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Genentech Initiates First Patent Litigation Against Pertuzumab Biosimilar HLX11

  • Genentech filed the first BPCIA litigation against Shanghai Henlius Biotech and Organon on August 14, 2025, alleging infringement of 24 patents by their proposed pertuzumab biosimilar HLX11.
  • The lawsuit represents the first patent challenge for a pertuzumab biosimilar, with Henlius and Organon's aBLA being the only publicly announced application currently pending with the FDA.
  • Genentech asserted 24 of the 47 patents it had listed during the BPCIA patent dance, including 10 method of treatment patents and 10 manufacturing patents.
  • The litigation seeks injunctive relief to prevent commercialization of HLX11 and damages for alleged patent infringement under the BPCIA framework.

MacroGenics Names Eric Risser as New CEO, Succeeding 24-Year Leader Scott Koenig

  • MacroGenics appointed Eric Risser as President and CEO effective August 13, 2025, replacing Scott Koenig who led the company for 24 years.
  • Risser brings nearly 30 years of biotech experience and has generated over $1.6 billion in non-dilutive capital through corporate development efforts since joining MacroGenics in 2009.
  • The leadership transition comes as MacroGenics focuses on developing innovative monoclonal antibody-based cancer therapeutics, with three FDA-approved products already in its portfolio.
  • Risser aims to create a more focused and capital-efficient biotechnology company that delivers high-value cancer therapies to patients.

Pulse Biosciences Advances nsPFA Technology with FDA Breakthrough Designation and Clinical Expansion

  • Pulse Biosciences received FDA Breakthrough Device Designation for its Cardiac Surgery System and Investigational Device Exemption approval, enabling clinical studies in atrial fibrillation patients.
  • The company is pursuing a Premarket Approval (PMA) pathway for its nsPFA technology, targeting the $5 billion atrial fibrillation market projected by 2030.
  • With $119.3 million in cash reserves extending through mid-2026, Pulse plans to initiate pivotal trials in mid-2025 while expanding European commercial operations.
  • The company's nanosecond Pulsed Field Ablation platform shows promise in both cardiac surgery and benign thyroid nodule treatment applications.

FDA Approves Expansion of Aquedeon's Duett Vascular Graft System Trial to 90 Patients

  • The FDA has approved expansion of Aquedeon Medical's IDE clinical trial for the Duett Vascular Graft System, increasing enrollment from the initial study to up to 90 patients across additional U.S. clinical sites.
  • The Duett System is designed to simplify and accelerate vascular anastomosis during complex aortic arch reconstruction surgery, potentially reducing deep hypothermic circulatory arrest duration and associated neurological risks.
  • The novel device addresses critical needs in open surgical repair of aortic arch aneurysms and dissections, procedures that are technically demanding and carry significant cardiac and neurological risks.
  • Principal investigator Dr. Wilson Szeto notes the technology has potential to transform aortic surgery by providing surgeons with innovative tools to enhance patient care for aortic disease.

Xspray Pharma Secures First Patent License Deal with Handa Therapeutics for Dasatinib Commercialization

  • Xspray Pharma has entered into its first patent licensing agreement with Handa Therapeutics, granting non-exclusive rights to commercialize dasatinib products in the US and selected Asian markets.
  • The deal will generate up to double-digit royalties on Handa's net proceeds, marking an important milestone in capitalizing on Xspray's intellectual property assets.
  • Xspray's lead product candidate Dasynoc awaits FDA approval with a PDUFA date of October 7, 2025, and the agreement ensures its launch won't be affected by regulatory exclusivities.
  • The licensing deal validates Xspray's comprehensive patent portfolio while maintaining the company's core strategy to develop improved protein kinase inhibitor drugs using its HyNap technology platform.

Orchestra BioMed Expands BACKBEAT Hypertension Trial Eligibility 24-Fold Following FDA Protocol Approval

  • Orchestra BioMed received FDA approval for a protocol update that expands patient eligibility for the BACKBEAT pivotal study by more than 24-fold compared to the original protocol.
  • The expanded criteria now include any hypertensive patients with Medtronic Azure or Astra pacemakers, including device replacements and those with NYHA class I or II heart failure.
  • The company targets mid-2026 for completion of enrollment in the study evaluating AVIM therapy for uncontrolled hypertension in pacemaker patients.
  • AVIM therapy previously demonstrated net reductions of 8.1 mmHg in ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure in the MODERATO II pilot study.

Arcellx Reports Strong CAR-T Clinical Data Despite 72% Revenue Drop in Q2 2025

  • Arcellx's lead CAR-T therapy anito-cel achieved a 97% overall response rate and 93.3% minimal residual disease negativity in 117 multiple myeloma patients from the Phase 2 iMMagine-1 study.
  • The company's Q2 2025 collaboration revenue dropped 72% to $7.6 million, missing analyst expectations by 43.8% due to completion of clinical trial manufacturing activities.
  • Net loss more than doubled to $52.8 million as the company increased commercial readiness spending ahead of a planned 2026 product launch.
  • FDA authorized an investigational new drug application for ACLX-004, expanding Arcellx's pipeline into acute myeloid leukemia treatment.

FibroGen Receives FDA Approval for Phase 3 Trial of Roxadustat in Lower-Risk MDS Patients with High Transfusion Burden

  • FibroGen has reached agreement with the FDA on key design elements for a pivotal Phase 3 trial of roxadustat in lower-risk myelodysplastic syndrome patients with high transfusion burden.
  • The oral HIF-PH inhibitor demonstrated promising efficacy in a post-hoc analysis, with 36% of high transfusion burden patients achieving transfusion independence compared to 7% on placebo.
  • The randomized, placebo-controlled trial will enroll approximately 200 patients and evaluate 8-week or 16-week transfusion independence as the primary endpoint.
  • FibroGen plans to submit the Phase 3 protocol to the FDA in the fourth quarter of 2025, addressing a significant unmet medical need in this patient population.

FDA Approves AJOVY as First CGRP Antagonist for Pediatric Migraine Prevention

  • Teva Pharmaceutical Industries received FDA approval for AJOVY as the first CGRP antagonist indicated for preventive treatment of episodic migraine in children and adolescents aged 6-17 weighing at least 45 kilograms.
  • This approval expands Teva's neuroscience portfolio and provides a new treatment pathway for a pediatric population with previously limited preventive migraine options.
  • The approval supports Teva's Pivot to Growth strategy and contributed to the company raising its 2025 revenue guidance to $16.8-17.2 billion.
  • Analysts project Teva will reach $17.9 billion in revenue and $1.5 billion in earnings by 2028, representing a 2.6% annual revenue growth rate.

FDA Provides Positive Feedback on Immutep's Eftilagimod Alfa for Head and Neck Cancer Treatment

  • Immutep received positive FDA feedback on eftilagimod alfa development for first-line treatment of head and neck squamous cell carcinoma patients with PD-L1 expression below 1.
  • The FDA agreed on the potential of efti combined with KEYTRUDA to address high unmet need in this patient segment, representing up to 20% of first-line HNSCC patients.
  • FDA outlined potential accelerated approval pathways including a randomized registrational trial or smaller single-arm study under Project FrontRunner initiative.
  • Current treatment options for PD-L1 CPS <1 patients are limited to chemotherapy, as anti-PD-1 therapy alone is only approved for patients with CPS >1.

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