Keros Therapeutics to Receive Development Milestone Payment from Partner Takeda

On July 30, 2026 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported that it will receive a $20 million development milestone payment under the terms of the license agreement of elritercept with partner Takeda, following the dosing of the first patient in the ELRiSE MDS clinical trial. ELRiSE MDS is a Phase 3, multicenter, open-label, randomized trial to compare the efficacy and safety of elritercept versus epoetin alfa for the treatment of anemia due to very low, low, or intermediate risk myelodysplastic syndromes ("MDS").

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"We are delighted by the continued progress of the elritercept program," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "We are encouraged by the positive signals that were observed in the Phase 2 clinical trial of elritercept in patients with very low-, low-, or intermediate-risk MDS, which were observed in patients with MDS both with and without ring sideroblasts."

Under the terms of the global license agreement with Takeda to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau, which became effective on January 16, 2025, Keros received a $200 million upfront cash payment in February 2025, and is eligible to receive development, commercial and sales milestones with the potential to exceed $1.1 billion. Keros will also be eligible to receive tiered royalties on net sales.

Keros expects to distribute 25% of the net cash proceeds from this milestone payment to its stockholders following receipt of the payment.

About Elritercept

Elritercept is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. Elritercept is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis.

(Press release, Keros Therapeutics, JUL 30, 2026, View Source [SID1234669537])

Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway

On July 30, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that it plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in August 2026 seeking accelerated approval of selinexor in combination with ruxolitinib for the treatment of patients with myelofibrosis.

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The planned submission follows productive engagements with the FDA, including written feedback that spleen volume reduction ≥ 35% (SVR35) appears to qualify as a reasonably likely surrogate endpoint (RLSE) to predict overall survival and can be used to support an sNDA under the accelerated approval pathway. The Company plans to use overall survival data from long-term follow-up of the ongoing Phase 3 SENTRY trial to verify clinical benefit. Overall survival is a pre-specified secondary endpoint of SENTRY. The trial does not permit patient crossover; patients, investigators and the Karyopharm study team remain blinded to treatment assignment during ongoing follow-up.

"The SENTRY trial generated one of the most compelling frontline datasets in myelofibrosis to date," said Dr. John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Center of Excellence for Blood Cancers and Myeloid Disorders. "The combination of selinexor and ruxolitinib demonstrated compelling spleen responses across a broad range of subgroups. The spleen responses were rapid, deep and sustained with promising overall survival findings and important evidence of disease modification. These results have the potential to redefine frontline treatment and establish a new treatment paradigm for patients with myelofibrosis."

"Patients with myelofibrosis have waited too long for meaningful innovation," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are grateful to the FDA for its thoughtful and collaborative engagement in helping define a rigorous path forward. If approved, selinexor in combination with ruxolitinib has the potential to become the first approved combination therapy for patients with myelofibrosis, incorporating a novel class of therapy. We believe this represents a potentially transformative opportunity for patients and a defining moment in Karyopharm’s history as we work with urgency toward our planned August sNDA submission."

The planned sNDA will be based on results from the randomized, double-blind, Phase 3 SENTRY trial that compared selinexor in combination with ruxolitinib against placebo in combination with ruxolitinib, including the statistically significant improvement in SVR35 at week 24, the rapid, deep and sustained nature of the spleen responses, a promising overall survival signal, reductions in variant allele frequency and the overall safety data package.

"The SENTRY trial generated a substantial body of evidence showing consistent improvements across multiple measures of clinical activity, including spleen response and a promising signal of overall survival," said Reshma Rangwala, M.D., Ph.D., Chief Medical Officer and Head of Research of Karyopharm. "Together, these findings reinforce the biologic rationale for combining XPO1 and JAK inhibition and support the potential of this novel combination to deliver meaningful long-term benefits for patients with myelofibrosis."

Karyopharm intends to request Priority Review at the time of submission of the sNDA, which, if granted, would result in a Prescription Drug User Fee Act (PDUFA) target action date approximately six months following the FDA’s receipt of the application.

About the Phase 3 SENTRY Trial

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L (N=353). Patients were randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline. The results from the Phase 3 SENTRY trial were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and were simultaneously published in the peer-reviewed Journal of Clinical Oncology. In addition, the results were presented at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, where the presentation was recognized as one of the six best abstracts at the meeting.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib.

1. Clarivate/DRG (2023)

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved and marketed by Karyopharm in the U.S. in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; and (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high-unmet need cancer indications.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

(Press release, Karyopharm, JUL 30, 2026, View Source [SID1234669536])

Karyopharm Announces Topline Results from Phase 3 XPORT-EC-042 Trial in Endometrial Cancer

On July 30, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported topline results from its Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression free survival. A trend favoring the selinexor arm was observed in the modified intent to treat (mITT) population (n=236), with a median PFS of 12.75 months in the selinexor arm compared to 7.43 months in the placebo arm (hazard ratio=0.76 [95% CI: 0.51, 1.12]; one-sided p-value=0.0791). The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed. Karyopharm intends to complete a full evaluation of the data from the XPORT-EC-042 trial and plans to present the data at a future medical meeting. The results of the XPORT-EC-042 trial do not affect ongoing trials of selinexor in other potential indications.

