News Headlines

  1. Miransertib (ARQ 092) Granted Fast Track Designation For The Treatment Of PIK3CA-Related Overgrowth Spectrum (PROS)

    ArQule, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to miransertib (ARQ 092) for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS), a group of related, ultra-rare genetic disorders characterized by excessive tissue growth in various parts of the body.

  2. Abeona Therapeutics Announces Authorization To Commence Phase 1/2 Gene Therapy Clinical Study For Patients With MPS IIIB In Spain

    Abeona Therapeutics Inc., a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, recently announced authorization to move forward with a Phase 1/2 clinical trial in Spain for the Company’s gene therapy product ABO-101 (AAV-NAGLU) for patients with MPS IIIB (Sanfilippo syndrome type B).

  3. Gilead And Galapagos Announce Filgotinib Meets Primary And All Key Secondary Endpoints In First Phase 3 Study In Rheumatoid Arthritis

    Gilead Sciences, Inc. and Galapagos NV recently announced that FINCH 2, a global, randomized, placebo-controlled, Phase 3 study of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents, achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 12.

  4. Variation In Cancer-Causing KRAS Mutations Greater Than Thought

    The effects of KRAS mutations underlying many different types of cancer are more diverse than previously thought, according to a new study led by the University of Eastern Finland. Different mutations in the same amino acid of the KRAS protein have so varied effects on protein function that they may require different approaches when it comes to treatment and drug development.

  5. IMV Inc. Announces Phase 2 Basket Trial In Collaboration With Merck To Evaluate DPX-Survivac In Combination With KEYTRUDA® Across Five Solid Tumor Indications

    IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, today announced that it has expanded its clinical program with a Phase 2 basket trial evaluating its lead candidate, DPX-Survivac, in combination with low dose cyclophosphamide and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with select advanced or recurrent solid tumors.

  6. Bertilimumab Granted Fast Track Designation For The Treatment Of Bullous Pemphigoid

    Immune Pharmaceuticals, Inc. (OTCQB: IMNP) (“Immune” or the “Company”), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bertilimumab for the treatment of bullous pemphigoid.

  7. ORYZON Receives Approval To Start ALICE: A Phase IIa Clinical Trial In AML With Iadademstat (ORY-1001)

    Oryzon Genomics (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has announced today that it has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct a Phase IIa clinical study with Iadademstat (ORY-1001) in elderly Acute Myeloid Leukemia (AML) patients not eligible for intensive chemotherapy.

  8. Foamix Announces Positive Topline Results From Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam For Moderate-To-Severe Acne

    Foamix Pharmaceuticals Ltd., a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced the topline results of its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne.

  9. ContraFect Completes Enrollment In Phase 2 Clinical Trial Evaluating CF-301 (Exebacase) In Patients With Staphylococcus Aureus Bacteremia

    ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that it has completed enrollment in the Phase 2 clinical trial evaluating its first-in-class lysin, CF-301, as a potential treatment for Staphylococcus aureus (Staph aureus) bacteremia including endocarditis.

  10. Fibrocell Announces FDA Fast Track Designation Of FCX-013 For Treatment Of Moderate To Severe Localized Scleroderma

    Fibrocell Science, Inc. (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma—a chronic, debilitating genetic skin disorder with no FDA approved therapies.