Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Alterity Therapeutics | ATH434 | Multiple system atrophy | IND approved by the FDA |
| Artiva Biotherapeutics | AB-201 | HER2-expressing cancer | IND approved by the FDA |
| Immunitas Therapeutics | IMT-009 | Solid tumors and hematological malignancies | IND approved by the FDA |
| Verismo Therapeutics | SynKIR-110 | Mesothelin-expressing ovarian cancer, cholangiocarcinoma and mesothelioma | IND approved by the FDA |
| Xpira Pharmaceuticals | Psilocybin | Anorexia nervosa | IND approved by the FDA |
| Belite Bio | LBS-008 | Stargardt disease | Approval for a phase 3 trial granted by China’s regulatory authority |
| Psyence | Psilocybin | Adjustment disorder due to an incurable cancer diagnosis | Approval for a phase 2a trial granted by the UK regulatory authority |
| Trials Initiated | |||
| Mind Medicine | MDMA-like substances | Mood disorders | Initiation of phase 1 trial |
| RVAC Medicines | RVM-V001 vaccine | COVID-19 | Initiation of phase 1 trial |
| Revolution Medicines | RMC-6291 | Cancers driven by the KRASG12C mutation | Initiation of phase 1 trial |
| Amydis Diagnostics | AMDXP-2011P | Parkinson’s disease and amyotrophic lateral sclerosis | Initiation of phase 1/2 trial |
| Immunis Biomedical | IMM01-STEM | Muscle atrophy | Initiation of phase 1/2 trial |
| Glyscend Therapeutics | GLY-200 | Type 2 diabetes | Initiation of phase 2 trial |
| Vir Biotechnology | VIR-2218 and VIR-3434 | Chronic hepatitis D virus | Initiation of phase 2 trial |
| Genelux | Olvimulogene nanivacirepvec | Platinum-resistant/refractory ovarian cancer | Initiation of phase 3 trial |
| POP Biotechnologies | EuCorVac-19 vaccine | COVID-19 | Initiation of phase 3 trial |
| Approvals | |||
| Bluebird Bio | Skysona (elivaldogene autotemcel) | Cerebral adrenoleukodystrophy | Approved by the FDA |
| Biocodex | Diacomit (stiripentol) | Seizures associated with Dravet syndrome | Approved by the FDA for expanded age indication |
| Eli Lilly | Retevmo (selpercatinib) | Advanced or metastatic solid tumors with an RET gene fusion | Approved by the FDA |
| Heron Therapeutics | Aponvie (aprepitant) | Postoperative nausea and vomiting | Approved by the FDA |
| Marius Pharmaceuticals | Kyzatrex (testosterone undecanoate) | Hypogonadism | Approved by the FDA |
| Edwards Lifesciences | PASCAL Precision transcatheter valve repair system | Degenerative mitral regurgitation | Approved by the FDA |
| AstraZeneca Merck |
Lynparza (olaparib) | HRD-positive ovarian cancer | Approved in China |
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