On March 10, 2025 2seventy bio, Inc. (Nasdaq: TSVT), reported a definitive merger agreement under which Bristol Myers Squibb (NYSE: BMY) ("BMS") will acquire all of the outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction for a total equity value of approximately $286 million, or $102 million net of estimated cash (Press release, 2seventy bio, MAR 10, 2025, View Source [SID1234651053]). The deal represents an 88% premium to the closing price of $2.66 on March 7, 2025.

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"A year ago, 2seventy decided to exclusively focus on unlocking the value of Abecma, with the goal of delivering more time for people living with multiple myeloma and maximizing value for all stakeholders," said Chip Baird, chief executive officer, 2seventy bio. "The strategic rationale for this acquisition is clear and today’s announcement represents the culmination of the journey for 2seventy bio. We believe that Abecma will continue to benefit from BMS’ experience and resources to ensure this important therapy is delivered to patients who need it. I would like to express my deep gratitude for current and past 2seventy team members and more broadly the dedicated community of patients, scientists, providers and partners that helped take cell and gene therapy from a complicated idea to reality for patients."

Transaction Details and Path to Completion
Under the terms of the agreement, BMS will promptly commence a tender offer to acquire all outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction. 2seventy bio’s Board of Directors unanimously recommends that 2seventy bio stockholders tender their shares in the tender offer.

The closing of the transaction is expected to occur in the second quarter of 2025 and is subject to customary closing conditions, including the tender of a majority of the outstanding shares of 2seventy bio’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, BMS will acquire all remaining shares of 2seventy bio common stock that are not tendered in the tender offer through a second-step merger at the same price in the tender offer of $5.00 per share.

Following the completion of this transaction, 2seventy bio’s common stock will no longer be listed for trading on Nasdaq.

In connection with the execution of the merger agreement, certain stockholders of 2seventy bio owning approximately 5.3% of the outstanding shares of 2seventy bio’s common stock have entered into tender and support agreements pursuant to which they have agreed to tender all of their owned shares in the offer.

Advisors
Goldman Sachs & Co. LLC is serving as exclusive financial advisor to 2seventy bio, and Goodwin Procter LLP is serving as legal counsel.

ABECMA U.S. INDICATION
ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA
ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
Warnings and Precautions:

Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes.

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 106 CAR-positive T cells.

The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 106 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 106 CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life- threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA.

In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%).

At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff.

Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia.

In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.

In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.

HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or contact Bristol-Myers Squibb at 1-866-340-7332.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion.

In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection.

Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 38% (133/349) of patients after ABECMA infusion 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.

Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively.

Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.

Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA.

Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA 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 ABECMA treatment, and until immune recovery following treatment with ABECMA.

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared to none in the standard regimens arm at the time of the safety update. The median time to onset of myeloid neoplasm from ide-cel infusion was 338 days (Range: 277 to 794 days). Three of these five patients have died following the development of myeloid neoplasm. One out of the five cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. 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 Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include pyrexia, CRS, hypogammaglobulinemia, infections – pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

On March 10, 2025 Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), reported financial results for the fourth quarter and full year 2024 and provided an overview of recent business updates (Press release, Coherus Biosciences, MAR 10, 2025, View Source [SID1234651037]).

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"2024 represents our transformation into an innovative oncology company, culminating in the agreement to divest UDENYCA," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "In 2025, we will be sharply focused on maximizing the revenue potential for LOQTORZI while advancing the development of our pipeline, including our first-in-class IL-27 antagonist, casdozokitug, and our CCR8-targeting antibody, CHS-114, in combination with LOQTORZI."

"Upon the completion of the UDENYCA divestiture and pay-off of our significant debt and royalty obligations, we are projecting a cash position of approximately $250 million," continued Mr. Lanfear. "These efforts, combined with organizational streamlining, are expected to provide Coherus with a cash runway exceeding two years, funding the development pipeline through key data catalysts in 2025 and 2026."

