On February 6, 2026 Kite, a Gilead Company (Nasdaq: GILD), reported the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed.

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Primary central nervous system lymphoma is a rare and fast‑growing lymphoma that originates in the brain, spinal cord, eye, or cerebrospinal fluid. Prognosis for PCNSL remains poor, with a five‑year survival rate of approximately 30%. More than half of patients see their disease come back after the first treatment, with subsequent survival of approximately two months, highlighting the urgent need for new and better treatment options.

The FDA decision is based on positive results from a Phase 1 investigator-sponsored study conducted by Dana-Farber Cancer Institute, which included patients with R/R PCNSL.

"We are pleased that our study, which highlighted the safety of axi-cel in central nervous system lymphoma, supported the FDA’s decision," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma, Dana-Farber Cancer Institute and Associate Professor of Neurology, Harvard Medical School. "This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options."

In the Phase 1 study, neurologic toxicities occurred in 85% (11/13) of patients with R/R PCNSL. Thirty-one percent (4/13) of patients had Grade 3 neurologic toxicities. The Grade 3 or 4 adverse events were hypotension (23%; 3/13), encephalopathy (15%; 2/13), seizure (15%; 2/13), gait disturbance (8%; 1/13), headache (8%; 1/13), hypoxia (8%; 1/13), muscular weakness (8%; 1/13), nausea (8%; 1/13), pyrexia (8%; 1/13), thrombosis (8%; 1/13), and tremor (8%; 1/13).

"We are encouraged by the positive results of the safety study in patients with central nervous system lymphoma, who were previously excluded from the trials supporting Yescarta’s approval," said Gallia Levy, MD, PhD, Senior Vice President and Global Head of Development, Kite. "We appreciate the FDA’s timely review and decision, which expands access to Yescarta for patients with primary central nervous system lymphoma—one of the most aggressive and underserved forms of the disease—and we are deeply grateful to the patients and clinicians who made this progress possible."

About Central Nervous System Lymphoma

Central nervous system lymphoma (CNSL) is an aggressive and rare form of non-Hodgkin lymphoma that has either originated in (primary) or spread (secondary) to the brain, eye, spinal cord, or cerebrospinal fluid. There is an estimated annual incidence of 1,500 cases of PCNSL in the United States; it comprises 3% of all primary brain tumors and 1% of all cases of non-Hodgkin lymphoma. Its prognosis has historically been poor, with a five-year survival rate of only 30%. CNSL is most likely to be seen in the elderly and people with a compromised immune system. R/R CNSL is considered an area of unmet clinical need with no standard-of-care treatment options.

About the Study

The Phase 1 safety study enrolled 18 patients (13 PCNSL, 5 SCNSL), of whom the first six patients were observed for treatment-limiting toxicities (TLTs). The primary endpoint was safety, measured by rate of TLTs and ≥ Grade 3 adverse events (AEs). Secondary endpoints included objective response rate, complete response rate, duration of response, progression-free survival and overall survival (OS).

About Yescarta

Please see full Prescribing Information, including BOXED WARNING below and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more 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).
U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA.
CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in Study 2, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in Study 1, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days).

CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in Study 3, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in Study 2. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities including immune effector cell-associated neurotoxicity syndrome (ICANS) that were fatal or life-threatening occurred following treatment with YESCARTA. Neurologic toxicities occurred in 78% (330/422) of patients with NHL (excluding central nervous system lymphoma) receiving YESCARTA, including ≥ Grade 3 in 25% in Study 1, Study 2, and Study 3.

Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in Study 2, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in Study 1 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in Study 2. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and median duration was 15 days in patients with LBCL in Study 1. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion in 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in Study 2. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities; 8% (3/39) developed Grade 3 and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset, and decrease the duration of CRS.

