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Incyte Reports Strong Q2 2025 Results with Jakafi Growth and New Drug Approvals

Drug ApprovalMonoclonal AntibodyOncology
  • Incyte reported strong second quarter 2025 financial results with Jakafi net revenues of $764 million, representing 8% year-over-year growth driven by increased demand across all indications.
  • The company achieved two significant regulatory milestones with FDA approvals of Zynyz for squamous cell anal carcinoma and Monjuvi for follicular lymphoma, expanding treatment options for cancer patients.
  • Niktimvo, launched in Q1 2025, demonstrated continued strong commercial uptake with $13.6 million in sales, while Opzelura revenues grew 35% to $164 million driven by increased patient demand in both atopic dermatitis and vitiligo.
  • The company raised its 2025 revenue guidance for Jakafi and other oncology products, reflecting strong first-half performance and successful product launches.

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

Crown Bioscience San Diego Receives CLIA Certification to Expand Clinical Testing Capabilities

Oncology
  • Crown Bioscience's San Diego laboratory has achieved Clinical Laboratory Improvement Amendments (CLIA) certification from the Centers for Medicare and Medicaid Services, enabling clinical-grade testing for drug development.
  • The certification allows the contract research organization to conduct clinical testing on human specimens, strengthening its position in oncology research and personalized medicine.
  • Crown Bioscience operates the world's largest commercially available patient-derived xenograft collection and approximately 1,000 tumor organoid models across 35 cancer indications.
  • The CLIA designation enhances the company's ability to support clients' clinical development and regulatory approval timelines with compliant biomarker data.

FDA Rejects Replimune's Melanoma Drug Amid Evolving Regulatory Standards

FDA ApprovalOncology
  • The FDA rejected Replimune's melanoma drug in a complete response letter, citing inadequate single-arm study design and patient enrollment differences as key concerns.
  • The agency questioned whether the single-arm study provided substantial evidence of effectiveness and raised issues with the company's confirmatory trial design.
  • Analysts interpret the rejection as evidence of changing FDA approval standards, with Replimune CEO expressing surprise at the decision given prior agency meetings.
  • The rejection highlights the evolving regulatory landscape for oncology drug approvals, particularly for single-arm studies in melanoma treatment.

Radiopharm Theranostics Appoints Leading Prostate Cancer Expert Dr. Oliver Sartor to Scientific Advisory Board

Oncology
  • Radiopharm Theranostics has appointed Dr. Oliver Sartor, an internationally recognized medical oncologist specializing in prostate cancer and radiopharmaceutical therapies, to its Scientific Advisory Board.
  • Dr. Sartor currently serves as Director of Radiopharmaceutical Clinical Trials at Mayo Clinic and has led multiple pivotal Phase 3 trials resulting in FDA approvals for radiopharmaceutical therapies.
  • The appointment strengthens Radiopharm's clinical expertise as the company advances its radiopharmaceutical pipeline, which includes one Phase 2 and three Phase 1 trials across various solid tumor cancers.

CGT Catapult Invests in Spliceor's Trans-Splicing Gene Therapy Platform for Liver Cancer

Oncology
  • The Cell and Gene Therapy Catapult made its first investment through the Cross-Catapult Investment Pilot in Spliceor, a Cambridge University spinout developing trans-splicing gene therapy for liver cancer.
  • Spliceor's platform targets hepatocellular carcinoma, which has a five-year survival rate of just 13.4% and affects approximately 6,500 new patients annually in the UK.
  • The funding will support pre-clinical development and team expansion as Spliceor advances its precise gene repair technology toward clinical trials.
  • This investment represents a new UK initiative supported by Innovate UK to strengthen the advanced therapies pipeline through targeted seed investments in early-stage companies.

