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January 7, 2014
09:34 EDTPCYC, JNJPharmacyclics says Phase III ibrutinib study meets primary endpoint
Pharmacyclics announced that an Independent Data Monitoring Committee unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICATM, ibrutinib, versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met. At the planned interim analysis, the Phase III RESONATE study demonstrated that IMBRUVICA showed a statistically significant improvement in progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Further, IMBRUVICA showed statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of IMBRUVICA was acceptable and consistent with prior clinical experience. The IDMC recommended that the sponsor provide access to IMBRUVICA for subjects on the ofatumumab arm. Pharmacyclics has informed the U.S. Food and Drug Administration of the recommendations of the IDMC. Similarily, Janssen (JNJ), the co-developer of IMBRUVICA, has informed the European Medicines Agency. Both companies are engaging in a dialogue with the Health Authorities to define the next regulatory steps and anticipate providing a comprehensive RESONATE study report to them within the coming months. The company anticipates that the detailed data analysis from this RESONATE Phase III study will be presented at an upcoming oncology conference.
News For PCYC;JNJ From The Last 14 Days
Check below for free stories on PCYC;JNJ the last two weeks.
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September 17, 2014
08:36 EDTJNJJanssen-Cilag announces results from post-hoc canagliflozin analysis
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08:12 EDTJNJJanssen-Cilag announces results from Phase 3 Invokana trial
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September 16, 2014
07:31 EDTJNJEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:03 EDTPCYCPharmacyclics VA contract worth $6 per share, says William Blair
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September 15, 2014
07:27 EDTJNJIBC Life Sciences to hold a conference
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September 11, 2014
08:28 EDTPCYCPharmacyclics VA contract has ceiling of $3.81B, says JPMorgan
JPMorgan says the Veterans Affairs contract won by Pharmacyclics for Imbruvica has a ceiling price of $3.81B over the entire 5-year period, and that actual sales will depend on the demand the drug generates. The firm notes Imbruvica’s contracted price has been negotiated for year one, and that the VA will either renegotiate the price each year or continue as is. JPMorgan keeps an Overweight rating on shares of Pharmacyclics.
07:11 EDTJNJMedivation price target raised to $112 from $89 at Stifel
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September 10, 2014
14:29 EDTPCYCPharmacyclics Veterans Affairs contract worth up to $17 per share, says Goldman
Today, the U.S. Department of Veterans Affairs awarded Pharmacyclics a contract worth up to $3.8B over the next five years to supply its cancer drug, Imbruvica. Goldman said the contract could be worth up to $17 per share if fully realized and views it as an unexpected windfall for the company.
14:07 EDTPCYCPharmacyclics ibrutinib designated as orphan treatment of follicular lymphoma
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13:11 EDTPCYCPharmacyclics climbs after leukemia drug wins VA contract
Shares of drug maker Pharmacyclics (PCYC) are rallying after a federal government website revealed that the company had won a contract that could be worth up to $3.8B. However, RBC Capital is warning that the deal is not as lucrative as it sounds and will not lead analysts to significantly raise their estimates for the company. WHAT'S NEW: A contract for Phamacyclics' Imbruvica drug, a treatment for chronic lymphocytic leukemia, was disclosed earlier today. The contract from Veterans Affairs, which has an award date of September 4, was revealed in a notice posted today to Federal Business Opportunities website and has a potential value of $3.809B, according to the posting. ANALYST REACTION: In a note to investors today, RBC Capital analyst Michael Yee wrote that the news is positive, but not to the extent that the size of the deal would suggest. Pharmacyclics is indicating that the size of the deal has been significantly misrepresented, Yee reported. Additionally, the order may not be a major surprise to analysts, since it is expected that the government will place orders for oncology drugs, he stated. Although Pharmacyclics is on pace to beat third quarter expectations, the order revealed today is unlikely to lead analysts to significantly raise their estimates, Yee stated. He kept a Sector Perform rating on the shares. PRICE ACTION: In early afternoon trading, Pharmacyclics advanced 5.5% to $125.
12:24 EDTPCYCPharmacyclics VA contract not likely to change estimates, says RBC Capital
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10:58 EDTPCYCPharmacyclics rises after VA contract award revealed
Shares of drugmaker Pharmacyclics are rising after a contract for its Imbruvica drug that was previously awarded by the Department of Veterans Affairs was disclosed. The contract, which has an award date of September 4, was revealed in an award notice posted today today to Federal Business Opportunities website and has a potential value of $3.809B, according to the posting. Pharmacyclics shares are up 6.5% to $126.35 in morning trading following the circulation of the FBO site posting.
10:51 EDTPCYCPharmacyclics receives contract up to $3B from Department of Veterans Affairs
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10:14 EDTJNJJohnson & Johnson says off to 'very good start' this year
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