On February 12, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that the first patient has been dosed in the PiNACLE – H2H Phase 3 trial evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the second-line (2L) setting.

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"Ronde-cel is a dual-targeting CD19/CD20 CAR T-cell product candidate that has demonstrated impressive clinical data in patients with aggressive large B-cell lymphoma," said Krish Patel, MD, Director of Lymphoma Research at Sarah Cannon Research Institute (SCRI). "One of our SCRI CAR T-cell sites is the first to enroll in this important trial designed to provide physicians the data we need to make the best treatment decisions for our patients. Furthermore, this trial represents a milestone in the field of cellular therapy, being the first trial to randomize patients between different CAR T-cell therapies."

"Data from Lyell’s single-arm pivotal PiNACLE trial in patients with later-stage large B-cell lymphoma are expected to be submitted for marketing approval to the FDA next year," said David Shook, MD, Lyell’s Chief Medical Officer. "We are now pleased to have underway PiNACLE – H2H, the first-of-its-kind Phase 3 head-to-head randomized controlled CAR T-cell trial. This strategy demonstrates Lyell’s confidence in ronde-cel’s potential to be the best-in-class CAR T-cell treatment for patients with relapsed or refractory disease."

PiNACLE – H2H is a Phase 3 head-to-head CAR T-cell randomized controlled clinical trial of ronde-cel versus Investigator’s choice of either liso-cel or axi-cel in patients with R/R LBCL receiving treatment in the 2L setting. Patients randomized to ronde-cel will be treated with a dose of 100 x 106 CAR T cells; patients in the control arm will be treated as per the product label. The primary endpoint of this superiority trial is event-free survival and the trial plans to enroll approximately 200 patients per arm (N = 400) with R/R LBCL, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma, Grade 3B follicular lymphoma, or transformed follicular or transformed mantle cell lymphoma who have not previously received CAR T-cell therapy. Patients may be treated with ronde-cel in either the inpatient or outpatient setting.

More information about the PiNACLE – H2H trial can be found on clinicaltrials.gov (NCT07188558) here.

Ronde-cel is also being studied in PiNACLE, a pivotal single-arm trial in the third- or later-line (3L+) setting. This registration trial is a seamless expansion of the 3L+ cohort from the multi-cohort multi-center Phase 1/2 trial and will enroll approximately 120 patients at approximately 25 sites. The dose is 100 x 106 CAR T cells and the primary endpoint is overall response rate. Patients may be treated with ronde-cel in either the inpatient or outpatient setting. More information about the PiNACLE trial can be found on clinicaltrials.gov (NCT05826535) here.

At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025, Lyell reported positive updated clinical data in patients with aggressive LBCL in the 3L+ and 2L settings from the Phase 1/2 trial. The oral presentation included updated data from the 3L+ cohort (now the ongoing PiNACLE pivotal trial), including a best overall response rate of 93% and a complete response rate of 76% in 29 efficacy-evaluable patients with R/R LBCL. The median progression-free survival was 18 months as of the data cutoff date of September 5, 2025. Updated data were also presented from the 2L cohort, including 18 efficacy evaluable patients (94% with high-risk primary refractory disease), and demonstrated an 83% best overall response rate and a 61% complete response rate. The safety profile was appropriate for outpatient administration of ronde-cel. Data from 25 patients treated with ronde-cel and receiving dexamethasone prophylaxis revealed no reports of Grade 3 or higher cytokine release syndrome (CRS) and one case (4%) of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS).

About Rondecabtagene Autoleucel (Ronde-cel)

Rondecabtagene autoleucel (ronde-cel, also known as LYL314) is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19-targeted CAR T-cell therapies for the treatment of R/R LBCL.

Ronde-cel is designed with an ‘OR’ logic gate to target B cells that express either CD19, CD20 or both, each with full potency. Ronde-cel is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a proprietary process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity.

Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) designation as well as Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of adults with R/R diffuse LBCL (DLBCL) in the 3L+ setting and has also received RMAT designation for the treatment of LBCL in the 2L setting. The FDA has also granted ronde-cel Orphan Drug Designation for the treatment of DLBCL/high grade B-cell lymphoma with MYC and BCL2 rearrangements.

(Press release, Lyell Immunopharma, FEB 12, 2026, View Source [SID1234662642])

On February 12, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the fourth quarter and full year ended December 31, 2025 and highlighted progress on key clinical development programs.

