CTI BioPharma announced that the Company received written communication from the FDA on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being conducted under the Company's Investigational New Drug application for pacritinib. This clinical hold impacts part of the clinical work currently being conducted under the IND and will also affect planned clinical trials.
•Under the partial clinical hold, clinical investigators may not enroll new patients or start pacritinib as initial or crossover treatment, and patients not deriving benefit after 30 weeks of pacritinib treatment should stop using pacritinib.
•In addition, the FDA has recommended that the Company make certain modifications of protocols, including modifying all protocols for randomized trials to disallow crossover to pacritinib, provide certain notifications, revise relevant statements in the related investigator's brochure and informed consent documents, and take certain other actions. The Company intends to implement the FDA's recommendations.
•All clinical investigators worldwide have been delivered a notice of the partial clinical hold
King added AGEN to the Watchlist. Agenus Inc. (AGEN:NASDAQ) “has a broad portfolio of immune checkpoint modulators, a great scientific platform, and partnerships for several of its clinical and preclinical therapies. Heat shock protein vaccines for glioblastoma multiforme and use in combination therapies are in Phase 2, and “investors can expect one or more clinical candidates to be declared in 2016,” King said.
Coherus Announces the Appointment of Jim Daly, Executive Chairman, Commercial Advisory Committee
Shingrix has impressed in the clinic, posting 97.2% overall efficacy compared with placebo in a Phase III trial. But its success in older adults is what may help it steal share from Merck's ($MRK) Zostavax, analysts have said; in those over 70 years of age, Shingrix has demonstrated 90% efficacy, where the efficacy of Merck's jab declines in older people.
Glaxo is currently gearing up to submit regulatory filings for Shingrix in North America, Japan and the EU, expected for the second half of 2016.
Roger M. Perlmutter, president, Merck Research Laboratories. “For example, we view KEYTRUDA as foundational in the next-generation treatment of malignant disease, and hence have embarked upon an exceptionally broad development program for this agent, with registration-enabling studies underway in more than a dozen tumor types. We will also pursue more than 100 studies involving combinations of KEYTRUDA with other drugs.”
How many of these studies involve INCY?
according to its most recent 13F filing with the Securities and Exchange Commission (SEC). The firm owned 141,525 shares of the company’s stock after buying an additional 2,501 shares during the period. California State Teachers Retirement System owned about 0.17% of Agenus worth $643,000 at the end of the most recent reporting period.
Several other large investors also recently added to or reduced their stakes in the stock. Trellus Management Company LLC raised its stake in Agenus by 76.4% in the fourth quarter. Trellus Management Company LLC now owns 115,009 shares of the company’s stock valued at $522,000 after buying an additional 49,809 shares in the last quarter. Detwiler Fenton Investment Management bought a new stake in Agenus during the fourth quarter valued at $78,000. Finally, Creative Planning raised its stake in Agenus by 1.4% in the fourth quarter. Creative Planning now owns 72,409 shares of the company’s stock valued at $329,000 after buying an additional 1,000 shares in the last quarter.
As of 1/15 short interest grew from 9.2M to 9.6M. Hardly improving when considering it is imploding.
Maddi, MrTurd, Sooz, do I hear a second?
Agenus Inc. (Nasdaq: AGEN) announced that the U.S. Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application for AGEN1884, an immune checkpoint modulator (CPM) antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). Clearance was also received for a second CPM antibody partnered with Incyte (NASDAQ: INCY) for INCAGN1876, which targets glucocorticoid-induced TNFR-related protein (GITR). Clinical trials for both candidates are expected to begin in the first half of 2016.
“I would like to acknowledge the research and development teams at Agenus, and Incyte for GITR, for their tireless efforts to achieve our goal of filing these INDs by the end of 2015.”
Ruxolitinib for treating polycythaemia vera that is resistant or intolerant to hydroxycarbamide
The combination will be assessed as a second line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation.
AstraZeneca and Incyte Corporation announced a new collaboration to evaluate the efficacy and safety of Incyte’s Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca’s next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib).
in the phase III JANUS 1 study on ruxolitinib as a second-line treatment for patients with metastatic pancreatic cancer. The company also completed enrolment in two phase II studies on ruxolitinib for colorectal and breast cancers. Results from these studies are expected in 2016.
Incyte Corporation (NASDAQ:INCY) belongs to Healthcare sector. Its net profit margin is -13.50% and weekly performance is -18.81%. On last trading day company shares ended up at $76.95. Incyte Corporation (NASDAQ:INCY) distance from 50-day simple moving average (SMA50) is -24.43%.