RECENT BUSINESS UPDATES

UDENYCA RESULTS AND DIVESTITURE

UDENYCA net product sales for Q4 2024 were $46.3 million, an increase of 28% compared to $36.2 million for Q4 2023, despite the temporary supply interruption. UDENYCA net product sales for FY 2024 were $206.0 million, an increase of 62% compared to $127.1 million for FY 2023.
Production of UDENYCA by the Company’s third-party labeling and packaging contract manufacturing organization (CMO) resumed in November 2024. An additional final packaging and labeling CMO is expected to deliver saleable product in late Q1 or in early Q2 2025, subject to U.S. Food and Drug Administration (FDA) authorization.
In December 2024, Coherus announced the divestiture of the UDENYCA franchise for up to $558.4 million. The transaction is subject to shareholder approval and other closing conditions and is expected to close late in the first quarter or early in the second quarter of 2025.
LOQTORZI RESULTS

LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), commercially launched across all lines of therapy in January 2024.
In November 2024, the National Comprehensive Cancer Network (NCCN) revised its treatment guidelines for NPC to designate LOQTORZI as the only treatment with Preferred status in NPC, both in first line (1L) with a Category 1 designation and in second line (2L) and later NPC.
LOQTORZI net product sales for Q4 2024 were $7.5 million, an increase of 29% compared to $5.8 million in Q3 2024. LOQTORZI net product sales in FY 2024 were $19.1 million.
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION IMMUNO-ONCOLOGY PIPELINE

LOQTORZI (toripalimab-tpzi) is a next-generation, differentiated PD-1 marketed in the U.S. in two indications. Coherus plans to maximize the value of this product by:

Combining LOQTORZI with internal pipeline assets, casdozokitug and CHS-114 in additional indications; and
Entering into capital-efficient external partnerships for additional label expansions. Additional partnerships evaluating LOQTORZI with novel promising cancer agents are planned for 2025.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC), and in combination activity in hepatocellular carcinoma (HCC).

Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC opened for enrollment.
Reported final data at ASCO (Free ASCO Whitepaper)-GI 2025 from a Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC. The data showed an overall response rate of 38% compared to initially announced 27%1, and complete responses (CR) per RECIST v1.1 increased to 17.2% compared to previously announced 10.3%2 and initial assessment of 0%1, demonstrating both an increase in overall response rate (ORR) and a deepening of responses compared to previous datasets. Importantly, responses were seen in viral and nonviral disease, and toxicity was consistent with the known safety profiles of atezolizumab and bevacizumab, with no new safety signals identified.
CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Phase 1 dose escalation is complete, establishing safety and proof of mechanism. Coherus expects to:

Report Phase 1 monotherapy biopsy data as well as CHS-114/toripalimab combination safety data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025.
Report first data for Phase 1b CHS-114/toripalimab combination dose optimization study in 2L HNSCC in Q2 2026.
Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026.
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS

Three Months Ended
December 31, Year Ended
December 31,
(in thousands) 2024 2023 Change 2024 2023 Change
Products
UDENYCA (a) $ 46,278 $ 36,189 $ 10,089 $ 205,951 $ 127,064 $ 78,887
CIMERLI – divested March 1, 2024 100 52,449 (52,349 ) 27,079 125,388 (98,309 )
YUSIMRY – divested June 26, 2024 33 2,214 (2,181 ) 7,541 3,574 3,967
LOQTORZI 7,522 554 6,968 19,131 554 18,577
Total net product revenue 53,933 91,406 (37,473 ) 259,702 256,580 3,122
Other revenue 211 118 93 7,258 664 6,594
Total net revenue $ 54,144 $ 91,524 $ (37,380 ) $ 266,960 $ 257,244 $ 9,716

(a) If the contemplated UDENYCA Sale is approved, Coherus anticipates the transaction would close late in the first quarter or early in the second quarter of 2025.

