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Incyte (Nasdaq:INCY) and Genmab A/S (Nasdaq:GMAB) today announced a clinical trial collaboration to evaluate INCB161734, Incyte’s investigational, potent and selective KRAS G12D inhibitor, in combination with petosemtamab, Genmab’s investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring KRAS G12D mutation, an area with substantial unmet medical need.

“Metastatic colorectal cancer remains difficult-to-treat, underscoring the importance of evaluating novel combinations grounded in complementary scientific approaches with the potential to enhance efficacy,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Our collaboration with Genmab will explore the potential of combining KRAS G12D inhibition with LGR5-targeted EGFR inhibition and standard-of-care chemotherapy, with the goal of advancing a new first-line treatment approach for patients with metastatic colorectal cancer.”

“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding potential treatment options for more patients.”

Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating INCB161734 in combination with petosemtamab and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.

KRAS mutations occur in approximately 40% of colorectal cancers, with G12D being the most common KRAS mutation. These cancers are associated with poor prognosis, underscoring the need for new treatment approaches. The collaboration reflects a shared focus on investigating whether agents with distinct and potentially complementary mechanisms, combined with standard-of-care chemotherapy, may offer a path toward a new treatment option for patients with KRAS G12D-mutated metastatic colorectal cancer.

About INCB161734

INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.

INCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073) study which is currently enrolling patients with previously untreated KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy.

INCB161734 is also being evaluated as a monotherapy and in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160).

About Petosemtamab (GEN1158)

Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Petosemtamab is being evaluated in combination with chemotherapy in two Phase 3 trials in first- and second-line RAS/BRAF wild-type metastatic CRC. Please visit https://clinicaltrials.gov/ for more information.

About Incyte®

Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

About Genmab

Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody-drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.

Incyte Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s clinical trial collaboration with Genmab; the design, initiation, timing, conduct, sponsorship and funding of the planned studies; the potential presented by INCB161734, petosemtamab and the combination of these investigational therapies with standard-of-care chemotherapy; the potential for the combination to provide a new treatment option for patients with first-line KRAS G12D-mutated metastatic colorectal cancer; expectations regarding the initiation, timing, progress and results of ongoing and planned clinical trials for INCB161734; whether or when INCB161734, petosemtamab or any combination regimen will be approved or commercially available for use in humans anywhere in the world; Incyte’s oncology portfolio and development strategy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including whether preclinical or early clinical results will be replicated in later-stage or larger clinical trials; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects in accordance with planned schedules; changes in clinical development plans; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory approval; the efficacy or safety of Incyte’s products and product candidates; Incyte’s ability to successfully develop and commercialize its product candidates; Incyte’s reliance on third parties and collaboration partners, including with respect to the planned studies described herein; the availability and effectiveness of competing treatments; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; greater than expected expenses, including expenses relating to clinical development, litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

Genmab Forward-Looking Statements

This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filingswith the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect®, and KYSO®.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261024426058/en/

Genmab A/S (Nasdaq: GMAB) and Incyte (Nasdaq: INCY) today announced a clinical trial collaboration to evaluate petosemtamab, Genmab’s investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with INCB161734, Incyte’s investigational, potent and selective KRAS G12D inhibitor, and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring a KRAS G12D mutation, an area with substantial unmet medical need.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261024542855/en/

“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding potential treatment options for more patients.”

“Metastatic colorectal cancer remains difficult-to-treat, underscoring the importance of evaluating novel combinations grounded in complementary scientific approaches with the potential to enhance efficacy,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Our collaboration with Genmab will explore the potential of combining KRAS G12D inhibition with LGR5-targeted EGFR inhibition and standard-of-care chemotherapy, with the goal of advancing a new first-line treatment approach for patients with metastatic colorectal cancer.”

Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating petosemtamab in combination with INCB161734 and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.

KRAS mutations occur in approximately 40% of colorectal cancers, with G12D being the most common KRAS mutation. These cancers are associated with poor prognosis, underscoring the need for new treatment approaches. The collaboration reflects a shared focus on investigating whether agents with distinct and potentially complementary mechanisms, combined with standard-of-care chemotherapy, may offer a path toward a new treatment option for patients with KRAS G12D-mutated metastatic colorectal cancer.

About Petosemtamab (GEN1158)
Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Petosemtamab is being evaluated in combination with chemotherapy in two Phase 3 trials in first- and second-line RAS/BRAF wild-type metastatic CRC. Please visit https://clinicaltrials.gov/ for more information.

About INCB161734
INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.

INCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073) study which is currently enrolling patients with previously untreated KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy.

INCB161734 is also being evaluated as a monotherapy and in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160).

About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.

About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Genmab Forward-Looking Statements
This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.comand the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®.

Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s clinical trial collaboration with Genmab; the design, initiation, timing, conduct, sponsorship and funding of the planned studies; the potential presented by INCB161734, petosemtamab and the combination of these investigational therapies with standard-of-care chemotherapy; the potential for the combination to provide a new treatment option for patients with first-line KRAS G12D-mutated metastatic colorectal cancer; expectations regarding the initiation, timing, progress and results of ongoing and planned clinical trials for INCB161734; whether or when INCB161734, petosemtamab or any combination regimen will be approved or commercially available for use in humans anywhere in the world; Incyte’s oncology portfolio and development strategy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including whether preclinical or early clinical results will be replicated in later-stage or larger clinical trials; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects in accordance with planned schedules; changes in clinical development plans; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory approval; the efficacy or safety of Incyte’s products and product candidates; Incyte’s ability to successfully develop and commercialize its product candidates; Incyte’s reliance on third parties and collaboration partners, including with respect to the planned studies described herein; the availability and effectiveness of competing treatments; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; greater than expected expenses, including expenses relating to clinical development, litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261024542855/en/

Key Takeaways INCY's Q3 revenues are expected to benefit from Jakafi sales, with the consensus estimate at $827M.Opzelura sales are estimated at $230M, supported by patient starts, refills and a CMS settlement.Niktimvo and other marketed drugs may boost revenues, while higher R&D and SG&A costs could raise expenses.
Incyte Corporation (INCY - Free Report) is scheduled to report third-quarter 2026 earnings on Oct. 29, before the opening bell. The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $1.48 billion, while the same for the bottom line is pinned at a loss of $3.50 per share.

Let us look at how things are likely to have shaped up for INCY in the to-be-reported quarter.

Factors Likely to Influence INCY's Q3 ResultsIncyte primarily derives product revenues from the sales of its lead drug, Jakafi (ruxolitinib), in the United States, as well as from the sales of other marketed drugs. Its momentum is likely to have continued on the back of strong Jakafi sales, a first-in-class, selective JAK1/JAK2 inhibitor, across all approved indications (polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease [GvHD]).

The Zacks Consensus Estimate for Jakafi's third-quarter sales is pegged at $827 million.

Incyte also earns product royalty revenues from Novartis (NVS - Free Report) for the commercialization of Jakafi in ex-U.S. markets.

While Incyte markets Jakafi in the United States, Novartis markets the same drug as Jakavi outside the United States. INCY is expected to have received higher royalties from NVS in the to-be-reported quarter due to potentially higher Jakavi sales.