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"As we enter 2026, Karyopharm is approaching a defining period marked by important upcoming clinical milestones and a continued focus on disciplined execution, positioning the Company at a potential inflection point," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "While selinexor has established a durable commercial foundation in multiple myeloma within a highly competitive treatment landscape, our late-stage programs in myelofibrosis and endometrial cancer represent an opportunity to fundamentally expand the impact and scale of our franchise."

"Top-line data from our Phase 3 SENTRY trial in myelofibrosis are expected in March, and our organization is energized and well positioned to support the next phase of this program. If SENTRY is successful, we have the potential to meaningfully improve outcomes for patients and introduce the first-ever combination therapy in myelofibrosis, a setting with significant unmet need. In endometrial cancer, we remain on track to report top-line data in mid-2026 from our Phase 3 trial evaluating selinexor in a defined, biomarker-driven patient population with limited effective treatment options. With the upcoming myelofibrosis readout as a key near-term catalyst and endometrial cancer representing a subsequent opportunity for further expansion, 2026 positions Karyopharm at a potential inflection point as we work to translate our science into durable patient impact and long-term value creation," added Mr. Paulson.

Fourth Quarter 2025 Highlights

XPOVIO Commercial Performance

U.S. net product revenue was $114.9 million for the year ended December 31, 2025 compared to $112.8 million for the year ended December 31, 2024. U.S. net product revenue for the fourth quarter of 2025 was $32.1 million compared to $29.3 million for the fourth quarter of 2024.

Demand for XPOVIO was consistent in 2025 versus 2024 in the highly competitive multiple myeloma marketplace, with the community setting continuing to drive approximately 60% of overall net product revenue.

Global patient access for selinexor expanded in 2025, with favorable reimbursement decisions in Spain and China, and additional regulatory approvals in multiple countries with selinexor now approved in more than 50 countries.
Research and Development (R&D) Highlights

Myelofibrosis

Completed enrollment in early September 2025 of the Phase 3 SENTRY trial (XPORT-MF-034; NCT04562389) which is evaluating 60 mg once-weekly selinexor in combination with ruxolitinib compared to ruxolitinib plus placebo in 353 JAKi-naïve patients with myelofibrosis. The preliminary baseline characteristics for patients enrolled in SENTRY as presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting (n=320) are representative of the intended patient population. In addition, preliminary blinded aggregate safety data from the first 61 patients with a median follow-up of greater than 12 months may suggest improvements in both hematologic and non-hematologic treatment-emergent adverse events as compared to the Phase 1 data evaluating selinexor 60 mg weekly in combination with standard of care ruxolitinib in JAKi-naïve myelofibrosis patients, as well as historical ruxolitinib monotherapy data. The Company cautions that preliminary baseline characteristics and preliminary blinded aggregate safety data from the Phase 3 SENTRY trial may not ultimately be reflective of the actual trial results.
Endometrial Cancer

Enrollment continues in the Phase 3 XPORT-EC-042 trial (NCT05611931) evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer.
Multiple Myeloma

Enrollment in the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) was completed in the fourth quarter of 2024 (n=117). The trial is being conducted in collaboration with the European Myeloma Network and is evaluating the all-oral combination of selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in patients with previously treated multiple myeloma who received an anti-CD38 in their immediate prior line of therapy.
Anticipated Catalysts and Operational Objectives

Myelofibrosis

Top-line data from the Phase 3 SENTRY trial is expected in March 2026.

Top-line data from all patients in the 60 mg cohort of the Phase 2 SENTRY-2 trial (NCT05980806) with at least 24 weeks of follow-up is expected in the second half of 2026. The Company continues to enroll patients into the Phase 2 SENTRY-2 trial.
Endometrial Cancer

Top-line data from the event-driven, Phase 3 XPORT-EC-042 trial is expected in mid-2026. The Company continues to enroll patients into the XPORT-EC-042 trial of selinexor as a maintenance monotherapy for patients with TP53 wild-type advanced or recurrent endometrial cancer.
Multiple Myeloma

Maintain the Company’s commercial foundation in the increasingly competitive multiple myeloma marketplace and drive increased XPOVIO revenues.

Continue to support global launches by our partners following regulatory and reimbursement approvals for selinexor in ex-U.S. territories.

Top-line data from the event-driven, Phase 3 XPORT-MM-031 (EMN29) trial is expected in the second half of 2026.
2026 Financial Outlook

Based on its current operating plans, Karyopharm expects the following for full year 2026:

Total revenue to be in the range of $130 million to $150 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.

