On April 13, 2026 Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is October 10, 2026.

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Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The FDA is also reviewing the BLA under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

The BLA is based on results from the IDeate-Lung01 Phase 2 trial, with support from the IDeate-PanTumor01 Phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 were presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) and published in the Journal of Clinical Oncology. Ifinatamab deruxtecan also was previously granted Breakthrough Therapy Designation by the FDA in August 2025 for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

"The FDA’s granting of Priority Review for ifinatamab deruxtecan marks a significant milestone in our effort to provide new and innovative treatment options for patients with extensive-stage small cell lung cancer," said John Tsai, MD, global head, R&D, Daiichi Sankyo. "We look forward to continuing to work with the FDA to bring this potential first-in-class B7-H3 directed DXd antibody drug conjugate to patients as quickly as possible."

"Small cell lung cancer remains one of the toughest cancers to treat, with few options if the disease progresses after standard of care treatments," said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "The FDA’s acceptance of the BLA reinforces the important role that ifinatamab deruxtecan could play in helping to address the needs of patients with extensive-stage small cell lung cancer."

About IDeate-Lung01

IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible to participate.

In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan (8 or 12 mg/kg) given intravenously once every three weeks. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan (12 mg/kg) intravenously at the same dosing interval.

The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), time to response (TTR), overall survival (OS), pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis.

IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About IDeate-PanTumor01

IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.

The Phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The Phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistant prostate cancer or esophageal squamous cell carcinoma.

The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating ORR, DOR, DCR, PFS, OS and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints also will be assessed.

IDeate-PanTumor01 will enroll approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov.

About small cell lung cancer

Approximately 250,000 patients are diagnosed with small cell lung cancer (SCLC) each year globally. There were approximately 27,000 new cases of SCLC in the U.S. in 2025, accounting for about 12% of all lung cancer cases. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. There are currently no B7-H3 directed medicines approved for the treatment of cancer.

About ifinatamab deruxtecan

Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Ifinatamab deruxtecan has been granted Orphan Drug Designation (ODD) by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. Ifinatamab deruxtecan also was granted ODD for the treatment of esophageal cancer by the FDA.

About the ifinatamab deruxtecan clinical development program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other cancer medicines across multiple cancers. The program is currently comprised of three Phase 3 trials in advanced/metastatic disease, including SCLC (IDeate-Lung02), castration-resistant prostate cancer (IDeate-Prostate01) and esophageal squamous cell carcinoma (IDeate-Esophageal01).

(Press release, Merck & Co, APR 13, 2026, View Source [SID1234664330])

On April 13, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer reported that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will participate in a fireside chat with Steven Saltzstein, CEO, Force Family Office. Joining them will be Dr. R. Todd Plott, Chief Medical Officer, Epiphany Dermatology and former consultant to the FDA who will provide additional insight on PH-762, an INTASYL compound, that silences the PD-1 gene implicated in various forms of skin cancer.

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"We are excited to hold this fireside chat with Force Family Office. Dr. Plott will discuss why the INTASYL siRNA program represents a differentiated approach to immuno-oncology," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

DATE: Wednesday April 15, 2026

TIME: 12 PM EDT

REGISTRATION LINK: PHIO Pharma – Force Family Office

Recent Company Highlights
Phio’s lead clinical candidate, PH-762, is being evaluated as an intratumoral therapy in cutaneous squamous cell carcinoma (cSCC), melanoma and Merkel cell carcinoma. In its Phase 1b trial, Phio has reported that 22 patients completed treatment across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events. The Company has also reported a pathological response rate in cSCC across all dosing cohorts of approximately 65%, including an 85% pathological response (6 of 7 patients) in the highest-dose cohort.

Phio has indicated that FDA engagement regarding next-stage clinical development is targeted for the second quarter of 2026 and has reported cash and cash equivalents projected to sustain operations into the first half of 2027.

(Press release, Phio Pharmaceuticals, APR 13, 2026, View Source [SID1234664329])

On April 13, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, and Mayo Clinic reported a strategic collaboration to advance development of SC451, Sana’s investigational hypoimmune-modified pancreatic islet cell therapy for type 1 diabetes. SC451 is designed to allow a single administration of pancreatic islet cells to support long-term glucose control without the need for ongoing insulin therapy or immunosuppression for patients with type 1 diabetes.

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The collaboration will draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments. These areas include:

End-to-end clinical and operational insight to optimize workflows, including product handling and delivery of SC451, and post-treatment care to enable broader adoption across Mayo Clinic and global care settings.
Surgical expertise, including refining procedural techniques.
Standardizing handling, delivery and post-treatment management.
Leadership in clinical trial design, including biomarker identification to guide patient selection and longitudinal monitoring.

Mayo Clinic will also look to advance its capabilities in the delivery of investigational islet cell therapies, further strengthening its leadership in innovative, multidisciplinary treatment approaches.

In connection with the collaboration, Mayo Clinic will make an equity investment in Sana Biotechnology, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. The organization also has the option to make an additional equity investment under the terms of the agreement.

"We are pleased to collaborate with Mayo Clinic as we advance SC451 toward a clinical trial that we are aiming to start this year," said Steve Harr, Sana President and Chief Executive Officer. "Mayo Clinic’s longstanding commitment to patient-centered care, combined with a depth of expertise in transplant medicine and immunology, will help guide the development and delivery of SC451. Recently presented data, showing that transplanted pancreatic islets modified with Sana’s hypoimmune platform technology survive and function without any immunosuppression for over a year in a patient with type 1 diabetes, make us optimistic about the potential for SC451 to transform the treatment of this disease."

