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Pipeline
June 1, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Novavax | NVX CoV2373 | coronavirus vaccine | initiation of phase 1/2 trial |
| RE-Stem Biotech | umbilical cord mesenchymal stem cells | severe cases of COVID-19 | initiation of phase 1/2 trial |
| ORYZON Genomics | vafidemstat | severe cases of COVID-19 | enrollment of first patient in phase 2 trial |
| SaNOtize Research and Development | Nitric Oxide Releasing Solution | prevention and early treatment of COVID-19 | enrollment of first patient in phase 2 trial |
| Genentech Gilead |
Actemra (tocilizumab) plus remdesivir | hospitalized patients with severe COVID-19 pneumonia | initiation of phase 3 trial |
| Covis Pharma | Alvesco (ciclesonide) | non-hospitalized patients 12 years of age and older with symptomatic COVID-19 | initiation of phase 3 trial |
| BioSig Technologies and ViralClear Pharmaceuticals | merimepodib oral solution | adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high-flow oxygen devices | IND approved by the FDA |
| Leading Biosciences | LB1148 | pulmonary dysfunction associated with COVID-19 pneumonia | IND approved by the FDA |
| NantKwest | BM-Allo.MSC | acute respiratory distress syndrome (ARDS) caused by COVID-19 | IND approved by the FDA |
| Octapharma USA | Octagam 10% [Immune Globulin Intravenous (Human)] | COVID-19 patients with severe disease progression | IND approved by the FDA |
| Color | LAMP technology | Covid-19 testing | Emergency Use Authorization (EUA) granted by the FDA |
| Fulgent Therapeutics | RT-PCR test | detection of SARS-CoV-2 | EUA granted by the FDA |
| G Medical Innovations Holdings | Vital Signs Monitoring System ECG Patch | remote monitoring of the QT interval of an ECG for hospitalized patients with COVID-19 being treated with drugs that can prolong QT intervals and may cause fatal arrhythmias | EUA granted by the FDA |
| Hologic | Aptima SARS-CoV-2 assay | detection of SARS-CoV-2 | EUA granted by the FDA |
| Other Trials and Actions | |||
| Anavex Life Sciences | ANAVEX 3-71 (AF710B) | neurodegenerative diseases | initiation of phase 1 trial |
| Vir Biotechnology | VIR-3434 | hepatitis B virus | initiation of phase 1 trial |
| Daiichi Sankyo | DS-6157 | patients with advanced gastrointestinal stromal tumor who have progressed on, or are intolerant to, standard treatment | first patient dosed in phase 1 trial |
| Innovent | IBI939 | advanced malignancies | first patient dosed in phase 1 trial |
| Poseida Therapeutics | P-PSMA-101 | metastatic castration-resistant prostate cancer | first patient dosed in phase 1 trial |
| Heron Therapeutics | HTX-034 | postoperative pain | initiation of phase 1/2 trial |
| Apollomics | APL-101 | non-small cell lung cancer MET exon 14 skipping mutation, and tumors with MET amplification or fusions | initiation of phase 2 trial |
| Arena Pharma | etrasimod | moderate-to-severe atopic dermatitis | completion of patient enrollment in phase 2b trial |
| Amplyx Pharmaceuticals | fosmanogepix (APX001) | Candida infections | completion of patient enrollment in phase 2 trial |
| KBP Biosciences | KBP-5074 | patients with moderate-to-severe chronic kidney disease and uncontrolled hypertension | completion of patient enrollment in phase 2b trial |
| Cidara Therapeutics | rezafungin | prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation | first patient dosed in phase 3 trial |
| Oncopeptides AB | Melflufen (melphalan flufenamide) | relapsed refractory multiple myeloma | completion of patient enrollment in phase 3 trial |
| BioXcel Therapeutics | BXCL501 | agitation in patients with schizophrenia and bipolar disorder | completion of patient enrollment in phase 3 trial |
| Alethia Biotherapeutics | AB-16B5 in combination with docetaxel | previously treated subjects with metastatic non-small cell lung cancer with disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody | IND approved by the FDA |