U.S. XPOVIO net product revenue to be in the range of $115 million to $130 million.

R&D and selling, general and administrative (SG&A) expenses to be in the range of $230 million to $245 million.

The Company expects its existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable it to fund its current operating plans into the second quarter of 2026.
Full Year and Fourth Quarter 2025 Financial Results

Total revenue: Total revenue for the fourth quarter of 2025 was $34.1 million, compared to $30.5 million for the fourth quarter of 2024, and $146.1 million for the year ended December 31, 2025, compared to $145.2 million for the prior year.

Net product revenue: Net product revenue was $32.1 million for the fourth quarter of 2025, compared to $29.3 million for the fourth quarter of 2024, and $114.9 million for the year ended December 31, 2025, compared to $112.8 million for the prior year.

License and other revenue: License and other revenue was $2.0 million for the fourth quarter of 2025, compared to $1.3 million for the fourth quarter of 2024, and $31.2 million for the year ended December 31, 2025, compared to $32.4 million for the prior year.

Cost of sales: Cost of sales was $1.5 million for the fourth quarter of 2025, compared to $1.3 million for the fourth quarter of 2024, and $5.9 million for the year ended December 31, 2025 compared to $6.0 million for the prior year.

R&D expenses: R&D expenses were $27.7 million for the fourth quarter of 2025, compared to $33.3 million for the fourth quarter of 2024, and $125.6 million for the year ended December 31, 2025, compared to $143.2 million for the prior year. The decreases in both periods reflect lower personnel and stock-based compensation costs and reduced overall clinical trial spending, partially offset by increased clinical trial and related costs for our myelofibrosis program.

SG&A expenses: SG&A expenses were $22.8 million for the fourth quarter of 2025, compared to $27.2 million for the fourth quarter of 2024, and $105.2 million for the year ended December 31, 2025, compared to $115.4 million for the prior year. The decreases in both periods reflect lower personnel-related costs and reduced commercial spending as part of the Company’s cost reduction initiatives.

Loss from operations: Loss from operations was $17.8 million for the fourth quarter of 2025, compared to $31.3 million for the fourth quarter of 2024, representing a 43% improvement. For the year ended December 31, 2025, loss from operations was $90.7 million, compared to $119.4 million for the prior year, representing a 24% improvement. The decreases reflect improved operating efficiency and disciplined cost management.

Interest income: Interest income was $0.6 million for the fourth quarter of 2025, compared to $1.5 million for the fourth quarter of 2024, and $2.8 million for the year ended December 31, 2025, compared to $7.4 million for the prior year. The decreases in both periods reflect lower investment balances during 2025 compared to 2024.

Interest expense: Interest expense was $12.6 million for the fourth quarter of 2025, compared to $11.2 million for the fourth quarter of 2024, and $45.8 million for the year ended December 31, 2025, compared to $37.4 million for the prior year. The increases in both periods reflect higher outstanding debt and higher interest rates following the Company’s financing transactions executed in October 2025.

(Loss) gain on extinguishment of debt: (Loss) gain on extinguishment of debt was a loss of $62.4 million for the year ended December 31, 2025, compared to a gain of $44.7 million for the prior year. The change reflects the impact of financing transactions completed in 2025, compared to 2024.

Other (expense) income, net: Other (expense) income, net was $10.0 million of expense in the fourth quarter of 2025, compared to $10.1 million of income in the fourth quarter of 2024, and $0.2 million of income for the year ended December 31, 2025, compared to $28.4 million in the prior year. The amounts primarily reflect non-cash fair value remeasurements of embedded derivatives and liability-classified common stock warrants related to the refinancing transactions completed in the second quarter of 2024 and the fourth quarter of 2025.

Net loss: Net loss was $102.2 million, or $5.71 per basic and diluted share, for the fourth quarter of 2025, compared to $30.8 million, or $3.67 per basic and diluted share, for the fourth quarter of 2024. Net loss for the year ended December 31, 2025 was $196.0 million, or $17.93 per basic and diluted share, compared to $76.4 million, or $9.41 per basic share and $14.00 per diluted share, for the prior year. Net loss included non-cash stock-based compensation expense of $3.9 million in each of the fourth quarters of 2025 and 2024, and $14.1 million and $18.4 million for the years ended December 31, 2025 and 2024, respectively. More than half of the full-year loss was driven by below-the-line items, primarily the loss on extinguishment of debt and interest expense, which are largely non-cash in nature.

