Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| AB Science | AB8939 | Refractory and relapsed AML and refractory MDS | IND approved by the FDA |
| Armata Pharmaceuticals | AP-SA02 | Staphylococcus aureus bacteremia | IND approved by the FDA |
| Avacta Group | AVA6000 | Solid tumors | IND approved by the FDA |
| Codiak BioSciences | ExoASO-STAT6 | Hepatocellular carcinomas | IND approved by the FDA |
| FAScinate Therapeutics | KM-819 | Parkinson’s disease | IND approved by the FDA |
| GlaxoSmithKline Surface Oncology |
GSK4381562 (formerly SRF813) | Tumors | IND approved by the FDA |
| Harmony Biosciences | Pitolisant | Idiopathic hypersomnia | IND approved by the FDA |
| InteRNA Technologies | INT-1B3 | Advanced solid tumors | IND approved by the FDA |
| Moleculin Biotech | WP1122 | Glioblastoma multiforme | IND approved by the FDA |
| Tonix Pharmaceuticals | TNX-1900, intranasal oxytocin | Migraine prevention | IND approved by the FDA |
| Treadwell Therapeutics | CFI-402257 | Advanced solid tumors and breast cancer | IND approved by the FDA |
| Cybin | Psilocybin | COVID-related distress in front-line clinicians | Phase 2 trial approved by the FDA |
| ABM Therapeutics | ABM-1310 | Advanced solid tumors with BRAF mutation | IND approved by China’s regulatory authority |
| Antengene | Selinexor | NonHodgkin’s lymphoma | IND approved by China’s regulatory authority |
| Kintor Pharma | Pyrilutamide | Male androgenetic alopecia | IND approved by China’s regulatory authority |
| Sterna Biologicals | SB010 | Moderate-to-severe asthma | Clinical trial authorization granted by Germany’s regulatory authority |
| Trials Initiated | |||
| BeiGene | BGB-23339 | Immune-mediated disorders | Initiation of phase 1 trial |
| National University Cancer Institute, Singapore MiNA Therapeutics |
MTL-CEBPA in combination with first-line standard of care | Previously untreated, advanced hepatocellular carcinoma | Initiation of phase 1 trial |
| Seres Therapeutics | SER-155 | To reduce the incidence of infection, mortality and GvHD in adults undergoing hematopoietic stem cell transplantation | Initiation of phase 1b trial |
| Notable Labs CicloMed |
Fosciclopirox | Refractory acute myelogenous leukemia | Initiation of phase 1b/2a trial |
| AL-S Pharma | AP-101 | Amyotrophic lateral sclerosis | Initiation of phase 2 trial |
| Clover Biopharma | SCB-2019 (CpG 1018/Alum) heterologous COVID-19 booster dose | COVID-19 booster vaccine | Initiation of phase 2 trial |
| G1 Therapeutics | Trilaciclib | Unresectable locally advanced or metastatic triple-negative breast cancer | Initiation of phase 2 trial |
| Isarna Therapeutics | ISTH0036 | Wet age-related macular degeneration and diabetic macular edema | Initiation of phase 2 trial |
| Talaris Therapeutics | FCR001, allogeneic cell therapy | Diffuse cutaneous systemic sclerosis | Initiation of phase 2 trial |
| Cassava Sciences | Simufilam | Alzheimer’s disease | Initiation of phase 3 trial |
| Daiichi Sankyo AstraZeneca |
Datopotamab deruxtecan | HR-positive, HER2-negative inoperable or metastatic breast cancer previously treated with chemotherapy | Initiation of phase 3 trial |
| HutchMed AstraZeneca |
Orpathys (savolitinib) plus Tagrisso (osimertinib) | Locally advanced or metastatic EGFR mutation + NSCLC with MET amplification after disease progression on EGFR inhibitor therapy | Initiation of phase 3 trial |
| Immunic | Vidofludimus calcium (IMU-838) | Relapsing multiple sclerosis | Initiation of phase 3 trial |
| InDex Pharmaceuticals | Cobitolimod | Moderate-to-severe left-sided ulcerative colitis | Initiation of phase 3 trial |
| Ionis Pharmaceuticals | Donidalorsen (IONIS-PKK-LRx) | Hereditary angioedema | Initiation of phase 3 trial |
| Jazz Pharmaceuticals | Zepzelca (lurbinectedin) in combination with Tecentriq (atezolizumab) | First-line maintenance treatment for extensive-stage small-cell lung cancer | Initiation of phase 3 trial |
| Ocuphire Pharma | Nyxol Eye Drops | Reversal of pharmacologically induced mydriasis | Initiation of phase 3 trial |
| Approvals | |||
| Aadi Bioscience | Fyarro, sirolimus protein-bound particles for injectable suspension (albumin-bound) | Locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor in adults | Approved by the FDA |
| BioMarin | Voxzogo (vosoritide) | Achondroplasia in children age five years and older with open epiphyses | Approved by the FDA |
| Halozyme Janssen Amgen |
Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) | Relapsed or refractory multiple myeloma | Approved by the FDA for additional indication |
| Pfizer BioNTech Moderna |
COVID-19 booster | Prevention of COVID-19 in adults age 18 and older | Emergency Use Authorization amendments approved by the FDA |
| Takeda | Livtencity (maribavir) | Posttransplant CMV infection in patients under age 12 years who weigh at least 35 kg and are resistant to several other antiviral drugs | Approved by the FDA |
| VBI Vaccines | PreHevbrio vaccine | Prevention of infection caused by all known subtypes of hepatitis B virus in adults | Approved by the FDA |
| SIGA Technologies | TPOXX (tecovirimat) | Smallpox | Approved in Canada |
| HUYA Biosciences | Hiyasta | Relapsed or refractory peripheral T-cell lymphoma | Approved in Japan |
| Junshi Biosciences | Toripalimab in combination with cisplatin and gemcitabine | Locally recurrent or metastatic nasopharyngeal carcinoma | Approved in China |
| TRACON Pharmaceuticals | Envafolimab | MSI-H or dMMR advanced solid tumors | Approved in China |
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