| CARsgen Therapeutics | CT041 claudin18.2-targeted CAR-T cell therapy | claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction or pancreas | IND approved by the FDA |
| Expression Therapeutics | ET3 | hemophilia A | IND approved by the FDA |
| Novaremed | NRD135S.E1 | painful diabetic peripheral neuropathy | IND approved by the FDA |
| Qurient | Q702 | patients with advanced solid tumors for whom standard of care therapies are currently ineffective | IND approved by the FDA |
| Sorrento Therapeutics | STI-6129 | advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis | IND approved by the FDA |
| Passage Bio | PBGM01 | GM1 gangliosidosis | Rare Pediatric Disease designation granted by the FDA |
| Azitra | ATR-12 | Netherton syndrome | Rare Pediatric Disease designation granted by the FDA |
| Seelos Therapeutics | SLS-005 | Sanfilippo syndrome | Rare Pediatric Disease Designation granted by the FDA |
| Daiichi Sankyo AstraZeneca |
ENHERTU (fam-trastuzumab deruxtecan-nxki) | gastric cancer, including gastroesophageal junction cancer | Orphan Drug designation granted by the FDA |
| Daiichi Sankyo AstraZeneca |
ENHERTU (fam-trastuzumab deruxtecan-nxki) | patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy | Breakthrough Therapy designation granted by the FDA |
| Orphayzme | arimoclomol | amyotrophic lateral sclerosis | Fast Track designation granted by the FDA |
| Protara Therapeutics | intravenous Choline Chloride | intestinal failure-associated liver disease | Fast Track designation granted by the FDA |
| Neuraptive Therapeutics | NTX-001 | peripheral nerve injuries | Fast Track designation granted by the FDA |
| AstraZeneca Merck |
Lynparza | adults with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone | approved by the FDA for additional indication |
| Bristol-Myers Squibb | Pomalyst (pomalidomide) | patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy or patients with Kaposi sarcoma who are HIV-negative | approved by the FDA |
| Bristol-Myers Squibb | Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) | first-line treatment of adults with metastatic non-small cell lung cancer whose tumors express PD-L1with no EGFR or ALK genomic tumor aberrations | approved by the FDA for new indication |
| Clovis Oncology | Rubraca (rucaparib) | patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy | approved by the FDA for new indication |
| Deciphera Pharmaceuticals | QINLOCK (ripretinib) | fourth line treatment for adults with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib | approved by the FDA |
| Genentech | Tecentriq (atezolizumab) | first-line treatment for metastatic non-small cell lung cancer tumors with high PD-L1 expression or PD-L1 stained tumor-infiltrating with no EGFR or ALK genomic tumor aberrations | approved by the FDA for additional indication |
| Amivas | artesunate for injection | severe malaria | approved by the FDA |
| Astellas Pharma | VESIcare LS (solifenacin succinate) oral suspension | neurogenic detrusor overactivity in children <2 years of age | approved by the FDA |
| Chiesi Group | Ferriprox (deferiprone) twice daily tablets | patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate | approved by the FDA for new formulation |
| Evofem Biosciences | Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel | prevention of pregnancy in females for use as on-demand contraception | approved by the FDA |
| Microbion | inhaled pravibismane (BisEDT antimicrobial suspension) | pulmonary infections in patients with cystic fibrosis | approved by the FDA |
| Sanofi Regeneron |
Dupixent (dupilumab) | children ages 6 to 11 years with moderate-to-severe atopic dermatitis | approved by the FDA |
| Sunovion Pharma | Kynmobi (apomorphine HCl) | acute, intermittent treatment of OFF episodes in Parkinson’s patients | approved by the FDA |
| Takeda | ALUNBRIG (brigatinib) | adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer | approved by the FDA |
