On March 27, 2026 European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reported it has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for Sarclisa intravenous (IV) formulation in the EU. If approved, Sarclisa would be the first available anticancer treatment to be administered through both an on-body injector (OBI) and manual injection, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both an OBI and manual injection. A final decision is expected in the coming months.

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"This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers," says Olivier Nataf, Global Head of Oncology at Sanofi. "Our aim is to evolve the treatment experience by combining the clinically proven efficacy of Sarclisa with innovative subcutaneous delivery via an on-body injector. This advancement reflects our unwavering commitment to patients and dedication to transforming care in ways that truly matter to people living with cancer."

The positive CHMP opinion is based on the results from the IRAKLIA phase 3 study in relapsed and/or refractory (R/R) MM (clinical study identifier: NCT05405166), which demonstrated non‑inferiority of the SC formulation compared to the IV formulation. Four additional studies supported the decision and include the GMMG-HD8 phase 3 study in transplant-eligible newly diagnosed MM (NDMM, TE) (clinical study identifier: NCT05804032), the IZALCO phase 2 study in R/R MM (clinical study identifier: NCT05704049), and the ISASOCUT phase 2 study in transplant-ineligible NDMM (NDMM, TI) (clinical study identifier: NCT05889221) and one phase 1b study in R/R MM patients who received at least two prior lines of therapy (clinical study identifier: NCT04045795).

Of the multiple SC studies two studies showed the use of Sarclisa SC + OBI was associated with greater patient satisfaction compared to IV administration, and patient and healthcare provider preference compared to Sarclisa manual injection, based on patient experience and satisfaction questionnaires fielded in the studies.

These collective results provide comprehensive evidence supporting the potential use of Sarclisa SC + OBI to advance patient care in NDMM and R/R MM, while maintaining Sarclisa’s strong efficacy and safety profile.

The studies were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines beginning with the push of a button, to administer Sarclisa SC formulation. The enFuse device uses a thinner and retractable needle that is smaller compared to the needles commonly used for large-volume injections, which may help support patient comfort.

Sarclisa IV is currently approved in four indications in the EU for both NDMM, TI and NDMM, TE, and as early as first relapse in R/R MM. In addition to the EU, a regulatory submission is also under review with the US Food and Drug Administration (FDA).

Sarclisa SC + OBI or manual injection is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose SC via an OBI versus weight-based dosed Sarclisa IV in combination with pomalidomide and dexamethasone (Pd) in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were objective response rate (ORR), according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC) and observed Sarclisa concentrations before dosing (C trough) at steady state (pre-dose at cycle 6, day 1 [C6D1]).

About the IZALCO study
IZALCO (clinical study identifier: NCT05704049) was a two-part, randomized, open-label phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via the OBI or by manual injection, in combination with carfilzomib and Kd, for the treatment of adult patients with R/R MM who have received one to three prior lines of therapy. The primary objective is ORR, as assessed by IRC. The key secondary endpoint is patient preference for the Sarclisa SC administered via an OBI versus manual administration of Sarclisa SC. Healthcare provider preference of delivery method is also assessed as exploratory endpoint.

About the ISASOCUT study
ISASOCOUT (clinical study identifier: NCT05889221) is an open-label phase 2 study assessing Sarclisa SC administered via the OBI in combination with bortezomib, lenalidomide and dexamethasone (VRd) in NDMM patients ineligible for autologous stem-cell transplant (ASCT). The primary objective is rate of very good partial response (VGPR) or better, according to the 2016 IMWG criteria assessed by IRC. The study is ongoing.

