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Home » Pipeline

Pipeline

December 14, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Sorrento Therapeutics intravenous (IV) STI-2020 (COVI-AMG) healthy volunteers and outpatient COVID-19 patients with mild symptoms IND approved by the FDA
Cyxone rabeximod patients with moderate Covid-19 regulatory authority granted in Poland to initiate phase 2 trial
Puretech LYT-100 (deupirfenidone) long COVID respiratory complications and related sequelae initiation of phase 2 trial
Senhwa Biosciences silmitasertib patients with moderate Covid-19 first patient enrolled in phase 2 trial
Inovio

Advaccine Biopharmaceuticals Suzhou
INO-4800 COVID-19 vaccine first patient dosed in phase 2 trial in China
Inovio INO-4800 COVID-19 vaccine first patient dosed in phase 2/3 trial
Moderna mRNA-1273 COVID-19 vaccine first adolescent patients dosed in phase 2/3 study
NeuroRx

Relief Therapeutics
RLF-100 (aviptadil) respiratory failure in patients with critical COVID-19 patient enrollment complete in phase 2b/3 trial
Rheonix Rheonix COVID-19 MDx Assay detection of SARS-CoV-2 expanded Emergency Use Authorization (EUA) to include use of saliva as a sample
LabCorp PIXEL home test kit for COVID-19 EUA granted by the FDA
Other Trials and Actions
Alligator Biosciences mitazalimab pancreatic cancer IND approved by the FDA
Antengene ATG-010 (selinexor) combined with R-GDP (SR-GDP) relapsed/refractory diffuse large B-cell lymphoma IND approved by China’s National Medical Products Administration
Cerecor CERC-007 relapsed or refractory multiple myeloma IND approved by the FDA
Eyenovia MicroLine (pilocarpine) presbyopia IND approved by the FDA for a phase 3 trial
Altimmune ALT-801 nonalcoholic steatohepatitis first patients dosed in phase 1 trial
Cabaletta Bio DSG3-CAART mucosal-dominant pemphigus vulgaris first patients dosed in phase 1 trial
Fusion Pharmaceuticals [225Ac]-FPI-1434 (FPI-1434) advanced solid tumors first patient dosed in multi-dose portion of phase 1 study
Larimar Therapeutics CTI-1601 Friedreich’s ataxia patient dosing complete in phase 1 trial
Panbela Therapeutics SBP-101 first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma patient enrollment complete in phase 1 trial
Arcturus Therapeutics ARCT-810 ornithine transcarbamylase deficiency first patients dosed in phase 1b trial
Celldex CDX-0159 chronic inducible urticaria first patients dosed in phase 1b trial
Arch Oncology AO-176 relapsed/refractory multiple myeloma first patient dosed in phase 1/2 trial
OSE Immunotherapeutics FR104 patients undergoing renal transplant approval from French National Agency for Medicines and Health Products Safety and the French Central Ethics Committee for a phase 1/2 trial
Spero Therapeutics SPR720 nontuberculous mycobacterial pulmonary disease first patient dosed in phase 2a trial
CG Oncology CG0070 in combination with Keytruda (pembrolizumab) patients with nonmuscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guerin first patient dosed in phase 2 trial
CytoKinetics CK-3773274 (CK-274) hypertrophic cardiomyopathy first patient dosed in second cohort of phase 2 trial
Magenta Therapeutics MGTA-145 stem cell mobilization therapy multiple myeloma initiation of phase 2 trial
Sojournix SJX-653 moderate to severe vasomotor symptoms due to menopause phase 2 trial resumed after pause due to COVID-19
Bellus Health BLU-5937 refractory chronic cough first patient dosed in phase 2b trial
Monopar Therapeutics Validive prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer initiation of phase 2b/3 trial
Aldeyra Therapeutics 0.25% reproxalap ophthalmic solution dry eye disease first patient enrolled in phase 3 trial
Alnylam lumasiran advanced primary hyperoxaluria type 1 patient enrollment complete in phase 3 trial
Arcutis Biotherapeutics roflumilast 0.3% cream chronic plaque psoriasis last patient visit complete in both phase 3 trials
Arena Pharmaceuticals once-daily etrasimod patients with moderately to severely active ulcerative colitis patient enrollment complete in phase 3 trial
Brickell Biotech sofpironium bromide gel, 15% primary axillary hyperhidrosis first patient dosed in phase 3 trial
Novaliq CyclASol (0.1% cyclosporine A in EyeSol) chronic dry eye disease first patient enrolled in phase 3 trial
Novocure Optune concurrent with radiation therapy newly diagnosed glioblastoma first patient enrolled in phase 3 trial
Relmada Therapeutics REL-1017 adjunctive treatment for major depressive disorder first patient enrolled in phase 3 trial
Ultragenyx UX701 Wilson disease Orphan Drug designation granted by the FDA
United Therapeutics treprostinil idiopathic pulmonary fibrosis Orphan Drug designation granted by the FDA
ReGelTec Hydrafil low back pain due to degenerative disc disease Breakthrough Device designation granted by the FDA
Turning Point Therapeutics repotrectinib patients with ROS1-positive metastatic nonsmall-cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor Breakthrough Therapy designation granted by the FDA
Advanced Bionics

Phonak
Marvel Cochlear Implant Platform and sound processor adult and pediatric cochlear implant wearers approved by the FDA
Biocryst Orladeyo (berotralstat) prophylaxis to prevent attacks of hereditary angioedema approved by the FDA
Novo Nordisk Saxenda (liraglutide) injection 3 mg obesity in adolescents (12–17 years) approved by the FDA for expanded indication

 

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