News Headlines

  1. Variation In Cancer-Causing KRAS Mutations Greater Than Thought
    9/11/2018

    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.

  2. IMV Inc. Announces Phase 2 Basket Trial In Collaboration With Merck To Evaluate DPX-Survivac In Combination With KEYTRUDA® Across Five Solid Tumor Indications
    9/11/2018

    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.

  3. Bertilimumab Granted Fast Track Designation For The Treatment Of Bullous Pemphigoid
    9/11/2018

    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.

  4. ORYZON Receives Approval To Start ALICE: A Phase IIa Clinical Trial In AML With Iadademstat (ORY-1001)
    9/11/2018

    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.

  5. Foamix Announces Positive Topline Results From Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam For Moderate-To-Severe Acne
    9/11/2018

    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.

  6. ContraFect Completes Enrollment In Phase 2 Clinical Trial Evaluating CF-301 (Exebacase) In Patients With Staphylococcus Aureus Bacteremia
    9/6/2018

    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.

  7. Fibrocell Announces FDA Fast Track Designation Of FCX-013 For Treatment Of Moderate To Severe Localized Scleroderma
    9/5/2018

    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.

  8. Tyme Exceeds Enrollment Expectations For The Phase II Trial Of SM-88 In Pancreatic Cancer
    9/5/2018

    Tyme Technologies, Inc. (NASDAQ:TYME), today announced that the number of currently consented or randomized subjects has exceeded the enrollment target for the Stage 1 dose selection portion of the Company’s Phase II trial in metastatic pancreatic cancer ahead of the trial’s anticipated timeline.

  9. ProQR Announces Positive Interim Results From Phase 1/2 Clinical Trial Of QR-110 In LCA10 Patients, And Plans To Start A Phase 2/3 Pivotal Trial
    9/5/2018

    ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced results from a planned interim analysis of its Phase 1/2 trial of QR-110 in patients with Leber’s congenital amaurosis 10 (LCA10) due to the p.Cys998X mutation in the CEP290 gene. LCA10 typically leads to childhood blindness and has no available treatment options.

  10. Inovio Doses 1st Subject In Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection
    9/5/2018

    Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today announced the dosing of the first subject with its vaccine to prevent infection from the deadly MERS virus (Middle East Respiratory Syndrome) in a Phase 1/2a study to evaluate INO-4700 (or GLS-5300).