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"These results are meaningful for a patient population lacking effective maintenance therapies that can delay disease progression," said Professor Ignace Vergote, MD, gynecologic oncologist at the Catholic University Leuven in Belgium, European Network for Gynaecological Oncological Trial groups (ENGOT) and global lead principal investigator. "The trend for a longer progression-free survival observed in the mITT population of the selinexor arm continues to highlight the potential of XPO1 inhibition in patients with TP53 wild-type/pMMR endometrial cancer."

"Delaying the progression of cancer by five months at the median is a meaningful and encouraging outcome," said Dr. Robert Coleman, M.D., FACOG, FACS, of Texas Oncology and the Gynecologic Oncology Group (GOG) and lead principal investigator in the United States. "Although I am disappointed that the PFS improvement was not statistically significant, I look forward to continuing to follow these results over time and presenting the data from this important trial at an upcoming medical meeting. This patient population who have TP53 wild-type/pMMR advanced or recurrent endometrial cancer remains in need of new treatment options."

"While disappointed by these unexpected results, we believe they advance the scientific understanding of XPO1 inhibition for tens of thousands of endometrial cancer patients worldwide. We are deeply committed to further investigating these data," said Reshma Rangwala, MD, PhD, Chief Medical Officer and Head of Research at Karyopharm. "I would like to thank all of the patients, their families and the clinical trial investigators and their staff, as well as ENGOT and GOG, for participating in this trial."

"While the results we are announcing today fell short of our expectations, they do not diminish our confidence in the broader potential of selinexor and benefit of XPO1 inhibition," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We remain focused on maximizing our opportunity in myelofibrosis and continuing to build on our profitable multiple myeloma business. Looking ahead, we expect several important milestones in our myelofibrosis program over the next year, including the submission of our sNDA, the potential addition of selinexor to relevant compendia guidelines and topline data from the 60 mg cohort of the Phase 2 SENTRY-2 trial, each anticipated in the second half of 2026."

About the Phase 3 XPORT-EC-042 Trial

EC-042 (XPORT-EC-042; ENGOT-EN20; GOG-3083; NCT05611931) is a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating selinexor as a maintenance-only therapy following chemotherapy or chemotherapy plus a checkpoint inhibitor in patients with TP53 wild-type advanced or recurrent endometrial cancer (N=257). Patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial includes two patient populations, for which the primary endpoint of progression free survival was tested sequentially: 1) a modified intent to treat population (mITT) that includes patients with either, a) TP53 wild-type tumors with proficient mismatch repair status (pMMR); or, b) TP53 wild-type tumors with deficient mismatch repair status (dMMR), who are medically ineligible to receive checkpoint inhibitors; and, 2) the trial’s original intent to treat (ITT) population, which includes all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status. Overall survival is a key secondary endpoint. The mITT population enrolled 236 patients. As of the data cut-off, 106 progression free survival events as assessed by the investigator had been observed in the mITT population. In connection with the EC-042 trial, Karyopharm entered into a global collaboration with Foundation Medicine, Inc. to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test to identify and enroll patients whose tumors are TP53 wild-type. The trial is being conducted in collaboration with the European Network of Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation, Inc.

About Endometrial Cancer

Endometrial cancer (EC) is the most common gynecologic malignancy in the U.S.1 In 2026, approximately 68,000 uterine cancers (predominantly endometrial) are expected to be diagnosed, with approximately 14,000 deaths.1 Worldwide there were about 420,368 cases with 97,723 deaths in 2022.2 Both incidence and mortality have continued to rise.3,4 Key risk factors include obesity, type 2 diabetes, high-fat diets, tamoxifen or oral estrogen use, and delayed menopause.5 TP53 is a well-recognized prognostic marker for EC; >50% of advanced or recurrent EC tumors are TP53wt (gene for tumor protein P53; wild-type), and ~40%-55% are both TP53wt and mismatch repair-proficient (pMMR).6-8 While immune checkpoint inhibitors have shown benefit in patients with mismatch repair–deficient (dMMR) and pMMR, the magnitude of benefit is greater for patients with dMMR tumors versus pMMR tumors.9-10 There remains an unmet need for targeted therapies for patients with pMMR EC.11

