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Clinical Trial News

Green Valley Pharmaceutical Suspends Production of Controversial Alzheimer's Drug GV-971 Amid License Renewal

Drug Approval
  • Green Valley Pharmaceutical has suspended production and sales of GV-971, China's first indigenous Alzheimer's therapy, after its license expired and entered regulatory review.
  • The seaweed-derived compound sodium oligomannate received conditional approval in 2019 but faced criticism from medical experts over inconsistent clinical trial results and short study duration.
  • Hospital and retail sales of GV-971 reached $45.4 million in 2022, while China's dementia patient population represents 17 million people, about 30% of the global total.
  • The company's global clinical trial launched in 2020 was terminated in 2022 due to funding shortages and COVID-19 pandemic disruptions.

US Small Molecule API CDMO Market Projected to Reach $12.49 Billion by 2030 Driven by FDA Approvals and HPAPI Demand

FDA Approval
  • The US Small Molecule Innovator API CDMO Market is valued at $8.78 billion in 2024 and expected to reach $12.49 billion by 2030, growing at a 6.03% CAGR.
  • Rising demand for highly potent active pharmaceutical ingredients (HPAPIs) across oncology, cardiovascular, and neurological disorders is driving market expansion.
  • In 2024, 50 novel drug approvals by the FDA, including new molecular entities and biologics, are boosting demand for specialized CDMO services.
  • CDMOs are evolving into strategic partners offering integrated end-to-end solutions, from early research to commercial-scale production, to support faster drug development timelines.

Nuevocor Receives FDA IND Clearance for Gene Therapy Targeting Rare Genetic Heart Disease

Rare Disease
  • Nuevocor announced FDA clearance of its Investigational New Drug application for NVC-001, an AAV-based gene therapy designed to treat LMNA-related dilated cardiomyopathy.
  • The therapy targets approximately 100,000 patients in the U.S. and Europe with this aggressive form of genetic heart disease that rapidly progresses to end-stage heart failure.
  • NVC-001 demonstrated significant benefits in survival and cardiac function in preclinical studies by addressing the mechanobiological root cause of disease.
  • The company plans to initiate a first-in-human Phase 1/2 clinical trial in early 2026 to evaluate safety, tolerability, and preliminary efficacy.

FDA Manufacturing Issues Delay Unicycive's Kidney Disease Drug Approval Process

Drug Approval
  • The FDA has identified manufacturing deficiencies at a third-party vendor for Unicycive Therapeutics' oxylanthanum carbonate, an investigational oral phosphate binder for kidney disease patients on dialysis.
  • The manufacturing issues have precluded FDA label discussions with the company, though a final decision is still expected by the June 28 PDUFA action date.
  • Oxylanthanum carbonate uses proprietary nanoparticle technology to deliver high phosphate binding potency while reducing pill burden for patients with hyperphosphatemia.
  • Unicycive's stock fell 27% in premarket trading following the announcement, as the company works with partners to resolve the FDA's cGMP compliance concerns.

AbbVie's Skyrizi and Rinvoq Drive Recovery as Humira Sales Plummet 50% Following Patent Loss

Drug Approval
  • AbbVie expects robust revenue growth in 2025, just two years after losing U.S. exclusivity for Humira in January 2023, with the flagship drug's sales declining nearly 50% to $1.12 billion in Q1 2025.
  • The company's ex-Humira platform grew over 21% year-over-year in Q1 2025, driven by newer immunology drugs Skyrizi and Rinvoq, which showed strong performance across inflammatory bowel disease indications.
  • AbbVie raised its guidance by $900 million and now expects $24.7 billion in combined sales from Skyrizi and Rinvoq this year, with potential for five new Rinvoq indications.
  • The immunology market remains highly competitive with Johnson & Johnson's Stelara and Tremfya, and Eli Lilly's recently approved Omvoh for ulcerative colitis and Crohn's disease.