Year to date, Incyte shares have gained 18.4% compared with the industry’s 6.7% growth.

Image Source: Zacks Investment Research

Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.

In the to-be-reported quarter, Opzelura (ruxolitinib cream) sales are expected to have been driven by continued growth in patient starts and refills in the United States for its two approved indications: atopic dermatitis and vitiligo. The European Union (EU) approval of Opzelura for moderate atopic dermatitis is expected to support Incyte’s sales growth in the coming quarters by expanding the drug’s addressable market beyond its existing European vitiligo indication.

The CMS settlement is expected to support Opzelura’s net sales in the second half of 2026, with Incyte estimating a combined $40-$50 million benefit in the third and fourth quarters from improved gross-to-net performance.

The Zacks Consensus Estimate for Opzelura’s third-quarter sales is pegged at $230 million.

While Jakafi’s sales and royalties are the key catalysts for Incyte’s revenue growth, sales of other drugs like Minjuvi, Pemazyre and Iclusig, and Olumiant’s royalties from Eli Lilly (LLY - Free Report) are also likely to have contributed to Incyte’s top line. INCY has a collaboration agreement with LLY for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases.

Incyte acquired exclusive global rights to Monjuvi/Minjuvi (tafasitamab), initially approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma, from MorphoSys in 2024. Last year, the FDA approved Monjuvi for relapsed or refractory follicular lymphoma, expanding its label and boosting sales. Minjuvi also secured approvals for this indication in the EU and Japan in 2025.

The Zacks Consensus Estimate for Iclusig, Minjuvi/Monjuvi and Pemazyre’s third-quarter sales is pegged at $35.2 million, $55 million and $23.5 million, respectively. Incremental sales from Zynyz are also expected to have contributed to Incyte’s revenues in the to-be-reported quarter.

Incyte and partner Syndax launched Niktimvo (axatilimab-csfr) in the United States in early 2025 after FDA approval for chronic graft-versus-host disease (cGvHD) patients who have failed at least two prior systemic therapies. Niktimvo is Incyte's second approved treatment for cGvHD (third-line). The Zacks Consensus Estimate for Niktimvo’s third-quarter sales is pegged at $64 million.

Incyte granted Mirum Pharmaceuticals worldwide rights to Atebrioz (zilurgisertib) in April 2026. Following its FDA approval for fibrodysplasia ossificans progressiva, the drug is expected to launch this month. Incyte is eligible for milestone payments and royalties on global sales. Investors will look for updates on the launch and potential revenue contribution during the upcoming earnings call.

Higher research and development (R&D) expenses, as well as increased selling, general and administrative (SG&A) costs, are likely to have escalated operating expenses in the third quarter of 2026.

INCY's Earnings Surprise HistoryIncyte has a mixed history of earnings surprises. The company beat earnings estimates in three of the trailing four quarters and missed in the remaining one, delivering an average surprise of 28.65%. In the last reported quarter, INCY posted an earnings surprise of 54.50%.

Earnings Whispers for INCYOur proven model does not conclusively predict an earnings beat for INCY this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter.

INCY’s Earnings ESP: Incyte’s Earnings ESP is -11.02% as the Most Accurate Estimate stands at a loss of $3.89, higher than the Zacks Consensus Estimate for a loss of $3.50. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter.

INCY’s Zacks Rank: INCY has a Zacks Rank #4 (Sell) at present.

Stock to ConsiderHere is a stock worth considering from the healthcare space, as our model shows that this has the right combination of elements to beat on earnings this reporting cycle.

Halozyme Therapeutics (HALO - Free Report) has an Earnings ESP of +2.78% and currently flaunts a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

HALO shares have gained 85.1% year to date. The company’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, delivering a negative average surprise of 19.12%. Halozyme is scheduled to report third-quarter results on Nov. 5.

The market expects Incyte (INCY - Free Report) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.

The earnings report, which is expected to be released on October 29, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus EstimateThis specialty drugmaker is expected to post quarterly loss of $3.50 per share in its upcoming report, which represents a year-over-year change of -254.9%.

Revenues are expected to be $1.48 billion, up 8.5% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.28% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Incyte?For Incyte, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -11.02%.

On the other hand, the stock currently carries a Zacks Rank of #5.

So, this combination makes it difficult to conclusively predict that Incyte will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Incyte would post earnings of $2 per share when it actually produced earnings of $3.09, delivering a surprise of +54.50%.

Over the last four quarters, the company has beaten consensus EPS estimates three times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Incyte doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.

WILMINGTON, Del.--(BUSINESS WIRE)---- $INCY #ESMO2026--Incyte to Highlight Key Oncology Data Presentations at the European Society for Medical Oncology (ESMO) Congress 2026.

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte today announced eight winners of the 2026 MPN Heroes® annual recognition program. The program, now in its 14th year, pays tribute to individuals whose contributions to patient care, research and advocacy make a meaningful difference for people affected by myeloproliferative neoplasms (MPNs). The 2026 Heroes join a distinguished group of over 100 past honorees whose remarkable contributions have spurred progress and enriched the lives of people throughou.

WILMINGTON, Del.--(BUSINESS WIRE)--3Q26 Earnings Announcement.

Key Takeaways MIRM's Atebrioz gets FDA approval to reduce new HO volume in FOP patients aged 12 and older.PROGRESS data showed a 3.2-cubic-centimeter reduction in new HO volume after 24 weeks.Atebrioz's pediatric program is advancing, with enrollment completed in one cohort and underway in another. Mirum Pharmaceuticals (MIRM - Free Report) announced that its oral pill zilurgisertib secured FDA approval for the treatment of fibrodysplasia ossificans progressiva (FOP) in patients aged 12 years and older. The drug will be marketed under the name Atebrioz.

Mirum Pharmaceuticals expects the drug to become commercially available in the United States in October through Mirum Access Plus, a patient support program designed to help navigate treatment access. It is currently under regulatory review for FOP indication in the European Union.

FOP is an ultra-rare genetic disease affecting about 300 people in the United States and 900 worldwide. It causes abnormal bone formation in soft tissues, which progressively restricts movement, mobility and daily activities.

Atebrioz is an oral activin receptor-like kinase 2 inhibitor and is recommended at a dose of 100 mg once daily for FOP. The drug is designed to reduce the volume of total new heterotopic ossification (HO). HO indicates the abnormal formation of extra bone tissue in muscles and other soft tissues where bone normally should not grow.

Mirum Pharmaceuticals obtained exclusive worldwide rights to Atebrioz from Incyte (INCY - Free Report) in April 2026 for the drug’s development and commercialization. Under the agreement, Incyte received an upfront payment and remains eligible to receive additional development, regulatory and sales-based milestone payments, along with tiered royalties on worldwide net sales.

Year to date, MIRM shares have rallied 13.5% compared with the industry’s 8.3% growth.

Image Source: Zacks Investment Research

MIRM’s Atebrioz Approval for FOP Validates PROGRESS DataThe FDA approval for Atebrioz was supported by data from cohort 1 of the phase II PROGRESS study conducted by Incyte, which evaluated Atebrioz in adults and children aged 12 years and older with FOP. The study assessed the total new HO volume, including growth of existing bone lesions and development of new lesions.

