OncoGenex Update (4-28-14) OGXI – OncoGenex’ Custirsen SYNERGY Trial Falls Short – In a major disappointment, OGXI and their partner TEVA announced top-line SYNERGY results that fell short.
Pharmacyclics (3/25/13) â BEAR RAID GIVES US OPPORTUNITY, PCYC BACK UNDER BUY LIMIT â Last week, Pharmacyclics shares dropped precipitously on the heels of several items â none of which were directly related to ibrutinibâs clinical trials, approval timeline and, hence, commercial potential. First, both ARIAâs Iclusig and ONXXâ Krypolis â two of the most[…]
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[…]
Special Update â Biotech Stock Sentiment Goes From Bad To Worse When the sector broke the March 28th lows last Monday (4/4), biotech stocks continued their violent Spring downfall. Despite the blink of an attempt at a recovery when the Fed minutes were released as bullish (4/9) â the âshort any rallyâ mentality resumed on[…]
MTSL Special Update â Biotech Stocks â Recent Selloff Reminiscent of Typical Sharp Pullbacks â Update & A Few Charts, Plus INCY, SGMO & PCYC Biotech stocks continue to be one of the strongest performers of the year (NBI +13%). However, the past week or so provided another meaningful selloff. In light of the strength[…]
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[…]
Biotech Stocks – Major Sentiment Shift Driven By Congressional Letter To GILD Over Sovaldi Pricing Leads To Widespread Heavy Selling In our most recent Issue (3/20), we mentioned that biotech stocks have finally succumbed to a selloff that’s been long overdue. Today’s action continues that downslide with the feeling of a true capitulation – volume[…]
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[…]
