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1:40AM Incyte reports additional analyses of symptomatic improvement and quality of life with Ruxolitinib in patients with myelofibrosis from the COMFORT-I study (INCY) 17.57 : Co announces additional symptom improvement and quality of life results from COMFORT-I, a randomized, double-blinded, placebo-controlled Phase III trial of Incyte's JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis. The data demonstrated that treatment with ruxolitinib resulted in significant reductions in spleen volume and improvements in Total Symptom Score while placebo-treated patients experienced progressive splenomegaly and worsening of symptoms. These data demonstrated that the primary endpoint of a 35% reduction in spleen volume was clearly associated with reduction of abdominal symptoms associated with an enlarged spleen. Importantly, many patients with less than 35% reduction in spleen volume also had meaningful improvement in abdominal symptoms. In addition, of patients who had a 50% or greater reduction in TSS (a key secondary endpoint), nearly 90% rated their disease as "much or very much improved" based on the PGIC scale. Also, over 50% of patients with a 25% to 50% TSS improvement rated their disease as "much or very much improved," indicating that a significant proportion of these ruxolitinib-treated patients also had meaningful improvement in their disease. Associated with these improvements were improvements in almost all sub-scales of the European Organization for Research and Treatment of Cancer Quality-of-Life 30 Questionnaire, a standard and well-validated measure of quality of life in cancer patients.
Incyte INCY Brean Murray Buy $23 » $25
Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1OayJhzNW
Incyte INCY Oppenheimer Outperform $23 » $25
http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm
7:07AM Incyte beats by $0.11, beats on revs (INCY) 18.26 : Reports Q1 (Mar) loss of $0.21 per share, $0.11 better than the Thomson Reuters consensus of ($0.32); revenues rose 85.0% year/year to $32 mln vs the $19.5 mln consensus. Research and development expenses for the quarter ended March 31, 2011 were $36.3 mln, as compared to $31.4 mln for the same period in 2010. As of March 31, 2011, cash, cash equivalents and marketable securities totaled $383.6 mln compared to $424.2 mln as of December 31, 2010. These amounts exclude $15.0 mln to be received from Novartis for the INCB28060 milestone earned and $37.9 mln of restricted cash held in an escrow account reserved for interest payments through October 2012 on the 4.75% Convertible Senior Notes due 2015.
Incyte Corporation's CEO Discusses Q1 2011 Results- Earnings Call Transcript
http://seekingalpha.com/article/267247-incyte-corporation-s-ceo-discusses-q1-2011-results-earnings-call-transcript?source=yahoo
Incyte Corporation (INCY) announced that it has earned a $15 million payment from Novartis (NVS) based on the achievement of a predefined milestone in an ongoing Phase I dose- escalation trial for INCB28060 in patients with solid tumors.
2:22AM Incyte's Ruxolitinib meets primary endpoint in second Phase III Study (INCY) 13.37 : Co announces that investigational Janus kinase inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis, when compared to best available therapy. The data from Novartis (NVS) COMFORT-II European Phase III trial show treatment with ruxolitinib provided a statistically significant reduction in spleen size in patients with myelofibrosis when compared with best available therapy. A US NDA submission by co and EU Marketing Authorization Application submission by NVS is on track for Q2 2011. Additional clinical studies evaluating ruxolitinib in other hematologic cancers and malignant diseases such as lymphoma and pancreatic cancer are planned for 2011.
and what I said then looks like more of the same today........ahhhhhhhhhhhh
7:42AM Incyte announced results from a Phase I/II study of Incyte's JAK inhibitor demonstrated marked and durable clinical benefits in patients with myelofibrosis (INCY) 14.03 : Co announced yesterday after the close that results from a Phase I/II study of Incyte's janus kinase (JAK) inhibitor with the investigational name INCB18424 (also known as INCB018424 and INC424) were published in The New England Journal of Medicine. The Phase I/II study of 153 patients showed that 70% to 82% of myelofibrosis patients receiving oral INCB18424 twice daily experienced 25% or more reduction in palpable spleen size which was durable for more than one year of follow-up. More than half of subjects treated with an optimized dose regimen which began with 15 mg twice daily achieved at least a 50% reduction in palpable spleen size. Incyte retained rights for the development and potential commercialization of INCB18424 in the US and out-licensed the compound to Novartis for development and potential commercialization outside the US
Incyte Reaches Agreement with the FDA on a Special Protocol Assessment for the Phase III Clinical Trial of INCB18424 in Polycythemia Vera
Global Phase III RESPONSE Clinical Trial to Begin in October
http://finance.yahoo.com/news/Incyte-Reaches-Agreement-with-bw-288749876.html?x=0&.v=1
Incyte Corporation Q2 2010 Earnings Call Transcript
August 05, 2010
http://seekingalpha.com/article/218882-incyte-corporation-q2-2010-earnings-call-transcript?source=yahoo
Results from an Ongoing Phase I/II Trial of Oral INCB7839 Presented at ASCO
http://finance.yahoo.com/news/Results-from-an-Ongoing-Phase-bw-964251851.html?x=0&.v=1
Promising PhII oral RA data triggers $30M milestone for Incyte.
