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New Pipeline Updates from Genentech, Planmed Oy, and Gibson Oncology

December 17, 2018

Company Drug/Device Medical Condition Status
Bio-Thera Solutions BAT4306F CD-20-positive B-cell non-Hodgkins lymphoma Phase I trial initiated
Alligator Bioscience ATOR-1015 advanced solid tumor disease Phase I trial initiated enrolling up to 53 subjects at five clinics in Sweden and Denmark
Rodin Therapeutics RDN-929 snyaptopathies, a group of over 100 brain diseases characterized by synaptic loss and disfunction Phase I trial initiated
Protagonist Therapeutics, Inc. PN-10943 inflammatory bowel disease Phase I trial initiated
Aridis Pharmaceuticals AR-501 (gallium citrate) chronic bacterial lung infections in patients with Cystic Fibrosis Phase I/II trial initiated enrolling 96 (48 healthy and 48 with Cystic Fibrosis) subjects
Constellation Pharmaceuticals, Inc. CPI-1205 metsastic castration-resistant prostate cancer (mCRPC) Phase II trial initiated enrolling up to 35 subjects
KaNDy Therapeutics NT-814 troublesome post-menopausal symptoms, including hot flashes Phase II trial initiated enrolling up to 165 menopausal subjects aged 40 to 65 years
Levo Therapeutics, Inc. intranasal carbetocin (LV-101) Prader-Willi syndrome (PWS) Phase III trial initiated
Generex Biotechnology Corporation AE37 plus Keytruda (pembrolizumab) triple negative breast cancer IND clearance granted by the FDA
Virtus Pharmaceuticals, LLC generic Levorphanol Tartrate 2 mg tablets severe pain ANDA approval granted by the FDA
Asana Biosciences Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002 moderate-to-severe atopic dermatitis Fast Track Designation granted by the FDA
Gibson Oncology, LLC LMP-400 small molecule topoisomerase 1inhibitor Ewing sarcoma Rare Pediatric Disease Designation (RPDD) granted by the FDA
Sandoz, Inc. and Pear Therapeutics, Inc. reSET-O Opioid Use Disorder (OUD) Clearance granted by the FDA
Planmed Oy new features and intended uses of Planmed Verity orthopedic imaging solution reconstructive surgeries Approval granted by the FDA
Genentech Tecentriq and Avastin metastatic non-squamous non-small cell lung cancer (NSCLC) Approval granted by the FDA
Mayne Pharma Group Limited Tolsura (SUBA-itraconazole) systemic fungal infections Approval granted by the FDA