After 24 weeks, patients treated with the drug achieved an average 3.2 cubic-centimeter reduction in total new HO lesion volume compared with a 24.6 cubic-centimeter increase in patients receiving placebo. The treatment benefit was sustained through week 48.

Atebrioz was generally well-tolerated, and the most common side effects were headache, joint pain, upper respiratory tract infection, nosebleeds and nausea.

The approval allows Mirum Pharmaceuticals to build a presence in the FOP market while it advances Atebrioz into younger pediatric patients. In this regard, the company is advancing cohorts 2 and 3 of the PROGRESS study. Enrollment has been completed in cohort 2 of children aged six to less than 12 years and cohort 3 is actively enrolling children aged two to less than 12 years with FOP.

MIRM’s Zacks Rank & Stock to ConsiderMirum Pharmaceuticals currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) and AC Immune (ACIU - Free Report) carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 85.4% year to date.

Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.

Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 19.8% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

FOSTER CITY, Calif. & WILMINGTON, Del.--(BUSINESS WIRE)--Mirum and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva.

Incyte (NASDAQ:INCY) executives outlined a strategy centered on expanding its non-JAKAFI business, advancing a broader late-stage pipeline and preparing for the loss of exclusivity for JAKAFI after 2029.

Chief Executive Officer Bill Meury said the company’s pipeline has changed substantially over the past year, citing proof-of-concept data for its CALR antibody 989 in myelofibrosis and essential thrombocythemia, its KRAS G12D inhibitor in pancreatic cancer, and its TGF-beta-by-PD-1 program in colorectal cancer. He also pointed to phase III data for povorcitinib, which is under FDA review, and the acquisition of Vega Therapeutics and its von Willebrand disease candidate latarcibart.

Meury said Incyte’s core business excluding JAKAFI is annualizing at roughly $2 billion in sales. The company aims to increase that figure to $3 billion to $4 billion by 2030. If its pipeline programs are successfully developed and launched, he said Incyte has the potential to grow at a 15% to 20% compound annual rate from 2030 through 2035. JAKAFI XR Conversion and MPN Pipeline Meury said the company expects extended-release JAKAFI XR formulary coverage to approach 70% to 80% by year-end. According to Meury, major pharmacy benefit managers and health plans have placed XR on formulary at parity with immediate-release JAKAFI and at a price acceptable to both Incyte and payers.

Incyte has projected that 10% to 30% of JAKAFI patients could convert to XR before loss of exclusivity. At the midpoint of that range, Meury said the conversion could preserve nearly $750 million in sales during the transition. He characterized XR as a bridge rather than a primary driver of Incyte’s long-term value.

President and Global Head of R&D Pablo Cagnoni said 989 is already in pivotal development for second-line essential thrombocythemia, while a second-line myelofibrosis study is being implemented. The company plans to provide more details on the myelofibrosis trial design during its next earnings call.

For frontline myelofibrosis, Incyte expects to present data at the American Society of Hematology meeting from a cohort in which roughly two-thirds of patients received 989 monotherapy and one-third received 989 with ruxolitinib. Cagnoni said the data will help determine the design of a planned frontline trial expected to begin in early 2027.

The company is also discussing potential endpoints with the FDA. Cagnoni said Incyte believes measures including hemoglobin, platelets, blasts and spleen size could support a composite endpoint that better reflects disease modification. The company continues to have a “constructive dialogue” with the agency, he said, but retains a path to approve 989 using existing endpoints if necessary.

Incyte also plans to present preclinical data at ASH for a next-generation mutant CALR antibody that Cagnoni said has a longer half-life and greater potency against Type 1 and Type 2 CALR mutations. Separately, the company will present a preclinical package for a next-generation JAK2 V617F inhibitor designed to improve on its discontinued earlier program.

Solid-Tumor Programs Advance At the European Society for Medical Oncology meeting, Incyte plans to provide an update on its KRAS G12D inhibitor, 734, in approximately 50 frontline pancreatic cancer patients treated in combination with either FOLFIRINOX or gemcitabine plus nab-paclitaxel. Cagnoni said the company expects to report strong efficacy data and six-month event-free survival, though progression-free survival is not yet mature.

He said Incyte views its efficacy and safety profile as comparable with that of its nearest competitor, while noting that patients in its study have had approximately 1.6 to 1.8 months longer treatment exposure. A phase III frontline pancreatic cancer study is enrolling and expanding globally, and Incyte plans to pursue an adjuvant pancreatic cancer program.

The company will also present data for 734 plus cetuximab in later-line colorectal cancer. Cagnoni said the response rate exceeded what would be expected from cetuximab alone and that the company intends to discuss a proposed pivotal trial with the FDA.

Incyte’s TGF-beta receptor II-by-PD-1 bispecific, 890, is being studied in microsatellite-stable colorectal cancer. Cagnoni said the drug’s design seeks to target TGF-beta receptor II only when the PD-1 arm is fully engaged, potentially avoiding the toxicity associated with systemic TGF-beta approaches. In a heavily pretreated group of about 100 patients, he said the program produced a 15% response rate with durable responses. The company plans to present data from about 50 frontline patients receiving 890 with FOLFOX and bevacizumab at ESMO, while its phase III trial is enrolling ahead of schedule.

Dermatology and Von Willebrand Disease Meury said povorcitinib could address hidradenitis suppurativa in both pre-biologic and post-biologic populations. He said the company’s open-label extension data from more than 1,200 participants have been reassuring and that the benefit-risk profile differs from that of JAK inhibitors in other settings because of patient selection, dosing and monitoring.

Incyte is preparing a U.S. launch effort that will include a sales organization covering more than 10,000 HS specialists, peer-to-peer programs, consumer advertising and payer-access initiatives. Germany is the company’s initial international target market. Meury also said Incyte expects fourth-quarter data for povorcitinib in prurigo nodularis and for OPZELURA in HS.

On business development, Meury highlighted the Vega acquisition as an example of the company’s preferred approach: acquiring a de-risked, late-stage asset in an area aligned with Incyte’s hematology expertise. Latarcibart uses a different approach to treating von Willebrand disease by modulating anticoagulant protein S. Cagnoni said a database analysis cited by the company estimated that about 30,000 patients with von Willebrand disease could qualify for prophylaxis, while only about 2,000 currently receive it.

Meury said business development remains a priority as Incyte seeks to supplement its internal pipeline, but stressed the importance of deploying capital carefully.

About Incyte (NASDAQ:INCY) Incyte Corporation is a biopharmaceutical company focused on discovering, developing and commercializing medicines for oncology and inflammatory diseases. Founded in 1991 and headquartered in Wilmington, Delaware, the company conducts research in areas including oncology, hematology, immunology and dermatology.

Incyte’s commercial portfolio includes Jakafi (ruxolitinib), a treatment for certain myelofibrosis, polycythemia vera and graft-versus-host disease; Opzelura (ruxolitinib) cream for atopic dermatitis and nonsegmental vitiligo; and Pemazyre (pemigatinib) for selected cancers involving abnormal FGFR signaling.

