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[…]
Category: Company Updates
Incyte Update (5-16-13)
ASCO ABSTRACTS CONFIRM BULLISH STANCE ON PCYC AND INCY â Â Keeping it simple, two key abstracts were released online last night for the upcoming ASCO conference (5/31-6/4, Chicago) support our favorable thesis on INCY and PCYC (). Incyteâs INCY’s Jakafi improves bone marrow fibrosis â Abstract #7030 is a study evaluating BM fibrosis in MF[…]
Pharmacyclics Update (4-24-13)
Pharmacyclics (4/24/13) â Completes Enrollment of RESONATE and SPARK Well Ahead of Schedule â Continue to Expect Ibrutib on Market This Year, Ahead of All Expectations. Completion of both trials, RESONATE (CLL) and SPARK (MCL), approximately 6-9 months ahead of forecasts supports our belief that ibrutinib is on track to be approved in the U.S. in[…]
Pharmacyclics Update (4-17-13)
Pharmacyclics (4/17/13) â JNJ Opens Ibrutinib Early Access Program (EAP) – Expect FDA Filing By Q3/Approval By Year-End – Raising BUY LIMIT to 90 and TARGET PRICE to 125 Last night, Janssen (in conjunction with Pharmacyclics) filed a Phase 4 Open Label Treatment Protocol for patients with relapsed/refractory mantle cell lymphoma (MCL) on www.clinicaltrials.gov. This early[…]
Incyte Update (6-13-13)
INCY – Abundance of Positive News – Solid Bari Long-Term Phase II Data, Jakafi Label Expansion, NVS Begins Hodgkin’s Lymphoma Study – Reiterate BUY – INCY and partner Eli Lilly released positive 52-week efficacy and safety data from the open-label, long-term extension of the Phase IIb JADA study of baricitinib (“bari”) in patients with active[…]
Pharmacyclics Update (5-2-13)
Pharmacyclics (5/2/13) â Ibrutinib On Market In 2013 Now Highly Likely; Synergy With Almost Every Hem/Onc Drug Around Leading To Widespread Combination Therapy â REITERATE BUY. The Pharmacyclicsâ first quarter conference call included more positive details that can be included in a short note. In a nutshell, the company will now be officially filing for approval[…]
Alkermes Update (4-17-13)
Alkermes (4/17/13)â Positive MDD Data Supports Increased BUY LIMIT and TARGET PRICE Alkermes eleased rather positive Phase II data from ALKS 5461 for the treatment of major depressive disorder (MDD). â5461 is a non-addictive opioid modulator, a combination of ALKS-33 and buprenorphine. The Phase II trial was highly statistically significant across major depression endpoints. The[…]
Pharmacyclics Update (4-10-13)
Pharmacyclics (4/10/13) âMajor Ibrutinib Competitor – ABT-199 – Still Seeing Tumor Lysis Syndrome; Richter’s Transformation Issues Completely Overblown. At the AACR, Rod Humerickhouse, M.D., Ph.D. of AbbVie presented an update on ABT-199, a Bcl-2 inhibitor, under development for hematologic malignancies similar to PCYC ibrutinib. Recall back in January, AbbVie suspended trials as two patients died from tumor lysis syndrome due (TLS) to[…]
Pharmacyclics Update (5-16-13)
ASCO ABSTRACTS CONFIRM BULLISH STANCE ON PCYCÂ â Keeping it simple, two key abstracts were released online last night for the upcoming ASCO conference (5/31-6/4, Chicago) support our favorable thesis on PCYC and INCY (see INCY update). PCYCâs ibrutinib combination in NHL – Abstract #8502 is a study testing the combination of ibrutinib plus standard[…]
Novavax Update (4-25-13)
NovaVax – Why VLPs are VIPs. The key to the NVAX vaccine platform technology is the use of virus-like particles (VLPs) to safely deliver key immune-identifying proteins to the body. Importantly, proof of concept is in place as VLPs are recombinant particles similar to currently marketed vaccines. Merck’s Recombivax HB and GSK’s Engerix B are recombinant[…]
Novavax Update (4-2-13)
NovaVax released positive Phase II data from their respiratory syncytial virus (RSV) vaccine development candidate, RSV-F. RSV-F exhibited a robust antibody response and clean safety profile in the trial that enrolled 330 women of childbearing age. The trial is a major step towards the commercial viability of the very first RSV vaccine candidate ever for use[…]
Pharmacyclics Update (4-5-13)
Pharmacyclics (4/5/13) â Ibrutinib â Expanding the Potential – Pancreatic Cancer, Combination Therapies and Recovery of Functional Immunity â Reiterate BUY UNDER 80 and TARGET PRICE OF 115. The AACR meeting begins this weekend in Washington, D.C. An overwhelming number of studies by every oncology company, both preclinical and human trials, are due to be[…]