1. American Cancer Society. Cancer Facts & Figures 2026. View Source Accessed February 8, 2026

2. IARC GLOBOCAN 2022, Global Estimates

3. Lu KH, et al. N Engl J Med. 2020;383:2053-2064

4. NCI. Cancer stat facts: uterine cancer. View Source Accessed October 7, 2025

5. American Cancer Society, Endometrial Cancer Risk Factors, 2025

6. Leslie KK, et al. Gynecol Oncol. 2021;161(1):113-121.

7. Vergote I, et al. J Clin Oncol. 2023;41(35):5400-5410.

8. Mirza MR, et al. Presentation at: ESMO (Free ESMO Whitepaper) Congress; October 20-24, 2023

9. Mirza MR, et al. N Engl J Med. 2023; 388:2145-2158.

10. Eskander RN, et al. N Engl J Med. 2023;388:2159-2170.

11. Makker V, et al. Gynecol Oncol. 2024 Jun:185: 202-211

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved and marketed by Karyopharm in the U.S. in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; and (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high-unmet need cancer indications.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.

Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia, and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

(Press release, Karyopharm, JUL 30, 2026, View Source [SID1234669535])

Ipsen delivers excellent H1 2026 results and upgrades its full-year guidance

On July 30, 2026 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2026.

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Extract of consolidated results H1 2026 H1 2025 % change
€m €m Actual CER
Total Sales 2 190.2 1 819.8 20.4 % 23.5 %
Core Operating Income 844.9 655.8 28.8 %
Core operating margin 38.6 % 36.0 % +2.5 pts
Core Consolidated Net Profit 607.7 508.3 19.6 %
Core earnings per share (fully diluted) €7.33 €6.07 20.7 %
IFRS Operating Income 564.8 451.6 25.1 %
IFRS operating margin 25.8 % 24.8 % +1.0 pts
IFRS Consolidated Net Profit 402.6 335.5 20.0 %
IFRS earnings per share (fully diluted) €4.86 €4.00 21.4 %
Free Cash Flow 651.7 483.2 34.9 %
Closing net cash/(debt) 1 004.9 487.6 n/a
"Our excellent first-half performance demonstrates the strength of Ipsen’s strategy, with all three therapeutic areas contributing to growth and the portfolio beyond Somatuline continuing to accelerate," said David Loew, Chief Executive Officer, Ipsen. "This momentum enables us to upgrade our 2026 guidance while continuing to invest in innovation and future growth. Importantly, we have significantly strengthened our late-stage pipeline in the first half, with positive Phase III lifecycle management readouts for Dysport in episodic and chronic migraine and Iqirvo in primary biliary cholangitis, alongside the completed acquisition of Memo Therapeutics AG and the proposed acquisition of Kartos Therapeutics. These transactions add two innovative clinical assets—navtemadlin and potravitug—with the potential to address significant unmet needs and create long-term value. Our expanding pipeline and focused business development strategy further contribute to Ipsen’s sustainable growth outlook and our ability to bring meaningful innovation to patients worldwide."

Full-year 2026 guidance

Based on the strong performance in the first half, Ipsen upgrades its financial guidance for 2026:

Total sales growth greater than 20.0%, at constant currency. Based on the average level of exchange rates in June 2026, an adverse effect on total sales of around 1% of currencies is expected
Core operating margin greater than 37.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external innovation opportunities and assumes the dilutive impact of the acquisitions of Memo Therapeutics AG and Kartos Therapeutics
Guidance4 on total sales and core operating margin in 2026 is assuming accelerated sales growth of the portfolio excluding Somatuline and the continued growth of Somatuline sales despite potential entry of generic lanreotide.

Pipeline progress since Q1 2026

Ipsen presented in May late-breaking Phase II data in Glabellar Lines for corabotase, its first-in-class recombinant neuroinhibitor (RNI), demonstrating a rapid onset of action, a statistically superior peak effect versus placebo at Week 4 and a clinically significant sustained duration of effect, outperforming both placebo and Dysport at Week 24. Corabotase has been recognized by the WHO (World Health Organization) and USAN (United States Adopted Name) as a novel botase molecule.

Ipsen announced positive topline Phase III results from the BEOND migraine program in July, with Dysport meeting the primary endpoint in both the episodic, E-BEOND and chronic, C-BEOND trials by demonstrating statistically significant reductions in monthly migraine days versus placebo. These results make Dysport the first botulinum toxin to show efficacy in Phase III trials across both episodic and chronic migraine prevention. Dysport was well tolerated, with a safety profile consistent with its established use and no new safety signals identified. Ipsen intends to submit to regulatory authorities and detailed results will be presented at a future scientific congress.

Ipsen announced positive topline results from the Phase IIIb ELSPIRE study of Iqirvo in primary biliary cholangitis (PBC) in July. The study met its primary endpoint, with 85% of patients receiving Iqirvo achieving alkaline phosphatase (ALP) normalization at Week 52 versus 23% on placebo (p=<0.0001), while maintaining a safety profile consistent with previous studies and identifying no new safety signals. ELSPIRE evaluated patients with ALP levels of 1-1.67x ULN, and supports the potential to significantly expand the addressable population for Iqirvo. Ipsen plans to submit the data to regulatory authorities and present these data at an upcoming scientific congress.