Net revenue for the fourth quarter of 2024, as compared to 2023, decreased $37.4 million primarily due to the Company’s divestiture of CIMERLI and YUSIMRY, partially offset by an increase in UDENYCA and LOQTORZI net sales.

For the full year 2024, UDENYCA net revenue increased $78.9 million primarily due to increased market share, offset by a change in UDENYCA segment mix and the impact of the fourth quarter temporary UDENYCA supply interruption. The $98.3 million decrease in net revenues of CIMERLI was primarily the result of the CIMERLI Sale. LOQTORZI net revenue reflects initial sales beginning in December 2023 following FDA approval. Other revenue in 2024 included $6.3 million for the sale to Apotex of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) was $33.9 million and $84.6 million during the three months ended December 31, 2024 and 2023, respectively, and $117.6 million and $159.0 million during the years ended December 31, 2024 and 2023, respectively. The decrease in COGS for the fourth quarter of 2024 compared to the same period in the prior year was primarily due to the $47.0 million charge in 2023 related to slow moving YUSIMRY inventory and products that were divested during the first half of 2024.

The decrease in cost of goods sold in the full year 2024 compared to 2023 was primarily due to a decrease of $56.9 million in costs from CIMERLI, which was divested during the first quarter of 2024 and a $47.0 million charge in the fourth quarter of 2023 related to slow moving YUSIMRY inventory. These decreases were partially offset by a $59.6 million increase in costs related to UDENYCA and LOQTORZI in 2024, which includes $14.1 million in charges for the write-down of UDENYCA inventory that did not meet acceptance criteria.

Research and development (R&D) expenses were $21.2 million and $26.4 million for the three months ended December 31, 2024 and 2023, respectively, and $93.3 million and $109.4 million for the years ended December 31, 2024 and 2023, respectively. The decreases were primarily due to savings from reduced headcount and lower costs related to biosimilar product divestitures, partially offset by increased costs for development of casdozokitug and CHS-114.

Selling, general and administrative (SG&A) expenses were $41.3 million and $49.5 million during the three months ended December 31, 2024 and 2023, respectively, and $167.7 million and $192.0 million during the years ended December 31, 2024 and 2023, respectively. The declines compared to the prior year periods were driven primarily by lower headcount and decreased operating costs following divestitures. The decrease for the year was partially offset by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, that was acquired in the Surface Oncology, Inc. acquisition and $6.7 million in divestiture-related costs incurred in the fourth quarter 2024.

Interest expense was $5.3 million and $10.6 million during the three months ended December 31, 2024 and 2023, respectively, and $27.2 million and $40.5 million during the years ended December 31, 2024 and 2023, respectively. The declines in both periods were primarily due to fully paying off the $250.0 million principal amount of the 2027 Term Loans in the second quarter 2024, partially offset by interest on the revenue participation right purchase and sale agreement and the $38.7 million principal amount of the senior secured term loan facility, both commencing May 8, 2024.

Gain on sale transactions, net was $176.6 million for the year ended December 31, 2024 and included a $153.8 million gain on the first quarter 2024 divestiture of our CIMERLI ophthalmology franchise and a $22.8 million gain on the second quarter 2024 divestiture of our YUSIMRY immunology franchise.

Net income (loss) for the fourth quarter of 2024 was a net loss of $50.7 million, or $(0.44) per share on a diluted basis, compared to a net loss of $79.7 million, or $(0.71) per share on a diluted basis for the same period in 2023. Net income for the year ended December 31, 2024 was $28.5 million, or $0.25 per share on a diluted basis, compared to a net loss of $237.9 million, or $(2.53) per share on a diluted basis for year ended December 31, 2023.

Non-GAAP net loss for the fourth quarter of 2024 was $32.5 million, or $(0.28) per share on a diluted basis, compared to $68.9 million, or $(0.62) per share for the same period in 2023. Non-GAAP net loss for the year ended December 31, 2024 was $86.3 million, or $(0.75) per share on a diluted basis, compared to $186.2 million, or $(1.98) per share for the same period in 2023. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $126.0 million as of December 31, 2024, compared to $117.7 million as of December 31, 2023.