Can Incyte Deliver on 447% EPS Forecasts and Pipeline Hype?Incyte NASDAQ: INCY executives outlined a strategy centered on expanding its non-JAKAFI business, advancing a broader late-stage pipeline and preparing for the loss of exclusivity for JAKAFI after 2029.

Chief Executive Officer Bill Meury said the company’s pipeline has changed substantially over the past year, citing proof-of-concept data for its CALR antibody 989 in myelofibrosis and essential thrombocythemia, its KRAS G12D inhibitor in pancreatic cancer, and its TGF-beta-by-PD-1 program in colorectal cancer. He also pointed to phase III data for povorcitinib, which is under FDA review, and the acquisition of Vega Therapeutics and its von Willebrand disease candidate latarcibart.

Get Incyte alerts:

5 top healthcare stocks for earnings growth in 2024Meury said Incyte’s core business excluding JAKAFI is annualizing at roughly $2 billion in sales. The company aims to increase that figure to $3 billion to $4 billion by 2030. If its pipeline programs are successfully developed and launched, he said Incyte has the potential to grow at a 15% to 20% compound annual rate from 2030 through 2035.

JAKAFI XR Conversion and MPN Pipeline Meury said the company expects extended-release JAKAFI XR formulary coverage to approach 70% to 80% by year-end. According to Meury, major pharmacy benefit managers and health plans have placed XR on formulary at parity with immediate-release JAKAFI and at a price acceptable to both Incyte and payers.

Argenx's 28% Surge & Promising Product Propel Investor ConfidenceIncyte has projected that 10% to 30% of JAKAFI patients could convert to XR before loss of exclusivity. At the midpoint of that range, Meury said the conversion could preserve nearly $750 million in sales during the transition. He characterized XR as a bridge rather than a primary driver of Incyte’s long-term value.

President and Global Head of R&D Pablo Cagnoni said 989 is already in pivotal development for second-line essential thrombocythemia, while a second-line myelofibrosis study is being implemented. The company plans to provide more details on the myelofibrosis trial design during its next earnings call.

For frontline myelofibrosis, Incyte expects to present data at the American Society of Hematology meeting from a cohort in which roughly two-thirds of patients received 989 monotherapy and one-third received 989 with ruxolitinib. Cagnoni said the data will help determine the design of a planned frontline trial expected to begin in early 2027.

The company is also discussing potential endpoints with the FDA. Cagnoni said Incyte believes measures including hemoglobin, platelets, blasts and spleen size could support a composite endpoint that better reflects disease modification. The company continues to have a “constructive dialogue” with the agency, he said, but retains a path to approve 989 using existing endpoints if necessary.

Incyte also plans to present preclinical data at ASH for a next-generation mutant CALR antibody that Cagnoni said has a longer half-life and greater potency against Type 1 and Type 2 CALR mutations. Separately, the company will present a preclinical package for a next-generation JAK2 V617F inhibitor designed to improve on its discontinued earlier program.

Solid-Tumor Programs Advance At the European Society for Medical Oncology meeting, Incyte plans to provide an update on its KRAS G12D inhibitor, 734, in approximately 50 frontline pancreatic cancer patients treated in combination with either FOLFIRINOX or gemcitabine plus nab-paclitaxel. Cagnoni said the company expects to report strong efficacy data and six-month event-free survival, though progression-free survival is not yet mature.

He said Incyte views its efficacy and safety profile as comparable with that of its nearest competitor, while noting that patients in its study have had approximately 1.6 to 1.8 months longer treatment exposure. A phase III frontline pancreatic cancer study is enrolling and expanding globally, and Incyte plans to pursue an adjuvant pancreatic cancer program.

The company will also present data for 734 plus cetuximab in later-line colorectal cancer. Cagnoni said the response rate exceeded what would be expected from cetuximab alone and that the company intends to discuss a proposed pivotal trial with the FDA.

Incyte’s TGF-beta receptor II-by-PD-1 bispecific, 890, is being studied in microsatellite-stable colorectal cancer. Cagnoni said the drug’s design seeks to target TGF-beta receptor II only when the PD-1 arm is fully engaged, potentially avoiding the toxicity associated with systemic TGF-beta approaches. In a heavily pretreated group of about 100 patients, he said the program produced a 15% response rate with durable responses. The company plans to present data from about 50 frontline patients receiving 890 with FOLFOX and bevacizumab at ESMO, while its phase III trial is enrolling ahead of schedule.

Dermatology and Von Willebrand Disease Meury said povorcitinib could address hidradenitis suppurativa in both pre-biologic and post-biologic populations. He said the company’s open-label extension data from more than 1,200 participants have been reassuring and that the benefit-risk profile differs from that of JAK inhibitors in other settings because of patient selection, dosing and monitoring.

Incyte is preparing a U.S. launch effort that will include a sales organization covering more than 10,000 HS specialists, peer-to-peer programs, consumer advertising and payer-access initiatives. Germany is the company’s initial international target market. Meury also said Incyte expects fourth-quarter data for povorcitinib in prurigo nodularis and for OPZELURA in HS.

On business development, Meury highlighted the Vega acquisition as an example of the company’s preferred approach: acquiring a de-risked, late-stage asset in an area aligned with Incyte’s hematology expertise. Latarcibart uses a different approach to treating von Willebrand disease by modulating anticoagulant protein S. Cagnoni said a database analysis cited by the company estimated that about 30,000 patients with von Willebrand disease could qualify for prophylaxis, while only about 2,000 currently receive it.

Meury said business development remains a priority as Incyte seeks to supplement its internal pipeline, but stressed the importance of deploying capital carefully.

About Incyte (NASDAQ:INCY)Incyte Corporation is a biopharmaceutical company focused on discovering, developing and commercializing medicines for oncology and inflammatory diseases. Founded in 1991 and headquartered in Wilmington, Delaware, the company conducts research in areas including oncology, hematology, immunology and dermatology.

Incyte's commercial portfolio includes Jakafi (ruxolitinib), a treatment for certain myelofibrosis, polycythemia vera and graft-versus-host disease; Opzelura (ruxolitinib) cream for atopic dermatitis and nonsegmental vitiligo; and Pemazyre (pemigatinib) for selected cancers involving abnormal FGFR signaling.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Incyte Corporation (INCY) Presents at Wells Fargo 21st Annual Healthcare Conference Transcript

Incyte Corporation is transitioning from a Jakafi-centric model to a diversified, multi-franchise biotech with several late-stage pipeline assets. 2Q26 results showed 17% underlying net sales growth, broad-based portfolio expansion, and strong operating leverage despite one-time Opzelura CMS benefits. INCY's pipeline maturity and upcoming 2H26 clinical readouts across dermatology, hematology, and oncology are pivotal for validating its multi-engine growth thesis.

 | Source: Knight Therapeutics

MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.

“This supplemental submission to ANVISA marks an important step in our efforts to expand MINJUVI®’s potential in earlier lines of therapy in Brazil,” said Samira Sakhia, President and Chief Executive Officer of Knight. “Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible.”

In September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (commercialized as MONJUVI® in the United States and MINJUVI® ex-U.S.). Knight has launched MINJUVI® in Brazil, Mexico and Argentina for use in combination with lenalidomide, followed by MINJUVI® monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplantation (ASCT). In March 2026, Knight announced the approval and launch of MINJUVI® in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in Brazil.1 Also in March 2026, Knight submitted MINJUVI® for the same indication in Argentina and Mexico.