About the GMMG-HD8 study
GMMG-HD8 (clinical study identifier: NCT05804032) was a randomized, open-label, multicenter phase 3 study evaluating the non-inferiority of Sarclisa SC administered via an OBI versus Sarclisa IV, both in combination with VRd at induction, for the treatment of patients with NDMM eligible for ASCT. The primary endpoint of the study is non-inferiority of SC to IV administration as measured by VGPR or better after induction therapy. Results from an interim analysis were submitted to support the conversion of the indication from Sarclisa IV to Sarclisa SC.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

About Sarclisa
Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor. Additionally, Sarclisa is approved in the EU in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with Kd, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. Sarclisa is also approved in the EU in combination with VRd as an induction treatment for transplant-eligible NDMM patients, based on the GMMG-HD7 phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

(Press release, Sanofi, MAR 27, 2026, View Source [SID1234663991])

On March 27, 2026 Agni Bio, Inc., a biotechnology company developing next-generation immunotherapies, reported that it has been selected to present a poster highlighting its AGB101 (Vβ17 x DLL3) program at the AACR (Free AACR Whitepaper) Annual Meeting 2026 in the Late Breaking Poster Session, taking place April 17–22, 2026 in San Diego and hosted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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The poster will feature preclinical data for AGB101, a first-in-class Vβ17 x DLL3 bispecific antibody designed to selectively redirect a defined subset of cytotoxic memory T cells to tumors. Agni Bio plans to initiate a Phase 1 clinical trial of AGB101 in the second half of 2026.

Key Highlights from the Poster Presentation:

Novel mechanism of action: AGB101 selectively engages Vβ17 T cell receptor (TCR)–expressing T cells, a memory T cell subset with enhanced cytotoxicity, persistence, and resistance to exhaustion.
Targeted tumor approach: The molecule targets DLL3, a solid tumor lineage antigen highly expressed in small cell lung cancer (SCLC) and other neuroendocrine tumors.
Selective immune activation: Unlike CD3-directed bispecific antibodies which non-selectively redirects the majority of T cells, AGB101 selectively redirects and expands Vβ17 cells to drive DLL3-dependent cytotoxicity.
Reduced cytokine release profile: Preclinical studies with AGB101 demonstrate lower levels of release of pro-inflammatory cytokines (including TNF-α, IL-4, and IL-1β) while maintaining cytotoxic effector function (Granzyme B), suggesting the potential for an improved safety profile relative to CD3-based approaches.
Robust anti-tumor activity: AGB101 achieved potent and durable cytotoxicity in vitro and demonstrated complete tumor regressions in multiple DLL3-positive in vivo models.
Durable and memory-driven responses: Data show selective expansion (up to 10–15-fold) of Vβ17 T cells with a strong CD8+ bias and enhanced anti-tumor activity upon tumor rechallenge.
"AGB101 represents a fundamentally new approach to T cell redirection by selectively harnessing a highly functional subset of memory T cells," said Matt Lorenzi, PhD, Chief Scientific Officer and Board Member of Agni Bio. "We believe this strategy has the potential to overcome key limitations of first-generation T cell engagers, including toxicity and limited durability, and we are excited to advance this program into the clinic later this year."

AGB101 is part of Agni Bio’s Vβ17 platform of TCR-directed bispecific antibodies designed to improve the precision and effectiveness of immune engagement in cancer and autoimmune therapies.

(Press release, Agni Bio, MAR 27, 2026, View Source [SID1234664176])

On March 27, 2026 OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, reported that it has entered into a securities purchase agreement for a private placement with certain institutional and accredited healthcare investors, raising gross proceeds of approximately $150 million.

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OnKure intends to use the net proceeds from the private placement to fund the preclinical and clinical development of its next-generation PI3Kα pan-mutant-selective inhibitor candidates in breast cancer and vascular anomalies, as well as for working capital and general corporate purposes. The private placement is being led by new investor, Access Biotechnology, with participation from other new and existing investors, including BVF Partners LP, RA Capital Management, Trails Edge Capital Partners, Coastlands Capital, StepStone Master G, L.P., Vivo Capital, ADAR1 Capital Management, Foresite Capital, Adage Capital Partners LP, Vestal Point Capital, Acorn Bioventures, Logos Capital and Prosight Capital.