Neurologic toxicities occurred in 85% (11/13) of patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in Study 4. 31% (4/13) of patients had Grade 3 neurologic toxicities. The median time to onset of neurologic toxicities was 3 days (range: 1 to 9 days) and the median time to onset of first Grade ≥ 3 neurologic toxicity was 9.5 days (range: 5 to 158 days). The median duration of neurologic toxicities was 59 days (range: 52 to 87 days) while 45% (5/11) of patients had ongoing neurological toxicities at the time of study withdrawal, death, or data cut off. The most common neurologic toxicities at the time of study withdrawal, death, or data cut off. The most common neurologic toxicities (≥ 10%) in patients with PCNSL included confusional state (38%), headache (31%), somnolence (31%), disturbance in attention (23%), lethargy (23%), tremor (23%), gait disturbance (15%), hypersomnia (15%), insomnia (15%), and seizures (15%).

Monitor patients for signs and symptoms of neurologic toxicities following infusion at least daily for 7 days; and for 2 weeks thereafter and treat promptly. Advise patients to avoid driving for at least 2 weeks following infusion.

HYPERSENSITIVITY REACTIONS

Allergic reactions may occur with the infusion of YESCARTA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV and management in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 30%) in:

patients with LBCL in Study 1 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, and febrile neutropenia.
patients with LBCL in Study 2 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, nausea, hypoxia, tremor, and cough.
patients with PCNSL in Study 4 included sinus tachycardia, CRS, pyrexia, headache, encephalopathy, hypotension, diarrhea, vomiting, chills, fatigue, musculoskeletal pain, hypoxia, rash maculo-papular, cough, nausea, constipation, musculoskeletal weakness, dizziness, thrombosis, gait disturbance, weight decreased, tremor, insomnia, and dyspnea.
patients with FL in Study 3 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, and tremor.
The most common (≥30%) Grade 3-4 laboratory abnormalities in:

patients with LBCL in Study 1 included leukocyte decrease, neutrophil decrease, lymphocyte decrease, and hemoglobin decrease.
patients with LBCL in Study 2 included lymphocyte decrease, leukocyte decrease, neutrophil decrease, hemoglobin decrease, platelet decrease, and phosphate decrease.
patients with FL in Study 3 included lymphocyte decrease, leukocyte decrease, neutrophil decrease, platelet decrease, and hemoglobin decrease.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

(Press release, Gilead Sciences, FEB 6, 2026, View Source [SID1234662530])

On February 6, 2026 Biogen Inc. (Nasdaq: BIIB) reported fourth quarter and full year 2025 financial results. Commenting on the results, President and Chief Executive Officer Christopher A. Viehbacher said:

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"Our 2025 performance reflected continued focus on strong execution and financial discipline, driven by our revenue of nearly $1 billion from LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY, progression of our pipeline, and resilience of our MS franchise. Our pipeline momentum continues with a strong start in 2026, with the FDA recently granting Priority Review for LEQEMBI IQLIK initiation and Breakthrough Therapy Designation for litifilimab in CLE. These milestones highlight both the innovative and differentiated value of our medicines and the strength of our late-stage pipeline. Going into 2026, we are looking forward to data
1 Growth products include SKYCLARYS, QALSODY, ZURZUVAE, VUMERITY and SPINRAZA, plus Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
1
from two Phase 3 studies in lupus for litifilimab, with 10 additional potentially registrational studies across our pipeline expected to read out sequentially over the next four years. This multi-year registrational data flow has the potential to drive meaningful innovation for patients and long-term value for shareholders."
Financial Highlights
Q4 ’25 Q4 ’24 fav/(unfav) fav/(unfav)
at CC* FY ’25 FY ’24 fav/(unfav) fav/(unfav)
at CC*
Total Revenue (in millions) $2,279 $2,455 (7)% (7)% $9,891 $9,676 2% 2%
GAAP diluted EPS $(0.33) $1.83 (118)% N/A $8.79 $11.18 (21)% N/A
Non-GAAP diluted EPS $1.99 $3.44 (42)% N/A $15.28 $16.47 (7)% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(In millions, except percentages) Q4 ’25 Q4 ’24 fav/(unfav) fav/(unfav)
at CC* FY ’25 FY ’24 fav/(unfav) fav/(unfav)
at CC*
Multiple Sclerosis (MS) product revenue(1)
$917 $1,070 (14)% (15)% $4,039 $4,350 (7)% (7)%
Rare disease revenue(2)
$515 $535 (4)% (4)% $2,154 $1,988 8% 9%
Biosimilars revenue $170 $202 (16)% (15)% $729 $793 (8)% (7)%
Other product revenue(3)
$66 $26 157% 158% $197 $83 139% 140%
Total product revenue $1,667 $1,833 (9)% (9)% $7,119 $7,214 (1)% (1)%
Revenue from anti-CD20 therapeutic programs $521 $465 12% 12% $1,861 $1,750 6% 6%
Alzheimer’s collaboration revenue(4)
$47 $27 77% 76% $178 $60 197% 197%
Contract manufacturing, royalty and other revenue $44 $130 (66)% (66)% $733 $653 12% 12%
Total revenue $2,279 $2,455 (7)% (7)% $9,891 $9,676 2% 2%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding. NMF = no meaningful figure.
(1) MS includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ZURZUVAE, ADUHELM and FUMADERM.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
Expense Summary
(In millions, except percentages) Q4 ’25 Q4 ’24 fav/(unfav) FY ’25 FY ’24 fav/(unfav)
GAAP cost of sales*
$496 $583 15% $2,404 $2,310 (4)%
% of Total Revenue 22% 24% 24% 24%
Non-GAAP cost of sales*
$445 $540 18% $2,089 $2,137 2%
% of Total Revenue 20% 22% 21% 22%
GAAP R&D expense $509 $513 1% $1,779 $1,980 10%
Non-GAAP R&D expense $478 $509 6% $1,731 $1,868 7%
GAAP SG&A expense $683 $680 —% $2,434 $2,404 (1)%
Non-GAAP SG&A expense $678 $673 (1)% $2,421 $2,340 (3)%
GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense $222 $19 NMF $472 $62 NMF

2
Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
IPR&D = in-process R&D. NMF = no meaningful figure.
*Excluding amortization and impairment of acquired intangible assets.

•The decrease in fourth quarter 2025 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix including lower contract manufacturing revenue.

•The increase in full year 2025 GAAP cost of sales as a percentage of total revenue was driven primarily by a pre-tax charge related to a judgment on Genentech’s claim for past royalties and interest on sales of TYSABRI. The decrease in full year 2025 Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix.

•The decrease in fourth quarter and full year 2025 GAAP and Non-GAAP R&D expense was driven primarily by the favorable impact from the Company’s Fit for Growth initiative and R&D funding received, partially offset by increased investment in late-stage programs including felzartamab and litifilimab.

•The increase in fourth quarter and full year 2025 GAAP and Non-GAAP SG&A expense was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Fourth quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $222 million.
Other Financial Highlights

•Fourth quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $70 million. This includes approximately $47 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $22 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. related to the commercialization of ZURZUVAE in the U.S.

•Full year 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $290 million. This includes approximately $219 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $71 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. related to the commercialization of ZURZUVAE in the U.S.

•Fourth quarter 2025 GAAP other expense was approximately $154 million and includes approximately $131 million related to litigation matters. Fourth quarter 2025 Non-GAAP other expense was approximately $46 million, primarily driven by net interest expense.

•Full year 2025 GAAP other expense was approximately $306 million and includes the aforementioned approximately $131 million related to litigation matters. Full year 2025 Non-GAAP other expense was approximately $179 million, primarily driven by net interest expense.

•Fourth quarter 2025 GAAP and Non-GAAP effective tax rates were 12.8% and 10.1%, respectively. Fourth quarter 2024 GAAP and Non-GAAP effective tax rates were 8.5% and 12.2%, respectively.