This supplemental submission to ANVISA builds on those approvals, seeking a first-line indication for MINJUVI® based on results from the Phase 3 frontMIND trial.

About MINJUVI®

MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI® is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).2

Additionally, MONJUVI® received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).2 This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, MINJUVI® received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI®monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI® is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.3

In Japan, MINJUVI® is approved for use in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).4 MINJUVI® is also approved for use in Japan in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).5

XmAb is a registered trademark of Xencor, Inc.

MONJUVI® and MINJUVI® are registered trademarks of Incyte. All other trademarks are the property of their respective owners.

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, accounting for a third of all NHLs and ranging between 20%−50% by country.6 DLBCL commonly presents with enlarged lymph nodes or rapidly growing mass along with B symptoms, which include fever, night sweats, and weight loss. The B symptoms can be seen in 30% of patients. Bone marrow involvement is more common in indolent disease and can be seen in up to 50% of the cases.7 Each year, approximately 25,000 people in the U.S. and up to projected 28,000 people in Western Europe are diagnosed with DLBCL.8,9 In Brazil, data from The Department of Information Technology of the Brazilian Public Unified Healthcare System (DataSUS) reported DLBCL as the most frequently diagnosed NHL with 39,012 cases reported between 2008 – 2017. With about 40% of DLBCL patients not responding to initial therapy or relapsing thereafter,10,11 there is a high medical need for new, effective therapies, particularly for high-risk patients.

About High-grade B-Cell Lymphoma (HGBL)

High-grade B-Cell Lymphoma (HGBL) is a rare and aggressive category of B-cell non-Hodgkin lymphoma (NHL) defined by the World Health Organization (WHO).12 It comprises two principal subtypes based on specific genetic characteristics: DLBCL/HGBL with MYC and BCL2 rearrangements, which encompasses most lymphomas previously known as double- or triple-hit lymphoma, and HGBL, not otherwise specified (NOS), a heterogeneous subtype defined by high-grade morphology in the absence of these genetic rearrangements.12,14 HGBL shares clinical features with DLBCL, including rapidly enlarging lymph nodes and B symptoms such as fever, night sweats, and weight loss, and accurate diagnosis requires expert pathologic review incorporating cytomorphology, immunohistochemistry, and fluorescence in situ hybridization (FISH).12,15 The aggressive nature of HGBL and the failure of intensified therapy to improve overall survival underscore the significant unmet need for more effective treatment options.12,13

About frontMIND trial

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).16

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.16

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).16

For more information about the frontMIND trial, please visit https://www.clinicaltrials.gov/study/NCT04824092.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on the TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at https://knighttx.com/ or www.sedarplus.ca.

Forward-Looking Statements for Knight

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2025, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References

MINJUVI (tafasitamab) Powder for solution for infusion 200 mg ANVISA; prescribing information January, 2026. Accessed February 19th 2026.MONJUVI (tafasitamab-cxix) [package insert]. Wilmington, DE: Incyte Corporation; June, 2025. Accessed June 8, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdfMinjuvi (tafasitamab) [summary of product characteristics]. Amsterdam, the Netherlands: Incyte Biosciences Distribution B.V.; January, 2026. Accessed June 8, 2026. https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdfIncyte. Minjuvi® (tafasitamab) Product Information (Japan) and Pharmaceuticals and Medical Devices Agency (PMDA) electronic package insert. Accessed June 2026. https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html.Biosciences Japan G.K. Incyte Japan announces approval of Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Incyte. Published June 19, 2026. Accessed July 30, 2026. https://investor.incyte.com/news-releases/news-release-details/incyte-japan-announces-approval-minjuvir-tafasitamab-0Wang SS. Epidemiology and etiology of diffuse large B-cell lymphoma. Semin Hematol. 2023;60(5):255-266. doi:10.1053/j.seminhematol.2023.11.004Padala SA, Kallam A. Diffuse large B-cell lymphoma. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; updated April 24, 2023. Accessed June 8, 2026. https://www.ncbi.nlm.nih.gov/books/NBK557796/Chihara D, Johnston K, Bolatova T, et al. An Epidemiological Model to Estimate the Prevalence of Diffuse Large B-Cell Lymphoma in the United States. Clin Lymphoma Myeloma Leuk. 2022;22(12):e1092-e1099. doi:10.1016/j.clml.2022.08.008Berhan A, Almaw A, Damtie S, Solomon Y. Diffuse large B cell lymphoma (DLBCL): epidemiology, pathophysiology, risk stratification, advancement in diagnostic approaches and prospects: narrative review. Discov Oncol. 2025;16(1):184. Published 2025 Feb 15. doi:10.1007/s12672-025-01958-wMartins DP, Correa-Netto NF, Melo N, Loggetto SR, de Liberal MMC. Overview of lymphoma diagnosis in Brazilian public health system patients: Open data analysis for health care planning. Hematol Transfus Cell Ther. 2022;44(1):40-48. doi:10.1016/j.htct.2020.08.017Sawalha Y. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies. J Pers Med. 2021;11(12):1345. Published 2021 Dec 10. doi:10.3390/jpm11121345Lymphoma Research Foundation. High-grade B-cell lymphoma. Updated May 2024. Accessed June 19, 2026. https://lymphoma.org/publication/high-grade-b-cell-lymphoma-fact-sheet/Davies AJ. The high-grade B-cell lymphomas: double hit and more. Blood. 2024;144(25):2583-2592. doi:10.1182/blood.2023020780Zayac AS, Landsburg DJ, Hughes ME, et al. High-grade B-cell lymphoma, not otherwise specified: a multi-institutional retrospective study. Blood Adv. 2023;7(21):6381-6394. doi:10.1182/bloodadvances.2023009731Olszewski AJ, Avigdor A, Bachy E, et al. Defining and treating high-grade B-cell lymphoma, NOS. Blood. 2022;140(9):943-954. doi:10.1182/blood.2022016534Lenz G, Trněný M, Burke JM, et al. Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. Lancet. Published online May 30, 2026. doi:10.1016/S0140-6736(26)00866-4 CONTACT INFORMATION:

Investor Contact: Knight Therapeutics Inc. Samira SakhiaArvind UtchanahPresident & Chief Executive OfficerChief Financial OfficerT: 514.484.4483T. 514.484.4483Email: [email protected]: [email protected]: www.knighttx.comWebsite: www.knighttx.com

Pre-Market Stock Futures: Futures are trading lower after a wild day on Wall Street, as stocks took off after Treasury Secretary Bessent announced the Treasury would double its current bond buyback, targeting 10- to 20-year and 20- to 30-year maturities. That sparked an initial big rally, which tapered by the close; still, all of the major indices finished the day higher. The Russell 2000 roared back after a rough Tuesday and finished at 3,032, up 0.48%, while the Dow Jones Industrials closed at 53,463, up 0.22%. The tech-heavy Nasdaq closed the day at 26,331, up 0.16%, and the S&P 500 closed at 7,707, up 0.21%.