Incyte says that a mid-stage study of its oral therapy for rheumatoid arthritis achieved positive top-line results at the midway point of an ongoing six-month study, triggering a $30 million milestone payment from Eli Lilly. The developer also revealed in its current quarterly statement that it will pocket a $3 million milestone from Pfizer for its CCR2 antagonist program.
Incyte to Report First Quarter 2010 Financial Results and Provide Update on Drug Discovery & Development Programs on May 6
Press Release Source: Incyte Corporation On Thursday April 22, 2010, 4:30 pm EDT
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY - News) announced today that it has scheduled its first quarter 2010 financial results conference call for 8:30 a.m. ET on Thursday, May 6, 2010. The schedules for the press release and conference call are as follows:
-- Q1 2010 Press Release: May 6, 2010 at 7:00 a.m. ET
-- Q1 2010 Conference Call: May 6, 2010 at 8:30 a.m. ET
-- Domestic Dial In Number: 877-407-8037
-- International Dial In Number: 201-689-8037
-- Conference ID # 349566
If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and dial-in number for international callers is 201-612-7415. To access the replay you will need the conference account number 278 and the ID number 349566.
The conference call will also be webcast live on CCBN and can be accessed at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.incyte.com%2Fwebcasts&esheet=6261164&lan=en_US&anchor=www.incyte.com&index=1&md5=f254b17c02cdbda19c96669b16efd6f6 under Investor Relations, Events and Webcasts.
Incyte Reports 2009 Financial Results; Strengthens Balance Sheet; Provides 2010 Financial Guidance
7:00a ET February 18, 2010 (Business Wire)
--Strong Year-End Cash Position with 2011 Debt Restructured
--Substantial Clinical Progress Achieved
--Conference Call Scheduled Today at 8:30 a.m. ET
Incyte Corporation (Nasdaq:INCY) today reported fourth quarter and full year 2009 financial results, provided an update on key fourth quarter accomplishments and 2010 objectives, and announced its 2010 financial guidance.
Paul A. Friedman, M.D., Incyte's President and Chief Executive Officer, stated, "We achieved all of our corporate goals in 2009 including the initiation of a global Phase III program for our lead compound, INCB18424, for myelofibrosis, the completion of a successful corporate financing and the establishment of two major alliances with top-tier pharmaceutical firms. Consequently, we are in a strong position to advance our pipeline and prepare for the potential launch of INCB18424 in myelofibrosis.
"Key objectives for 2010 include completing our US Phase III registration trial for INCB18424 in myelofibrosis, determining product registration requirements for INCB18424 as a treatment for polycythemia vera and possibly essential thrombocythemia, and reporting Phase II results for INCB28050 for rheumatoid arthritis which we expect will support moving forward into a larger Phase IIb trial with our partner, Eli Lilly."
David C. Hastings, Incyte's Executive Vice President and Chief Financial Officer, stated, "By successfully completing our equity and senior convertible note offering in 2009 we strengthened our balance sheet and removed a significant financial overhang from the Company. Additionally, with the completion of two collaborative agreements in the fourth quarter, we ended the year, on a pro forma basis, with approximately $624 million in cash, cash equivalents and marketable securities."
Below is a summary of recent accomplishments:
Business Development
-- Novartis: Collaboration and license agreement for two hematology-oncology programs; INCB18424, JAK1/JAK2 Inhibitor, and INCB28060, cMET inhibitor
-- Lilly: Collaboration for development and commercialization of oral anti-inflammatory and autoimmune therapies for INCB28050, JAK1/JAK2 Inhibitor
Clinical Programs
JAK1/JAK2 Inhibitor: INCB18424 (oral formulation) for Myelofibrosis (MF), Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
-- Continued patient enrollment of the Phase III registration trials, COMFORT-I and COMFORT- II: -- COMFORT-I is expected to enroll approximately 240 MF patients and includes over 90 clinical sites in the US, Canada and Australia. We expect recruitment for this study to complete in the first quarter of this year.
-- COMFORT-II is fully enrolled with over 200 MF patients at approximately 65 clinical sites in Europe.
-- Presented positive clinical results from three ongoing Phase II trials at the 2009 American Society of Hematology Annual Meeting in December involving patients with myelofibrosis, patients with advanced polycythemia vera and essential thrombocythemia refractory to hydroxyurea and patients with relapsed or refractory hematological malignancies.