2025 Outlook

Coherus projects post-UDENYCA-close cash of approximately $250 million and cash runway projections exceeding two years, past key data readouts expected in 2026. Approximately 50 employees associated with UDENYCA are expected to transfer to Accord BioPharma, Inc. as part of the asset purchase agreement and Coherus’ headcount will be reduced by approximately 30% following the transaction to approximately 155.

Conference Call Information

When: Monday, March 10, 2025, starting at 5:00 p.m. Eastern Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

Webcast: View Source
An archived webcast will be available on the "Investors" section of the Coherus website at View Source

On March 10, 2025 enGene Holdings Inc. (Nasdaq: ENGN, or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported its financial results for the first quarter ended January 31, 2025, and provided a business update (Press release, enGene, MAR 10, 2025, View Source [SID1234651054]).

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"With the expansion of LEGEND study sites into Europe and Asia, enrollment in our pivotal cohort continues to track in-line with our plan to file a BLA for detalimogene in mid-2026," said Ron Cooper, Chief Executive Officer of enGene. "We look forward to the remainder of 2025, during which we expect to announce enrollment completion of LEGEND’s pivotal cohort and provide additional updates on other LEGEND study cohorts. We continue to believe in detalimogene’s opportunity to transform the treatment landscape of NMIBC through a unique and differentiated overall profile that is highly attractive to both patients and physicians due to its potential for tolerability, ease-of-use, and efficacy."

Recent Corporate Updates

LEGEND study trial site expansion: Over the course of the first quarter of 2025, the Company expanded its clinical footprint for the LEGEND study with the addition of trial sites in Europe and Asia. In addition, all four of LEGEND’s cohorts are now open for enrollment, including the pivotal cohort evaluating detalimogene voraplasmid (also known as detalimogene, and previously EG-70) in high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with CIS as well as Cohort 2a and 2b (i.e., NMIBC patients with CIS who are naïve to treatment with BCG and NMIBC patients with CIS who have been exposed to BCG, but have not received adequate BCG treatment), and Cohort 3 (BCG-unresponsive high-risk NMIBC patients with papillary-only disease). Global enrollment is taking place under an amended protocol that is designed to align with the American Urological Association’s current treatment guidelines and real-world practices.

LEGEND study now includes maintenance dosing: The amended LEGEND protocol allows patients from all cohorts who are in complete response at 12 months to continue receiving detalimogene on a dose-reduced maintenance schedule throughout their second year of treatment. At the end of year two, patients may elect to remain on maintenance therapy for another year, for a total of three years of therapy. Maintenance treatment consists of two instillations of detalimogene per three-month cycle, administered at week one and at week two of each cycle. The maintenance regimen is intended to evaluate the potential of longer-term detalimogene treatment to improve or maintain durability of response with the lower patient burden associated with a less frequent dosing regimen.

First Quarter 2025 Financial Results

As of January 31, 2025, cash, cash equivalents and marketable securities were $272.8 million. The Company expects that its existing cash, cash equivalents and marketable securities will fund operating expenses, debt obligations and capital expenditures into 2027.

Three Months ended January 31, 2025

Total operating expenses were $26.6 million for the three months ended January 31, 2025, compared to $10.8 million for the three months ended January 31, 2024. Research and development expenses increased by $14.3 million, mainly due to increasing manufacturing and clinical costs related to our pivotal LEGEND study and headcount costs. General and administrative expenses increased by $1.5 million, primarily driven by increased headcount intended to support the Company’s operation as a publicly traded company.

