Category: Company Updates

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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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Novavax Update (7-5-13)

NVAX – Novavax Announces Positive Results of RSV F Protein Vaccine in Elderly – Paving Way For The Ultimate INFLUENZA/RSV Combination Vaccine  – Raising BUY LIMIT and TARGET PRICE – The successful trial exhibited evidence of a real vaccine across the board. In 220 patients, the F-Protein vaccine: a) was well-tolerated without any vaccine-related serious[…]

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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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Novavax Update (7-31-13)

NVAX – ISCONOVA DEAL SOUND STRATEGIC MOVE – BUY NVAX AHEAD OF CLOSING – BUY UNDER 3 1/2, TARGET PRICE 8.  Novavax announced today that as of yesterday (the initial Offer deadline), approximately 97.4% of the common stock and 100% of the warrants issued by Isconova (ISO, www.isconova.com), respectively, have been tendered. As a result,[…]

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Coronado Update (7-5-13)

CNDO –  TRUST-1 Fully Enrolled (And Then Some) On Schedule, The Clock Is Set – CNDO Now Under BUY LIMIT.  Coronado announced completion of enrollment of TRUST-I, its Phase II clinical trial with TSO (Trichuris suis ova or CNDO-201) in 250 Crohn’s disease patients. As expected, top-line data is expected in the fourth quarter –[…]

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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 Update (7-10-13)

PCYC – Ibrutinib NDA Filed – Well Ahead of Expectations, in MCL and (surprise!) in CLL, Too – Expect Rapid FDA Turnaround And Street Numbers to Come Way Forward – Pharmacyclics’ filing on July 10 is well ahead of the September 30 company forecast, which is also three months ahead of initial forecast (end 2013)[…]

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Onyx Update (7-1-13)

ONXX – AMGN Bid Sets Biotechs On Fire and Sets A New Valuation on The New Blockbuster Drugs Fourth of July fireworks have come early for the Biotechs as the BTK and NBI are both up over 3% on ONXX takeover speculation. The spark was ONXX disclosed it rejected a takeover bid from Amgen for[…]

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