JAK1/JAK2 Inhibitor: INCB28050 for Rheumatoid Arthritis (RA) and Other Inflammatory Conditions
-- Completed patient enrollment for a six-month double-blind placebo-controlled dose-ranging Phase II trial involving 127 RA patients. The three and six month results from this trial are expected to be available in the first and second half of 2010, respectively.
Sheddase Inhibitor: INCB7839 for Breast Cancer
-- Data from a Phase I/II trial presented at the 32nd San Antonio Breast Cancer Symposium suggest that INCB7839, in combination with trastuzumab (Herceptin(R)) based regimens, may provide additional benefits over traditional trastuzumab based regimens in a defined subgroup of breast cancer patients.
2010 Clinical Program Goals
Oncology Programs
JAK1/JAK2 Inhibitor: INCB18424 (oral formulation)
-- Complete and present results from the Comfort-I Phase III US trial and begin preparation of the New Drug Application for MF to insure earliest possible filing in 2011
-- Confirm regulatory requirements with the FDA for approval in two other myeloproliferative neoplasms, first in PV followed by ET
-- In conjunction with the Children's Oncology Group at the National Cancer Institute, support initiation of a Phase I/II trial in children with relapsed or refractory solid tumors, hematological malignancies and myeloproliferative neoplasms
Sheddase Inhibitor: INCB7839
-- Meet with the FDA to discuss registration requirements for use in patients with p95 HER2 positive breast cancer provided results from the ongoing clinical development program in this subset of patients continues to demonstrate positive results
Early Stage Oncology Programs
-- cMET Inhibitor, INCB28060: Complete an initial Phase I/II trial in patients with solid tumors and transfer the program to Novartis
-- IDO Inhibitor, INCB24360: Initiate a Phase I/II trial in patients with solid tumors
-- Discovery: File an Investigational New Drug Application for another oncology compound that addresses a new target
Inflammation Programs
JAK1/JAK2 Inhibitor: INCB28050
-- Complete the Phase II trial and present top-line results for the three-month portion of the study in the first half of this year; present the full six month results at the American College of Rheumatology Annual Meeting
-- Based on these results, decide whether to exercise our co-development option and participate in the Phase IIb program
JAK1/JAK2 Inhibitor: INCB18424 (topical formulation)
-- Present full results from the three-month Phase IIb trial at a scientific meeting
-- Decide on the appropriate next clinical trials
-- Evaluate potential strategic alliance opportunities
2009 Fourth Quarter and Full Year Financial Results
Net Loss
Quarter Ended December 31, 2009
Net loss for the fourth quarter ended December 31, 2009 was $88.4 million, or $0.74 per share, as compared to $48.4 million, or $0.50 per share, for the same period in 2008. Included in the net loss for the quarter ended December 31, 2009 were the following:
-- a one-time non-cash charge of $34.3 million or $0.29 per share related to a mark-to-market adjustment in the value of the embedded derivative liability related to the 4.75% Convertible Senior Notes due 2015; and
-- a non-cash expense of $4.7 million or $0.04 per share related to the amortization of the discount on the 4.75% Convertible Senior Notes.
Excluding these items, the net loss for the quarter was $0.41 per share. (1)
As a result of the completion of its 4.75% Convertible Senior Notes private placement, the Company decreased the original carrying value of the Notes by $148.1 million to reflect an embedded derivative liability related to the underlying number of common shares available at the time of the Notes issuance. On November 24, 2009, the Company's stockholders approved an increase in the Company's authorized common shares, and the Company recorded a mark-to-market adjustment in the value of the embedded derivative liability that resulted in a $34.3 million one-time non-cash charge. As a result of the increase in authorized common shares, the Company is no longer required to account for the embedded derivative as a liability and has reclassified it to additional-paid-in-capital.
Also included in net loss for the quarter ended December 31, 2009 was $1.9 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, compared to $3.9 million for the same period in 2008.
Year Ended December 31, 2009
Net loss for the full year 2009 was $211.9 million, or $2.06 per share as compared to $178.9 million, or $1.99 per share, for the full year 2008. Included in the net loss for the year ended December 31, 2009 were the following:
-- the aforementioned $34.3 million one-time non-cash charge associated with the 4.75% Convertible Senior Notes, or $0.33 per share on a year to date basis;
-- the aforementioned non-cash expense related to the amortization of the discount of $4.7 million on the 4.75% Convertible Senior Notes, or $0.05 per share on a year to date basis; and a
-- a non-cash charge of $5.7 million or $0.06 per share related to the repurchase of 3 1/2% Convertible Senior and Subordinated Notes.
Excluding these items, the net loss for the year was $1.62 per share. (1)
Also included in net loss for the year ended December 31, 2009 was $10.0 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, compared to $15.0 million for the same period in 2008.