For the three months ended January 31, 2025, net loss attributable to common shareholders was approximately $24.6 million, or $0.48 per share, compared to approximately $10.7 million, or $0.46 per share, for the same period for the three months ended January 31, 2024. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease with a significant patient burden, high clinical needs, and massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated deeper into the muscle of the bladder wall. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene

Detalimogene is a novel, investigational, non-viral genetic medicine for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, simplify safe handling and cold storage complexities, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Fast Track designation from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

About the Pivotal LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk, non-muscle invasive bladder cancer (NMIBC). LEGEND’s pivotal cohort (Cohort 1) consists of approximately 100 patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS) (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, three additional cohorts are actively enrolling patients, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region

On March 10, 2025 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported its financial results for the fiscal year ended December 31, 2024 and provided a business update (Press release, Fennec Pharmaceuticals, MAR 10, 2025, View Source [SID1234651038]).

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"2024 marked the beginning of a foundational transformation for Fennec, setting the stage for the PEDMARK strategy that we are utilizing throughout 2025 to realize our next phase of growth. With key management and commercial hires in Q3 and Q4, we strengthened our leadership team and with this enhanced expertise, we are now well-positioned to drive execution and excellence in the field. We are seeing encouraging momentum in early 2025, particularly with adoption by academic institutions and new patient segments, reinforcing the value and need for PEDMARK," said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. "Global access to PEDMARK has also expanded meaningfully, with recent PEDMARQSI commercial launches in the United Kingdom and Germany in 2025. With the right foundational strategies now in place, we are confident that our strong and focused execution will translate into significant shareholder value in 2025 and beyond."

Business Highlights:

● U.S. Clinical Compendia Update: All medical compendia have incorporated Fennec’s clinical updates, and AHFS, the largest online platform for pharmacists, has updated its content to reflect and differentiate PEDMARK in accordance with its labeling. We also continue to advance our efforts to have PEDMARK added to the NCCN Drug and Biologics Compendium, a key step in further expanding access and reimbursement pathways.

● PEDMARQSIÒ Commercial Launch in Europe: In December 2024, Norgine received positive guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSI for the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors and PEDMARQSI is currently available in the U.K. In February 2025, Norgine announced that it has commercially launched PEDMARQSI in Germany. Both milestones mark an important step in achieving Fennec’s mission of expanding access to PEDMARQSI to cancer patients across the globe at risk of hearing loss.

● Ex-U.S. Opportunities for PEDMARKÒ: In Japan, the investigator-initiated clinical trial (STS-J01) in Japan evaluating PEDMARKÒ fully enrolled in Q4 2024 and the results of the trial are expected in the second half of 2025 with the potential evaluation for registration of PEDMARK in Japan thereafter. Further, Fennec has partnered with Inpharmus, formerly named TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC, for the distribution of PEDMARK in Turkey and Gulf Cooperation Council Countries.

●Early Repayment of $13 Million of the Company’s Approximately $32 Million Outstanding Convertible Debt Facility: In December 2024, Fennec announced the early partial repayment of a significant portion of its debt to Petrichor in a financial and strategic action that optimizes the Company’s balance sheet and overall capital structure, while effectively saving approximately $1.5 million in future annual interest payments and eliminating potential dilutive shares.

Financial Results for the Fourth Quarter and Full Fiscal Year Ended December 31, 2024

● Net Product Sales – For the fourth quarter of 2024, the Company recorded net product sales of $7.9 million compared to $7.0 million in the third quarter of 2024, representing an increase of approximately 13%. For the full fiscal year (FY) 2024, the Company recorded $29.6 million compared to $21.3 million in 2023, representing an increase of approximately 40%. The increase in sales in both the quarter and year reflects strong growth in accounts and increased penetration in the AYA market opportunity.

