PCYC – Imbruvica Handily Beats Consensus, Co. Issues Ultra-Conservative Guidance, Autoimmune Underway, ASCO Nearing & An MM Signal Note – The Shorts Last Gasp PCYC shares have come under pressure after posting $56 m. in Imbruvica sales ($52 m. end user sales), well above $41 m. consensus. The company issued initial guidance for the rest[…]

PCYC – ASH DATA CONTINUES TO DIFFERENTIATE IBRUTINIB DESPITE THE NOISE – REITERATE BUY – Despite the aggressive stock sell-off, data at the ASH conference this past week further cements ibrutinib as the new standard of care in MCL and CLL. While updated data from GILD (idelalisib, Syk inhibitor), Roche (Rituxan, GA-101), AbbVie (ABT-199), INFI[…]

PCYC – Imbruvica Approved For CLL, The Big Market – The FDA has approved Imbruvica for the treatment of relapsed/refractory chronic lymphocytic leukemia (R/R CLL). In our view, CLL approval was highly likely to occur before the 2/28 PDUFA date. However, some believed that a) an FDA advisory panel was needed; and/or b) the RESONATE[…]

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[…]

SPECIAL UPDATE – PCYC – GILD Severely Restrictive Zydelig Label Underscores Imbruvica’s Superior Profile – Reiterate BUY – Gilead received approval midday for Zydelig (idelalisib) for three blood cancers – refractory CLL, indolent FL and SLL – some what ahead of the August/September PDUFA dates.  While the approvals were widely expected, the strict BLACK BOX[…]

PCYC – EHA Abstracts & Marketing VP Quits – Can It Get Any Noisier Right Before ASCO? The availability of EHA abstracts and the announcement that Paula Boultbee, a VP of Marketing, has resigned – taken together has led to significant pressure on PCYC stock. After the ASCO abstracts revealed to us that Imbruvica’s competitive[…]

PCYC – IMBRUVICA RESONATES – Pharmacyclics has stopped the Phase III RESONATE trial early due to positive efficacy. The trial was discontinued early because the primary and key secondary endpoints of progression-free survival (PFS) and overall survival (O/S) were met. As a reminder, RESONATE is a global Phase III trial testing ibrutinib versus ofatumumab in[…]

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[…]

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[…]

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[…]

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[…]