Cash Position
As of December 31, 2009, cash, short-term and long-term marketable securities totaled $473.9 million, excluding $56.2 million in restricted cash for an escrow account reserved for the first 3 years of interest payments on the 4.75% Convertible Senior Notes, compared to $217.8 million as of December 31, 2008. In January 2010, the Company received an additional $60 million milestone payment from Novartis for the initiation of the COMFORT II clinical trial and $90 million upfront payment related to its recent collaborative agreement with Lilly.
Excluding the proceeds from its follow on equity offering and its private placement of the 4.75% Convertible Senior Notes, repurchases of a portion of the 3 1/2% Convertible Senior Notes and 3 1/2% Convertible Subordinated Notes, funding of the interest escrow, and the upfront payment received under the collaboration and license agreement with Novartis, the Company used $133.0 million in cash and marketable securities in the year ended December 31, 2009 including legal and transaction fees related to its recent collaborative agreements with Novartis and Lilly.
Revenues
Total revenues for the fourth quarter and full year ended December 31, 2009 were $6.9 million and $9.3 million, respectively, as compared to $0.9 million and $3.9 million for the same periods in 2008. The increase was primarily the result of revenues recognized in the fourth quarter under the Company's collaborative agreements with Novartis and Lilly.
Operating Expenses
Research and development expenses for the quarter ended December 31, 2009 were $34.3 million, as compared to $38.3 million for the same period in 2008. Included in research and development expenses for the quarter ended December 31, 2009 was a non-cash expense of $1.3 million related to the impact of expensing share-based payments, including employee stock options, as compared to $2.6 million for the same period in 2008.
Research and development expenses for the full year 2009 were $119.4 million, as compared to $146.4 million for 2008. Included in research and development expenses for the full year 2009 was a non-cash expense of $7.1 million related to the impact of expensing share-based payments, including employee stock options, as compared to $10.7 million for 2008.
The decrease in research and development expenses for the quarter and full year 2009 were due to prioritization of its pipeline to focus on products the Company believes have a greater likelihood of creating near-term value. The Company expects its research and development expenses to vary from quarter to quarter, primarily due to the timing of its clinical development activities.
Selling, general and administrative expenses for the quarter ended December 31, 2009 were $13.8 million, as compared to $4.6 million for the same period in 2008. Included in selling, general and administrative expenses for the quarter ended December 31, 2009 was a non-cash expense of $0.6 million related to the impact of expensing share-based payments, including employee stock options, as compared to $1.3 million for the same period in 2008.
Selling, general and administrative expenses for the full year 2009 were $27.6 million, as compared to $17.1 million for 2008. Included in selling, general and administrative expenses for the full year 2009 was a non-cash expense of $2.9 million related to the impact of expensing share-based payments, including employee stock options, as compared to $4.3 million for 2008.
Increased selling, general and administrative expenses for the quarter and full year 2009 reflected the Company's initial sales and marketing activities for the potential commercialization of INCB18424 for myeloproliferative neoplasms and legal and transaction costs for its recent collaborative agreements with Novartis and Lilly.
Interest Income and Interest Expense
Interest income for the three and twelve months ended December 31, 2009 was $0.2 million and $1.2 million, respectively, as compared to $1.0 million and $5.8 million, respectively, for the comparable periods in 2008. The decrease was due to a lower yield and a lower average cash balance for the quarter and year ended December 31, 2009 as compared to the same periods in 2008. Included in interest and other income (expense), net for the year ended December 31, 2009 was a $1.3 million non-cash other-than-temporary impairment charge.
Interest expense for the three and twelve months ended December 31, 2009 was $12.9 million and $32.1 million, respectively, as compared to $6.3 million and $24.9 million for the comparable periods in 2008. Included in interest expense for the quarter and the year ended December 31, 2009, was $1.0 million and $8.0 million, respectively, of non-cash charges to amortize the discount on the Company's 3 1/2% Convertible Senior Notes as compared to $2.3 million and $8.8 million, respectively, for the same periods in 2008. Also included in interest expense for the quarter and the year ended December 31, 2009 was $4.7 million of non-cash charges to amortize the discount on the Company's 4.75% Convertible Senior Notes.