•Full year 2025 GAAP and Non-GAAP effective tax rates were 16.9% and 15.5%, respectively. Full year 2024 GAAP and Non-GAAP effective tax rates were 14.4% and 14.6%, respectively.
Financial Position

•Fourth quarter 2025 net cash flow from operations was approximately $512 million. Capital expenditures were approximately $44 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $468 million.

•Full year 2025 net cash flow from operations was approximately $2.2 billion. Capital expenditures were approximately $154 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $2.1 billion.
3

•As of December 31, 2025, Biogen had cash and cash equivalents totaling approximately $4.2 billion with approximately $6.3 billion in total debt, resulting in net debt of approximately $2.0 billion.

•For the fourth quarter of 2025 the Company’s weighted average shares were 147 million and 148 million, used to calculate the Company’s GAAP and Non-GAAP diluted EPS, respectively. All unvested equity-based awards are antidilutive for GAAP due to reporting a net loss for the fourth quarter of 2025. For full year 2025 the Company’s weighted average diluted shares were 147 million.

Full Year 2026 Financial Guidance

For the full year 2026, Biogen expects a Non-GAAP diluted EPS guidance range as follows:
Full Year 2026 Guidance
Non-GAAP diluted EPS
$15.25 to $16.25

Total revenue is expected to decline by a mid-single digit percentage for 2026 as compared to 2025 as further declines in multiple sclerosis product revenue, excluding VUMERITY, are expected to be partially offset by increases in revenue from growth products.

For full year 2026 as compared to full year 2025, Biogen expects the gross margin percentage, and combined Non-GAAP R&D expense and Non-GAAP SG&A expense to be roughly consistent year-over-year. Biogen expects full year 2026 Non-GAAP effective tax rate to be between approximately 17% and 18%.

This guidance also assumes that foreign exchange rates as of January 30, 2026, will remain in effect for the remainder of the year, net of hedging activities.

Unless expressly stated above, this financial guidance does not include any acquired IPR&D, impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are hard to predict. Other important financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2026 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the fourth quarter will be broadcast via the internet at 8:30 a.m. ET on February 6, 2026 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, FEB 6, 2026, View Source [SID1234662525])

On February 6, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC).

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Immutep Chief Executive Officer, Marc Voigt, said, "The excellent pace of enrolment globally in the TACTI-004 trial speaks to the promise of efti and the need for more efficacious therapies in the first line setting for patients with advanced/metastatic non-small cell lung cancer. Our team continues to work hard to bring this innovative cancer immunotherapy to market and looks forward to delivering on additional important upcoming milestones ahead, including the futility analysis in the first quarter and completing patient enrolment in the third quarter this year."

The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival.

The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, FEB 6, 2026, View Source;v=undefined [SID1234662513])

On February 5, 2026 Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, reported the addition of the LeukoStrat KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM laboratories worldwide.

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The assay is available to detect key AML-associated KMT2A rearrangements, which account for the vast majority of KMT2A fusion partners in AML1 and those most commonly targeted in menin-inhibitor clinical development programs. Later this year, the assay will be enhanced with four additional KMT2A rearrangements which are frequently found in acute lymphocytic leukemia (ALL), expanding its utility across leukemias.

The LeukoStrat KMT2A + MRD Assay accurately identifies and quantifies common KMT2A rearrangements that drive KMT2A-translocated acute leukemias, offering translational researchers and biopharmaceutical partners a critical tool to assess MRD and to evaluate therapeutic response. With unprecedented sensitivity down to 0.005% (5×10-5) and precise quantitation through normalization against a control gene, the assay enables far more rapid turnaround time and more sensitive detection of low-level KMT2A rearrangements that traditional cytogenetics and FISH methods miss. The LeukoStrat KMT2A + MRD Assay and Software streamline both initial screening and longitudinal MRD monitoring from a single workflow, facilitating efficient implementation both in research laboratories and as a service supporting clinical research.

