Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Napo Pharmaceuticals | NP-300 | Moderate-to-severe diarrhea from bacterial, viral and parasitic infections, including Vibrio cholerae | IND approved by the FDA |
| CatalYm | Visugromab | Advanced solid tumors that are relapsed/refractory to prior anti-PD1/PD-L1 treatment | IND approved by the FDA for phase 2 trial |
| Azura Ophthalmics | AZR-MD-001 | Meibomian gland dysfunction | IND approved by the FDA for phase 2 trial |
| MoonLake Immunotherapeutics | Sonelokimab | Active psoriatic arthritis | IND approved by the FDA for phase 2 trial |
| C4 Therapeutics | CFT1946 | BRAF-V600 mutant solid tumors | Study May Proceed letter issued by the FDA for phase 1/2 trial |
| Angel Pharmaceuticals | Mupadolimab | Non-small cell lung cancer and head and neck cancer | IND approved by China’s regulatory authority |
| Qu Biologics | QBECO SSI | Reduction of postoperative immune suppression, disease progression in patients with late-stage colorectal cancer | Approval for a phase 2 trial granted by Canada’s regulatory authority |
| Everest Medicines | EVER001 | Glomerular diseases | IND approved by China’s regulatory authority |
| atai Life Sciences EmpathBio |
EMP-01, MDMA derivative | Post-traumatic stress disorder | Approval for a phase 1 trial granted by New Zealand’s regulatory authority |
| Trials Initiated | |||
| Aura Biosciences | Belzupacap sarotalocan | Nonmuscle-invasive bladder cancer | Initiation of phase 1 trial |
| CinRx Pharma | CIN-109 | Obesity | Initiation of phase 1 trial |
| Harbour BioMed | HBM9378 | Moderate-to-severe asthma | Initiation of phase 1 trial |
| Lassen Therapeutics | LASN01 | Fibrosis | Initiation of phase 1 trial |
| VBI Vaccines | VBI-2901 multivalent coronavirus vaccine | COVID-19 vaccine | Initiation of phase 1 trial |
| Kling Biotherapeutics | KBA1412 | Advanced solid tumors | Initiation of phase 1b trial |
| Avidity Biosciences | AOC 1020 | Adults with facioscapulohumeral muscular dystrophy | Initiation of phase 1/2 trial |
| Ichnos Sciences | ISB 1442 | Relapsed/refractory multiple myeloma | Initiation of phase 1/2 trial |
| Evommune | EVO101 | Atopic dermatitis | Initiation of phase 2a trial |
| Alumis | ESK-001 | Moderate-to-severe plaque psoriasis | Initiation of phase 2 trial |
| EyePoint Pharmaceuticals | EYP-1901 | Nonproliferative diabetic retinopathy | Initiation of phase 2 trial |
| Sparrow Pharmaceuticals | SPI-62 | Cushing’s syndrome | Initiation of phase 2 trial |
| SpringWorks Therapeutics | Nirogacestat | Recurrent ovarian granulosa cell tumors | Initiation of phase 2 trial |
| Telix Pharmaceuticals | TLX591 (177Lu-DOTA-rosopatamab) | First recurrence of prostate-specific antigen after initial therapy for prostate cancer | Initiation of phase 2 trial in Australia |
| Acticor Biotech | Glenzocimab | Acute ischemic stroke | Initiation of phase 2/3 trial |
| aTyr Pharma | Efzofitimod | Pulmonary sarcoidosis | Initiation of phase 3 trial |
| Neurophth Therapeutics | NR082 | Leber hereditary optic neuropathy | Initiation of phase 3 trial |
| Oncternal Therapeutics | Zilovertamab | Relapsed/refractory mantle cell lymphoma | Initiation of phase 3 trial |
| REVA Medical | MOTIV sirolimus-eluting bioresorbable vascular scaffold | Chronic limb-threatening ischemia | Initiation of phase 3 trial |
| Approvals | |||
| Harrow Sintetica |
Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% | Ocular surface anesthesia | Approved by the FDA |
| Santen UBE |
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% eye drops | Primary open-angle glaucoma or ocular hypertension | Approved by the FDA |
| Daiichi Sankyo | Ezharmia (valemetostat tosilate) | Relapsed/refractory adult T-cell leukemia/lymphoma | Approved in Japan |
| Legend Biotech | Carvykti (ciltacabtagene autoleucel) | Relapsed/refractory multiple myeloma | Approved in Japan |
| Merck | Keytruda (pembrolizumab) | HER2-negative breast cancer at high risk of recurrence, renal cell carcinoma, cervical cancer and stage IIB or IIC melanoma | Approved in Japan |
| Regeneron Sanofi |
Dupixent (dupilumab) injection | Adults with prurigo nodularis | Approved by the FDA |
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