Tag: pharmacyclics

Pharmacyclics Update (4-5-13)

Pharmacyclics (4/5/13) – Ibrutinib – Expanding the Potential – Pancreatic Cancer, Combination Therapies and Recovery of Functional Immunity – Reiterate BUY UNDER 80 and TARGET PRICE OF 115. The AACR meeting begins this weekend in Washington, D.C. An overwhelming number of studies by every oncology company, both preclinical and human trials, are due to be[…]

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Pharmacyclics Update (2-21-13)

Abbott To Develop Diagnostic for p17 del Gene in High-Risk CLL for PCYC/JNJ – Abbott Labs announced that it would collaborate with PCYC and JNJ to develop a companion diagnostic test using their FISH technology to identify patients with high-risk CLL patients that present with a deletion of the p17 chromosome. As a reminder, ibrutinib[…]

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[*Breaking News*] Pharmacyclics Update (2-12-13)

FDA Grants Ibrutinib Breakthrough Therapy Designation – Could Be On The Market in Q1:14 – Raising BUY LIMIT and TARGET PRICE. The FDA has granted PCYC’s ibrutinib Breakthrough Therapy Designation for the treatment of relapsed/refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglubinemia (WM). This is a major positive for Pharmacyclics that could conceivably lead to[…]

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Pharmacyclics Update (12-11-12)

Pharmacyclics’ stock is on fire as the company has presented outstanding data for ibrutinib at the American Society of Hematology meeting. We know we sound biased but the bottom line is: ibrutinib really is an unbelievable drug and the data at ASH is overwhelmingly positive in so many ways. It’s doing everything one could dream[…]

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Pharmacyclics Update (3-25-13)

Pharmacyclics (3/25/13) – BEAR RAID GIVES US OPPORTUNITY, PCYC BACK UNDER BUY LIMIT – Last week, Pharmacyclics shares dropped precipitously on the heels of several items – none of which were directly related to ibrutinib’s clinical trials, approval timeline and, hence, commercial potential.  First, both ARIA’s Iclusig and ONXX’ Krypolis – two of the most[…]

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Pharmacyclics Update (2-15-13)

PCYC held its quarterly call this week, two days after announcing the receipt of a “Breakthrough Therapy Designation” from the FDA for ibrutinib in refractory MCL/WM. The plethora of positive data continues to build for ibrutinib, and management confirmed the NDA filing for relapsed/refractory MCL by year-end. No one knows exactly what the new designation[…]

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Pharmacyclics Update (1-31-13)

PCYC = Janssen (JNJ) To Begin Front-Line Phase III Mantle Cell Lymphoma and Phase II Refractory Follicular Lymphoma Studies. We have discovered that www.clinicaltrials.gov recently (1/29) posted two new ibrutinib studies. First, and most important in our view, is the Phase III trial of ibrutinib in front-line mantle cell lymphoma (MCL) in combination with bendamustine[…]

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Pharmacyclics Update (3-06-13)

Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study.  Pharmacyclics’ partner Janssen has filed to begin a Phase 3b study, enrolling 200 patients who have participated in ibrutinib studies. This is a long-term follow-up study to give patients ibrutinib for up to 3 years, a logical trial to continue to monitor the long-term safety and efficacy of[…]

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[*Breaking News*] Pharmacyclics Update (3-6-13)

Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study. Pharmacyclics’ partner Janssen has filed to begin a Phase 3b study, enrolling 200 patients who have participated in ibrutinib studies. This is a long-term follow-up study to give patients ibrutinib for up to 3 years, a logical trial to continue to monitor the long-term safety and efficacy of[…]

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Pharmacyclics Update (1-18-13)

We attended the Pharmacyclics‘ presentation and breakout session at JP Morgan. While the company repeated much of the powerful ASH data from a month earlier, we did learn some new and not unimportant pieces of information.  First, the company is about to open RESONATE 17 – a likely fast-track registration trial of ibrutinib (the fourth[…]

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