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Drug & Device Pipeline News
November 6, 2023
This week’s Pipeline features a phase 1 trial approval for recurrent glioblastoma and high-grade astrocytoma, a phase 3 trial initiation for keratoconus and an FDA drug approval for an erosive esophagitis treatment.
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Mustang Bio | MB-109 | Recurrent glioblastoma and high-grade astrocytoma | IND for a phase 1 trial approved by the FDA |
| Tenaya Therapeutics | TN-401 gene therapy | PKP2-associated arrhythmogenic right ventricular cardiomyopathy | IND for a phase 1b trial approved by the FDA |
| Cocrystal Pharma | CC-42344 | Pandemic and seasonal influenza A | Approval for a phase 2a trial granted by the UK’s regulatory authority |
| Oncoinvent | Radspherin | Peritoneal carcinomatosis from ovarian cancer | IND for a phase 2 trial approved by the FDA |
| Oncoinvent | Radspherin | Peritoneal carcinomatosis from colorectal cancer | IND for a phase 2b trial approved by the FDA |
| Trials Initiated | |||
| Ichnos Sciences | ISB 2001 | Multiple myeloma | Initiation of a phase 1 trial |
| HuidaGene Therapeutics | HG004 gene therapy | Inherited retinal dystrophies caused by RPE65 mutations | Initiation of a phase 1/2a trial |
| Triumvira Immunologics | TAC01-HER2 | Relapsed/ refractory gastric and gastroesophageal junction tumors | Initiation of phase 2 portion of a phase 1/2 trial |
| Volastra Therapeutics | VLS-1488 | Advanced solid tumors | Initiation of a phase 1/2 trial |
| Bridge Biotherapeutics | BBT-207 | Non-small cell lung cancer with EGFR mutations | Initiation of a phase 1/2 trial in Korea |
| Ashvattha Therapeutics | D-4517.2 | Wet age-related macular degeneration or diabetic macular edema | Initiation of a phase 2 trial |
| aTyr Pharma | Efzofitimod | Systemic sclerosis-related interstitial lung disease | Initiation of a phase 2 trial |
| Kymera Therapeutics | KT-474 | Hidradenitis suppurativa | Initiation of a phase 2 trial |
| NovelMed Therapeutics | NM8074 | Paroxysmal nocturnal hemoglobinuria | Initiation of a phase 2 trial |
| AceLink Therapeutics | AL01211 | Fabry disease | Initiation of a phase 2 trial in China |
| Corcept Therapeutics | Miricorilant | Non-alcoholic steatohepatitis | Initiation of a phase 2b trial |
| Epion Therapeutics | EpiSmart | Keratoconus | Initiation of a phase 3 trial |
| United Therapeutics | Tyvaso (treprostinil) inhalation solution | Progressive pulmonary fibrosis | Initiation of a phase 3 trial |
| InnoCare Pharma | Orelabrutinib | Primary immune thrombocytopenia | Initiation of a phase 3 trial in China |
| Approvals | |||
| Coherus BioSciences Junshi Biosciences |
Loqtorzi (toripalimab-tpzi) | Metastatic/ recurrent nasopharyngeal carcinoma | Approved by the FDA |
| Eli Lilly | Omvoh (mirikizumab-mrkz) | Moderately-to-severely active ulcerative colitis | Approved by the FDA |
| Phathom Pharmaceuticals | Voquenza (vonoprazan) tablets | Erosive esophagitis | Approved by the FDA |
| Santhera Pharmaceuticals | Agamree (vamorolone) | Duchenne muscular dystrophy | Approved by the FDA |
| Genentech | Vabysmo (faricimab-svoa) | Macular edema following retinal vein occlusion | Approved by the FDA for new indication |
| Merck | Keytruda (pembrolizumab) | Locally advanced unresectable/ metastatic biliary tract cancer | Approved by the FDA for new indication |
| Novartis | Cosentyx (secukinumab) | Hidradenitis suppurativa | Approved by the FDA for new indication |
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