Incyte Receives FDA Breakthrough Therapy Designation for INCA033989, Transforming ET Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Source: Businesswire
Updated: 11 hour ago0mins
- Breakthrough Therapy Designation: Incyte's INCA033989 has received FDA Breakthrough Therapy designation for patients with Type 1 CALR mutations who are resistant or intolerant to at least one cytoreductive therapy, highlighting its potential to significantly transform the treatment landscape for essential thrombocythemia (ET).
- Clinical Trial Plans: Incyte plans to initiate a Phase 3 clinical program evaluating INCA033989 in mid-2026 for patients with all types of CALR mutations, aiming to expedite the development process to meet urgent patient needs for new therapies.
- Early Data Support: Preliminary Phase 1 data indicate that INCA033989 is well-tolerated and demonstrates rapid and durable normalization of platelet counts across evaluated doses in Type 1 CALR mutation patients, showcasing its effectiveness in treatment.
- Broad Market Potential: With CALR mutations present in 25% of ET patients, and 55% being Type 1 mutations, Incyte's novel therapy is poised to address a significant treatment gap, catering to the growing medical needs of this patient population.
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Analyst Views on INCY
Wall Street analysts forecast INCY stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for INCY is 95.60 USD with a low forecast of 73.00 USD and a high forecast of 125.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
8 Buy
10 Hold
1 Sell
Moderate Buy
Current: 100.460
Low
73.00
Averages
95.60
High
125.00
Current: 100.460
Low
73.00
Averages
95.60
High
125.00
Barclays
NULL -> Overweight
upgrade
$101 -> $115
2025-11-24
Reason
Barclays
Price Target
$101 -> $115
2025-11-24
upgrade
NULL -> Overweight
Reason
Barclays raised the firm's price target on Incyte to $115 from $101 and keeps an Overweight rating on the shares. The firm updated the company's model ahead of data releases in December.
Piper Sandler
Allison Bratzel
Overweight
upgrade
$82 -> $102
2025-11-04
Reason
Piper Sandler
Allison Bratzel
Price Target
$82 -> $102
2025-11-04
upgrade
Overweight
Reason
Piper Sandler analyst Allison Bratzel raised the firm's price target on Incyte to $102 from $82 and keeps an Overweight rating on the shares. The firm notes the company shared strong Q3 results, with Jakafi posting a $20M beat and Opzelura beating consensus by $11M, with non-GAAP EPS of $2.26 representing 63c upside from consensus. Given continued commercial momentum, coupled with key leadership changes, strategic partnerships, and pipeline prioritizations, Piper thinks the risk/reward remains favorable at current levels and remains a buyer.
Wells Fargo
Wells Fargo
Overweight
maintain
$97
2025-11-03
Reason
Wells Fargo
Wells Fargo
Price Target
$97
2025-11-03
maintain
Overweight
Reason
Commenting on the INCB0989 abstract, Wells Fargo says early signs look highly encouraging in myelofibrosis and safety looks good. The firm believes Incyte's shares should trade up on the abstract. Wells thinks the early data cut demonstrates '989 is safe in combination with Jakafi, significant monotherapy treatment activity, while combo data is early but encouraging. Further, it believes '989 will exceed expectations at American Society of Hematology. The firm has an Overweight rating on the shares with a price target of $97.
Guggenheim
Michael Schmidt
Neutral -> Buy
upgrade
$125
2025-11-03
Reason
Guggenheim
Michael Schmidt
Price Target
$125
2025-11-03
upgrade
Neutral -> Buy
Reason
Guggenheim analyst Michael Schmidt upgraded Incyte to Buy from Neutral with a $125 price target.
See All Ratings
About INCY
Incyte Corporation is a biopharmaceutical company, which is focused on the discovery, development, and commercialization of therapeutics. The Company operates in two therapeutic areas. One therapeutic area is Hematology/Oncology, which is comprised of Myeloproliferative Neoplasms and Graft-Versus-Host Disease, as well as solid tumors and hematologic malignancies. Its other therapeutic area is Inflammation and Autoimmunity, which includes its Dermatology commercial franchise. Its hematology and oncology franchise are comprised of six products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib), NIKTIMVO (axatilimab-csfr), and ZYNYZ (retifanlimab-dlwr), as well as numerous clinical development programs. The Company's pipeline also includes two first-in-class small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and INCB000547, an oral MRGPRX4 antagonist.
About the author
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Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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