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Clinical Trial News

Candel Therapeutics Strengthens Board with Industry Veteran Ahead of Key BLA Submission

  • Candel Therapeutics appointed Dr. Maha Radhakrishnan to its Board of Directors, bringing over 20 years of product development and commercialization experience from major biotech and pharmaceutical companies.
  • The appointment strategically positions Candel as it prepares for its Biologics License Application submission for CAN-2409 in intermediate-to-high-risk prostate cancer, anticipated in Q4 2026.
  • Dr. Radhakrishnan's expertise will support Candel's multimodal immunotherapy approach across multiple cancer indications, including treatments that have received FDA Fast Track and RMAT designations.

PCI Pharma Services Unveils Advanced Sterile Manufacturing Facility to Boost Biologic Production Capacity

Monoclonal Antibody
  • PCI Pharma Services is launching a new 50,000-square-foot sterile fill-finish facility in Bedford, NH, expected to reach full GMP production by summer 2025.
  • The facility features high-speed integrated fillers capable of producing up to 300,000 vials at speeds of 400 per minute, with twin 430-square-foot lyophilizers and fully isolated containment systems.
  • This marks PCI's third high-throughput sterile fill-finish facility built since 2021, enhancing capacity for late-phase clinical and commercial biologic drugs including monoclonal antibodies and fusion proteins.
  • The company is also establishing a Development Center of Excellence at the Bedford campus, expected to be operational by early 2026, handling both small molecules and biologics including antibody-drug conjugates.

MIT and Recursion Release Boltz-2: Open-Source AI Model Achieves 1000x Speed Boost in Drug Discovery Screening

AIDrug Discovery
  • MIT and Recursion have released Boltz-2, the first open-source biomolecular co-folding model that jointly predicts 3D complex structures and molecular binding affinity with unprecedented speed and precision.
  • The AI model approaches the accuracy of free energy perturbation (FEP), a gold-standard physics-based method, while performing up to 1,000 times faster, significantly reducing cost and time for large-scale molecular screening.
  • Boltz-2 outperformed all CASP16 affinity challenge participants and is released under the permissive MIT license, making the model, weights, and training pipeline available for both academic and commercial use.
  • The model was trained using Recursion's NVIDIA-powered supercomputer BioHive-2 and incorporates molecular dynamics simulations and approximately 5 million binding affinity measurements.

Vivoryon's Varoglutamstat Shows Sustained Kidney Function Improvement in Phase 2 Meta-Analysis

  • Vivoryon Therapeutics presented meta-analysis data from two independent Phase 2 studies (VIVIAD and VIVA-MIND) showing varoglutamstat significantly improved kidney function (eGFR) in elderly patients at the ERA 2025 congress.
  • The first-in-class glutaminyl cyclase inhibitor demonstrated statistically significant and clinically meaningful improvements starting at week 24 and sustained through week 96 compared to placebo.
  • Meta-analysis confirmed substantially larger effect sizes in diabetic patients, leading to plans for a dedicated Phase 2b trial in diabetic kidney disease patients with chronic kidney disease stage 3b/4.
  • Varoglutamstat represents a potential new therapeutic approach for diabetic kidney disease through its anti-inflammatory and anti-fibrotic mechanisms targeting pathologically relevant proteins.

Aytu BioPharma Secures Exclusive Rights to First-in-Class Antidepressant EXXUA for $22B US Market

Drug Approval
  • Aytu BioPharma has secured exclusive US commercialization rights for EXXUA (gepirone), the first FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder in adults.
  • EXXUA demonstrated significant improvement in depression symptoms across clinical trials involving over 5,000 patients, with sexual side effects comparable to placebo rather than typical antidepressants.
  • The company plans to launch EXXUA in Q4 2025 to compete in the over $22 billion US prescription MDD market, targeting 21 million affected Americans.
  • The transaction was financed by healthcare-focused institutional investors including Nantahala Capital Management and Stonepine Capital Management.

