Home » Drug & Device Pipeline News - April 1, 2024
Drug & Device Pipeline News - April 1, 2024
April 1, 2024
This week’s Pipeline features a phase 2b trial approval for gastroparesis, a phase 2 trial start for active pulmonary sarcoidosis and an FDA device approval for symptomatic severe aortic stenosis.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Bio-Thera Solutions | BAT8006 | Platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer | IND for a phase 2 trial approved by the FDA |
NMD Pharma | NMD670 | AChR or MuSK antibody-positive generalized myasthenia gravis | IND for a phase 2b trial approved by the FDA |
Renexxion Ireland Dr. Falk Pharma |
Naronapride | Gastroparesis | IND for a phase 2b trial approved by the FDA |
Trials Initiated | |||
CinFina Pharma | CIN-110 | Obesity | Initiation of a phase 1 trial |
Iambic Therapeutics | IAM1363 | HER2-driven cancers | Initiation of a phase 1 trial |
Public Health Vaccines | PHV01 Marburg virus vaccine | Marburg virus | Initiation of a phase 1 trial |
Rhythm Pharmaceuticals | RM-718 | Obesity and hypothalamic obesity | Initiation of a phase 1 trial |
Valneva | VLA1601 Zika virus vaccine | Zika virus | Initiation of a phase 1 trial |
Tectonic Therapeutic | TX45 | Group 2 pulmonary hypertension in patients secondary to heart failure with preserved ejection fraction | Initiation of a phase 1b trial |
Immuneering | IMM-6-415 | Advanced solid tumors with RAF or RAS mutations | Initiation of a phase 1/2a trial |
ProLynx | PLX038 | Locally advanced or metastatic triple-negative breast cancer | Initiation of a phase 2 trial |
Molecure | OATD-01 | Active pulmonary sarcoidosis | Initiation of a phase 2 trial |
PMV Pharmaceuticals | Rezatapopt | Advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type | Initiation of a phase 2 trial |
Innovent Biologics | IBI310 | Resectable MSI-H/dMMR colon cancer (stage cT4 or cN+) neoadjuvant therapy | Initiation of a phase 3 trial |
Approvals | |||
Akebia Therapeutics | Vafseo (vadadustat) | Anemia due to chronic kidney disease in adults on dialysis | Approved by the FDA |
Italfarmaco | Duvyzat (givinostat) | Duchenne muscular dystrophy in patients age 6 years and older | Approved by the FDA |
Johnson & Johnson | Opsynvi (macitentan and tadalafil) | Pulmonary arterial hypertension | Approved by the FDA |
Merck | Winrevair (sotatercept-csrk) | Pulmonary arterial hypertension | Approved by the FDA |
Alexion | Ultomiris (ravulizumab-cwvz) | AQP4 antibody-positive neuromyelitis optica spectrum disorder | Approved by the FDA for a new indication |
Medexus Pharmaceuticals | Ixinity [coagulation factor IX (recombinant)] | On-demand, prophylactic and perioperative treatment of patients under age 12 years with hemophilia B | Approved by the FDA for expanded indication |
Esperion | Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe) tablets | Prevention of heart attacks and cardiovascular procedures in both primary and secondary prevention patients regardless of statin use | Approved by the FDA for expanded patient population |
argenx | Vyvgart (efgartigimod alfa) | Primary immune thrombocytopenia | Approved in Japan |
Medtronic | Evolut FX+ transcatheter aortic valve replacement system | Symptomatic severe aortic stenosis | Approved by the FDA |