Biotechnology company Incyte Corp. (INCY) was trading around $3 when RTTNews profiled the stock last June. The stock now trades around $14, representing a gain of more than 300% in nine months.
Let's take a look at the company's upcoming catalysts.
Incyte's top-line 3-month results from a mid-stage study of oral rheumatoid arthritis drug INCB28050 are expected to be released in the coming quarter (Q2).
INCB28050 is an orally-available, potent and selective JAK1/JAK2 inhibitor. There are four known JAK (janus-associated kinase) enzymes that play a key role in inflammatory diseases like rheumatoid arthritis - JAK 1, 2, 3 and TYK2. The JAK inhibitor drugs work by blocking those enzymes.
INCB28050 is currently under a phase II study and as mentioned earlier, the top-line 3-month results of the study are expected to be released in the coming quarter and final 6-month results in the second-half of 2010.
In late December of 2009, Incyte licensed INCB28050 to Eli Lilly & Co. (LLY) in a potential $755 million deal - with Incyte receiving $90 million as upfront payment and an additional $665 million that will be received from Lilly if the drug achieves development, regulatory and commercial milestones.
Rheumatoid arthritis is a debilitating autoimmune disease, which causes pain, swelling, stiffness and loss of function in the joints, and affects over 2 million people in the United States. There have been substantial advances in the treatment of rheumatoid arthritis and the mainstay of treatment for the disease is TNF blockers, which are usually injected or given via intravenous drip. In rheumatoid arthritis patients, a protein TNF alpha (Tumor necrosis factor-alpha) is produced in excess resulting in the destruction of cartilage and bone.
Some of the most commonly prescribed TNF blocker drugs for rheumatoid arthritis include Amgen's Enbrel ; Abbott's Humira and Johnson & Johnson's Remicade.
Enbrel is administered as a subcutaneous injection once or twice weekly, Humira is administered by injection under the skin of thighs or abdomen every-other-week and Remicade is administered as an intravenous infusion. The administration of TNF blockers is very inconvenient for patients and also time-consuming. Therefore an oral agent that is as effective as TNF blocker drugs and with minimal adverse events remains the "holy grail".
Incyte is one of the companies that are in the race to develop an oral drug for rheumatoid arthritis. Pfizer Inc.'s (PFE) oral drug for rheumatoid arthritis CP 690,550 is under phase III testing.
The most-advanced drug in development in Incyte's pipeline is oral JAK inhibitor INCB18424, which is being evaluated as a potential treatment for myelofibrosis in a phase III study.
Myelofibrosis is a disorder in which fibrous tissue replaces the blood-producing cells in the bone marrow, resulting in abnormally shaped red blood cells, anemia, and an enlarged spleen. The disease usually affects people between the ages of 50 and 70. There is currently no known cure for myelofibrosis other than stem cell transplantation and there are no adequately effective therapies.
Some of the treatments that are currently used to delay or relieve symptoms of myelofibrosis are the combination of male sex hormones (androgens) and the corticosteroid prednisone, blood transfusions, erythropoietin (a synthetic version of the hormone produced by the body) or darbepoietin, and chemotherapy drug hydroxyurea or interferon-alpha. When the spleen becomes extremely large and painful, it is removed or treated with radiation therapy.
Last November, Incyte inked a potential $1 billion deal with Novartis AG (NVS) to develop and commercialize INCB18424.
Under the terms of the deal, Incyte retained the exclusive rights for the development and potential commercialization of INCB18424 in the U.S. and handed over the ex-US rights of the drug to Novartis. Novartis will also be responsible for the future worldwide development of INCB28060, an oral cMET inhibitor for rheumatoid arthritis, which is under phase II testing.
Incyte expects to complete the phase III study of INCB18424 for myelofibrosis in the second half of this year and file a New Drug Application with the FDA for INCB18424 in the first half of 2011.
The oral formulation of INCB18424 is also being evaluated as a potential treatment for Polycythemia Vera and Essential Thrombocythemia and the company is planning to initiate late stage studies for those indications in the second half of this year and first half of 2011, respectively. Polycythemia Vera and Essential Thrombocythemia are myeloproliferative disorders in which the bone marrow cells proliferate uncontrollably.
INCB18424 in topical form is under phase II testing as a treatment for psoriasis and the full results of the trial are slated to be presented at the Society of Investigative Dermatology in May. Incyte is also evaluating potential alliance opportunities for the topical form of INCB18424.
Yet another investigational drug of Incyte is INCB13739, which is under phase II testing for type-2 diabetes. INCB13739 is an orally bioavailable inhibitor of 11beta-hydroxysteroid dehydrogenase type 1, an enzyme that converts inactive cortisone into the potent biologically active hormone cortisol.
Obesity and type-2 diabetes are metabolic problems caused by too much cortisol. According to Incyte, by selectively inhibiting 11beta-HSD1 and reducing the level of cortisol in key metabolic tissues, INCB13739 has the potential to simultaneously target multiple cardiovascular risk factors in patients with type-2 diabetes.
With a number of key events lined up, Incyte is worth on the watch list this year too.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.