Category: Company Updates

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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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Nektar Update (9-26-13)

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[…]

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Isis Update (9-19-13)

ISIS – Sustainable Responses Reported in Updated Phase I Data for SMN-Rx in Children with SMA:  Isis announced this morning follow-up preliminary data from a single dose, open-label Phase I study of SMN-Rx in children with spinal muscular atrophy (SMA), show that most SMA children receiving the two highest doses of the drug (6 mg[…]

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Isis Update (9-3-13)

ISIS Delivers Powerful Phase II Data for APOCIII-Rx – Raising BUY LIMIT and PRICE TARGET – Isis has presented rather positive Phase II data for APOCIIIRx in patients with high triglycerides and Type 2 diabetes at the American Diabetes Association (ADA) meeting.  In our view, this is a major unexpected surprise in the ISIS story[…]

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Coronado Update (10-14-13)

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[…]

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Isis Update (9-23-13)

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[…]

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Incyte Update (8-21-13)

Incyte’s Jakafi Delivers Great Phase II Pancreatic Data:  Incyte (INCY) has reported great top-line results from their Phase II, randomized, double-blind, placebo-controlled RECAP trial of Jakafi in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer. The hazard ratio (HR) for overall survival (OS) in the intent to treat population was[…]

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Incyte Update (8-8-13)

INCY – Q2 Beats Street On Jakafi & Raises 2013 Forecast, Burgeoning Pipeline – Raising BUY LIMIT and PRICE TARGET. The key near-term driver for INCY is Jakafi growth and with the increased sales guidance, the company is delivering.  The drug’s overall profile continues to improve as witnessed by label expansion for patients with low[…]

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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 (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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Isis Update (9-9-13)

ISIS And BIIB Ink Another Big Deal For Neuro:  Isis and Biogen Idec have entered into a broad, multi-year collaboration to leverage antisense technology to advance the treatment of neurological diseases. The agreement combines BIIB’s expertise in neurology with ISIS’ leadership in antisense technology to develop novel therapies to treat neurological disorders. This is the[…]

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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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