Treasury Bonds: An announced bond buyback brought more than just the Treasury into the government-debt buying picture. Yields plunged across the Treasury curve, especially on the long end where the buybacks are concentrated. When it was all said and done on Wednesday, the 30-year long bond yield plunged almost 10 basis points to close at 5.19%, while the benchmark 10-year note was last seen at 4.64%, down almost 7 basis points. Many in the fixed-income complex felt the move was a political ploy, and that with the bond vigilantes ostensibly taking care of some of the Federal Reserve’s inflation problems, it was unnecessary. 

Oil and Gas: Oil closed higher on Wednesday, with both benchmarks ending the session near 4-week highs. Continued geopolitical tension in the Middle East and slow traffic through the Strait of Hormuz remain the biggest obstacles for a sector still trying to stabilize. By the final bell, Brent Crude closed at $91.65, up 0.69%, while West Texas Intermediate was last seen at $84.39, up 0.39%. Natural gas also had a solid day, finishing the session up 1.37% at $2.81. 

Gold: Precious metals had a huge day Wednesday, as bullion surged to close above the critical $4,500 level at $ 4,521, up 4.35%, while Silver joined the party, finishing at $66.89, up 5.83%. Yahoo Finance noted that Wednesday’s rally was driven by a sharp drop in long-term U.S. Treasury yields and a weaker U.S. dollar after the Treasury Department announced plans to double its bond buyback operations. 

Crypto: Cryptocurrencies surged higher on Wednesday, driven by the U.S. Treasury’s decision to double long-term bond buybacks to ease liquidity, a new SEC proposal outlining a crypto regulatory framework, and a high-profile crypto industry summit held at the White House. At 8 AM EDT, Bitcoin was trading at $71,960, while Ethereum was trading at $2,308.

24/7 Wall St. reviews dozens of analyst research reports every day to identify fresh investment ideas for investors and traders alike. These daily analyst notes include recommendations on stocks to buy, sell, or avoid, as well as new coverage initiations. Important reminder: No single analyst report should ever be the sole basis for buying or selling a stock.

Here are some of the top Wall Street analyst upgrades, downgrades, and initiations from Thursday, August 20, 2026.  

Upgrades: Analog Devices (NYSE: ADI | ADI Price Prediction) was upgraded to Outperform from Market Perform at Bernstein, with a $465 target price. Crown Castle (NYSE: CCI) was upgraded to Overweight from Equal Weight at Barclays, which trimmed the target price for the shares to $85 from $92. Etsy (NYSE: ETSY) was upgraded to Buy from Neutral at Bank of America, which has a $105 target price for the stock. EPR Properties (NYSE: EPR) was raised to Overweight from Equal Weight at KeyBanc, with a $70 target price. Merck & Co (NYSE: MRK) was upgraded to Overweight from Equal Weight at Morgan Stanley, which lifted the target price for the healthcare giant to $179 from $116. Downgrades: Allstate (NYSE: ALL) was downgraded to Underperform from Market Perform at Keefe Bruyette, which lowered the price target for the insurance giant to $250 from $255. Cactus (NYSE: WHD) was downgraded to Neutral from Buy at Citigroup, which has a $75 target price for the shares. Coty (NYSE: COTY) was cut to Sector Perform from Outperform at RBC Capital, which lowered the target price to $3 from $8. Liberty Latin America (NASDAQ: LILA) was cut to Underweight from Equal Weight at Morgan Stanley, with an unchanged $7 target price. TJX Companies (NYSE: TJX) was downgraded to Neutral from Buy at Citigroup, with a $154 target price. Initiations: Alphabet (NASDAQ: GOOGL) was initiated with a Buy rating at Rosenblatt, with a $410 target price. eBay (NASDAQ: EBAY) was started with a Buy rating at Rosenblatt, which has a $120 target price for the stock. Incyte (NASDAQ: INCY) was started with a Buy rating at Canaccord, with a $152 target price objective. Madison Square Garden Entertainment (NYSE: MSG) was initiated with a Neutral rating at Piper Sandler, with an $86 target price. Shopify (NASDAQ: SHOP) was initiated with a Buy rating at Rosenblatt, with a $175 target price. Contact [email protected] for any questions or corrections.

Biopharmaceutical company Incyte Corporation (INCY) gets Big Money support to gain 23% so far in 2026.

In this article:INCY

-0.33%

INCY discovers, develops, and sells proprietary therapeutics focused on hematology, oncology, inflammation, and autoimmunity. The company’s second-quarter fiscal 2026 earnings report, INCY showed $1.67 billion in quarterly revenue (a 38% year-over-year gain) led by Jakafi ($817 million) and Opzelura ($450 million), net sales of $1.49 billion (a 40% rise), and raised annual net sales guidance to a high end of $5.26 billion.

It’s no wonder INCY shares are up 23% this year, and they could rise more. MoneyFlows data shows how Big Money investors are again betting heavily on the stock.

Incyte Attracts Big Money Institutional volumes reveal plenty. In the last year, INCY has endured some choppiness. But it’s once again enjoying strong investor demand, which we believe to be institutional support.

Each green bar signals unusually large volumes in INCY shares. They reflect our proprietary inflow signal, pushing the stock higher:

INCY is up 48.4% in a year thanks to institutional support – green inflow signals came in bursts throughout the period. Source: www.moneyflows.com Plenty of health care names are under accumulation right now. But there’s a powerful fundamental story happening with Incyte.

Incyte Fundamental Analysis Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, INCY has had strong sales and earnings growth:

3-year sales growth rate (+15%) 3-year EPS growth rate (+1,355%) Source: FactSet

Also, EPS is estimated to ramp higher this year by +106.4%.

Now it makes sense why the stock has been generating Big Money interest. INCY has a track record of strong financial performance.

Marrying great fundamentals with MoneyFlows software has found some big winning stocks over the long term.

Incyte has been a top-rated stock at MoneyFlows for years. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis.

In the last year, INCY has drawn five outlier inflow signals and gained 48.4%. The blue bars below show when INCY was a top pick on the Outlier 20 report…institutions can move shares higher:

Five outlier inflow signals have sent INCY shares higher – it’s attracted 30 outlier inflow signals since 2000. Source: www.moneyflows.com Tracking unusual volumes reveals the power of money flows.

This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward.

Incyte Price Prediction The INCY action isn’t new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio.

Disclosure: the author holds no position in INCY at the time of publication.

If you are a Registered Investment Advisor (RIA) or are a serious investor, take your investing to the next level and follow our free weekly MoneyFlows insights.

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Lucas is a well-versed equity investor and educator. He currently is co-founder of research and analytics firm, MAPsignals.com, which focuses on finding outlier stocks by following the Big Money.

Latest news and analysis

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) announced today that it granted restricted stock unit awards (RSUs) representing an aggregate of 21,556 shares of the Company’s common stock and stock option awards to purchase an aggregate of 18,172 shares of the Company’s common stock to 24 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 3, 2026, 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 the employee's continued service with the Company on each such date. The stock options have an exercise price of $118.43 per share, which is equal to the closing price of the Company’s common stock on the grant date. Each stock option has a ten-year term and vests as to 25% of the original number of shares subject to the stock option on the one-year anniversary of the vesting commencement date with the remainder vesting in 36 successive equal monthly installments, subject to the employee’s continued service with the Company on each such date.

