Incyte Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of proprietary therapeutics in the United States and internationally. The company offers JAKAFI, a drug for the treatment of myelofibrosis and polycythemia vera cancers; PEMAZYRE, a fibroblast growth factor receptor kinase inhibitor for the treatment of adults; and ICLUSIG, a kinase inhibitor to treat chronic myeloid leukemia and philadelphia-chromosome positive acute lymphoblastic leukemia. Its clinical stage products include ruxolitinib, a drug that is in Phase III clinical trial for steroid-refractory chronic graft-versus-host-diseases (GVHD); itacitinib, which is in Phase III clinical trial to treat naïve chronic GVHD; and pemigatinib that is in Phase II clinical trial for treating bladder cancer, cholangiocarcinoma, 8p11 myeloproliferative syndrome, and Tumor agnostic. In addition, the company engages in developing Parsaclisib, which is in Phase II clinical trial for follicular lymphoma, marginal zone lymphoma, and mantel cell lymphoma. Additionally, the company develops Retifanlimab that is in Phase II clinical trials for MSI-high endometrial cancer, merkel cell carcinoma, and anal cancer, as well as in Phase II clinical trials for patients with non-small cell lung cancer. It has collaboration agreements with Novartis International Pharmaceutical Ltd.; Eli Lilly and Company; Agenus Inc.; Calithera Biosciences, Inc; MacroGenics, Inc.; Merus N.V.; Syros Pharmaceuticals, Inc.; Innovent Biologics, Inc.; Zai Lab Limited; and Cellenkos, Inc., as well as clinical collaborations with MorphoSys AG and Xencor, Inc. to investigate the combination of tafasitamab, plamotamab, and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma, and relapsed or refractory follicular lymphoma. The company was incorporated in 1991 and is headquartered in Wilmington, Delaware.
IPO Year:
Exchange: NASDAQ
Website: incyte.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
7/2/2024 | $52.00 → $48.00 | Market Perform → Underperform | BMO Capital Markets |
5/23/2024 | $55.00 | Hold | Deutsche Bank |
4/23/2024 | Neutral | Cantor Fitzgerald | |
2/23/2024 | $81.00 | Buy | Jefferies |
2/14/2024 | Mkt Outperform → Mkt Perform | JMP Securities | |
12/13/2023 | $78.00 | Market Perform → Outperform | Leerink Partners |
12/4/2023 | $86.00 | Neutral → Buy | Guggenheim |
11/21/2023 | $98.00 → $65.00 | Buy → Neutral | Goldman |
7/25/2023 | $82.00 | Buy | Citigroup |
5/4/2023 | $84.00 | Buy → Neutral | BofA Securities |
New antitumor response data from a range of doses and regimens unveiled today at Incyte investor event These results build upon safety and tolerability data presented earlier today during a mini-oral presentation at the European Society of Medical Oncology (ESMO) Congress 2024 Findings support the initiation of a pivotal trial in ovarian cancer, expected to begin in 2025; additional plans to evaluate INCB123667 in combination with other treatments are underway Incyte (NASDAQ:INCY) today announced new early clinical data for INCB123667, a highly selective, potential first-in-class CDK2 inhibitor, in patients with advanced solid tumors. The trial results, presented during a mini-oral p
- Phase 3 POD1UM-303/InterAACT2 trial met primary endpoint of progression-free survival and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) taking retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) - Late-breaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024 support the planned U.S. filing of a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by year-end 2024 - Incyte to host an in-person analyst and investor event to review key data at ESMO on Saturday, September 14, 2024 from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) Incyte (NASDAQ:INCY
Incyte (NASDAQ:INCY) today announced that it granted restricted stock unit awards (RSUs) representing an aggregate of 11,497 shares of the Company's common stock to 14 new employees. The awards were made under the Company's 2024 Inducement Stock Incentive Plan, with a grant date and vesting commencement date of September 3, 2024, and were approved by the compensation committee of the Company's board of directors as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Each RSU vests as to 25% of the shares subject to the RSU on each of the first four anniversaries of the vesting commencement date, subject to
- Presidential Symposium to feature Phase 3 retifanlimab (Zynyz®) results in squamous cell anal carcinoma (SCAC); filing of supplemental Biologics License Application (sBLA) in SCAC planned by year end 2024 - Mini oral presentation to highlight initial Phase 1 data from potential first-in-class CDK2 inhibitor program in patients with CCNE1 ovarian and other advanced cancers - Incyte to host an in-person analyst and investor event to review key data at ESMO, including new results from a later CDK2 data cut-off, on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) Incyte (NASDAQ:INCY) today announced that the Company will present key data from its oncology portf
- Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®) or placebo in combination with lenalidomide and rituximab met its primary endpoint of progression free survival (PFS) in relapsed or refractory follicular lymphoma (FL) - Based on these results, Incyte expects to file a supplemental Biologics License Application for tafasitamab in combination with lenalidomide and rituximab in FL by the end of the year Incyte (NASDAQ:INCY) today announces positive topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combinatio
Niktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD Pivotal data from the AGAVE-201 study supporting the approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups Syndax conference call and webcast scheduled for today at 6:00 p.m. ET Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (NASDAQ:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of syste
Incyte (NASDAQ:INCY) announced today that it will present at the following investor conferences during the month of September: Wells Fargo Healthcare Conference on Wednesday, September 4, 2024 at 12:45 pm (EDT) Morgan Stanley 22nd Annual Global Healthcare Conference on Friday, September 6, 2024 at 10:45 am (EDT) Cantor Global Healthcare Conference on Thursday, September 19, 2024 at 9:45 am (EDT) The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical ne
Incyte (NASDAQ:INCY) today announced that it granted restricted stock unit awards (RSUs) representing an aggregate of 7,009 shares of the Company's common stock to 19 new employees. The awards were made under the Company's 2024 Inducement Stock Incentive Plan, with a grant date and vesting commencement date of August 1, 2024, and were approved by the compensation committee of the Company's board of directors as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Each RSU vests as to 25% of the shares subject to the RSU on each of the first four anniversaries of the vesting commencement date, subject to th
– Total revenues of $1,044 million in the second quarter (Q2'24) (+9% Y/Y) – Jakafi® (ruxolitinib) net product revenues of $706 million in Q2'24 (+3% Y/Y), total patients increased +7% Y/Y; raising the bottom end of full year 2024 guidance to a new range of $2,710 - $2,750 million – Opzelura® (ruxolitinib) net product revenues of $122 million in Q2'24 (+52% Y/Y); continued uptake in atopic dermatitis (AD) and vitiligo in the U.S.; launch momentum and reimbursement expansion in vitiligo in Europe – Incyte announces increased R&D focus on innovative high impact clinical programs; acquisition of Escient Pharmaceuticals completed – $2.0 billion share repurchase completed, underscoring c
Incyte (NASDAQ:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, July 30, 2024. The schedule for the press release and conference call/webcast is as follows: Q2 2024 Press Release: July 30, 2024 at 7:00 a.m. ET Q2 2024 Conference Call: July 30, 2024 at 8:00 a.m. ET Domestic Dial-In Number: 877-407-3042 International Dial-In Number: 201-389-0864 Conference ID Number: 13747471 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 the dial-in number for international callers is 201-6
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New antitumor response data from a range of doses and regimens unveiled today at Incyte investor event These results build upon safety and tolerability data presented earlier today during a mini-oral presentation at the European Society of Medical Oncology (ESMO) Congress 2024 Findings support the initiation of a pivotal trial in ovarian cancer, expected to begin in 2025; additional plans to evaluate INCB123667 in combination with other treatments are underway Incyte (NASDAQ:INCY) today announced new early clinical data for INCB123667, a highly selective, potential first-in-class CDK2 inhibitor, in patients with advanced solid tumors. The trial results, presented during a mini-oral p
- Presidential Symposium to feature Phase 3 retifanlimab (Zynyz®) results in squamous cell anal carcinoma (SCAC); filing of supplemental Biologics License Application (sBLA) in SCAC planned by year end 2024 - Mini oral presentation to highlight initial Phase 1 data from potential first-in-class CDK2 inhibitor program in patients with CCNE1 ovarian and other advanced cancers - Incyte to host an in-person analyst and investor event to review key data at ESMO, including new results from a later CDK2 data cut-off, on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) Incyte (NASDAQ:INCY) today announced that the Company will present key data from its oncology portf
Niktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD Pivotal data from the AGAVE-201 study supporting the approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups Syndax conference call and webcast scheduled for today at 6:00 p.m. ET Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (NASDAQ:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of syste
