PCYC â Imbruvica Approved For CLL, The Big Market â 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 â ASH DATA CONTINUES TO DIFFERENTIATE IBRUTINIB DESPITE THE NOISE â REITERATE BUY â 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 â Pharmacyclicsâ IMBRUVICA Gains FDA Approval For MCL; CLL Coming Soon â Reiterate BUY LIMIT and TARGET PRICE â In a watershed moment for oncology and biotech companies â PCYCâs 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 – ARIAâs 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 â Several MTSL Stocks Now Below BUY LIMITS. PCYC Is No ARIA Questions on whether the[…]
Novavax (NVAX) â Stocks of biotechnology companies that reach major inflection points tend to outperform for several years. After a major leap forward in 2013, NVAX is executing its clinical plan with a clearly defined and risk-adjusted strategy. NVAXâs addressable markets are approximately $4 billion per year. Global flu vaccines represent a $3 billion market[…]
PCYCâs 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 â FDA Approves Rocheâs Gazyva (GA-101) In CLL, Bodes Well For Ibrutinib â JNJ/PCYC Going For Knockout Blow After Posting New Trials – BUY PCYC Before Approval The FDA has approved Roche/Genentechâs 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[…]
Nektar’s NKTR-181 Disappoints, Misses Primary Endpoint on Mixed Phase II Data – Preliminary top-line results from a Phase II trial of NKTR-181(‘181) for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis of the knee missed their primary endpoint due to a unusual lack of a placebo rebound. The drug candidate was shown to[…]
PCYC â IMBRUVICA RESONATES â 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[…]
Special Update – NVAX – Novavax H7N9 Published In The NEJM – First Industry Vaccine For H7N9 Elicits Major Protective Immune Response In Blinding Speed – In a prestigious surprise, Novavax released its Phase I trial of 284 subjects injected with the H7N9 flu virus vaccine – published in the most recent online edition of[…]
CNDO – TSO Misses Primary and Second Endpoints in TRUST-I Crohn’s Study – Coronado announced disappointing TRUST-I results in Crohn’s disease. The trial missed both key endpoints – the primary endpoint was a change in CDAI score of >100 and the key secondary measure of remission, defined as achieving CDAI 150 points. In the corresponding[…]
ISIS Presents More Impressive Phase II Data for APOCIII-Rx at NLA – Over the weekend, ISIS presented data on APOCIII-Rx in patients with familial chylomicronemia syndrome (FCS) at the National Lipid Association (NLA) meeting. FCS is a rare disease that only affects 3,000-5,000 patients globally and is characterized by severely high triglyceride (TG) levels. The[…]