"This transformational financing enables us to advance the development strategy for our next‑generation PI3Kα pan‑mutant selective inhibitor candidates, which represent a defining phase of our mutation‑selective strategy. We appreciate the significant commitment by the participating specialist biotech investors who believe in the potential of our PI3Ka pan-mutant portfolio," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. "We believe the clinical experience generated from the PIKture‑01 trial provided important validation of our approach to selectively targeting PI3Kα while avoiding class‑limiting toxicities predictably seen by insufficiently selective inhibitors. These insights directly informed the design of our pan‑mutant programs, defining the high bar attributes of our molecules. With the additional capital raised through this private placement, we are focused on leveraging our chemistry platform and clinical insights into PI3Kα signaling into differentiated, next-generation candidates for breast cancer and vascular anomalies, with the goal of delivering medicines that offer meaningful improvements in efficacy and tolerability for patients."

Next-Generation PI3Kα Pan-Mutant Programs

The portfolio includes two next-generation PI3Kα pan-mutant programs, OKI-345 in breast cancer and OKI-355 in vascular anomalies. These candidates are designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses, both as monotherapy and in combination regimens. The pan-mutant candidates are designed to have minimal drug-drug interaction potential, supporting broad combinability with current standards of care. Together with a commanding intellectual property estate, OnKure believes it is well positioned to address a significant unmet need across various PI3Kα-driven indications.

PI3Kα mutations represent the most common driver alterations in key subtypes of vascular anomalies, where PIK3CA variants lead to dysregulated signaling that promotes abnormal cell growth, proliferation, and survival. OnKure believes that OKI-355 has significant potential to address this large and underserved patient population as a differentiated systemic chronic therapy.

OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for each of OKI‑345 and OKI‑355 in the first half of 2027.

PIKture‑01 Trial and OKI-219 Update

The PIKture-01 trial is a global, multi-center, dose-escalation, first-in-human phase 1a/1b study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs for the treatment of HR+ and HER2+ advanced breast cancer. As of March 26, 2026, the PIKture-01 trial has completed enrollment in single-agent OKI-219 dose escalation (n=38) and OKI-219 + fulvestrant dose escalation (n=33). Phase 2 dose evaluation in the OKI-219 + tucatinib and trastuzumab triplet and the OKI-219 + ribociclib and fulvestrant triplets will be completed in 2026. Given the progress of the Company’s PI3Kα pan-mutant inhibitors, OnKure is not planning to pursue further clinical development of OKI-219 independently at this time. Mature data from PIKture-01 will be presented by the end of the year.

Additional information about PIKture-01 may be found at www.ClinicalTrials.gov, using Identifier: NCT06239467.

Private Placement and Appointment of Liam Ratcliffe to Board of Directors

Pursuant to the terms of the securities purchase agreement, OnKure has agreed to sell an aggregate of 26,713,636 shares of its Class A common stock ("Common Stock") at a purchase price of $4.15 per share and, in lieu of Common Stock, pre-funded warrants to purchase 9,430,959 shares of Common Stock at a purchase price of $4.1499 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.0001 per share and will be immediately exercisable. The private placement is expected to close on March 31, 2026, subject to satisfactory closing conditions. With the net proceeds from the private placement, OnKure expects to extend its cash runway into 2029.

In conjunction with the financing, Liam Ratcliffe, M.D., Ph.D., Head of Biotechnology, Access Biotechnology will join OnKure’s Board of Directors. Andrew Phillips, Ph.D., OnKure’s Chairman of the Board of Directors, commented, "we are grateful for the commitment of our new and existing investors to the growth of OnKure. We are very pleased to welcome Liam to our Board of Directors. Liam is a well-respected leader who brings a remarkable track record of accomplishment to our Board."