Cash position: Cash, cash equivalents, restricted cash and investments as of December 31, 2025 totaled $64.1 million, compared to $109.1 million as of December 31, 2024.

Conference Call Information

Karyopharm will host a conference call today, February 12, 2026, at 8:00 a.m. Eastern Time, to discuss the fourth quarter 2025 financial results, the financial outlook for 2026 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website. An archived webcast will be available on the Company’s website approximately two hours after the event.

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. Patients are 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.

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. Patients treated with the most commonly prescribed JAK inhibitor often require blood transfusions, and more than 30% will discontinue treatment due to anemia.2 Anemia and transfusion dependence are correlated with poor prognosis and shortened survival.3

1. Clarivate/DRG (2023)

2. Palandri, F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis. Blood Cancer J. 11, 4 (2021).

3. Pardanani, A., & Tefferi, A. (2011). Prognostic relevance of anemia and transfusion dependency in myelodysplastic syndromes and primary myelofibrosis. Haematologica, 96(1), 8–10.

About the Phase 3 XPORT-EC-042 Trial

EC-042 (XPORT-EC-042; NCT05611931) is a global, Phase 3, randomized, double-blind clinical trial evaluating selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer. The EC-042 trial is expected to enroll approximately 276 patients who will be 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 will be tested sequentially: 1) a modified intent to treat population (mITT) that will include 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. The key secondary endpoint of overall survival will be evaluated in the ITT population. The mITT population is expected to include approximately 220 patients. 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.

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 Eng 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 in the U.S. and marketed by Karyopharm 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; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. 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, including in myelofibrosis and endometrial cancer.

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).

For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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%.

The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
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, FEB 12, 2026, View Source [SID1234662641])

On February 12, 2026 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the full year (FY) 2025 and for the fourth quarter of 2025.

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Extract of consolidated results4 for FY25 and FY24

FY 2025 FY 2024 % change
€m €m Actual CER
Total Sales 3,675.9 3,400.6 8.1 % 10.9 %
Core Operating Income 1,294.1 1,109.4 16.7 %
Core operating margin 35.2 % 32.6 % +2.6pts
Core Consolidated Net Profit 1,009.1 857.8 17.6 %
Core earnings per share (fully diluted) €12.09 €10.27 17.8 %
IFRS Operating Income 625.9 496.7 26.0 %
IFRS operating margin 17.0 % 14.6 % +2.4pts
IFRS Consolidated Net Profit 444.5 347.3 28.0 %
IFRS earnings per share (fully diluted) €5.32 €4.15 28.3 %
Free Cash Flow 1,000.6 774.4 29.2 %
Closing net cash/(debt) 559.9 160.3 n/a

"In 2025, Ipsen delivered strong sales and profit growth," said David Loew, Chief Executive Officer, Ipsen. "We continued to execute across all three therapeutic areas, with a notable performance from Iqirvo. We have advanced multiple pipeline programs and further strengthened our innovation engine through targeted business development, including the acquisition of Imcheck Therapeutics. We also achieved promising proof-of-concept for IPN10200, our first-in-class differentiated long-acting recombinant molecule.

We are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and a better outlook for Somatuline given the production challenges faced by generic competition. We anticipate five regulatory and clinical milestones this year and to further deliver on our external innovation strategy."

Full-year 2026 guidance and mid-term outlook
Ipsen has set for FY 2026 the following financial guidance:

Total sales growth greater than 13.0%, at constant currency. Based on the average level of exchange rates in January 2026, an adverse effect on total sales of around 2% of currencies is expected
Core operating margin greater than 35.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities
Guidance on total sales and core operating margin is assuming accelerated sales growth of the portfolio excluding Somatuline and the growth of Somatuline sales due to generic lanreotide challenges. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions.

As part of its ongoing review of long-term assumptions including competitive intensity and product lifecycle considerations, Ipsen no longer expects to achieve the €500m peak sales for Onivyde and Tazverik.

Based on higher expected Somatuline sales due to continued generic lanreotide production challenges and the performance of the broader portfolio, Ipsen is highly confident on its 2027 mid-term outlook to exceed the total-sales average growth5 of at least 7% per year for the period 2023-27 and core operating margin in 2027 of at least 32%6 of total sales.

Pipeline progress
During 2025, Ipsen achieved a number of important regulatory and clinical milestones across its portfolio, reflecting continued advancement of its pipeline across the three therapeutic areas.

In the first quarter of 2025, the regulatory filing for tovorafenib, an oral, type II RAF-kinase inhibitor for pediatric low-grade glioma, was accepted for review by the European Medicines Agency (EMA).