Aytu BioPharma Raises $16.6M to Launch First-in-Class Depression Treatment EXXUA

Drug Approval
  • Aytu BioPharma completed an upsized public offering raising $16.6 million to commercialize EXXUA, the first FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder.
  • EXXUA represents a breakthrough in depression treatment as it demonstrates comparable sexual side effects to placebo, addressing a major limitation of current antidepressants.
  • The company plans to launch EXXUA in Q4 2025 to compete in the $22 billion U.S. prescription major depressive disorder market.
  • Clinical trials involving over 5,000 patients showed significant improvement in depression symptoms with EXXUA's novel mechanism of action.

Nemluvio Shows Sustained Long-Term Efficacy in Atopic Dermatitis with Two-Year Extension Data

Monoclonal AntibodyDrug Approval
  • New two-year data from the ARCADIA long-term extension study demonstrate that Nemluvio (nemolizumab) maintains sustained and increased improvements in itch, skin lesions, sleep, and quality of life in patients with moderate-to-severe atopic dermatitis.
  • At week 104, more than 85% of evaluable patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI), with approximately 85% achieving at least four-point improvement in itch scores.
  • The study reinforces Nemluvio's rapid onset of action at week 4 and demonstrates a consistent safety profile with no new safety signals identified during prolonged treatment up to two years.

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

NCT04202679CompletedPhase 3
Sanofi
Posted 1/16/2020

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03985943CompletedPhase 3
Galderma R&D
Posted 6/27/2019

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04204616Active, Not RecruitingPhase 3
Galderma R&D
Posted 1/11/2021

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

NCT03989206Active, Not RecruitingPhase 3
Galderma R&D
Posted 12/30/2019

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03989349CompletedPhase 3
Galderma R&D
Posted 6/30/2019

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

NCT04183335CompletedPhase 3
Sanofi
Posted 12/12/2019

Denovo Biopharma Forms Neuroscience Advisory Board to Advance Precision Medicine Approach for Treatment-Resistant Depression

Precision MedicineAI
  • Denovo Biopharma has established a neuroscience Scientific Advisory Board chaired by Dr. Charles B. Nemeroff to guide development of its Phase 3-ready biomarker-guided depression therapy DB104.
  • The company's lead asset liafensine is a first-in-class triple reuptake inhibitor that targets serotonin, norepinephrine, and dopamine transporters for treatment-resistant depression.
  • Denovo's AI-based platform identified a novel genetic biomarker at the ANK3 gene that correlates with liafensine efficacy, representing the first genetic biomarker validated in psychiatry.
  • The advisory board includes industry veterans with experience developing major CNS treatments including Cymbalta, Trintellix, and Cobenfy for schizophrenia.

GlycoMimetics Stockholders Approve Merger with Crescent Biopharma, Creating New Oncology-Focused Entity

OncologyPrecision Medicine
  • GlycoMimetics stockholders approved the proposed merger with Crescent Biopharma on June 5, 2025, along with all related proposals including a 1-for-100 reverse stock split.
  • The combined company will trade on Nasdaq under the name "Crescent Biopharma, Inc." with ticker symbol "CBIO" starting June 16, 2025, with approximately 14.8 million shares outstanding.
  • Crescent Biopharma focuses on precision-engineered molecules for solid tumors, including lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody.
  • The merger combines GlycoMimetics' glycobiology platform for cancer and inflammatory diseases with Crescent's pipeline of three oncology programs targeting validated biology.

China's Biopharma Sector Showcases Innovation Leadership at BIOSeedin 2025 Conference

  • The 5th annual BIOSeedin Innovation Partnering Conference attracted over 2,000 registrants from 10 countries, facilitating 7,275 meeting requests and confirmed deals across oncology, rare diseases, and next-generation modalities.
  • Chinese biotech companies now contribute 38% of global ADC patents and hold 32% of patents for breakthrough modalities including PD-1xLAG-3 bispecifics and tumor-activated ADC linkers.
  • The conference showcased 40 companies with diverse therapeutic assets, including 10 breakthrough-designated programs and two Phase III candidates approaching 2026 NDAs.
  • Industry leaders emphasized China's evolution from fast follower to global innovator, with cost-efficient clinical execution enabling rapid validation of complex biologics and gene-editing platforms.

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