Leerink Partners is acting as lead placement agent for the financing. Evercore ISI, LifeSci Capital, and Oppenheimer & Co. are serving as co-placement agents for the financing.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering. The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state securities laws, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of Common Stock and the Common Stock issuable upon exercise of the pre-funded warrants, in each case sold under the terms of the securities purchase agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, OnKure Therapeutics, MAR 27, 2026, View Source [SID1234663992])

On March 27, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and MSD K.K. (Headquarters: Tokyo, Representative Director: Prashant Nikam, "MSD"), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, reported that an application for LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, has been submitted in Japan for the additional dosage and administration in combination with WELIREG (belzutifan), the first-in-class oral hypoxiainducible factor-2 alpha (HIF-2α) inhibitor from MSD, for the treatment of unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy.

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This application is based on the results of the Phase 3 LITESPARK-011 trial evaluating the dual regimen of LENVIMA plus WELIREG for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/ programmed death-ligand 1 (PD-L1) therapy. The data from this trial were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium in February 2026. At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), the LENVIMA plus WELIREG combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the primary endpoints, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. The safety profile of this combination was consistent with those reported for each agent administered as monotherapy, and no new safety signals were identified.

In 2022, approximately 435,000 people worldwide were newly diagnosed with kidney cancer, and about 156,000 people died from the disease. 1 In Japan, it is estimated that roughly 21,000 people were newly diagnosed and about 7,000 died in 2022.2 RCC accounts for approximately 85% of kidney cancers3, and the five-year survival rates for patients with stage III and IV RCC have been reported as 63%–78% and 27%–28%4, respectively, indicating that the disease still has a high unmet medical needs.

LENVIMA is approved in combination with KEYTRUDA (pembrolizumab) in Japan for the first-line treatment of unresectable or metastatic RCC. WELIREG is approved in Japan for the treatment of unresectable or metastatic RCC that has progressed following cancer chemotherapy. Additionally, supplemental New Drug Applications (sNDA) for the LENVIMA and WELIREG combination therapy for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PDL1 inhibitor has been accepted by the U.S. Food and Drug Administration (FDA), with a PDUFA (Prescription Drug User Fee Act) target action date set for October 4, 2026.

Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of contribution to patients with cancer.

About LENVIMA (lenvatinib)

LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1- 4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below.

Thyroid cancer
– Indication as monotherapy
(Approved mainly in Japan, the United States, Europe, China and Asia)
Japan: Unresectable thyroid cancer
The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC)
Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)

Hepatocellular carcinoma
– Indication as monotherapy
(Approved mainly in Japan, the United States, Europe, China and Asia)
Japan: Unresectable hepatocellular carcinoma
The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
– Indication in combination with KEYTRUDA (generic name: pembrolizumab) and transarterial chemoembolization (Approved in China)

Thymic carcinoma
– Indication as monotherapy (Approved in Japan)
Japan: Unresectable thymic carcinoma

Renal cell carcinoma (In Europe other than the United Kingdom, the agent was launched under the brand name Kisplyx)
– Indication in combination with everolimus
(Approved mainly in the United States, Europe and Asia) The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy
– Indication in combination with KEYTRUDA
(Approved mainly in Japan, the United States, Europe and Asia)
Japan: Radically unresectable or metastatic renal cell carcinoma
The United States: The first-line treatment of adult patients with advanced renal cell carcinoma
Europe: The first-line treatment of adult patients with advanced renal cell carcinoma

Endometrial carcinoma
– Indication in combination with KEYTRUDA
(Approved mainly in Japan, the United States, Europe and Asia)
Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy
The United States: The treatment of patients with advanced endometrial carcinoma that is pMMR or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery.

About WELIREG (belzutifan)

WELIREG, Merck & Co., Inc., Rahway, NJ, USA’s, known as MSD outside of the United States and Canada, first-in-class hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, is an orally administered small-molecule designed to reduce transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2α signaling, WELIREG aims to disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival. WELIREG has demonstrated antitumor activity in certain von Hippel-Lindau (VHL) diseaseassociated tumors, renal cell carcinoma and in pheochromocytoma or paraganglioma. As part of a broader clinical program, Merck & Co., Inc., Rahway, NJ, USA continues to research WELIREG monotherapy and combination approaches for people with genitourinary, breast and gynecologic cancers across a range of treatment settings to further define where HIF-2α inhibition may provide clinical benefit and to better understand which patients are most likely to respond. WELIREG has been approved in Japan for the treatment of certain von Hippel–Lindau (VHL) disease–associated tumors, as well as for unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy.