In May 2025, Ipsen presented Phase II data from the ELMWOOD study of Iqirvo (elafibranor) at the European Association for the Study of the Liver (EASL) Congress, demonstrating a favorable safety profile and dose-dependent efficacy over 12 weeks in people living with primary sclerosing cholangitis, a condition with high unmet medical need.

In July 2025, the European Commission approved Cabometyx (cabozantinib) for the treatment of previously treated advanced neuroendocrine tumors (NETs), based on positive results from the Phase III CABINET trial.

In September 2025, positive Phase II data from the LANTIC trial in aesthetics were reported, demonstrating a differentiated, long-acting clinical profile for IPN10200. During the year, Ipsen also initiated a Phase II study of IPN10200 in cervical dystonia, representing the fourth clinical study in the development plan of the global long-acting recombinant molecule across therapeutic and aesthetic indications.

In December 2025, Ipsen announced that the pivotal Phase II FALKON trial of fidrisertib in fibrodysplasia ossificans progressiva (FOP) did not meet its primary endpoint and that the study was subsequently closed; fidrisertib was generally well-tolerated, with no safety concerns identified.

In addition, Ipsen initiated multiple Phase I oncology studies across IPN01195, a RAF inhibitor, the antibody-drug conjugate IPN60300 and the T-cell activator IPN01203, further strengthening its targeted oncology pipeline.

External innovation
In December 2025, Ipsen expanded its immuno-oncology portfolio with the acquisition of ImCheck Therapeutics, a biotechnology company developing next-generation immuno-oncology therapies including IPN60340 (ICT01), a first-in-class monoclonal antibody targeting BTN3A, currently in Phase I/II development, with a Phase IIb/III study planned to start in 2026. IPN60340 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults.

Interim data orally presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard-of-care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard-of-care (Ven-Aza). In January 2026, Ipsen also announced that IPN60340 received U.S. FDA Breakthrough Therapy Designation in first-line unfit acute myeloid leukemia.

In December 2025, Ipsen further strengthened its oncology and early-stage pipeline through two additional targeted business development and research collaborations. Ipsen entered into an exclusive licensing agreement with Simcere Zaiming for rights outside Greater China to SIM0613, an antibody–drug conjugate (ADC) targeting LRRC15. Ipsen also announced a new research collaboration and option agreement with the Université de Montréal and IRICoR, encompassing two discovery-stage programs focused on novel inhibition of pathways complementary to the MAP kinase pathway.

2026 Upcoming Milestones
Ipsen anticipates several key milestones across its portfolio in 2026, including:

Tovorafenib (FIREFLY-1) – European regulatory decision for pediatric low-grade glioma
Bylvay (BOLD) – Readout of pivotal Phase III in biliary atresia
Iqirvo (ELSPIRE) – Readout of pivotal Phase III in primary biliary cholangitis
Dysport (BEOND) – Readout of pivotal Phase III trials in chronic and episodic migraine
IPN10200 (LANTIC) – Readout of Phase II in lateral canthal lines and forehead lines
These milestones reinforce Ipsen’s commitment to advancing innovative therapies and expanding treatment options for patients worldwide.

Full data from the Phase II LANTIC study of IPN10200, which demonstrated a positive first-in-class, differentiated long-acting clinical profile enabling the initiation of Phase III, are expected to be presented in the first half of 2026 at an upcoming congress.

Galderma arbitration
In January 2026, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision in favor of Ipsen, dismissing the claim brought by Galderma in connection with Ipsen’s termination of the R&D agreement. The Tribunal confirmed Ipsen’s full rights to its clinical-stage toxin programs in the aesthetics field, including IPN10200. Ipsen continues to assess all options to maximize the value of its long-acting program.

Environmental, Social and Governance
Ipsen took important steps in 2025 to deliver its ambitious sustainability strategy, continuing to embed sustainability across its operations and decision-making. From reducing its environmental footprint to advancing patient access and strengthening its workplace culture, Ipsen reinforced its commitment to delivering progress for patients, employees, communities, and the planet.

Ipsen made good progress across multiple environmental targets, including:

54% reduction in Scopes 1 & 2 greenhouse gas emissions (vs. a 2019 baseline)
16% reduction in Scope 3, fully in line with our 2030 targets (vs. a 2019 baseline)
100% of Ipsen’s global electricity now comes from renewable sources
55% of the company fleet now comprised of electric vehicles as of 2025 through the Fleet for Future Project
Ipsen received an A rating from CDP for our best-practice environmental actions and transparency, and for demonstrating our comprehensive understanding of environmental dependencies, risks, and opportunities.