2010 Financial Guidance
The Company expects cash use in 2010 to range from $165 million to $175 million, not including any potential milestones from its collaborative partners. This increase as compared to 2009 is primarily a result of the Company's increased investments in its clinical pipeline, particularly INCB18424 in MF and two of the other myeloproliferative neoplasms, PV and ET, pre product launch manufacturing and marketing costs for INCB18424 and the Phase II development of INCB28050 for rheumatoid arthritis. This cash use guidance also includes approximately $7 million for net lease related costs for the Company's closed California facilities. Excluded from this guidance are $19 million of cash escrowed for interest payments on the Company's 4.75% Convertible Senior Notes and any amounts used to redeem its 3 1/2% Convertible Senior and Subordinated Notes. On January 28, 2010, Incyte announced that it will redeem all of the outstanding 3 1/2% Convertible Senior and Subordinated Notes on February 22, 2010. The Company will use approximately $175.6 million in cash to redeem these Notes, assuming none of these Notes are converted.
The Company's guidance is as follows:
-- Revenues of $66 - $68 million, including $66 million of amortization of deferred revenue related to the Company's collaborations with Novartis and Lilly, but excluding any potential milestones received from collaborations;
-- Research and development expenses of $138 - $145 million, including a non-cash expense of $10 - $12 million related to the impact of expensing share-based payments, including employee stock options;
-- Selling, general and administrative expenses of $40 - $45 million, including a non-cash expense of $6 - $7 million related to the impact of expensing share-based payments, including employee stock options; increased selling, general and administrative expenses reflect the increase in sales and marketing activity as the Company prepares for the potential commercialization of INCB18424 for myeloproliferative neoplasms;
-- Interest income of $0.5 - $1.0 million;
-- Interest expense of approximately $44 million, including a non-cash expense of $23.5 million related primarily to the amortization of the discount on the 4.75% Convertible Senior Notes; and
-- A non-cash charge on the pending redemption of the 3 1/2% Senior and Subordinated Convertible Notes of up to $5.1 million.
up about $6 since I posted that.........and still rodney dangerfield on Ihub..............lol......they snooze and lose
Incyte: Positioned for Success
It’s raining good news for Incyte (INCY), which entered into a deal with Eli Lilly (LLY) regarding one of its pipeline candidates. The two companies have entered into a worldwide license and collaboration agreement related to the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor, INCB28050, and certain other follow on drugs for inflammatory and autoimmune diseases. INCB28050 is currently being studied in a phase II trial for the treatment of rheumatoid arthritis [RA].
As per the agreement, while Lilly will receive worldwide rights to the compound, Incyte has retained its co-development and co-promotion rights. Under the deal, Incyte will receive an initial payment of $90 million as well as another $665 million in the form of milestone payments. In addition, the company is also eligible to receive tiered, double-digit royalty payments on global sales of the drug on successful commercialization. Following the transaction, Lilly’s fourth quarter earnings will be impacted by 5 cents.
This is the second deal for Incyte within a span of one month. Back in November, Incyte entered into a collaboration and license agreement with Novartis (NVS) regarding two of its pipeline candidates -- INCB18424, an oral JAK1/JAK2 inhibitor and INCB28060, an oral cMET inhibitor. While the former is currently being studied in a phase III clinical trial for myelofibrosis [MF], the latter has yet to enter its phase I trial as a potential treatment for multiple cancers. Along with MF, INCB18424 is in phase II trial for patients with advanced polycythemia vera [PV] and essential thrombocythemia [ET].
We believe the recent deals with big pharma players prove the huge underlying potential of Incyte’s compounds. RA is an autoimmune disease affecting about 1% of the world's population. None of the current available treatment is curative and there is a significant unmet clinical need in this area.
Additionally, the MF drug holds immense potential as there are currently no approved specific therapies for MF, PV or ET which collectively constitute the major myloproliferative diseases. These disorders are estimated to affect more than 200,000 patients in the US and over twice that worldwide.
Incyte, being in a tight liquidity position, decided earlier this year to prioritize its pipeline development. Successful commercialization of these compounds with the aid of Incyte’s collaborating partners should enable Incyte to improve its financial position considerably. We have a Neutral recommendation on the stock.
7:05AM Incyte misses by $0.05, beats on revs (INCY) 11.06 : Reports Q4 (Dec) loss of $0.41 per share, excluding non-recurring items, $0.05 worse than the First Call consensus of ($0.36); revenues of $6.9 mln vs the $2.5 mln consensus. Co expects 2010 revenues of $66-$68 million, including $66 million of amortization of deferred revenue related to the Company's collaborations with Novartis and Lilly, but excluding any potential milestones received from collaborations (consensus is for revs of $38.7 mln)The Company expects cash use in 2010 to range from $165 million to $175 million, not including any potential milestones from its collaborative partners. This increase as compared to 2009 is primarily a result of the Company's increased investments in its clinical pipeline, particularly INCB18424 in MF and two of the other myeloproliferative neoplasms, PV and ET, pre product launch manufacturing and marketing costs for INCB18424 and the Phase II development of INCB28050 for rheumatoid arthritis. This cash use guidance also includes approximately $7 million for net lease related costs for the Company's closed California facilities. Excluded from this guidance are $19 million of cash escrowed for interest payments on the Company's 4.75% Convertible Senior Notes and any amounts used to redeem its 3 1/2% Convertible Senior and Subordinated Notes. On January 28, 2010, Incyte announced that it will redeem all of the outstanding 3 1/2% Convertible Senior and Subordinated Notes on February 22, 2010. The Company will use approximately $175.6 million in cash to redeem these Notes, assuming none of these Notes are converted.