– Total revenues of $1,044 million in the second quarter (Q2'24) (+9% Y/Y) – Jakafi® (ruxolitinib) net product revenues of $706 million in Q2'24 (+3% Y/Y), total patients increased +7% Y/Y; raising the bottom end of full year 2024 guidance to a new range of $2,710 - $2,750 million – Opzelura® (ruxolitinib) net product revenues of $122 million in Q2'24 (+52% Y/Y); continued uptake in atopic dermatitis (AD) and vitiligo in the U.S.; launch momentum and reimbursement expansion in vitiligo in Europe – Incyte announces increased R&D focus on innovative high impact clinical programs; acquisition of Escient Pharmaceuticals completed – $2.0 billion share repurchase completed, underscoring c
Incyte (NASDAQ:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, July 30, 2024. The schedule for the press release and conference call/webcast is as follows: Q2 2024 Press Release: July 30, 2024 at 7:00 a.m. ET Q2 2024 Conference Call: July 30, 2024 at 8:00 a.m. ET Domestic Dial-In Number: 877-407-3042 International Dial-In Number: 201-389-0864 Conference ID Number: 13747471 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 the dial-in number for international callers is 201-6
– Total revenues of $881 million in the first quarter (Q1'24) (+9% Y/Y) – Jakafi® (ruxolitinib) net product revenues of $572 million in Q1'24, total paid patients increased +5% Y/Y; reiterating full year 2024 guidance of $2,690 - $2,750 million – Opzelura® (ruxolitinib) net product revenues of $86 million (+52% Y/Y) in Q1'24; continued uptake in atopic dermatitis (AD) and vitiligo – Incyte to acquire Escient Pharmaceuticals and its pipeline of first-in-class oral MRGPR antagonists with the potential to treat multiple mast cell-mediated diseases Conference Call and Webcast Scheduled Today at 8:00 a.m. ET Incyte (NASDAQ:INCY) today reports 2024 first quarter financial results, and p
EP262, a first-in-class oral Mas-related G protein-coupled receptor X2 (MRGPRX2) antagonist with the potential to treat a broad range of inflammatory disorders, has demonstrated proof-of-mechanism in chronic inducible urticaria and is in a Phase 2 study for chronic spontaneous urticaria EP547 is a first-in-class oral MRGPRX4 antagonist with the potential to treat cholestatic pruritus and other conditions with severe pruritus Acquisition supports Incyte's portfolio strategy and complements its expanding R&D activities in Inflammation and Autoimmunity (IAI) Incyte analyst and investor call scheduled for April 23, 2024 at 8:00 a.m. ET Incyte (NASDAQ:INCY) and Escient Pharmaceutica
Incyte (NASDAQ:INCY) announced today that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, April 30, 2024. The schedule for the press release and conference call/webcast is as follows: • Q1 2024 Press Release: April 30, 2024 at 7:00 a.m. ET • Q1 2024 Conference Call: April 30, 2024 at 8:00 a.m. ET • Domestic Dial-In Number: 877-407-3042 • International Dial-In Number: 201-389-0864 • Conference ID Number: 13745743 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 the dial-in number for inter
Two late-breaking abstracts have been accepted for oral presentation, including randomized studies evaluating ruxolitinib cream (Opzelura®) in hidradenitis suppurativa and povorcitinib (INCB54707) in prurigo nodularis Analyst and investor event to discuss key data presentations scheduled for Monday, March 11, 2024 at 9:00 a.m. PT / 12:00 p.m. ET Incyte (NASDAQ:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego. "We are pleased to convene at this year's AAD Annual Meeting and share data, including two late-breaking p
Total FY'23 net product and royalty revenues of $3.7 billion (+14% Y/Y); total FY'23 net product revenues of $3.2 billion (+15% Y/Y) Jakafi® (ruxolitinib) net revenues of $2.6 billion (+8%) for FY'23; Jakafi net revenues guidance range of $2,690 - $2,750 million for FY 2024 Opzelura® (ruxolitinib) cream net revenues of $109 million in Q4'23 and $338 million for FY'23, driven by strong demand in atopic dermatitis and the successful launch in vitiligo Advancing high potential pipeline provides opportunity for over 10 new launches by 2030 Incyte to host an in-person and webcast investor event on Monday, March 11, 2024 from 9:00-10:30 a.m. PT to discuss key data presentations a
BMO Capital Markets downgraded Incyte from Market Perform to Underperform and set a new price target of $48.00 from $52.00 previously
Deutsche Bank initiated coverage of Incyte with a rating of Hold and set a new price target of $55.00
Cantor Fitzgerald initiated coverage of Incyte with a rating of Neutral
Jefferies initiated coverage of Incyte with a rating of Buy and set a new price target of $81.00
JMP Securities downgraded Incyte from Mkt Outperform to Mkt Perform
Leerink Partners upgraded Incyte from Market Perform to Outperform and set a new price target of $78.00
Guggenheim upgraded Incyte from Neutral to Buy and set a new price target of $86.00