AIML Innovations Secures Provisional Patents for AI-Powered ECG Signal Processing Technology

AI
  • AI/ML Innovations Inc. has filed comprehensive provisional patent applications with the USPTO through its subsidiary Neural Cloud Solutions, covering advanced neural network architectures and cloud-based ECG signal optimization workflows.
  • The patent filings protect key innovations within AIML's proprietary AI signal-processing platforms MaxYield™ and CardioYield™, including a dynamic ECG reporting engine that supports clinical workflows with customizable components.
  • These patents strengthen AIML's position in AI-assisted cardiology by protecting both algorithmic foundations and deployment infrastructure, supporting the company's global commercialization strategy.
  • The company maintains a growing regulatory portfolio including a 510(k) premarket notification and registered FDA Device Master File, demonstrating commitment to rigorous validation and broad interoperability.

AstraZeneca Exercises Option for Quell's CAR-Treg Therapy in Inflammatory Bowel Disease

  • AstraZeneca has selected and licensed Quell Therapeutics' lead CAR-Treg cell therapy candidate for inflammatory bowel disease, triggering a $10 million milestone payment.
  • This marks the second major milestone in the companies' 2023 collaboration, following a similar achievement in Type 1 diabetes in November 2024.
  • The engineered T-regulatory cell therapy utilizes Quell's proprietary Foxp3 Phenotype Lock technology to address underlying immune drivers of IBD.
  • AstraZeneca will advance the candidate through CTA/IND-enabling studies while Quell provides manufacturing support for first-in-human trials.

Gyre Therapeutics Initiates Phase 1 Trial of F230 for Pulmonary Arterial Hypertension in China

Rare Disease
  • Gyre Therapeutics has successfully dosed the first volunteer in a Phase 1 clinical trial evaluating F230, a novel endothelin A receptor antagonist, for treating pulmonary arterial hypertension in China.
  • F230 is a fully synthetic small molecule designed to selectively block the ETA receptor, targeting pulmonary vascular remodeling and pressure reduction in PAH patients.
  • This milestone marks Gyre's expansion into the PAH field, leveraging China's growing PAH market valued at $370 million in 2023 and projected to reach $480 million by 2031.
  • The Phase 1 trial will evaluate safety, tolerability, and pharmacokinetics in healthy volunteers as part of Gyre's fibrosis-first therapeutic strategy.

Day One Biopharmaceuticals Appoints Michael Vasconcelles as Head of R&D to Drive Pipeline Expansion

OncologyTargeted TherapyLeadership Change
  • Day One Biopharmaceuticals has appointed Michael Vasconcelles, M.D., as Head of Research and Development, bringing over 25 years of oncology research and development expertise to the company.
  • Dr. Vasconcelles will oversee the company's research, development, and medical affairs infrastructure while supporting OJEMDA's growth and expanding the pipeline of targeted therapies.
  • The appointment comes at a pivotal time for Day One as it transitions from focusing primarily on pediatric cancer to developing transformative medicines for patients of all ages with life-threatening diseases.
  • Dr. Vasconcelles previously served as Executive Vice President at ImmunoGen, where he led the transformation into a global biotech enterprise and optimized ELAHERE's commercialization strategy.

Curadev and Memorial Sloan Kettering Expand Collaboration to Advance Novel STING Agonist CRD3874-SI

Oncology
  • Curadev Pharma and Memorial Sloan Kettering Cancer Center are expanding their collaboration through MSK's Therapeutics Accelerator program to advance development of CRD3874-SI, a first-in-class allosteric STING agonist.
  • The collaboration builds on an ongoing Phase 1a/b clinical trial for sarcoma and Merkel cell carcinoma patients and aims to explore CRD3874-SI's potential in additional cancer types.
  • CRD3874-SI has demonstrated encouraging safety and efficacy profiles in first-in-human studies and is moving forward into multiple solid-tumor expansion cohorts.
  • The expanded partnership provides Curadev with MSK's expertise and institutional resources, including medical, clinical, and regulatory advice to accelerate drug development.

A Study of CRD3874-SI in People With Solid Tumors

NCT06021626RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 8/25/2023

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