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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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