LITESPARK-011 Results

Data from LITESPARK-011 (ClinicalTrials.gov, NCT04586231) were presented at the ASCO (Free ASCO Whitepaper) GU Symposium held in February 2026. LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR), and overall survival (OS). Secondary endpoints include objective response rate (ORR) per RECIST v1.1 as assessed by BICR, duration of response (DOR) per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).

At a pre-specified second interim analysis with a median follow-up of 29.0 months (range, 19.3- 49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol. Regarding secondary endpoints, at the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib. WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to treatment discontinuation in 11.1% of patients receiving WELIREG plus LENVIMA and in 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.

(Press release, Eisai, MAR 27, 2026, View Source [SID1234663976])

On March 27, 2026 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a biotechnology company focused on identifying and advancing innovative therapeutics, reported its fourth quarter and full year 2025 financial results and provided a corporate update.

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Recent Highlights:

In January 2026, Axion Bio, Inc., a wholly owned subsidiary of Instil, discontinued clinical development of AXN-2510 and entered into a termination agreement with ImmuneOnco Biopharmaceuticals (Shanghai) Inc. to terminate the license and collaboration agreement for AXN-2510 and AXN-27M.
Following this decision, Instil will focus on its next phase of strategic development through external innovation and disciplined capital deployment.
The company is pursuing potential acquisitions and in-licensing opportunities that could provide access to promising novel therapeutic candidates. Instil is evaluating opportunities across several therapeutic areas.
"We have been taking important steps to sharpen Instil’s strategic focus and position the company for its next phase of strategic development," said Bronson Crouch, Chief Executive Officer, Instil. "We are focused on identifying high-quality opportunities that can position Instil for long-term value creation. Our priority is to leverage our balance sheet to pursue acquisitions and in-licensing opportunities that can drive meaningful shareholder value. We believe this disciplined approach to capital deployment can allow us to build a differentiated pipeline and advance innovative therapies for patients with serious diseases."

There can be no assurance that any transaction will result from these efforts, nor as to the timing of any such outcome. Instil does not intend to provide further updates unless and until a specific transaction is approved or disclosure is otherwise deemed appropriate.

Fourth Quarter and Full Year 2025 Financial and Operating Results:

As of December 31, 2025, Instil had $76.3 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $6.6 million in cash and cash equivalents, $0.2 million in restricted cash and $69.5 million in marketable securities, compared to $115.1 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities, as of December 31, 2024. Instil expects that its cash, cash equivalents, restricted cash and marketable securities as of December 31, 2025 will enable it to fund its current operating plan beyond 2027.

In-process research and development expenses were nil and $10.0 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to nil and $10.0 million for the fourth quarter and full year ended December 31, 2024.

Research and development expenses were $3.5 million and $24.7 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $1.1 million and $11.8 million for the fourth quarter and full year ended December 31, 2024, respectively.

General and administrative expenses were $6.1 million and $27.2 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $10.4 million and $44.2 million for the fourth quarter and full year ended December 31, 2024, respectively.

Restructuring and impairment charges were nil and $16.6 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $0.3 million and $7.5 million for the fourth quarter and full year ended December 31, 2024, respectively.

Net loss per share, basic and diluted was $1.21 and $10.70 for the fourth quarter and full year ended December 31, 2025, respectively, compared to $1.82 and $11.39 for the fourth quarter and full year ended December 31, 2024, respectively. Non-GAAP net loss per share, basic and diluted was $0.97 and $6.91 for the fourth quarter and full year ended December 31, 2025, respectively, compared to $1.08 and $7.59 for the fourth quarter and full year ended December 31, 2024, respectively.

(Press release, Instil Bio, MAR 27, 2026, View Source [SID1234663977])