clawing its way back to 10
wow, if only we could all evolve vertical relationships; imagine a world in which innovative front-end technologies ceaselessly synergize turn-key networks; it would be a landslide, a paradigm shift, a breakpoint. Now all I need to do is visualize my bleeding-edge niches and I will be complete...
— Grayson C.
paying off the bonds caused some action
still the Rodney Dangerfield of biotech stocks....re the public....and the money managers are STILL loading up....while IHUBBERs sleep.....yawnnnnnnnnnnn
BOFA/Merril INCY future path secured by promising new cancer drug
We are initiating coverage of Incyte Corporation (INCY) with a Buy rating and a
$12 PO based on our expectations that the company’s key pipeline product will be
the first to launch into an untapped $1 billion+ market, and competition is two-plus
years behind. INCY is an unprofitable, developmental-stage biotech company
with a focus on discovering and developing novel medicines. While it has not
been an easy road for INCY shareholders, we have confidence in our positive
stance based on the strong clinical data shown in high unmet medical need
diseases for the lead program, backed by a very favorable partnership with
Novartis. Key near-term risks are timeline delays, regulatory, and pipeline news.
Lead program has demonstrated impressive profile
INCY’s lead program ‘424 is a twice-daily oral pill that inhibits Jak2, a kinase that
is mutated in a series of related blood disorders. Although INCY is developing
‘424 for disease states that are relatively rare, ‘424 has demonstrated impressive
and durable efficacy and should: (1) enjoy rapid market penetration; (2) command
comparable pricing to other drugs targeting rare diseases (>$50K/patient/yr); and
(3) be used as chronic therapy in a loyal patient base. Copycat products in early
stage development do not appear distinct enough to warrant long-term market
erosion concerns. Regulatory clarity on development of ‘424 for additional
indications (1H10) and Phase 3 data for ‘424 in its first indication (2H10) are key
stock catalysts, and should boost investor confidence in ‘424’s potential.
Additional shot on goal could create more value
Our $12 PO is based on our DCF sum-of--parts, with the vast majority of value
assigned to ‘424 ($11/sh). INCY may create additional value by licensing another
Jak2 inhibitor ‘050 for inflammation after 2Q10 proof of efficacy data.
institutions are loading up!!!!!!!!!!!!!! people on IHUB are asleep here...........wake up!!!!!!!!!!!!!!!!
Wells Fargo And Co Added More 531,945 Incyte Corp Ltd (INCY) Shares.
By: Staff Writer
Mffais.com
Published: Tuesday, November 17, 2009
LONG BEACH, CA (Mffais.com) -- Wells Fargo And Co Added More shares of Incyte Corp Ltd (INCY). The number of shares affected was 531,945 which was a 158.43% change from the 335,755 number of shares. The ending number of shares of Incyte Corp Ltd (INCY) owned by Wells Fargo And Co at the time reported was 867,700, these transaction(s) occurred on/as-of 2009-09-30 but information regarding them was just made public today.
Alyeska Investment Group Lp Added More 116,223 Incyte Corp Ltd (INCY) Shares.
By: Staff Writer
Mffais.com
Published: Tuesday, November 24, 2009
LONG BEACH, CA (Mffais.com) -- Alyeska Investment Group Lp Added More shares of Incyte Corp Ltd (INCY). The number of shares affected was 116,223 which was a 197.32% change from the 58,900 number of shares. The ending number of shares of Incyte Corp Ltd (INCY) owned by Alyeska Investment Group Lp at the time reported was 175,123, these transaction(s) occurred on/as-of 2009-09-30 but information regarding them was just made public today.
Dreyfus Premier Opportunity Funds - Health Care Fund Newly Added 28,340 Incyte Corp Ltd (INCY) Shares.
By: Staff Writer
Mffais.com
Published: Tuesday, September 22, 2009
LONG BEACH, CA (Mffais.com) -- Dreyfus Premier Opportunity Funds - Health Care Fund Newly Added shares of Incyte Corp Ltd (INCY). The number of shares affected was 28,340 which was a 100% change from the 0 number of shares. The ending number of shares of Incyte Corp Ltd (INCY) owned by Dreyfus Premier Opportunity Funds - Health Care Fund at the time reported was 28,340, these transaction(s) occurred on/as-of 2009-07-31 but information regarding them was just made public today.