Sutro Biopharma Partners with FDA to Establish Regulatory Standards for Antibody Drug Conjugates

Oncology
  • Sutro Biopharma has entered into a research collaboration with the FDA to develop reference materials that will improve regulatory standards and enhance analytical methods for antibody drug conjugate development.
  • The partnership will utilize Sutro's cell-free XpressCF® technology to precisely engineer ADCs with predefined attributes, combined with FDA's analytical capabilities to fully characterize these materials.
  • The collaboration involves Sutro and the FDA's Office of Pharmaceutical Quality jointly leading study design and selection of target antigens, payload-linkers, and drug conjugation sites representative of both approved and developmental ADCs.
  • Results from this collaboration are expected to enhance the FDA's capacity for analytical characterization of ADCs and improve quality assessments across the industry.

FDA Requests Additional Manufacturing Data for Telix's Kidney Cancer Diagnostic Drug Zircaix

Oncology
  • The FDA has requested additional manufacturing data from Telix Pharmaceuticals for its kidney cancer diagnostic drug Zircaix, citing deficiencies in proving commercial manufacturing comparability to clinical trial processes.
  • Zircaix would be the first PET scan-based drug specifically designed for kidney cancer detection in the United States, targeting clear cell renal cell carcinoma which affects over 430,000 people worldwide.
  • Telix shares plunged 18.8% following the announcement, marking the company's worst trading day on record as investors reacted to potential regulatory delays.
  • The company believes the FDA's concerns are readily addressable and plans to begin submission remediation immediately to advance the approval process.

Eli Lilly Advances LOXO-435 in Phase 1 FORAGER-1 Study for FGFR3-Altered Advanced Cancers

Targeted TherapyOncology
  • Eli Lilly's FORAGER-1 Phase 1 study is evaluating LOXO-435 (LY3866288) as both monotherapy and combination treatment for locally advanced or metastatic solid tumors with FGFR3 gene alterations.
  • The open-label, multicenter trial tests the oral drug alone and in combination with pembrolizumab and enfortumab vedotin to determine optimal dosage and assess safety and efficacy.
  • The study began January 12, 2023, with primary completion date yet to be announced, representing a potential advancement in targeted cancer therapy for FGFR3-altered tumors.
  • Success in this study could enhance Eli Lilly's competitive position in the oncology market and potentially impact the company's stock performance positively.

Lantern Pharma Secures European Patent for AI-Developed Cancer Therapy LP-284

AIOncology
  • Lantern Pharma received European Patent Office allowance for LP-284, a next-generation acylfulvene targeting relapsed or refractory non-Hodgkin's lymphoma with patent exclusivity through early 2039.
  • The AI-developed drug candidate achieved clinical trial readiness in under three years at approximately $1.5-2.0 million cost and is currently in Phase 1 trials for aggressive NHL subtypes.
  • LP-284 has earned FDA Orphan Drug Designations for mantle cell lymphoma and high-grade B-cell lymphomas, addressing a $4 billion annual global blood cancer market.
  • The European patent strengthens Lantern's global intellectual property portfolio alongside existing patents in the US, Japan, India, and Mexico, positioning LP-284 for worldwide commercialization.

Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients with Relapsed or Refractory Lymphomas and Solid Tumors

NCT06132503RecruitingPhase 1
Lantern Pharma Inc.
Posted 1/3/2023

NHS Launches New Glioblastoma Trial After Patient Shows Complete Tumor Clearance with Ipilimumab

OncologyRare Disease
  • The NHS has launched the Win-Glio trial testing ipilimumab immunotherapy in 16 glioblastoma patients before standard treatment, following a remarkable case where one patient remains tumor-free over two years after treatment.
  • Ben Trotman, diagnosed with glioblastoma in October 2022, shows no signs of tumor recurrence 2 years and 8 months after receiving ipilimumab, despite not having planned follow-up surgery to remove remaining visible tumor.
  • The trial represents a strategic shift to administer immunotherapy when patients' immune systems are strongest, before radiotherapy and chemotherapy weaken their ability to respond to treatment.
  • Led by Dr. Paul Mulholland at University College London Hospital, the study was funded through over £1 million raised in memory of Baroness Margaret McDonagh, who died from glioblastoma in 2023.

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