Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Drug Farm | DF-003 | Heart and chronic kidney disease | IND for a phase 1 trial approved by the FDA |
| Skyline Therapeutics | SKG0106 | Neovascular age-related macular degeneration | IND for a phase 1/2a trial approved by the FDA |
| Benitec Biopharma | BB-301 | Oculopharyngeal muscular dystrophy-related dysphagia | IND for a phase 1b/2a trial approved by the FDA |
| AIM ImmunoTech | Ampligen (rintatolimod) plus Imfinzi (durvalumab) | Pancreatic cancer | Approval for a phase 1b/2 trial granted by the Netherlands regulatory authority |
| Mindset Pharma | MSP-1014 | Major depressive disorder | Approval for a phase 2 trial granted by the UK’s regulatory authority |
| Arch Biopartners | LSALT peptide | Cardiac surgery-associated acute kidney injury | Study May Proceed letter for a phase 2 trial issued by the FDA |
| SciSparc | SCI-110 | Tourette syndrome | Approval for a phase 2b trial granted by Germany’s regulatory authority |
| May Health | Ovarian Rebalancing device | Inducing ovulation in women with polycystic ovary syndrome- associated infertility | IND for a phase 3 trial approved by the FDA |
| Triple Hair Group | Therapy-07 | Androgenic alopecia | Approval for a phase 3 trial granted by Health Canada |
| Alcyone Therapeutics | ThecaFlex DRx System | Routine administration of subcutaneous therapeutics to the cerebrospinal fluid | IDE for a phase 3 trial approved by the FDA |
| Femasys | FemBloc | Permanent birth control | IDE for a phase 3 trial approved by the FDA |
| Trials Initiated | |||
| Portage Biotech | PORT-6 | Solid tumors, including prostate, renal and non-small cell lung cancer | Initiation of a phase 1a trial |
| Carisma Therapeutics | CT-0508 plus Keytruda (pembrolizumab) | HER2 overexpressing cancers | Initiation of a phase 1 trial |
| Cystetic Medicines | CM001 | Cystic fibrosis | Initiation of a phase 1 trial |
| International AIDS Vaccine Initiative (IAVI) | IAVI C108 Sudan virus vaccine candidate | Sudan virus | Initiation of a phase 1 trial |
| Jasper Therapeutics | Briquilimab | Lower-risk myelodysplastic syndrome | Initiation of a phase 1 trial |
| Sosei Heptares | HTL0048149 | Schizophrenia | Initiation of a phase 1 trial |
| Toragen | TGN-S11 | Human papillomavirus-induced cancer | Initiation of a phase 1 trial |
| InnoCare Pharma | ICP-488 | Psoriasis | Initiation of a phase 1 trial in China |
| Microba Life Sciences | MAP 315 | Inflammatory bowel disease | Initiation of a phase 1 trial in Australia |
| Lobe Sciences | L-130 | Chronic cluster headaches | Initiation of a phase 1 trial in Jordan |
| Inozyme Pharma | INZ-701 | Infants with ENPP1 deficiency | Initiation of a phase 1b trial |
| Enterome | EO4010 | Unresectable, previously treated metastatic colorectal cancer | Initiation of a phase 1/2 trial |
| Freeline Therapeutics | FLT201 | Gaucher disease type 1 | Initiation of a phase 1/2 trial |
| Palleon Pharmaceuticals | E-602 plus Libtayo (cemiplimab) | Advanced cancers | Initiation of a phase 1/2 trial |
| Kyverna Therapeutics | KYV-101 | Lupus nephritis | Initiation of a phase 1/2 trial in Germany |
| SELLAS Life Sciences | GFH009 | Relapsed/refractory acute myeloid leukemia | Initiation of a phase 2a trial |
| BioCity Biopharma | SC0062 | Chronic kidney disease | Initiation of a phase 2 trial in China |
| Memo Therapeutics | AntiBKV | BK polyomavirus infection in renal transplant patients | Initiation of a phase 2/3 trial |
| Bayer | Finerenone | Chronic kidney disease and type 1 diabetes | Initiation of a phase 3 trial |
| BioNTech OncoC4 |
BNT316/ONC-392 (gotistobart) | Metastatic, immunotherapy-resistant non-small cell lung cancer | Initiation of a phase 3 trial |
| Karyopharm Therapeutics | Selinexor plus Jakafi (ruxolitinib) | JAKi-naïve patients with myelofibrosis | Initiation of a phase 3 trial |
| PolyPid | D-PLEX100 | Prevention of abdominal colorectal surgical site infections | Initiation of a phase 3 trial |
| Approvals | |||
| BioMarin Pharmaceutical | Roctavian (valoctocogene roxaparvovec-rvox) | Adults with severe hemophilia A | Approved by the FDA |
| CellTrans | Lantidra (allogeneic pancreatic islet cellular therapy) | Type 1 diabetes | Approved by the FDA |
| Eisai | Leqembi (lecanemab) | Alzheimer’s disease | Approved by the FDA |
| Pfizer | Ngenla (somatrogon-ghla) | Pediatric growth hormone deficiency in patients age three years and older | Approved by the FDA |
| Pfizer | Litfulo (ritlecitinib) | Severe alopecia areata in patients age 12 years and older | Approved by the FDA |
| Sarepta Therapeutics | Elevidys (delandistrogene moxeparvovec-rokl) | Ambulatory patients age four through five with Duchenne muscular dystrophy and a confirmed mutation in the DMD gene | Approved by the FDA |
| UCB | Rystiggo (rozanolixizumab-noli) | Generalized myasthenia gravis in adult patients who are AchR or anti-MuSK antibody positive | Approved by the FDA |
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