"Invivoscribe is setting a new standard for how researchers and biopharmaceutical partners can identify, monitor and understand disease response," said Jeff Miller, CEO and CSO at Invivoscribe. "Our LeukoStrat KMT2A + MRD Assay provides partners with a powerful tool for exploratory and pivotal analyses in menin-inhibitor trials, offering precise insights into subject response throughout treatment. This assay builds on our international reputation as the ideal partner for pharmaceuticals looking to accelerate KMT2A trials using MRD as a surrogate endpoint and for companion diagnostic development as these therapies advance toward approval."

The assay integrates with LeukoStrat KMT2A + MRD Software for rapid, objective analysis, enabling labs and biopharmaceutical partners to unlock complex molecular insights. When paired with Invivoscribe’s globally standardized LabPMM network and regulatory expertise, it supports the full development pathway from early-phase trials through CDx validation and commercialization.

For a comprehensive approach to therapy development, biopharmaceutical partners can combine the LeukoStrat KMT2A + MRD Assay for treatment monitoring with Invivoscribe’s established myeloid portfolio of IVDR and research use only LeukoStrat CDx and MRD assays, including prognostic biomarkers such as FLT3 and NPM1.2,3,4,5 Invivoscribe’s proven track record in companion diagnostics (CDx) development and successful global regulatory submissions positions the company as a trusted strategic partner for menin-inhibitor programs progressing toward approval.

(Press release, Invivoscribe Technologies, FEB 5, 2026, View Source [SID1234662521])

On February 5, 2026 Partner Therapeutics, Inc. (PTx), a privately held, fully integrated biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zenocutuzumab‑zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab-zbco is being developed in a subset of patients with cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion.

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Cholangiocarcinoma (CCA) is a rare, aggressive malignancy of the bile ducts, typically diagnosed at an advanced stage when curative options are limited. There are approximately 8,000 cases annually in the United States, and the five-year survival rate for all stages remains below 15 percent, emphasizing the need for new therapeutic approaches. NRG1 gene fusions result from structural DNA rearrangements and typically occur without other oncogenic alterations. Like other fusions, they are best detected with a combination of tissue-based RNA and DNA next generation sequencing.

Systemic first-line treatment regimens in cholangiocarcinoma yield modest clinical benefit, with overall response rates (ORRs) of 26% to 29% and median overall survival (OS) of 11.7 to 12.8 months. Second-line treatment with FOLFOX provides an ORR of 5%, progression free survival of 4.0 months, and median OS of 6.2 months. Zenocutuzumab-zbco has shown activity in patients with cholangiocarcinoma harboring NRG1 gene fusion.

"Patients with cholangiocarcinoma face a particularly aggressive cancer with poor prognosis and limited treatment options. Receiving Orphan Drug Designation for zenocutuzumab in patients with CCA harboring the NRG1 gene fusion is a significant regulatory milestone for Partner Therapeutics and highlights the urgent need for new and effective treatment options for patients with this disease" said Juan W. Valle, MD, Chief Medical Officer of the Cholangiocarcinoma Foundation.

The FDA grants Orphan Drug Designation to investigational products designed to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. Designation benefits may include up to seven years of market exclusivity upon approval, exemption from FDA user fees, eligibility for clinical‑trial tax credits, and closer collaboration with the Agency during development.

Zenocutuzumab‑zbco, marketed as BIZENGRI, received Breakthrough Therapy Designation from the FDA in October 2025 and was granted accelerated approval in December 2024 for adults with advanced unresectable or metastatic non‑small cell lung cancer and pancreatic ductal adenocarcinoma harboring NRG1 gene fusions following prior therapy.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1 Gene Fusions

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions, including NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECUATIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions

BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis

BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction

BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity

Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, FEB 5, 2026, View Source [SID1234662520])