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Everest Medicines Reports Strong H1 2025 Growth with Advanced mRNA Platform and Pipeline Expansion

CAR-TDrug Approval
  • Everest Medicines achieved 48% year-over-year revenue growth to RMB 446 million in H1 2025, driven by strong performance of NEFECON® and XERAVA®.
  • The company's proprietary AI-enabled mRNA platform advanced significantly with EVM16 personalized cancer vaccine entering first-in-human trials and EVM14 receiving FDA IND clearance.
  • NEFECON® became the first etiological treatment for IgA nephropathy to receive full approval in China, with production expansion approved to meet growing demand.
  • EVER001, a next-generation BTK inhibitor, demonstrated encouraging Phase 1b/2a results in primary membranous nephropathy with sustained efficacy through 52 weeks.

FDA-Approved Shield Blood Test Shows 84% Sensitivity for Colorectal Cancer Detection in Updated Clinical Data

Drug Approval
  • The Shield blood test demonstrated 84% overall sensitivity for colorectal cancer detection and 90% specificity for advanced neoplasia in updated clinical data from the ECLIPSE study.
  • The test showed stage-specific performance with 62% sensitivity for stage I cancer, 100% for stage II, and 96% for stage III colorectal cancer.
  • FDA approval in March 2024 and inclusion in NCCN guidelines mark the first blood-based test recommended for primary colorectal cancer screening.
  • The noninvasive alternative aims to improve screening rates among the 40% of eligible patients who currently decline traditional screening methods.

Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode

NCT04136002Completed
Guardant Health, Inc.
Posted 10/8/2019

Tetraspecific Antibodies Poised for First FDA Approval by 2029, Market Report Reveals

OncologyDrug Approval
  • The first tetraspecific antibody approval is expected by 2029, marking a significant milestone in multispecific immunotherapy development.
  • Sichuan Baili Pharmaceutical's Emfizatamab is currently in Phase II trials for hematological malignancies, representing a leading candidate in the field.
  • The bispecific antibody market has already exceeded $10 billion, with tetraspecific antibodies expected to capture even greater market share due to their enhanced targeting capabilities.
  • China and the USA are dominating the tetraspecific antibody clinical development landscape, with multiple companies advancing candidates through trials.

FDA Approves Foresee's CAMCEVI ETM 21mg for Advanced Prostate Cancer Treatment

Drug ApprovalOncology
  • The FDA has approved CAMCEVI ETM (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for advanced prostate cancer treatment.
  • The approval was based on a successful Phase 3 clinical study with 144 advanced prostate cancer patients, demonstrating 97.9% of subjects achieved the primary efficacy endpoint.
  • CAMCEVI ETM is exclusively licensed to Accord BioPharma for U.S. commercialization, with commercial launch expected after obtaining a J-code.
  • This represents Foresee Pharmaceuticals' second FDA-approved prostate cancer treatment, following CAMCEVI 42 mg which launched in April 2022.

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

NCT03261999CompletedPhase 3
Foresee Pharmaceuticals Co., Ltd.
Posted 9/26/2017

Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

NCT04260126CompletedPhase 2
PDS Biotechnology Corp.
Posted 3/29/2021

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

NCT05501886RecruitingPhase 3
Celcuity Inc
Posted 12/8/2022

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

NCT05147272TerminatedPhase 1
Repare Therapeutics
Posted 12/16/2021

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 7/12/2017

Teva Launches First Generic GLP-1 Weight Loss Drug as FDA Approves Generic Saxenda

Drug Approval
  • Teva Pharmaceuticals received FDA approval and launched the first-ever generic GLP-1 receptor agonist indicated for weight loss in the United States.
  • The generic liraglutide injection targets the $165 million annual Saxenda market and is approved for adults with obesity or overweight conditions and pediatric patients aged 12-17 years.
  • This marks Teva's fifth first-to-market generic entry in 2025, supporting the company's Pivot to Growth Strategy and complex generics portfolio expansion.
  • The drug carries significant safety warnings including potential thyroid tumors and cancer risks, requiring careful patient monitoring and contraindications for certain populations.