During the preceding 12 months of this action Dreyfus Premier Opportunity Funds - Health Care Fund type of transactions of Incyte Corp Ltd (INCY) Summarized:
Transactions: 1 Buying: 1 Buying Pct.: 100.00 % No Change: 0 No Change Pct.: 0.00 % Selling: 0 Selling Pct.: 0.00 %
Score: 5.00 Brand New: 1 Increase Existing: 0 No Change: 0 Sold Some: 0 Dumped All: 0 No Comparison: 0
Compared to only the 3 months prior of this transaction:
Transactions: 1 Buying: 1 Buying Pct.: 100.00 % No Change: 0 No Change Pct.: 0.00 % Selling: 0 Selling Pct.: 0.00 %
Score: 5.00 Brand New: 1 Increase Existing: 0 No Change: 0 Sold Some: 0 Dumped All: 0 No Comparison: 0
for those who want more science on 13739 see this
http://www.incyte.com/pdfs/EASD_2009_INCB13739.pdf
what really excites me is this one....INCB13739
The concept of 11beta-HSD1 inhibition as a potential therapy for humans has moved a substantial stride forward today with the publication of a Phase II trial of INCB13739 in patients with
type 2 diabetes inadequately controlled on metformin. We already know that inhibition of this enzyme is beneficial for rodents with metabolic disease, but what remained crucially unknown was whether the concept was useful in humans and whether the expected endocrine effects of loss of glucocorticoid regeneration in the splanchnic bed would lead to unacceptable side effects. The present data not only show INCB13739 produces a significant lowering of HbA1c, fasting blood glucose, insulin resistance and cholesterol levels without weight gain, but reassure that the endocrine changes appear relatively mild. Crucially, there were no changes in plasma cortisol in the morning and salivary cortisol at night, underlining the compensatory nature of the endocrine changes. Moreover, plasma testosterone levels in males and in females examined and the androgenic target sex hormone-binding globulin were unaltered. Thus, major short-term endocrine side effects appear unlikely with INCB13739 therapy, although these clearly need to be scrutinized in longer-term trials. These encouraging findings should reassure of the value of further studies.
1:44AM Incyte Pharma: Data from a Ph. I/II study suggest that INCB7839 in combination with trastuzumab may improve clinical response rtes in HER2 positive patients with advanced metastatic disease (INCY) 8.02 : Co announces positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 46 patients with HER2 positive metastatic breast cancer. The results suggest that, when compared to a historical control study of trastuzumab as monotherapy, INCB7839 in combination with trastuzumab provided improvements in time to progression and response rate in patients with HER2 positive metastatic breast cancer. These improved outcomes were achieved despite the presence of more advanced disease in the study population when compared to the historical control. The improved response rate observed in this study are thought to result from an increased response in the p95HER2 positive subpopulation.
Incyte (INCY) Outperform Rating Alert, Watch for 23.3% Technical Uptrend Continuation
Tuesday 12/08/2009 9:10 AM ET - Comtex Smartrend(r)
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Symbol Last %Chg
INCY 8.00 0.88%
As of 10:50 AM ET 12/8/09
Incyte (NASDAQ:INCY) maintained Outperform, $16 target, at Leerink Swann. The stock closed yesterday at $7.93 on volume of 2,956,329 shares, below average daily volume of 3,002,101.
Incyte is currently above its 50-day moving average of $6.99 and above its 200-day moving average of $4.67.
SmarTrend is bullish on shares of INCY and our subscribers received an Uptrend alert on November 03, 2009 at $6.43, which has returned 23.3% to date.
Write to Chip Brian at cbrian@tradethetrend.com
8:05AM Incyte announces data from 3 phase II trials to be presented at the ASH annual meeting demonstrate that INCB18424, has potential in multiple hematology conditions (INCY) 8.29 +0.22 : Co announces that INCB18424 its selective, orally available janus kinase inhibitor, will be the subject of three oral presentations at the 51st American Society of Hematology Annual Meeting in New Orleans. "INCB18424 continues to provide durable and previously unachievable clinical benefits in patients with myelofibrosis with or without JAK2 activating mutations. It is equally gratifying to see significant clinical benefits in patients with advanced polycythemia vera and essential thrombocythemia including normalization of blood counts, normalization of hematocrit without the need for phlebotomy, rapid and durable reductions in enlarged spleens as well as rapid and durable reductions in symptoms, particularly pruritus. "Additionally, in an exploratory trial in highly refractory patients with secondary acute myeloid leukemia and other leukemias for which no standard therapies are likely to lead to a durable remission, it is encouraging to see patients obtain clinical benefit including the achievement of stable disease as well as complete and partial responses. Our experience with INCB18424 in these highly refractory leukemia patients, along with the growing body of evidence indicating that JAK activation may play a determining role in a number of hematologic malignancies, suggests that use of a selective JAK inhibitor may help provide underserved patients in multiple hematological cancers with improved clinical outcomes."