"Mayo Clinic is committed to advancing innovative therapies that address significant unmet patient needs, and through this collaboration, we seek to advance potential treatment options for patients with type 1 diabetes," said Vijay Shah, MD, Mr. and Mrs. Ronald F. Kinney Executive Dean of Research, Mayo Clinic. "By bringing together complementary expertise in cell therapy development and transplant immunology, we aim to thoughtfully and rigorously evaluate this investigational approach with the goal of improving the lives of those living with the condition."

About SC451 – Sana’s Therapeutic Candidate for Type 1 Diabetes
SC451 is an investigational, gene-modified, stem-cell derived pancreatic islet cell therapy that Sana is advancing toward the clinic as a potential single treatment for patients with type 1 diabetes (T1D) that leads to euglycemia without the need for exogenous insulin or immunosuppression. SC451 is a potentially scalable solution, manufactured from cells that have been modified to overcome both allogeneic and autoimmune rejection through Sana’s proprietary hypoimmune (HIP) technology. An investigator-sponsored clinical study evaluating the transplantation of donor-derived, HIP-modified pancreatic islet cells into a patient with T1D show these cells are well-tolerated, survive, evade detection by the immune system, and continue to produce insulin in the patient through 14 months of follow-up to date. The company expects to file an Investigational New Drug application and initiate a Phase 1 clinical study of SC451 as early as this year.

(Press release, Sana Biotechnology, APR 13, 2026, View Source [SID1234664328])

On April 13, 2026 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported follow-up histology tissue analysis data from its first-in-human early feasibility study of its Targeted Hyperthermia Therapy (‘THT’) in late stage melanoma patients who had failed on standard immunotherapy protocols (the "Study"). An extensive multiplex histological tissue analysis conducted at Dalhousie University of representative tissues from Study patients showed extensive natural killer cell infiltration in tumor tissues biopsied after treatment with THT indicative of innate immune activation. Also, analysis of samples from Study patients who only partially responded to the THT treatment showed a significant increase in T-regulatory cells and strong PD-L1 expression suggesting that these tumors may benefit from adding PD-1 immunotherapy in combination with Sona’s THT treatment.

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Dr. Carman Giacomantonio, Sona’s CMO, commented, "We are very proud and excited to report that the detailed histological tissue analysis from representative patient samples validates our pre-clinical findings. Our analysis confirms that patients responding to Sona’s THT treatment experienced a strong immunogenic response characterized by extensive innate immune activation with abundant macrophage infiltration and a robust natural killer cell infiltration. Notably, in partially responding patients, we observed a significant increase in T-regulatory cells and strong expression of PD-L1. The significance of this in response is these patients would be predicted to respond to PD-1 and CTLA-4 immunotherapy, particularly if administered in timely combination with our THT."

These results, together with our pre-clinical modelling studies, give us great confidence that immunotherapy response rates, which are typically below 20% for colorectal cancer, can be increased by first priming tumors with Sona’s THT therapy before administering immunotherapy, giving hope to the four out of five colorectal cancer sufferers for whom no treatment tends to work."

This histology tissue analysis, together with the Study’s protocol and other findings are now being prepared for submission to a scientific journal for peer review and publication.

In the Study, ten advanced-stage melanoma patients, all of whom were failing to respond to standard immunotherapy treatment, were recruited into this early feasibility study. Under the study protocol, patients had up to four tumors treated with Sona’s THT on days one and eight of the Study. By day 15, 8/10 patients experienced a clinical response to the THT treatment with a majority (6/8) showing no detectable residual melanoma in representative, biopsied tumors, with two patients showing no response.

(Press release, Sona Nanotech, APR 13, 2026, View Source [SID1234664327])

On April 13, 2026, Revolution Medicines, Inc. ("Revolution Medicines") reported positive Phase 3 results from the RASolute 302 trial for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who had been previously treated. The trial met all primary and key secondary endpoints, including progression-free survival and overall survival. Based on these results, Revolution Medicines intends to submit these data to global regulatory authorities, including to the U.S. Food and Drug Administration (FDA) as part of a future New Drug Application under a Commissioner’s National Priority Voucher.

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In June 2025, Royalty Pharma (the "Company") and Revolution Medicines announced a $2 billion funding agreement, consisting of a synthetic royalty of up to $1.25 billion on daraxonrasib and a senior secured loan of up to $750 million.

Royalty Pharma funded $250 million upfront and today’s announcement triggered an additional $250 million in funding to Revolution Medicines. With the second tranche, Royalty Pharma is now entitled to total tiered royalties of 4.55% on daraxonrasib sales (and zoldonrasib if approved in an overlapping daraxonrasib indication) between $0 billion to $2 billion, 2.50% on sales between $2 billion to $4 billion and 1.00% on sales between $4 billion to $8 billion.

There is an additional $750 million in synthetic royalty funding available to Revolution Medicines at their option following the achievement of certain regulatory, commercial and clinical milestones related to daraxonrasib, including the next $250 million available on FDA approval in metastatic PDAC. Should Revolution Medicines fully draw on the remaining $750 million in synthetic royalty funding, Royalty Pharma’s royalty rate on daraxonrasib would increase to 7.80% on sales between $0 billion to $2 billion, 4.55% on sales between $2 billion to $4 billion and 2.40% on sales between $4 billion to $8 billion.

Furthermore, Royalty Pharma is providing a senior secured term loan of up to $750 million in three tranches, and the first $250 million tranche must be drawn following FDA approval of daraxonrasib for metastatic PDAC. The two additional $250 million tranches are available at Revolution Medicines’ option based on the achievement of certain trailing four-quarter net sales milestones for daraxonrasib.

(Filing, 8-K, Royalty Pharma , APR 13, 2026, View Source [SID1234664326])