Goldman downgraded Incyte from Buy to Neutral and set a new price target of $65.00 from $98.00 previously
Citigroup initiated coverage of Incyte with a rating of Buy and set a new price target of $82.00
BofA Securities downgraded Incyte from Buy to Neutral and set a new price target of $84.00
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Mechelen, Belgium; 12 June 2023, 22:01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that during its meeting of 12 June 2023, the Board of Directors co-opted Dr. Susanne Schaffert as non-executive independent Director. Dr. Schaffert replaces Dr. Rajesh Parekh who stepped down on 10 June 2023. After an extraordinary 27-year career at Novartis in various global roles, including commercialization, market access, investor relations, business development & licensing, acquisitions and company integration, Dr. Schaffert retired in 2022 as President of Novartis Oncology and Member of the Novartis Executive Committee. In that role, Dr. Schaffert ran a global $15 billion business acr
Incyte (NASDAQ:INCY) announces the appointment of Susanne Schaffert, Ph.D., as a new member of its Board of Directors. "On behalf of the Incyte Board of Directors, I am happy to welcome Susanne. Her extensive commercial, development and industry experience will greatly complement our Board and we look forward to Susanne's contributions to our continued growth and future success," said Hervé Hoppenot, Chief Executive Officer, Incyte. "I am very excited for the opportunity to join the Incyte Board of Directors and helping the organization in its commitment to leading scientific innovation and developing new medicines for patients in need. I look forward to being part of this dynamic Company
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced the appointment of Shannon Campbell as Executive Vice President & Chief Commercial Officer. Ms. Campbell is an accomplished healthcare leader with demonstrated success leading commercial businesses across a range of specialty markets, including oncology. "Shannon will be instrumental in advancing Merus' mission to become a commercial-stage company, further advancing the strategy for our lead clinical progr
Incyte (NASDAQ:INCY) announces the appointment of Otis Brawley, M.D., as a new member of its Board of Directors, effective September 27, 2021. "We are very pleased to welcome Otis to the Incyte Board of Directors. His distinguished career and extensive clinical experience will be a great addition to our Board and we expect he will contribute greatly to our continued success in the future," said Hervé Hoppenot, Chief Executive Officer, Incyte. "As part of the Incyte Board, I join a very experienced and diverse team dedicated to scientific discovery and to the development of new, innovative medicines for patients. I am excited for this opportunity, and look forward to participating in the l
Crescendo Biologics Ltd (Crescendo), a clinical-stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announces the appointment of Dr Michael Booth as Chief Financial Officer (CFO). Mike joins with over 20 years' experience in corporate finance within the biopharmaceutical industry. Mike joins Crescendo at an important stage of its development, following the initiation of its Phase Ia/Ib trial for Crescendo's lead Humabody® programme, CB307, a first-in-class PSMA x CD137 T cell enhancer. Mike will be responsible for Crescendo's financial strategy and reporting, as well as global investor relations. Prior to joining Crescendo, Mike served as Division
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The S&P 500 index climbed to new all-time highs, rising 0.3% during Tuesday’s session, aiming for a potential sixth consecutive positive close and remaining resilient after Fed Chair Jerome Powell‘s testimony before the Senate Banking Committee. Powell used both hawkish tones – stating that it is not yet appropriate to cut rates until greater confidence on the 2% target is achieved – and dovish tones, noting recent progress and warning that a weakening labor market could be a significant factor for a rate cut. Markets are looking ahead with confidence to the upcoming June inflation report, due this Thursday, which could solidify the already high expectations for a rate cut in September
Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page. Seaport Global analyst Jim Mitchell downgraded the rating for The Goldman Sachs Group, Inc. (NYSE:GS) from Buy to Neutral. Goldman Sachs shares fell 0.7% to trade at $460.26 on Tuesday. See how other analysts view this stock. UBS analyst David Vogt downgraded Pure Storage, Inc. (NYSE:PSTG) from Neutral to Sell, but raised the price target from $44 to $47. Pure Storage shares fell 4.8% to trade at $62.36 on Tuesday. See how other analysts view this stock. Citigroup analyst Anthony Pe
BMO Capital analyst Evan Seigerman downgrades Incyte (NASDAQ:INCY) from Market Perform to Underperform and lowers the price target from $52 to $48.
