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Home » Pipeline

Pipeline

August 17, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
SAB Biotherapeutics SAB-185 COVID-19 first patient dosed in phase 1 trial
Arcturus Therapeutics ARCT-021 investigational vaccine COVID-19 patient dosing complete in first cohort of phase 1/2 trial
Kamada plasma-derived immunoglobulin (IgG) product hospitalized, non-ventilated COVID-19 patients with pneumonia first patient enrolled in phase 1/2 trial
Biophytis Sarconeos (BIO101) COVID-19 patients with respiratory failure approval for a phase 2/3 trial granted by the Brazilian Health Regulatory Agency
Romark NT-300 (nitazoxanide extended-release tablets) mild or moderate COVID-19 initiation of phase 3 trial
Organicell Regenerative Medicine Organicell Flow mild to moderate respiratory distress due to COVID-19 two emergency INDs approved by the FDA
Baxter HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) renal replacement patients of low weight and low blood volume who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic Emergency Use Authorization (EUA) granted by the FDA
Helix Helix COVID-19 next-generation sequencing test SARS-CoV-2 in upper respiratory specimens EUA granted by the FDA
Appili Therapeutics favipiravir COVID-19 IND approved by the FDA
Other Trials and Actions
Altimmune NasoShield, a single dose intranasal anthrax vaccine anthrax exposure patient enrollment complete in phase 1b trial
Arrowhead Pharmaceuticals ARO-ENaC cystic fibrosis first patients dosed in phase 1/2 trial
Oncopeptides melflufen and dexamethasone patients with immunoglobulin light chain (AL) amyloidosis following at least one prior line of therapy first patient enrolled in phase 1/2 trial
Sapience Therapeutics ST101 adults with unresectable and metastatic solid tumors who are not eligible for other therapies or have progressed on prior therapies first patient dosed in phase 1/2 trial
Vaccibody AS

Nektar Therapeutics
bempegaldesleukin with VB10.NEO personalized neoantigen cancer vaccine advanced squamous cell carcinoma of the head and neck first patient dosed in phase 1/2a trial
BioPath Holdings prexigebersen (BP1001) in combination with frontline therapy decitabine and venetoclax acute myeloid leukemia enrollment and dosing of the first patient in stage 2 of phase 2 trial
Gyroscope Therapeutics GT005 geographic atrophy secondary to dry age-related macular degeneration initiation of phase 2 trial
Eloxx Pharmaceuticals ELX-02 cystic fibrosis enrollment resumed in phase 2 trial
Treadwell Therapeutics CFI-400945 in combination with durvalumab advanced or metastatic triple negative breast cancer initiation of phase 2 study
Seelos Therapeutics SLS-005 (trehalose) amyotrophic lateral sclerosis approval of phase 2b/3 study granted by the FDA
Boehringer Ingelheim nintedanib children and adolescents age 6 to 17 with clinically significant fibrosing interstitial lung disease initiation of phase 3 trial
Fibrogen Pamrevlumab combined with systemic corticosteroids nonambulatory patients with Duchenne muscular dystrophy initiation of phase 3 trial
Rafael Pharmaceuticals CPI-613 (devimistat) in combination with modified FOLFIRINOX (mFFX) metastatic pancreatic cancer patient enrollment complete in phase 3 trial
American Gene Technologies AGT103-T HIV IND approved by the FDA
India Globalization Capital IGC-AD1 mild to severe dementia due to Alzheimer’s disease IND approved by the FDA
Kahr Medical DSP107 advanced solid tumors IND approved by the FDA
LogicBio LB-001 (in vivo gene editing program) pediatric patients with methylmalonic acidemia IND approved by the FDA
Tonix Pharmaceuticals TNX-102 SL alcohol use disorder IND approved by the FDA for phase 2 trial
Aquestive Therapeutics AQST-108 oral sublingual systemic epinephrine film allergic reactions (Type 1), including anaphylaxis Fast Track designation granted by the FDA
Kazia Therapeutics paxalisib (formerly GDC-0084) diffuse intrinsic pontine glioma Rare Pediatric Disease designation granted by the FDA
Bayer Lampit (nifurtimox) pediatric patients (birth to age 17) for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi). approved by the FDA
Guardant Health Guardant360 CDx comprehensive genomic profiling in patients with solid tumors approved by the FDA
Genentech

PTC Therapeutics
Evrysdi (risdiplam) spinal muscular atrophy in adults and children age two months and older approved by the FDA
joimax Intrac electromagnetic navigation tracking and control system minimally invasive spinal surgery approved by the FDA
Life Spine PLATEAU-X Ti Lateral Lumbar Spacer System surgical treatment of spinal disorders approved by the FDA
NS Pharma Viltepso (viltolarsen) injection patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy approved by the FDA
Trevena Olinvyk (oliceridine) moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate approved by the FDA
ViiV Healthcare

Shionogi
Dovato (dolutegravir/lamivudine) complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato approved by the FDA for expanded indication

 

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