75 posts!!! we are still undiscovered by the public........the mutual fund mgrs and hedge fund mgrs are loading the boat here...wake up or be left behind!!!!!!!!!!!!!!!I told you all to buy like hell at 5.30.........did you ?
this answers the last question mark for INCY they are off to the races
great news! avg vol pm already... big squeeze coming!
awesome - just picked up 500 shares in pre-market.
Incyte Announces Major Collaboration and License Agreement for Two Hematology-Oncology Programs
Novartis to Develop and Commercialize Incyte’s Lead JAK1/JAK2 Inhibitor, INCB18424, for Territories Outside the US and Incyte’s cMET Inhibitor, INCB28060, Worldwide
Incyte May Receive Over $1 Billion in Payments, Including $150 Million Upfront Plus an Immediate $60 Million Development Milestone in Addition to Future Potential Milestones and Royalties
Press Release
Source: Incyte Corporation
On 1:15 am EST, Wednesday November 25, 2009
Companies:Incyte Corporation
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (NASDAQ: INCY - News) announced today that it has entered into a collaboration and license agreement with Novartis for two of its investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis, a serious life-threatening neoplastic condition characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms, and INCB28060, an oral cMET inhibitor that is about to enter Phase I development as a potential treatment for multiple cancers.
Paul A. Friedman, Incyte’s president and CEO, stated, “This agreement reflects our objective to retain US rights to INCB18424 and puts us in a strong position to transition Incyte into a successful commercial company with sufficient resources to continue to advance other promising compounds in our pipeline. Additionally, the appreciation from Novartis for INCB18424’s potential to treat the unmet patient need in myelofibrosis and other cancers, and their proven success in rapidly commercializing new targeted oncology treatments, were determining factors in our decision to choose Novartis as our collaborative partner.”
Under the terms of the agreement, Incyte will retain exclusive rights for the development and potential commercialization of INCB18424 in the US. Novartis will have responsibility for the future development and commercialization of INCB18424 in all hematology–oncology indications outside of the US. Novartis will also be responsible for the future worldwide development of INCB28060.
Novartis will make an upfront payment of $150 million to Incyte plus an immediate $60 million milestone payment for the initiation of the European Phase III trial of INCB18424, COMFORT-II, that began in July of this year. Novartis will receive ex-US commercialization rights for Incyte’s lead JAK inhibitor and global commercialization rights for the cMET inhibitor. Each company will be responsible for costs in their respective territories for the JAK inhibitor, with costs of collaborative studies shared equally. Incyte may also be eligible over time for additional payments of up to approximately $1.1 billion if future contingent development and commercialization milestones are achieved. Incyte is also eligible to receive tiered, double-digit royalty payments on future ex-US INCB18424 sales. Novartis will be responsible for all costs and activities for the cMET inhibitor after the Phase I clinical trial. Incyte is eligible to receive royalties on future sales of INCB28060 and has retained an option to co-develop and co-promote INCB28060.
pic worth 1000 words on INCY
http://witchdoctor.files.wordpress.com/2008/02/bull.jpg
surf...........INCY has NO retail following!!! its all institutional...........up 50% in 15 days and no POSTS here?
LMAO
7.72? nice move from post 64 huh.....did you play or watch Rome burn?
Incyte INCY Cowen & Co upgraded from Neutral to Outperform today
shares popping this morning..........up 3%
The real reason to BUY......................
after the approval of INCB18424 analyst will look hard at
INCB 13739 and say WOW....these folks have CASH, an approved Drug, and a PIPELINE.....HOLY SH@T this baby goes to $100...now ask yourself ....Where will you be then? loaded? or on the sidelines scratching you A$$?
silence is golden........here we look at a lead pipe cinch for FDA approval.......the SPA they got only requires them to repeat what they have already proven on a larger scale; its something akin to putting an 8 ft tall basket in front of micheal jordan or kobi bryant....lots of details about that on ALPHA........................................................
http://seekingalpha.com/article/155055-incyte-presents-investors-with-unique-dilemmas
from my own email to followers........................
INCY has SPA with FDA
http://investor.incyte.com/phoenix.zhtml?c=69764&p=IROL-NewsText&t=Regular&id=1309330&
INCY has raised capital to roll over their debt past FDA approval on great terms
http://investor.incyte.com/phoenix.zhtml?c=69764&p=IROL-NewsText&t=Regular&id=1335438&
current prices IMO are as low as you will see them in the next 6 mos
and WTF? we have 59 posts here.....and while the world sleeps
I will just LOAD up and wait
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