Ipsen is proud to be one of the first biopharmaceutical companies to achieve full gender parity within the Executive Leadership Team, and with women now representing 53% of the Global Leadership Team.

Consolidated financial statements
The Board of Directors approved the consolidated financial statements on 11 February 2026. The consolidated financial statements have been audited, and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements 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 CET. Participants can access the webcast here. Analysts can join the call and ask questions by registering here.

(Press release, Ipsen, FEB 12, 2026, View Source [SID1234662640])

On February 12, 2026 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported that it will participate in the following scientific and investor conferences:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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American Association for Cancer Research Immuno-Oncology Conference (Los Angeles, CA)
Date: Wednesday, February 18
Time: 7:30-10 PM PT, Poster Session A
Poster Presentation: Treatment of RRP with DNA immunotherapy INO-3107 induces activation and enrichment of pro-inflammatory CD4+ T cell responses in blood and airways of patients with clinical response

Oppenheimer 36th Annual Healthcare Life Sciences Conference (Virtual)
Date: Wednesday, February 25
Time: 12:40 -1:10 PM ET
Format: Fireside Chat
Webcast: https://event.summitcast.com/view/CTtthLh2Bi2D9aYoKpvtEv/degYsHNqjq4UMJYMr4minN

Festival of Biologics (San Diego, CA)
Date: Wednesday, March 4
Time: 3:10 PM PT
Presentation: Safety and Pharmacokinetics of SARS-CoV-2 DNA-Encoded Monoclonal Antibodies (DMAbs) in Healthy Adults: A Phase 1 Trial

Citizens Life Sciences Conference (Miami Beach, FL)
Date: Tuesday, March 10
Time: 1:40 – 2:05 PM ET
Format: Fireside Chat
Webcast: https://event.summitcast.com/view/BuMiPNPtyHKimMF6k4AFMd/j7XuLLN6VFvrBMcQmqB55w

Available abstracts will be shared on INOVIO’s website following presentations. Replay of the investor events will be available for 90 days at the links above and on the INOVIO events page. Members of INOVIO’s management team will also be conducting one-on-one meetings with investors during the investor conferences.

(Press release, Inovio, FEB 12, 2026, View Source [SID1234662639])

On February 12, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported that the strong commercial performance of Iqirvo in its first full year on the primary biliary cholangitis (PBC) market has triggered a US$20M milestone payment from Ipsen under the companies’ licensing agreement.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The commercial success of Iqirvo in 2025 underscores the strength of our partnership with Ipsen and exceeded our initial expectations with first-year net sales reaching US$208M. This performance activated a US$20M milestone payment ahead of plan, reinforcing GENFIT’s financial position. This momentum also led to the receipt of an additional €30M tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility in a non-dilutive way.

In parallel, Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial in primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.

Beyond Iqirvo, GENFIT continues to advance its oncology program. The ongoing Phase 1b study in cholangiocarcinoma (CCA), evaluating GNS561 in combination with a MEK inhibitor, is progressing in line with expectations. As communicated in December 2025, early positive activity was observed in the first evaluable patients at Week 6. Enrollment for a the next escalated-dose cohort has now been completed, with no dose-limiting toxicities (DLTs) reported to date. Recruitment for the following one will now proceed, consistent with the predefined dose‑escalation process. Multi-cohort readouts on safety, tolerability and activity along with the determination of the recommended Phase 2 doses remain expected by the end of the first half of 2026.

Pascal Prigent, CEO of GENFIT declared: "We are pleased with Ipsen’s continued success with Iqirvo. Net sales have surpassed US$200M in 2025 and this remarkable performance has allowed us to get the first commercial milestone a year earlier than anticipated. We believe that this commercial trajectory has the potential to be transformative for our business model. We are also pleased with the progress of our GNS561 program, with a new cohort fully recruited. This program might bring significant hope for patients with a devastating disease, and we are eagerly awaiting new data. As we are also anticipating the first ACLF patients to be included in a phase 2 evaluating G1090N in the second half of the year we believe 2026 will be a landmark year for GENFIT."

GENFIT will publish its 4Q25 revenue and cash position on February 26, 2026.

(Press release, Genfit, FEB 12, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-receive-us20m-milestone-after-ipsens-iqirvor-exceeds [SID1234662638])