Tag: pharmacyclics

Pharmacyclics Update (11-14-13)

PCYC’s Imbruvica CLL Dose in Label, Approval Likely Sooner Than Later:  The label for Imbruvica also includes the 90 pill per month dosage than will be used to treat CLL, in addition to the 120 pill per month dosage for MCL.  The read through from this is the FDA is acknowledging there will be usage[…]

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Pharmacyclics & Biotechs Update (10-9-13)

PCYC – ARIA’s Iclusig FDA Hold Indirectly Adds to PCYC Share Break In Biotech Bloodbath During Government Shutdown/GILD Stops Idelalisib CLL Study Early On Favorable Risk/Benefit. Biotech Meltdown Was Long Overdue, Painful In Short Run, Healthy For Long Run – Several MTSL Stocks Now Below BUY LIMITS. PCYC Is No ARIA Questions on whether the[…]

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Pharmacyclics Update (7-10-13)

PCYC – Ibrutinib NDA Filed – Well Ahead of Expectations, in MCL and (surprise!) in CLL, Too – Expect Rapid FDA Turnaround And Street Numbers to Come Way Forward – Pharmacyclics’ filing on July 10 is well ahead of the September 30 company forecast, which is also three months ahead of initial forecast (end 2013)[…]

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Pharmacyclics Update (4-24-13)

Pharmacyclics (4/24/13) – Completes Enrollment of RESONATE and SPARK Well Ahead of Schedule – Continue to Expect Ibrutib on Market This Year, Ahead of All Expectations. Completion of both trials, RESONATE (CLL) and SPARK (MCL), approximately 6-9 months ahead of forecasts supports our belief that ibrutinib is on track to be approved in the U.S. in[…]

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Pharmacyclics Update (11-13-13)

PCYC – Pharmacyclics’ IMBRUVICA Gains FDA Approval For MCL; CLL Coming Soon – Reiterate BUY LIMIT and  TARGET PRICE – In a watershed moment for oncology and biotech companies – PCYC’s ibrutinib, branded IMBRUVICA, has received FDA approval for patients with mantle cell lymphoma (MCL) who have been previously treated as a monotherapy. The drug[…]

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Pharmacyclics Update (8-29-13)

PCYC – Ibrutinib One Step Closer To Market – FDA Accepts NDA for Ibrutinib In MCL and CLL/SLL and Grants Priority Review – Exactly 60 days after the filing (6/28), the FDA completed their review and determined that the application is sufficiently complete to permit a substantive review for both previously treated mantle cell lymphoma[…]

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Pharmacyclics Update (5-16-13)

ASCO ABSTRACTS CONFIRM BULLISH STANCE ON PCYC  – Keeping it simple, two key abstracts were released online last night for the upcoming ASCO conference (5/31-6/4, Chicago) support our favorable thesis on PCYC and INCY (see INCY update). PCYC’s ibrutinib combination in NHL – Abstract #8502 is a study testing the combination of ibrutinib plus standard[…]

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Pharmacyclics Update (4-17-13)

Pharmacyclics (4/17/13) – JNJ Opens Ibrutinib Early Access Program (EAP) – Expect FDA Filing By Q3/Approval By Year-End – Raising BUY LIMIT to 90 and TARGET PRICE to 125 Last night, Janssen (in conjunction with Pharmacyclics) filed a Phase 4 Open Label Treatment Protocol for patients with relapsed/refractory mantle cell lymphoma (MCL) on www.clinicaltrials.gov. This early[…]

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Pharmacyclics & Biotechs Update (11-1-13)

PCYC – FDA Approves Roche’s Gazyva (GA-101) In CLL, Bodes Well For Ibrutinib – JNJ/PCYC Going For Knockout Blow After Posting New Trials – BUY PCYC Before Approval The FDA has approved Roche/Genentech’s drug (GA-101) almost two months ahead of schedule (PDUFA 12/20/13, FDA Newsroom). As a reminder, Roche filed the BLA at the end[…]

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Pharmacyclics Update (8-8-13)

PCYC – Q2 CC – Introducing The Ibrutinib Commercial Powerhouse; Raising BUY LIMIT and TARGET PRICE – As the days countdown to the final FDA approval, PCYC has enlisted a truly impressive lineup to launch ibrutinib in the U.S. The company has prepared its sales, marketing and medical affairs departments, led by experienced industry executives[…]

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Pharmacyclics Update (5-2-13)

Pharmacyclics (5/2/13) – Ibrutinib On Market In 2013 Now Highly Likely; Synergy With Almost Every Hem/Onc Drug Around Leading To Widespread Combination Therapy – REITERATE BUY.  The Pharmacyclics’ first quarter conference call included more positive details that can be included in a short note. In a nutshell, the company will now be officially filing for approval[…]

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Pharmacyclics Update (4-10-13)

Pharmacyclics (4/10/13) –Major Ibrutinib Competitor – ABT-199 – Still Seeing Tumor Lysis Syndrome; Richter’s Transformation Issues Completely Overblown. At the AACR, Rod Humerickhouse, M.D., Ph.D. of AbbVie presented an update on ABT-199, a Bcl-2 inhibitor, under development for hematologic malignancies similar to PCYC ibrutinib.  Recall back in January, AbbVie suspended trials as two patients died from tumor lysis syndrome due (TLS) to[…]

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