● Cash Position – Cash and cash equivalents were $26.6 million as of December 31, 2024. Of note, for the fourth quarter of 2024, our cash flow from operations decreased by $0.6 million. For the FY 2024, there was a $13.4 million increase in cash and cash equivalents between December 31, 2023 and December 31, 2024. The increase in cash was primarily due to the $43 million in upfront cash from the Norgine transaction and cash collected from product sales offset by operating expenses and the $13 million convertible debt paydown in December 2024.
● Selling and Marketing Expenses – The Company recorded $3.9 million in selling and marketing expenses in the fourth quarter of 2024 compared to $4.6 million in the third quarter of 2024. For the FY 2024, the Company recorded $18.4 million in selling and marketing compared to $12.1 million in fiscal year 2023. The increase is largely related to increased payroll and additional marketing expenses in the comparable periods as we focused on expanding our outreach to community oncology centers and the adolescent and young adult (AYA) population.

● General and Administrative (G&A) Expenses – The Company recorded $4.1 million in G&A expenses fourth quarter of 2024 compared to $7.0 million in the third quarter of 2024. For the FY 2024, the Company recorded $23.1 million in G&A expenses compared to $20.6 million in fiscal year 2023. For the fourth quarter of 2024, G&A expenses decreased due largely to lower cash based stock compensation and a one-time severance payment related to the previous CEO in the third quarter. For the full year G&A expenses were higher both due to European pre-commercialization related expenses, expenses associated with the Norgine transaction and intellectual property expenses related to ongoing litigation.

Fourth Quarter and Full-Year 2024 Conference Call Information

Date: Monday, March 10, 2025

Time: 8:30 a.m. ETWebcast Link: View Source

Participant Link: https://register.vevent.com/register/BIeb244773eed644bd83882935e4272e91

To access the live webcast link, log onto www.fennecpharma.com and proceed to the News & Events/Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on www.fennecpharma.com for thirty days.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete audited condensed consolidated financial statements for the period ended December 31, 2024 and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

Unaudited Consolidated

Statements of Operations:

(U.S. Dollars in thousands except per share amounts

Three Months Ended

Twelve Months Ended

December 31,

December 31,

December 31,

December 31,

2024

2023

2024

2023

Revenue

Product sales, net

$

7,925

$

9,735

$

29,580

$

21,252

Licensing revenue

—

—

17,958

—

Total revenue

7,925

9,735

47,538

21,252

Operating expenses:

Cost of product sales

669

685

3,184

1,259

Research and development

50

32

307

56

Selling and marketing

3,944

3,868

18,426

12,123

General and administrative

4,196

6,968

23,053

20,585

Total operating expenses

8,859

11,553

44,970

34,023

Loss from operations

(934)

(1,818)

2,568

(12,771)

Other (expense)/income

Realized foreign exchange (loss)/gain

(27)

2

(82)

5

Amortization expense

(25)

(70)

(89)

(287)

Unrealized loss on securities

(66)

4

(80)

(39)

Interest income

399

115

1,682

441

Interest expense

(966)

(915)

(4,069)

(3,394)

Total other (expense)/income

(685)

(864)

(2,638)

(3,274)

Net (loss) / income

$

(1,619)

$

(2,682)

$

(70)

$

(16,045)

Basic net loss per common share

$

(0.06)

$

(0.10)

$

(0.00)

$

(0.60)

Diluted net loss per common share

$

(0.06)

$

(0.10)

$

(0.00)

$

(0.60)

Weighted-average number of common shares outstanding basic

27,460

26,833

27,294

26,574

Weighted-average number of common shares outstanding diluted

27,460

26,833

27,294

26,574

December 31,

December 31,

2024

2023

Assets

Current assets

Cash and cash equivalents

$

26,634

$

13,269

Accounts receivable, net

12,884

8,814

Prepaid expenses

3,080

583

Inventory

1,060

2,156

Other current assets

364

21

Total current assets

44,022

24,843

Non-current assets

Other non-current assets, net of amortization

924

2,021

Total non-current assets

924

2,021

Total assets

$

44,946

$

26,864

Liabilities and shareholders’ (deficit) equity

Current liabilities:

