Investigational New Drug Application

After the usual 30-day review period, the Food and Drug Administration (FDA) placed GH Research’s (NASDAQ: GHRS) Investigational New Drug (IND) application for a Phase 1 clinical trial of proprietary inhalable 5-MeO-DMT compound GH001 on clinical hold due to “insufficient...

The FDA has signed off I-Mab (NASDAQ: IMAB) Investigational New Drug (IND) application for Protollin, an Alzheimer's candidate. Brigham and Women's Hospital and Inspirevax granted I-Mab and Nhwa global exclusive licenses to develop, manufacture, and commercialize Protollin....

The FDA has accepted Antares Pharma Inc's (NASDAQ: ATRS) Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.  The active IND enables Antares to initiate a Phase 1 study for ATRS-1902 for acute adrenal insufficiency, known as an adrenal crisis...

The FDA has signed off Lipocine Inc's (NASDAQ: LPCN) Investigational New Drug Application (IND) to initiate a Phase 2 study to evaluate LPCN 1154 for the treatment of postpartum depression (PPD) in adults. A pharmacokinetic (PK) study to assess dose proportionality is planned to...

The FDA has signed off Seres Therapeutics Inc's (NASDAQ: MCRB) Investigational New Drug (IND) application for SER-155 to initiate Phase 1 trial. SER-155 is a cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal antibiotic-resistant bacterial...

The FDA has signed off investigational new drug application of Scopus BioPharma Inc's (NASDAQ: SCPS) for CpG-STAT3siRNA, the company's distinctive immuno-oncology RNA therapy for the treatment of multiple cancers. A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will...

The FDA has signed off DiaMedica Therapeutics Inc's (NASDAQ: DMAC) Investigational New Drug (IND) application to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS)....

After receiving Type C Meeting Responses from the FDA, MindMed (NASDAQ: MNMD) has selected Generalized Anxiety Disorder as an initial indication for its Project Lucy, evaluating LSD. The company is on target to formally submit its Investigational New Drug (IND) application for Project Lucy in...