Ipsen announced in July that the Phase III BOLD trial evaluating Bylvay (odevixibat) versus placebo in patients with biliary atresia who had already undergone a Kasai hepatoportoenterostomy did not meet its primary endpoint of improved native liver survival. Topline safety data remained consistent with odevixibat’s well-established profile in its approved indications, with no new signals identified.

External innovation

Ipsen recently announced its agreement to acquire Kartos Therapeutics, a clinical-stage biopharmaceutical company, centered on navtemadlin, a Phase III oral MDM2 inhibitor for myelofibrosis designed to restore p53 tumor-suppressor activity in patients with a suboptimal response to ruxolitinib. Top-line data from the registrational POIESIS trial are expected in 2027. Under the terms of the agreement, Kartos shareholders will receive $450m upfront and may be eligible for up to $1.3bn in milestone payments, with closing anticipated by the end of Q3 2026, subject to customary conditions.

Ipsen acquired Memo Therapeutics AG in July, a clinical-stage biotechnology company focused on potravitug, a Phase II antibody targeting BK polyomavirus (BKPyV), a frequent cause of nephropathy, graft loss and transplant failure in kidney transplant recipients. Potravitug received FDA Fast Track designation in 2023 and EU Orphan Drug designation in 2025. Under the terms of the agreement, Memo Therapeutics AG shareholders received €200m upfront, with the potential for total consideration exceeding €700m through development, regulatory and sales milestones.

Consolidated financial statements

The Board of Directors approved the condensed consolidated financial statements on 29 July 2026. The Company’s auditors performed a limited review of the H1 2026 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section.

Conference call

A conference call and webcast for investors and analysts will begin today at 2pm CEST. Participants can access the webcast here. Analysts can join the call and ask questions by registering here.

Calendar

Ipsen intends to publish its year-to-date and third-quarter sales update on 22 October 2026.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2026 (H1 2026) and the three-month period to 30 June 2026 (Q2 2026), compared to the six-month period to 30 June 2025 (H1 2025) and the three-month period to 30 June 2025 (Q2 2025), respectively, unless stated otherwise. Commentary is based on the performance in H1 2026, unless stated otherwise.

(Press release, Ipsen, JUL 30, 2026, View Source [SID1234669534])

Illumina Reports Financial Results for Second Quarter of Fiscal Year 2026

On July 30, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the second quarter of fiscal year 2026.

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Second quarter 2026 results
•Revenue of $1.16 billion for Q2 2026, up 9.5% from Q2 2025 and up 8.1% excluding the impacts of currency, acquisitions, and China ("ROW1 organic revenue growth")
•GAAP operating margin of 21.1% and non-GAAP operating margin of 22.5%
•GAAP diluted EPS of $1.35 and non-GAAP diluted EPS of $1.31

"Illumina delivered strong results during the second quarter. Momentum continued to build through the first half of 2026, as our technology is enabling clinical customers to expand sequencing-intensive applications. Based on this performance, we are increasing our revenue and earnings guidance for the year," said Jacob Thaysen, Chief Executive Officer of Illumina. "Demand for NovaSeq X remains high as we expand our workflow and multiomics capabilities, broadening the value of Illumina’s ecosystem."

Fiscal year 2026 guidance
For fiscal year 2026, we now expect:
•Total revenue of $4.60-$4.64 billion, versus prior guidance of $4.52-$4.62 billion
•ROW organic revenue growth greater than 5%, versus prior guidance of 2%-4%
•Non-GAAP operating margin of 23.4%-23.6%, unchanged from prior guidance
•Non-GAAP diluted EPS of $5.30-$5.40, versus prior guidance of $5.15-$5.30

Second quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q2 2026 Q2 2025 Q2 2026 Q2 2025
Revenue
$ 1,159 $ 1,059 $ 1,159 $ 1,059
Gross margin
66.4 % 65.6 % 68.2 % 69.4 %
Operating profit
$ 245 $ 214 $ 260 $ 252
Operating margin 21.1 % 20.2 % 22.5 % 23.8 %
Diluted EPS $ 1.35 $ 1.49 $ 1.31 $ 1.19

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.

Capital expenditures for free cash flow purposes were $39 million for Q2 2026. Cash flow provided by operations was $201 million, compared to $234 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $162 million for the quarter, compared to $204 million in the prior year period. Depreciation and amortization expense was $70 million for Q2 2026. At the close of the quarter, the company held $1.17 billion in cash, cash equivalents and short-term investments.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, July 30, 2026. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

(Press release, Illumina, JUL 30, 2026, View Source [SID1234669533])