Pipeline

September 28, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Ampio Pharmaceuticals Ampion respiratory distress due to COVID-19 IND approved by the FDA
DURECT DUR-928 hospitalized COVID-19 patients with acute liver or kidney injury first patient dosed in phase 2 trial
Rigel Pharmaceutical fostamatinib hospitalized COVID-19 patients initiation of phase 2 trial
Johnson & Johnson/Janssen JNJ-78436735 (COVID-19 vaccine) COVID-19 initiation of phase 3 trial
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test v2.0 COVID-19 detection Emergency Use Authorization granted by the FDA
Other Trials and Actions
Advaxis ADXS-504 prostate cancer IND approved by the FDA
American Cryostem ATCell, expanded autologous adipose-derived mesenchymal stem-cell therapy postconcussion syndrome IND approved by the FDA
Athenex TCRT-ESO-A2, autologous T cell receptor - T cell therapy solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients IND approved by the FDA
Genocea Biosciences GEN-011 patients with solid tumors who have failed standard-of-care checkpoint inhibitor therapy IND approved by the FDA
Morphosys


I-Mab		 MOR210/TJ210 relapsed or refractory advanced solid tumors IND approved by the FDA
Cytokinetics CK-3772271 hypertrophic cardiomyopathy first patient dosed in phase 1 trial
InMed Pharmaceuticals INM-755 epidermolysis bullosa dosing complete in phase 1 trial
Jasper Therapeutics JSP191 patients with myelodysplastic syndromes and acute myeloid leukemia who are undergoing blood or hematopoietic cell transplantation first patient dosed in phase 1 trial
Millendo Therapeutics MLE-301 vasomotor symptoms in menopausal women first patient dosed in phase 1 trial
Morphic Therapeutic MORF-057 inflammatory bowel disease first patient dosed in phase 1 trial
BioMarin BMN 307 phenylketonuria first patient dosed in phase 1/2 trial
Neximmune NEXI-001 acute myeloid leukemia dosing complete in first cohort of phase 1/2 trial
BridgeBio/Calcilytix Therapeutics encaleret (CLTX-305) autosomal dominant hypocalcemia Type 1 (ADH1) initiation of phase 2 trial
Calithera elaglenastat (CB-839) in combination with pembrolizumab, carboplatin and pemetrexed stage IV non-squamous NSCLC whose tumors have a KEAP1 or NRF2 mutation first patient randomized in phase 2 trial
Frequency Therapeutics FX-322 sensorineural hearing loss patient enrollment complete in phase 2a trial
Intensity Therapeutics INT230-6 in combination with Yervoy (ipilimumab) breast cancer, liver cancer and sarcoma first patient dosed in phase 2 trial
Lipocine LPCN 1144 non-cirrhotic non-alcoholic steatohepatitis last patient enrolled in phase 2 trial
MiMedx micronized injectable amniotic tissue osteoarthritis of the knee phase 2b trial complete
Nordic Bioscience Clinical Development

AKL Research and Development		 AAPA osteoarthritis first patient enrolled in phase 2 trial
Principia Biopharma rilzabrutinib IgG4-related disease first patient dosed in phase 2a trial
Cortexyme atuzaginstat (COR388) mild to moderate Alzheimer’s disease patient enrollment complete in phase 2/3 trial
MiMedx micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection plantar fasciitis patient enrollment complete in phase 3 trial
Swedish Orphan Biovitrum

Selecta Bioscience		 SEL-212 chronic refractory gout first patient randomized in phase 3 trial
Athersys MultiStem cell therapy Acute Respiratory Distress Syndrome (ARDS) Regenerative Medicine Advanced Therapy designation granted by the FDA
Medeor Therapeutics MDR-101 immune tolerance in kidney transplant recipients Regenerative Medicine Advanced Therapy designation granted by the FDA
Gyroscope Therapeutics GT005 geographic atrophy secondary to dry age-related macular degeneration Fast-Track designation granted by the FDA
Leap Therapeutics DKN-01 patients with gastric and gastroesophageal junction adenocarcinoma tumors with DKK1 expression, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate HER2/neu-targeted therapy Fast-Track designation granted by the FDA
Innova Therapeutics IVT-8086 osteosarcoma Rare Pediatric Disease designation granted by the FDA
Mereo Biopharma setrusumab osteogenesis imperfecta Rare Pediatric Disease designation granted by the FDA
Baxter International Clinimix (amino acids in dextrose) and Clinimix E (amino acids with electrolytes in dextrose and calcium) injections patients requiring parenteral nutrition FDA approved for new formulations
Surmodics Pounce Thrombus Retrieval System nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature FDA approved

 

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