GlobeNewswire Press

  1. Calithera Biosciences Initiates Phase 1/2 Trial Of Telaglenastat In Combination With The PARP Inhibitor Talazoparib 3/26/2019

    Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced that the first patient has been treated in the Phase 1/2 open-label clinical trial of the glutaminase inhibitor telaglenastat (CB-839) in combination with Pfizer’s poly adenosine diphosphate ribose polymerase (PARP) inhibitor talazoparib, also known as Talzenna®, in patients with advanced or metastatic solid tumors.

  2. Onconova Achieves Over 75 Percent Of Planned Enrollment In Pivotal Phase 3 INSPIRE Study Of Rigosertib In Myelodysplastic Syndromes 3/25/2019

    Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing small molecule drug candidates to treat cancer today announced that it has surpassed the 75 percent enrollment milestone in its pivotal Phase 3 trial of rigosertib for the potential treatment of high-risk myelodysplastic syndromes (HR-MDS), a study known as INSPIRE.

  3. Developing Vaccines And Therapies For The Highly Pathogenic Nipah And Hendra Viruses 3/25/2019

    Bethesda, MD, March 20, 2019 – The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), along with Uniformed Services University of the Health Sciences (USU), Profectus Biosciences, Inc., the Vanderbilt University Medical Center, Mapp Biopharmaceutical, Inc., and the University of Texas Medical Branch (UTMB) have been awarded up to $24.5 million to advance treatments for two lethal henipaviruses.

  4. Conatus Announces Top-line Results From ENCORE-NF Phase 2b Clinical Trial In NASH Fibrosis 3/21/2019

    Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced top-line results from the company’s Phase 2b ENCORE-NF clinical trial in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis. The trial’s primary endpoint was a ≥1 CRN fibrosis stage improvement with no worsening of steatohepatitis compared with placebo at week 72.

  5. Aptevo Therapeutics Begins Phase 1 Clinical Trial Of APVO210 A Novel Bispecific Antibody For The Treatment Of Autoimmune And Inflammatory Diseases 3/20/2019

    Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel oncology, autoimmune and hematology therapeutics, announced today that it has commenced dosing in a Phase 1 clinical trial of APVO210, a novel bispecific antibody candidate built on Aptevo’s ADAPTIR™ therapeutic protein platform which is being developed to treat autoimmune and inflammatory diseases.

  6. Crinetics Pharmaceuticals Doses First Patients In Phase 2 Clinical Trials Of CRN00808 For Acromegaly 3/19/2019

    Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced the dosing of the first patients in the ACROBAT EVOLVE and EDGE trials for CRN00808 in patients with acromegaly.

  7. Rain Therapeutics Announces First Patient Dosed In Phase 2 Trial Of Tarloxotinib For The Treatment Of Non-Small-Cell Lung Cancer With EGFR Exon 20 Insertion Or HER2-Activating Mutations 3/19/2019

    Rain Therapeutics Inc., a privately-held, clinical stage biotechnology company focused on biomarker-driven, small molecule therapeutics for patients with cancer, today announced that it has dosed the first patient in its Phase 2 clinical trial of tarloxotinib (Tarlox).

  8. CytoDyn Reaches Historical Milestone, Submits First Of Three Sections Of BLA To FDA For Leronlimab (PRO 140) As A Combination Therapy For HIV 3/18/2019

    CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has filed with the U.S. Food and Drug Administration (FDA) the non-clinical portion of its Biologics License Application (BLA) using the FDA’s Rolling Review process.

  9. Innovate Biopharmaceuticals Announces Entry Into Securities Purchase Agreement To Fund Initiation Of The First Phase 3 Celiac Disease Clinical Trial 3/18/2019

    Innovate Biopharmaceuticals, Inc. (“Innovate” or the “Company”) (Nasdaq: INNT), a clinical stage biotechnology company focused on developing novel autoimmune and inflammation therapeutics, announced that on March 17, 2019, it entered into an agreement (the “Agreement”) with SDS Capital Partners II LLC and certain other accredited investors (together, the “Purchasers”) providing for the sale by the Company at a purchase price of $2.33 per share as further described below of up to 4,291,845 shares (the “Shares”) of its common stock (the “Common Stock”), up to 2,575,107 five-year term warrants with an exercise price as further described below at a premium to the purchase price and up to 4,291,845 12-month term warrants at an exercise price of $4.00 (total of up to 6,866,952 shares of Common Stock).

  10. EMA Grants Orphan Medicinal Product Designation For Retrotope's RT001 In The Treatment Of Infantile Neuroaxonal Dystrophy (INAD), A PLA2G6 Associated Neurodegeneration (PLAN) 3/13/2019

    Retrotope received notification from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) that its request for orphan medicinal product designation for the treatment of INAD with RT001, a chemically-fortified polyunsaturated fatty acid drug, has been granted by the European Commission.