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Clinical Trial News

Varda Space Industries Secures $187 Million Series C to Advance Microgravity Drug Manufacturing

  • Varda Space Industries raised $187 million in Series C funding led by Natural Capital and Shrug Capital, bringing total capital raised to $329 million for microgravity-enabled pharmaceutical manufacturing.
  • The company has completed three successful orbital missions and demonstrated breakthrough crystallization of ritonavir Form III, a previously unstable drug formulation that could not be produced on Earth.
  • Varda opened a new 10,000 square foot laboratory in El Segundo to develop processes for crystallizing biologics, targeting the $210 billion monoclonal antibody market.
  • The company's reusable orbital capsules reach Mach 25 during reentry and serve dual purposes as pharmaceutical laboratories and hypersonic testbeds for government partners.

Sanofi Advances Long-Term Amlitelimab Study for Moderate to Severe Atopic Dermatitis

  • Sanofi is conducting a Phase 2/Phase 3 long-term extension study to evaluate the safety, tolerability, and efficacy of subcutaneous amlitelimab in patients with moderate to severe atopic dermatitis.
  • The open-label study began on August 22, 2022, and follows participants from previous amlitelimab trials, with treatment administered every four weeks via subcutaneous injection.
  • The study includes both responder and non-responder participants from previous trials, with protocols for drug withdrawal and treatment restoration to monitor treatment durability.
  • Positive results from this ongoing research could strengthen Sanofi's competitive position in the dermatological treatment market and potentially impact investor confidence in the company's pipeline.

Medidata Expands Partnership with University of Sydney to Accelerate Clinical Trial Innovation

  • Medidata has expanded its six-year partnership with the NHMRC Clinical Trials Centre at the University of Sydney, now supporting 30 concurrent studies through its unified platform.
  • The collaboration enables streamlined clinical trial operations by consolidating multiple data systems, improving data management capabilities and research efficiency.
  • The CTC utilizes Medidata solutions particularly for studies that may contribute to regulatory submissions, with emphasis on adaptive and platform trial development.
  • The partnership demonstrates Medidata's proactive approach to global data privacy and security compliance while supporting complex and evolving trial settings.

TandemAI and Perpetual Medicines Merge to Advance AI-Driven Small Molecule and Peptide Drug Discovery

AIDrug Discovery
  • TandemAI and Perpetual Medicines have completed a strategic merger to create an expanded AI and physics-based drug discovery platform covering both small molecules and peptides.
  • The combined company will leverage TandemAI's proven track record with over 150 pharmaceutical partners and Perpetual's computational peptide discovery platform to accelerate therapeutic development.
  • More than ten client programs from TandemAI are expected to reach clinical trials within the next 12 months, demonstrating the commercial viability of their AI-driven approach.
  • The merger positions the combined entity to capitalize on the growing commercial opportunity in peptide therapeutics, particularly following the success of GLP-1, IL-23, and PCSK9 drug classes.

Renasant Bio Raises $54.5M to Develop Novel Ion Channel Therapies for ADPKD

  • Renasant Bio secured $54.5 million in seed funding from investors including 5AM Ventures, Atlas Venture, OrbiMed and Qiming Venture Partners USA to develop treatments for autosomal dominant polycystic kidney disease (ADPKD).
  • The company is developing corrector and potentiator therapies inspired by cystic fibrosis treatments, targeting malformed ion channels that cause ADPKD in approximately 12 million people worldwide.
  • Renasant's lead small molecule corrector candidate is currently in preclinical testing and designed to work across the wide range of mutations that cause ADPKD, with clinical trials planned for the next few years.

Renovaro Biosciences Converts $9.7M Debt to Equity, Strengthens AI-Driven Drug Discovery Platform

AIPrecision MedicineDrug Discovery
  • Renovaro Inc. (NASDAQ:RENB) announced that senior debt holders agreed to convert approximately $9.7 million of outstanding debt into equity through the issuance of 53.6 million shares at $0.30 per share.
  • The debt conversion significantly enhances the company's balance sheet by eliminating debt obligations and interest payments, providing greater financial flexibility for growth initiatives.
  • The biotechnology company focuses on AI-driven precision medicine, developing innovative therapies and diagnostics in oncology, infectious disease, and autoimmune disorders using machine learning integrated with biomedical research.

Neurizon Receives FDA Approval for Strategy to Lift Clinical Hold on ALS Drug NUZ-001

FDA Approval
  • Neurizon Therapeutics received written FDA confirmation accepting its strategy to lift the clinical hold on NUZ-001, an investigational treatment for amyotrophic lateral sclerosis (ALS).
  • The company has completed two required preclinical pharmacokinetic studies ahead of schedule to address FDA concerns about systemic exposure data.
  • Neurizon anticipates submitting its complete response to the FDA in the coming weeks and expects the clinical hold to be lifted by August 2025.
  • The regulatory progress positions NUZ-001 for entry into the HEALEY ALS Platform Trial in the second half of 2025.

Genomenon and UCB Partner to Advance Thymidine Kinase 2 Deficiency Diagnosis Through Genomic Intelligence

Rare Disease
  • Genomenon and UCB have formed a strategic partnership to accelerate awareness, diagnosis, and research for thymidine kinase 2 deficiency (TK2d), a rare mitochondrial disease characterized by progressive muscle weakness.
  • The collaboration has resulted in the curation and classification of nearly 100 TK2 gene variants, with approximately 40% being previously unrepresented in ClinVar and 25% classified as pathogenic or likely pathogenic.
  • Through Genomenon's AI-powered genomic intelligence platform and expert curation, the comprehensive variant data is now freely available to global clinical communities via both Mastermind and ClinVar databases.
  • The partnership aims to reduce barriers to genetic diagnosis and resolve variants of uncertain significance, ultimately improving patient outcomes for individuals with rare diseases.

Biomarker-Driven Precision Medicine Transforms Treatment Landscape for Metastatic Castration-Sensitive Prostate Cancer

Precision Medicine
  • The AMPLITUDE trial demonstrated significant benefits of abiraterone plus olaparib in metastatic castration-sensitive prostate cancer patients with DNA damage response alterations, particularly those with BRCA1/2 mutations.
  • The PSMA ADDITION trial showed promising results for lutetium-177-PSMA-617 in PSMA-positive disease, while the CAPITELLO study is investigating capivasertib in PTEN-deficient patients.
  • Implementation of precision medicine approaches will require routine molecular testing and multidisciplinary treatment planning to guide treatment decisions based on tumor genetics rather than clinical factors alone.
  • Despite compelling evidence for triplet therapy from ARASENS and PEACE-1 trials, real-world utilization remains suboptimal with 25-30% of patients still receiving ADT monotherapy.

Formycon Completes Enrollment for Keytruda Biosimilar Study, Skips Phase III Trial with FDA Approval

FDA ApprovalOncology
  • Formycon AG successfully completed patient enrollment for its Dahlia pharmacokinetic study with 96 participants, comparing biosimilar candidate FYB206 to Keytruda in melanoma patients.
  • The FDA approved a streamlined clinical development program allowing Formycon to skip the Phase III trial, accelerating development and reducing costs significantly.
  • Results from the primary endpoint are expected in Q1 2026, with potential market entry after Keytruda's exclusivity expires in 2029 for the US and 2030 for the EU.
  • The development targets the world's best-selling drug with $29.5 billion in 2024 sales, potentially reaching over $50 billion by 2032.

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