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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Beam Therapeutics | BEAM-201 | Relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma | IND approved by the FDA for a phase 1 trial |
AltruBio | ALTB-268 | Ulcerative colitis | IND approved by the FDA for a phase 1 trial |
Pyxis Oncology | PYX-201 | Solid tumors | IND approved by the FDA for a phase 1 trial |
Pyxis Oncology | PYX-106 | Solid tumors | IND approved by the FDA for a phase 1 trial |
BioCardia | Allogeneic NK1R+ human mesenchymal stem cells | Ischemic heart failure | IND approved by the FDA for a phase 1/2 trial |
Opus Genetics | OPGx-001 | Leber congenital amaurosis resulting from biallelic mutations in the LCA5 gene | IND approved by the FDA for a phase 1/2 trial |
IN8bio | INB-400 | Newly diagnosed glioblastoma | IND approved by the FDA for a phase 2 trial |
Hexaell Biotechnology | HepaCure Biocolumn bioartificial liver | Acute-on-chronic liver failure syndromes | IND approved by China’s regulatory authorities for a phase 1/2 trial |
Trials Initiated | |||
Cytokinetics | CK-3828136 | Heart failure with reduced ejection fraction and other types of heart failure | Initiation of phase 1 trial |
Federation Bio | FB-001 | Enteric hyperoxaluria | Initiation of phase 1 trial |
Horizon Therapeutics | HZN-457 | Gout | Initiation of phase 1 trial |
Sionna Therapeutics | SION-638 | Cystic fibrosis | Initiation of phase 1 trial |
Innovent Biologics Union Therapeutics |
Orismilast | Inflammatory disorders including psoriasis and atopic dermatitis | Initiation of phase 1 trial in China |
Arcutus Biotherapeutics | ARQ-255 | Alopecia areata | Initiation of phase 1b trial |
Bio-Path Holdings | BP1001-A | Solid tumors, including ovarian, endometrial, pancreatic and breast cancer | Initiation of phase 1/1b trial |
iOnctura SA | IOA-289 | Metastatic pancreatic cancer | Initiation of phase 1b trial |
Dragonfly Therapeutics | DF9001 | Locally advanced or metastatic solid tumors | Initiation of phase 1/2 trial |
Qurient | Q901 | Advanced solid tumors | Initiation of phase 1/2 trial |
Baudax Bio | BX1000 | Neuromuscular blockade in patients undergoing elective surgery | Initiation of phase 2 trial |
Dragonfly Therapeutics | DF1001 | Advanced solid tumors | Initiation of phase 2 trial |
Lynk Pharmaceuticals | LNK01003 | Active ulcerative colitis | Initiation of phase 2 trial |
Ventyx Biosciences | VTX958 | Moderate-to-severe plaque psoriasis | Initiation of phase 2 trial |
Otsuka Pharmaceuticals Sunovion Pharmaceuticals |
Ulotaront | Major depressive disorder | Initiation of phase 2/3 trial |
Celcuity | Gedatolisib | HR+/HER2- advanced breast cancer | Initiation of phase 3 trial |
Approvals | |||
Rigel Pharmaceuticals | Rezlidhia (olutasidenib) | Relapsed/refractory acute myeloid leukemia with susceptible IDH1 mutation | Approved by the FDA |
SCYNEXIS | Brexafemme (ibrexafungerp tablets) | Reduction in the incidence of recurrent vulvovaginal candidiasis | Approved by the FDA for additional indication |
Endomag | Magtrace lymphatic tracer | Breast cancer surgery | Approved by the FDA |
Acutus Medical | AcQMap 3D Imaging and Mapping Catheter | Ultrasound imaging | Approved in the European Union |
PTC Therapeutics | Waylivra (volanesorsen) | Familial partial lipodystrophy | Approved in Brazil |

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