Accounts payable

$

2,875

$

3,778

Accrued liabilities

3,428

3,754

Operating lease liability – current

248

21

Contract liability – current

2

—

Total current liabilities

6,553

7,553

Long term liabilities

Term loan

18,206

30,000

PIK interest

1,271

1,219

Debt discount

(139)

(288)

Contract liability – long-term

24,561

2

Total long term liabilities

43,899

30,933

Total liabilities

50,452

38,486

Commitments and Contingencies

Shareholders’(deficit) equity:

Common stock, no par value; unlimited shares authorized; 27,292 shares issued and outstanding (2023 -26,361)

145,608

144,307

Additional paid-in capital

66,958

62,073

Accumulated deficit

(219,315)

(219,245)

Accumulated other comprehensive income

1,243

1,243

Total shareholders’ (deficit) equity

(5,506)

(11,622)

Total liabilities and shareholders’ (deficit) equity

$

44,946

$

26,864

Working capital

Fiscal Year Ended

Selected Asset and Liability Data:

December 31, 2024

December 31, 2023

(U.S. Dollars in thousands)

Cash and equivalents

$

26,634

$

13,269

Other current assets

17,388

11,574

Current liabilities

6,553

7,553

Working capital

$

37,469

$

17,290

Selected Equity:

Common stock and additional paid in capital

212,566

206,380

Accumulated deficit

(219,315)

(219,245)

Shareholders’ equity

(5,506)

(11,622)

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.i

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.ii Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.iii

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

As a reminder, PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. PEDMARK is recommended for the AYA population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

On March 10, 2025 Agilent Technologies Inc. (NYSE: A) reported its PD-L1 IHC 28-8 pharmDx kit has received two new companion diagnostic indications approvals under EU IVDR1, expanding the eligibility of treatment to early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients (Press release, Agilent Technologies, MAR 10, 2025, View Source [SID1234651055]). These two new indications bring the total indications launched in Europe for PD-L1 IHC 28-8 pharmDx to nine. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

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Lung cancer and malignant melanoma are major healthcare concerns worldwide, with lung cancer accounting for over two million new cases in 2020 and an estimated 1.77 million deaths each year, and malignant melanoma accounting for over 324,000 new cases in 2020 and over 57,000 deaths each year2. PD-L1 is a critical biomarker for potential response to anti-PD-1 therapies, which are revolutionizing the treatment of cancer. Pathology labs play an important role in informing treatment decisions.

When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, in the European Union: (a) resectable NSCLC patients with PD-L1 expression ≥1% and at high risk of recurrence may be eligible for treatment with Bristol Myers Squibb’s OPDIVO (nivolumab) in combination with platinum based chemotherapy; and (b) patients 12 years of age and older with tumor cell PD-L1 expression < 1% that have previously untreated advanced (metastatic or unresectable) melanoma may be eligible for treatment with Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab).

PD-L1 IHC 28-8 pharmDx is the only clinically validated test for identifying patients for these treatments; these two new indications will aid pathologists, in conjunction with oncologists, in selecting appropriate treatment options, offering hope for patients diagnosed with these cancers. IVDR compliance certification further enhances the confidence of patients, consumers, and healthcare professionals in the EU by demonstrating that these medical devices can be safely relied upon as part of the diagnostic workflow.

Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, remarked: "The two added indications of PD-L1 IHC 28-8 pharmDx will give physicians in Europe critical information to inform treatment decisions for patients with these common and potentially deadly cancers. This endorsement underscores Agilent’s leadership in the development of companion diagnostics for groundbreaking therapies containing anti-PD-1 antibodies."

An innovative industry leader with more than 50 years of experience, Agilent launched the first FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company; Opdualag is a trademark of Bristol-Myers Squibb Company.

In Vitro Diagnostic Medical Devices Regulation (europa.eu)
Sung. H., Ferlay. J., et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA. Cancer J. Clin. 2021, 71, 209–249