About Incyte
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen listed on the Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1],[2] In the pivotal Phase 3 inMIND clinical trial, patients with R/R FL receiving the Minjuvi combination regimen experienced a significant improvement in progression-free survival, with a 57% reduction in the risk of disease progression, relapse or death, compared with placebo plus lenalidomide and rituximab.[3] Follicular lymphoma is the second most common non-Hodgkin lymphoma (NHL), with over 10,000 Australians living with the disease and approximately 1,500 Australians diagnosed each year.[4],[5] , /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the listing of Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1] This milestone follows the Australian registration of Minjuvi for R/R FL by the Therapeutic Goods Administration (TGA) in April 2026, via the Project Orbis process.[6]

The PBS listing of Minjuvi marks the availability of the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this group of patients.[1],[2] Effective 1 August 2026, eligible patients with FL who have experienced relapses or disease progression on existing therapies will now have equitable access to a new treatment option for this difficult-to-treat condition.[1]

"As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia," said Carlo Montagner, ST Chief Executive Officer. "After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay."

ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore.

Minjuvi is a CD19 targeting immunotherapy that works within a patient's immune system to help find and eliminate malignant B-cells.[7] In combination with rituximab and lenalidomide, Minjuvi delivers a complementary immune-mediated approach that helps control disease progression and supports improved long-term outcomes for patients with follicular lymphoma.[7]

The PBS reimbursement underscores the growing recognition of innovative immunotherapy-based treatment strategies in follicular lymphoma and reinforces ST's commitment to improving access to life-changing therapies for patients across the Asia-Pacific region.

"While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment," said Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne. "Today's PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for R/R FL."

Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting.[7] Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.[7]

"Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community," said Sharon Winton, Chief Executive Officer of Lymphoma Australia. "As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families."

The PBS listing of Minjuvi for R/R FL means these patients will now have equitable access to a new targeted immunotherapy combination treatment when they need it. It is important that patients with R/R FL speak with their doctor to understand the most suitable treatment option available for them.

For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.

PBS Information:

This medicine is listed on the Pharmaceutical Benefits Scheme (PBS) — AUTHORITY REQUIRED. Refer to the PBS Schedule www.pbs.gov.au for full authority information.

Important Safety Information on Minjuvi[7]

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded. In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

Ends.

About Minjuvi® (tafasitamab)

Minjuvi® (tafasitamab) is a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody. Minjuvi incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).[7] Incyte licenses exclusive worldwide rights to develop and commercialise Minjuvi from Xencor, Inc. 

In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. 

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. 

In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorisation from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy. 

In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory DLBCL. Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory FL (2L+ FL). 

In Australia, Minjuvi® (tafasitamab) is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).[7]

▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA.[7]

XmAb® is a registered trademark of Xencor, Inc. 

Monjuvi and Minjuvi are registered trademarks of Incyte. 

About the inMIND Study[3]

A global, double-blind, randomised, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years), including 548 participants with R/R FL. 54 Australians participated in the study across 12 local trial sites around the country.

The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.

The clinical trial met its primary endpoint, with the data demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56].

Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of Minjuvi to lenalidomide in combination with rituximab. The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.

About Specialised Therapeutics

Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas.           

Additional information can be found at www.stbiopharma.com.

REFERENCES:

[1]. Australian Government, Department of Health, Disability and Ageing. PBS Schedule: PBS Publications & Downloads [August 2026].

[2]. NCCN Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. Version 3.2026.

[3]. Sehn LH, et al. Lancet. 2026 Jan 10;407(10524):133-146.

[4]. Lymphoma Australia. Types of Lymphoma: Follicular Lymphoma. [Accessed July 2026].

[5]. Australian Institute of Health and Welfare (AIHW). Cancer Data in Australia: Prevalence Data Workbook – Blood Cancer Histology. [Accessed July 2026].

[6]. Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG): MINJUVI (tafasitamab). [Accessed July 2026].

[7]. MINJUVI Australian Product Information. 20 April 2026.

SOURCE Specialised Therapeutics

It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.

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Value ScoreFor value investors, it's all about finding good stocks at good prices, and discovering which companies are trading under their true value before the broader market catches on. The Value Style Score utilizes ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to help pick out the most attractive and discounted stocks.

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Stock to Watch: Incyte (INCY - Free Report) Wilmington, Delaware based Incyte Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. The company conducts its European clinical development operations in Geneva, Switzerland.

INCY is a #3 (Hold) on the Zacks Rank, with a VGM Score of A.

Additionally, the company could be a top pick for growth investors. INCY has a Growth Style Score of B, forecasting year-over-year earnings growth of 15.7% for the current fiscal year.

Two analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.14 to $7.87 per share. INCY boasts an average earnings surprise of +28.7%.

With a solid Zacks Rank and top-tier Growth and VGM Style Scores, INCY should be on investors' short list.

Incyte Corporation (INCY) Q2 2026 Earnings Call Transcript

Can Incyte Deliver on 447% EPS Forecasts and Pipeline Hype?Incyte NASDAQ: INCY reported second-quarter 2026 net product sales of $1.49 billion, up 40% from a year earlier, supported by demand growth across its marketed portfolio and a one-time non-cash benefit tied to the resolution of a CMS matter involving OPZELURA.

Excluding the $246 million one-time benefit, total net sales increased 17% year over year, Chief Executive Officer Bill Meury said on the company’s earnings call. Meury said every marketed product recorded year-over-year growth in both U.S. and international markets.

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5 top healthcare stocks for earnings growth in 2024The company raised its full-year 2026 total net sales outlook to a range of $5.13 billion to $5.26 billion. It also increased OPZELURA sales guidance and narrowed and raised its outlook for the hematology and oncology portfolio.

Jakafi Remains Foundational as Other Products Expand Jakafi second-quarter sales were $817 million, up 7% from the prior-year period. Prescription demand increased 9% across myelofibrosis, polycythemia vera and graft-versus-host disease, with polycythemia vera serving as the largest growth driver, Meury said.

Argenx's 28% Surge & Promising Product Propel Investor ConfidenceIncyte recently launched Jakafi XR, an extended-release version of the product. Jakafi XR generated $10 million in second-quarter sales, primarily from initial inventory build. The company expects full-year XR sales of approximately $40 million to $50 million, included within its broader Jakafi guidance.

Mohamed Issa, executive vice president and head of U.S. Commercial, said payer reimbursement has begun and several major insurers have placed Jakafi XR on formulary. Incyte is targeting 50% to 70% formulary coverage by year-end and expects the extended-release product to represent roughly 3% to 5% of demand by December.

Sales from Incyte’s business excluding Jakafi totaled $671 million, up 127% year over year. Excluding the one-time OPZELURA benefit, the segment grew 44%. Meury said the company remains on track toward its objective of generating $3 billion to $4 billion in net sales from the core business excluding Jakafi by 2030.

OPZELURA Benefit Lifts Guidance OPZELURA contributed $450 million in second-quarter sales, including $204 million in net product sales and the $246 million non-cash benefit associated with the CMS settlement and the reversal of previously accrued balances related to Medicaid rebate litigation.

