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[…]
Incyteâs Jakafi Delivers Great Phase II Pancreatic Data:Â 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[…]
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[…]
PCYC â Ibrutinib One Step Closer To Market â FDA Accepts NDA for Ibrutinib In MCL and CLL/SLL and Grants Priority Review â 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[…]
ISIS And BIIB Ink Another Big Deal For Neuro:Â 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[…]
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[…]
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[…]
ISIS Delivers Powerful Phase II Data for APOCIII-Rx â Raising BUY LIMIT and PRICE TARGET â 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[…]
