (NYSE:MDT) or Johnson & Johnson (NYSE:JNJ) could not easily afford it, but it is large enough to where its assets would have a material effect on the businesses of a would be acquirer. Regardless, whether acquired or not, OPK stock looks like a good long-term investment.
Rayaldee - Produktion startet Ende November
RAYALDEE launch scheduled for late November 2016: The U.S. Food and Drug Administration (FDA) approved RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is a patented product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3). OPKO has now completed hiring and training a highly specialized marketing and sales team, which is ready for the November 2016 launch.
Sicher waren die Quartalszahlen nicht so überragend , dafür haben wir hier ganz gute Zukunftsausichten .
Auf jeden Fall freue ich mich hier auf den baldigen Produktionsbeginn von Rayaldee.
http://www.opko.com/assets/...pproval-PI-_C_C_june-16-2016-Insert.pdf
OPKO Health looks attractive as Rayaldee received FDA approval.
The FDA approval and Rayaldee’s sales potential is not priced into the stock.
I see large upside potential for OPKO in 2017 and beyond.
Market Size & Potential Sales
There are about 9 million patients in the U.S. with SHPT with Vitamin D insufficiency in stage 3/4 chronic kidney disease. Opko estimates the total market potential for Rayaldee to be $12 billion annually. This gives Rayaldee an estimated price of $1333 on an annual basis. Opko only needs a little over 750,000 patients or 8% of the market for Rayaldee to become a blockbuster drug with sales of at least $1 billion.
Gibts nen Produktionsbeginn Termin?