6 analysts have shared their evaluations of Incyte (NASDAQ:INCY) during the recent three months, expressing a mix of bullish and bearish perspectives. The table below provides a snapshot of their recent ratings, showcasing how sentiments have evolved over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 2 1 3 0 0 Last 30D 0 0 0 0 0 1M Ago 0 0 1 0 0 2M Ago 2 1 1 0 0 3M Ago 0 0 1 0 0 The 12-month price targets, analyzed by analysts, offer insights with an average target of $69.83, a high estimate of $84.00, and a low estimate of $52.00. Experiencing a 12.71% decline, the current average
Cantor Fitzgerald analyst Eric Schmidt reiterates Incyte (NASDAQ:INCY) with a Neutral.
The Nasdaq 100 index posted its fourth consecutive session in the green on Thursday, closing up 0.6% at 19,576 points and reaching new all-time highs as tech stocks drive broader market gains. The S&P 500 also recorded its fourth straight positive day, rising 0.2% to a record closing level of 5,433 points, rebounding from a morning dip caused by disappointing unemployment claims data. In the afternoon, traders regained confidence in risky assets after U.S. Treasury Secretary Janet Yellen expressed optimism about continued progress in disinflation. While Yellen noted easing labor market pressures, she emphasized that the job market remains strong. The market anticipates a rate cut in
Incyte Corporation (NASDAQ:INCY) ("Incyte" or the "Company") announced today the preliminary results of its modified "Dutch auction" tender offer to purchase up to $1.672 billion in value of shares of its common stock, which expired at 12:00 midnight, at the end of the day, New York City time, on June 10, 2024.Based on the preliminary count by Computershare Trust Company, N.A., the depositary for the tender offer, a total of approximately 29.8 million shares of Incyte's common stock were properly tendered and not properly withdrawn at or below the purchase price of $60.00 per share, including approximately 14.8 million shares that were tendered through notice of guaranteed delivery. Incyte h
This whale alert can help traders discover the next big trading opportunities. Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner. Traders often look for circumstances when the market estimation of an option diverges away from its normal worth. Abnormal amounts of trading activity could push option prices to hyperbolic or underperforming levels. Here's the list of options activity happening in today's session: Symbol PUT/CALL Trade Type Sentiment Exp. Date Strike Price Total Trade Price Open Interest Volume CERE PUT TRADE NEUTRAL 07/19/24 $40.00 $56.0K 3 2.9K LFMD CALL SWEEP BULLISH 11/15/24 $7.50 $54.4K 2.
Hedge funds made strategic adjustments to their portfolios throughout the first quarter of 2024. Firms are looking for high-return opportunities beyond the mega-cap tech giants preferring to focus on cyclical sectors and artificial intelligence (AI)-related infrastructure stocks. Except for Apple Inc (NASDAQ:AAPL), positions in several ‘Magnificent Seven’ stocks — Alphabet Inc (NASDAQ:GOOGL), Amazon.com Inc (NASDAQ:AMZN), Nvidia Corp (NASDAQ:NVDA), Microsoft Corp (NYSE:MSFT), and Meta Platforms Inc (NASDAQ:META) — were trimmed from hedge funds. Still, the strong performance of the so-called ‘Magnificent 7′ tech stocks maintained their weight at 13% of hedge fund long portfolios, acc
Submission status for INCYTE CORP's drug JAKAFI (SUPPL-25) with active ingredient RUXOLITINIB PHOSPHATE has changed to 'Approval' on 09/27/2021. Application Category: NDA, Application Number: 202192, Application Classification: Labeling
Submission status for INCYTE CORP's drug JAKAFI (SUPPL-23) with active ingredient RUXOLITINIB PHOSPHATE has changed to 'Approval' on 09/22/2021. Application Category: NDA, Application Number: 202192, Application Classification: Efficacy
Submission status for INCYTE CORP's drug OPZELURA (ORIG-1) with active ingredient RUXOLITINIB has changed to 'Approval' on 09/21/2021. Application Category: NDA, Application Number: 215309, Application Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Submission status for INCYTE CORP's drug PEMAZYRE (SUPPL-1) with active ingredient PEMIGATINIB has changed to 'Approval' on 02/23/2021. Application Category: NDA, Application Number: 213736, Application Classification: Labeling