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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Pfizer BioNTech |
COVID-19 vaccine | COVID-19 | first women in the late stages of pregnancy dosed in a clinical trial |
| AstraZeneca Oxford University |
COVID-19 vaccine | COVID-19 | initiation of patient enrollment of children age 6 to 17 |
| GlaxoSmithKline Sanofi |
recombinant-protein COVID-19 vaccine with new antigen dosages | COVID-19 | initiation of phase 2b trial with revamped vaccine |
| Biophytis | Sarconeos (BIO101) | acute respiratory failure associated with COVID-19 | patient enrollment underway in France and Belgium for part 2 of phase 2/3 trial |
| PTC Therapeutics | PTC299 | patients hospitalized with COVID-19 | initiation of the second stage of a phase 2/3 trial |
| Novavax | NVX-CoV2373 | COVID-19 vaccine | completion of patient enrollment in phase 3 trial |
| Pharma Mar | Aplidin (plitidepsin) | hospitalized patients with moderate COVID-19 infection | approval from the Medicines and Healthcare products Regulatory Agency for UK patients to enroll in phase 3 NEPTUNO trial |
| Other Trials and Actions | |||
| NeoImmuneTech | NT-I7 | progressive multifocal leukoencephalopathy | IND approved by the FDA |
| Curocell | CRC01 | relapsed/refractory diffuse large B-cell lymphoma | IND approved by the Ministry of Food and Drug Safety of South Korea |
| Dialco Medical | DIMI renal replacement system | hemodialysis | Investigational Device Exemption (IDE) granted by the FDA |
| Gala Therapeutics | RheOx Bronchial Rheoplasty System | chronic bronchitis | IDE granted by the FDA |
| AbFero Pharmaceuticals | SP-420 | myelodysplastic and myelofibrosis patients with transfusional iron overload | initiation of phase 1 trial |
| LG Chem Life Sciences | LG00303174 | chronic inflammatory diseases | first patient dosed in phase 1 trial |
| Longeveron | Lomecel-B | hypoplastic left heart syndrome | completion of phase 1 trial |
| INOVIO | INO-4500 DNA vaccine | Lassa fever | first patient dosed in phase 1b trial |
| Locus Bioscience | LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage | Escherichia coli (E. coli) bacteria causing urinary tract infections | completion of phase 1b trial |
| Salarius Pharmaceuticals | seclidemstat | relapsed and refractory Ewing sarcoma and Ewing-related sarcomas | initiation of expansion stage of ongoing phase 1/2 trial |
| Cartesian Therapeutics | Descartes-11 | newly diagnosed high-risk multiple myeloma | initiation of phase 2a trial |
| Bridge Biopharma ML Bio Solutions |
BBP-418 | limb-girdle muscular dystrophy type 2i | first patient dosed in phase 2 trial |
| Ocuphire Pharma | Nyxol and low-dose pilocarpine | presbyopia | first patients enrolled in phase 2 trial |
| Stealth Biotherapeutics | elamipretide | dry age-related macular degeneration with geographic atrophy | patient enrollment complete in phase 2 trial |
| Akero Therapeutics | efruxifermin | nonalcoholic steatohepatitis | initiation of phase 2b trial |
| The Center for Probe Development and Commercialization | [18F]PSMA-1007 | diagnostic imaging product targeting prostate-specific membrane antigens | initiation of phase 3 trial |
| Immunocore | tebentafusp | uveal melanoma | Breakthrough Therapy designation granted by the FDA |
| Dascena | GI Bleed Risk Alert System | early prediction of gastrointestinal bleeding in adult patients in a hospital setting | Breakthrough Device designation granted by the FDA |
| Regeneron Sanofi |
Libtayo (cemiplimab-rwlc) | first-line treatment for advanced nonsmall-cell lung cancer with high PD-L1 expression (?50%) | approved by the FDA |
| EndoClot Plus | EndoClot Polysaccharide Hemostatic System | management of bleeding during GI procedures | approved by the FDA |
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