U.S. OPZELURA sales excluding the one-time benefit rose 22% to $161 million. Prescription volume increased 26%, compared with 21% growth for the overall market, according to Meury. The company said OPZELURA captured 46% of branded topical new prescription volume.

The CMS resolution improved the product’s average selling price and gross-to-net profile, Meury said. He said the gross-to-net rate moved from the low 60% range to the high 50% range. Incyte now expects $1.05 billion to $1.10 billion in full-year OPZELURA sales, including an estimated $300 million to $310 million impact from the settlement.

International OPZELURA sales rose 34% to $43 million. The company expects a final European Commission decision for OPZELURA in moderate atopic dermatitis during the third quarter after receiving a positive opinion from the Committee for Medicinal Products for Human Use in June.

Hematology and Oncology Portfolio Gains Momentum Hematology and oncology sales increased 69% to $222 million. Niktimvo generated $60 million in sales, up 67%, with more than 300 new patients initiating therapy during the quarter and more than 1,200 patients treated. Incyte said it holds approximately one-third of the third-line-and-beyond market.

MONJUVI sales increased 72% to $54 million, driven primarily by uptake in follicular lymphoma in international markets, including Japan following a recent approval and launch. ZYNYZ sales rose fourfold to $50 million, with the company reporting more than a 40% share in first-line squamous cell carcinoma of the anal canal in the U.S. 12 months after launch.

Incyte narrowed and raised its 2026 hematology and oncology sales forecast to $860 million to $890 million.

Pipeline Updates Include Vega Acquisition and Program Discontinuation The company said it has advanced 13 of 15 planned pivotal studies, with the remaining two expected to begin by year-end. Regulatory reviews are ongoing for povorcitinib in hidradenitis suppurativa and tafasitamab in newly diagnosed diffuse large B-cell lymphoma, with potential approvals and launches beginning later in 2026 and extending into 2027.

Incyte also acquired Vega Therapeutics, adding latarcibart, a phase III treatment candidate for von Willebrand disease. Pablo Cagnoni, Incyte’s president and global head of research and development, said data from the VIVID-3 study showed an 81% median reduction in annualized bleeding rate across patients with different von Willebrand disease subtypes and bleeding types. Top-line data from the phase III VIVID-6 trial are expected by early 2029.

Meanwhile, Incyte discontinued development of its 058 program targeting JAK2 V617F in myeloproliferative neoplasms. Cagnoni said the company concluded that the molecule did not demonstrate the profile needed to be a differentiated therapy, though Incyte continues to view JAK2 V617F as an important target and is prioritizing next-generation programs.

The company plans to present expanded early-stage data for its KRAS G12D inhibitor, INCB161734, its TGF-beta receptor 2 by PD-1 bispecific antibody, and its CDK2 inhibitor at the European Society for Medical Oncology Congress in October.

Expenses Rise With Development Investment and Vega Transaction GAAP operating expenses were $976 million in the quarter, up 42% from a year earlier. Incyte said the comparison reflected a lower prior-year expense base following a $242 million Novartis settlement in the second quarter of 2025. Excluding that favorable adjustment, operating expenses rose 5%.

GAAP research and development expense increased 4% to $517 million, while selling, general and administrative expense rose 6% to $352 million, driven in part by pre-launch activities for povorcitinib. The company ended the quarter with $4.5 billion in cash and cash equivalents, including the impact of the Vega acquisition completed in July.

Incyte raised its 2026 GAAP R&D and SG&A expense outlook to $4.915 billion to $4.995 billion. The revised forecast includes approximately $1.27 billion related to the Vega transaction’s upfront in-process research and development payment and transaction costs, as well as roughly $50 million for continued phase III development of latarcibart.

About Incyte (NASDAQ:INCY)Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company's research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.

The company's flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.

The popular research service can help you become a smarter, more self-assured investor, giving you access to daily updates of the Zacks Rank and Zacks Industry Rank, the Zacks #1 Rank List, Equity Research reports, and Premium stock screens.

Zacks Premium also includes the Zacks Style Scores.

What are the Zacks Style Scores? The Zacks Style Scores is a unique set of guidelines that rates stocks based on three popular investing types, and were developed as complementary indicators for the Zacks Rank. This combination helps investors choose securities with the highest chances of beating the market over the next 30 days.

Based on their value, growth, and momentum characteristics, each stock is assigned a rating of A, B, C, D, or F. The better the score, the better chance the stock will outperform; an A is better than a B, a B is better than a C, and so on.

The Style Scores are broken down into four categories:

Value ScoreValue investors love finding good stocks at good prices, especially before the broader market catches on to a stock's true value. Utilizing ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and many other multiples, the Value Style Score identifies the most attractive and most discounted stocks.

Growth ScoreGrowth investors are more concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, the Growth Style Score analyzes characteristics like projected and historic earnings, sales, and cash flow to find stocks that will see sustainable growth over time.

Momentum ScoreMomentum investors, who live by the saying "the trend is your friend," are most interested in taking advantage of upward or downward trends in a stock's price or earnings outlook. Utilizing one-week price change and the monthly percentage change in earnings estimates, among other factors, the Momentum Style Score can help determine favorable times to buy high-momentum stocks.

VGM ScoreIf you want a combination of all three Style Scores, then the VGM Score will be your friend. It rates each stock on their combined weighted styles, helping you find the companies with the most attractive value, best growth forecast, and most promising momentum. It's also one of the best indicators to use with the Zacks Rank.

How Style Scores Work with the Zacks Rank The Zacks Rank is a proprietary stock-rating model that harnesses the power of earnings estimate revisions, or changes to a company's earnings expectations, to help investors build a successful portfolio.

Investors can count on the Zacks Rank's success, with #1 (Strong Buy) stocks producing an unmatched +23.94% average annual return since 1988, more than double the S&P 500's performance. But the model rates a large number of stocks, and there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.

But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.

That's where the Style Scores come in.

You want to make sure you're buying stocks with the highest likelihood of success, and to do that, you'll need to pick stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you like a stock that only has a #3 (Hold) rank, it should also have Scores of A or B to guarantee as much upside potential as possible.

The direction of a stock's earnings estimate revisions should always be a key factor when choosing which stocks to buy, since the Scores were created to work together with the Zacks Rank.

For instance, a stock with a #4 (Sell) or #5 (Strong Sell) rating, even one that boasts Scores of A and B, still has a downward-trending earnings forecast, and a much greater likelihood its share price will decline as well.

Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.

Stock to Watch: Incyte (INCY - Free Report) Wilmington, Delaware based Incyte Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. The company conducts its European clinical development operations in Geneva, Switzerland.

INCY is a #3 (Hold) on the Zacks Rank, with a VGM Score of A.

It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 15.11; value investors should take notice.

Two analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.14 to $7.87 per share. INCY boasts an average earnings surprise of +18.3%.

With a solid Zacks Rank and top-tier Value and VGM Style Scores, INCY should be on investors' short list.

Drugmaker Incyte Corp reported on Tuesday higher second-quarter earnings and raised its annual revenue forecast after it settled ​a lawsuit with the U.S. government over Medicaid rebates ‌tied to eczema cream Opzelura.