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Clinical Trial News

Gilead's HIV Prevention Drug Yeztugo Exceeds Launch Expectations, Projected to Reach $5 Billion by 2031

  • Gilead Sciences' HIV prevention drug Yeztugo is performing "well ahead of expectations" following its recent US and European launch, with unaided awareness reaching 72% compared to typical industry launch levels.
  • The twice-yearly pre-exposure prophylaxis therapy demonstrated 100% efficacy in preventing HIV cases in trials involving South African and Ugandan women, leading to its approval in June.
  • GlobalData forecasts Yeztugo will generate nearly $5 billion in global sales by 2031, positioning it as one of Gilead's most lucrative assets in the competitive HIV prevention market.
  • Gilead's overall HIV portfolio reported strong Q2 results with $4.15 billion in sales, driven by blockbuster drug Biktarvy which achieved $3.5 billion in quarterly revenue.

Faron Secures Extended Patent Protection for Bexmarilimab Cancer Immunotherapy Through 2040

Monoclonal Antibody
  • Faron Pharmaceuticals received US Patent No. 12,371,486 covering treatment of Clever-1 positive cancers with bexmarilimab, extending patent protection from 2037 to February 2040.
  • The new patent specifically covers treating cancers with Clever-1 positive cells in the tumor microenvironment, including acute myeloid leukemia and myelodysplastic syndrome.
  • Bexmarilimab is currently being investigated in Phase I/II clinical trials as an immunotherapy that reprograms macrophages to enhance immune response against tumors.
  • The extended patent life provides additional commercial protection for the investigational anti-Clever-1 antibody, which targets immunosuppressive pathways in cancer treatment.

HOPE Therapeutics Receives Florida Regulatory Approval for Dura Medical Acquisition to Expand Precision Psychiatry Network

  • HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, received final clearance from Florida's Agency for Health Care Administration to proceed with the acquisition of Dura Medical LLC, a revenue-generating and EBITDA-positive precision psychiatry clinic network.
  • Dura Medical provides comprehensive interventional psychiatry services including ketamine infusion therapy, transcranial magnetic stimulation, and Spravato® for treating severe depression, PTSD, and related CNS disorders in both veteran and civilian populations.
  • The acquisition, combined with previously announced purchases of Neurospa TMS and Cohen and Associates, will establish HOPE's coverage along Florida's west coast and support Dura's mission to treat more than 10,000 patients by 2026.
  • The deal represents a strategic expansion for HOPE's network of interventional psychiatry clinics, with Dura Medical founder Stephen Durand pioneering the combination of psychedelic medications with neuroplastic technologies for treating suicidal depression and PTSD.

Iovance Biotherapeutics Implements Major Restructuring Amid Regulatory Setbacks and Commercial Challenges

Oncology
  • Iovance Biotherapeutics reduced its workforce by 19% in Q3 2025 and targets $100 million in annual savings to extend cash runway to late 2026.
  • The company withdrew its EU Marketing Authorization Application for Amtagvi after EMA feedback revealed clinical data misalignment, delaying European approval.
  • Amtagvi generated $54.1 million in Q2 2025 revenue, but the company revised 2025 revenue guidance downward by 40% to $250-300 million.
  • Clinical trials for Amtagvi in non-small cell lung cancer and endometrial cancer are progressing, with data expected in H2 2025.

RemeGen Receives FDA Clearance for Phase II Trial of Bispecific Antibody RC148 in Advanced Solid Tumors

  • RemeGen Co., Ltd. announced FDA clearance of its IND application for RC148, a PD-1 and VEGF-targeting bispecific antibody, to proceed with Phase II clinical trials in the United States.
  • RC148 is designed for treating multiple advanced malignant solid tumors and represents an innovative molecule developed using RemeGen's proprietary bispecific antibody technology platform.
  • The FDA clearance marks a significant milestone that should expedite RC148's global development process, while clinical trials are already proceeding in China as both monotherapy and combination therapy.
  • This regulatory approval enables RemeGen to expand its clinical development program internationally and advance the therapeutic potential of its dual-targeting approach.

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

FDA 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.

Trinity Biotech Launches FDA-Cleared Preeclampsia Testing Service with Potential $10 Million Cost Savings

  • Trinity Biotech announced the launch of an FDA-cleared PreClara Ratio biomarker test for preeclampsia risk assessment, planned for Q3 2025 rollout through its New York reference laboratory.
  • The sFlt-1/PlGF test targets approximately 500,000 women annually affected by hypertensive disorders of pregnancy in the United States, a leading cause of maternal and neonatal complications.
  • Recent U.S.-based studies published in March 2025 demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients when incorporated into standard care.
  • The service launch establishes groundwork for Trinity Biotech's proprietary PrePsia technology and represents a strategic milestone in the company's maternal health portfolio expansion.

GSK Secures $370 Million Settlement and Future Royalties in CureVac-BioNTech mRNA Patent Dispute

  • GSK will receive $370 million upfront from CureVac following a patent settlement involving BioNTech and Pfizer over mRNA vaccine technology, with $320 million paid in cash.
  • The pharmaceutical giant will collect 1% royalties on US sales of Pfizer-BioNTech's influenza, COVID-19, and combination mRNA vaccines starting in 2025.
  • The settlement includes significant reductions in royalties GSK must pay on its own future mRNA vaccine products and potential additional payments of $130 million if BioNTech's acquisition of CureVac closes.
  • CureVac and its partners will receive a total of $740 million from the broader patent dispute resolution with Pfizer and BioNTech over mRNA COVID-19 vaccine technology.

Dewpoint Therapeutics Cuts 70% of Workforce, Refocuses on Lead Cancer Drug DPTx3186

  • Dewpoint Therapeutics laid off approximately 70% of its workforce and consolidated operations to Boston following a high burn rate despite raising $287 million across three funding rounds.
  • The biotech will prioritize clinical development of its lead candidate DPTx3186, a beta-catenin inhibitor targeting the WNT signaling pathway for gastric cancer treatment.
  • The company plans to advance DPTx3186 into clinical trials by the end of the year while maintaining select partnerships including ALS programs with Mitsubishi Tanabe and cardiomyopathy work with Bayer Pharma.
  • CEO Ameet Nathwani indicated the company is in final stages of raising new private funding to support the streamlined operations and pipeline focus.

Kura Oncology's Ziftomenib Receives FDA Priority Review for NPM1-Mutant AML, PDUFA Date Set for November 2025

OncologyPrecision Medicine
  • Kura Oncology's lead asset ziftomenib has advanced to FDA Priority Review for relapsed/refractory NPM1-mutant acute myeloid leukemia, with a PDUFA date of November 30, 2025.
  • The KOMET-001 pivotal trial demonstrated a 23% complete remission rate in heavily pretreated, high-risk patients, with manageable safety profile and no significant cardiac safety issues.
  • Ziftomenib is the only menin inhibitor to receive both Priority Review and Breakthrough Therapy Designation for this indication, positioning it as a potential first-in-class treatment.
  • The company reported Q2 2025 collaboration revenue of $15.3 million, missing analyst expectations of $39.1 million, while maintaining $630.7 million in cash reserves extending runway into 2027.

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