CRISPR Gene Therapy Exa-cel Delivers Sustained Quality of Life Improvements in Blood Disorders

Drug ApprovalGene Editing
  • Treatment with exagamglogene autotemcel (exa-cel), a CRISPR-based gene therapy, led to significant and sustained improvements in health-related quality of life for patients with severe sickle cell disease and transfusion-dependent beta thalassemia.
  • Patients with sickle cell disease saw quality of life scores not only improve but exceed population norms, with adult patients experiencing the largest gains in social and emotional functioning.
  • Beta thalassemia patients reported mean gains of 14.0 points in EQ-5D-5L scores by month 48 for adults and 6.1 points by month 24 for adolescents, all exceeding minimal clinically important difference thresholds.
  • The findings represent among the first quantified patient-reported quality-of-life changes following CRISPR-based gene editing treatment, based on data from ongoing clinical trials with median follow-up of 33.6 months for sickle cell disease and 38.4 months for beta thalassemia.

A Long-term Follow-up Study in Participants Who Received CTX001

NCT04208529Unknown StatusPhase 3
Vertex Pharmaceuticals Incorporated
Posted 1/20/2021

A Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease

NCT03745287CompletedPhase 2
Vertex Pharmaceuticals Incorporated
Posted 11/27/2018

Amgen Secures Expanded FDA Approval for Repatha® in Cardiovascular Risk Management

Drug Approval
  • Amgen received expanded FDA approval for Repatha®, broadening its use for adults at risk of major cardiovascular events.
  • The company reported significant Q2 earnings growth with revenue rising to $9,179 million during the same quarter.
  • The expanded approval may help Amgen counter biosimilar competition and patent expirations while potentially stabilizing revenue streams.
  • Amgen's current share price of $288.47 remains below the consensus price target of $311.88, reflecting an 8.12% discount.

European Regulators Approve First-in-Class Topical Anti-Androgen Therapy for Acne Treatment

Drug Approval
  • The European Medicines Agency's CHMP issued a positive opinion recommending approval of Winlevi® (clascoterone 1% cream) for facial acne treatment in adults and adolescents aged 12 to <18 years.
  • The approval follows a successful re-examination after an initial negative opinion, with the CHMP now concluding the benefit-risk profile is favorable for both age groups.
  • Winlevi® represents a first-in-class topical anti-androgen therapy that inhibits androgen receptors in the skin, reducing sebum production and inflammation.
  • The approval significantly expands access to topical anti-androgen treatment for European adolescents, who previously had no such therapeutic option available.

Akeso Reports Record Sales Growth as Ivonescimab Meets Overall Survival Endpoint in Phase III Trial

Drug Approval
  • Akeso's commercial sales surged 49.20% to RMB 1,401.6 million in the first half of 2025, driven by expanded indications and NRDL inclusion for its bispecific antibodies.
  • Ivonescimab achieved a statistically significant overall survival benefit in the final analysis of the HARMONi-A Phase III trial, marking a key milestone for the PD-1/VEGF bispecific.
  • The company is advancing its "IO 2.0 + ADC 2.0" strategy with 23 registrational/Phase III trials for ivonescimab and cadonilimab across multiple cancer types.
  • Akeso's non-oncology portfolio expanded with approvals for ebdarokimab and ebronucimab, while gumokimab and manfidokimab showed positive Phase III results.

Abbott Secures First Denosumab Biosimilar Approval in Thailand, Expanding Access to Bone Disease Treatment

Drug Approval
  • Abbott received regulatory approval for Thailand's first denosumab biosimilar, making advanced osteoporosis and cancer-related bone loss therapy more affordable for an estimated 3 million affected Thais.
  • The approval addresses a significant treatment gap, as fewer than 40% of hip fracture patients in Thailand currently begin anti-osteoporosis therapy due to barriers including cost and treatment availability.
  • Thailand faces a growing osteoporosis burden with 1 in 5 women and 1 in 10 men affected, and the country's aging population is projected to reach 25% aged 60 or older within the next decade.
  • This launch builds on Abbott's expanding biosimilar portfolio in the Asia-Pacific region, following recent approvals in Malaysia and India as part of the company's strategy to increase access to high-quality medicines.

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