Phase 2 Trial

Valneva SE (NASDAQ: VALN) and Pfizer Inc (NYSE: PFE) have reported further Phase 2 data for their Lyme disease vaccine candidate, VLA15.  The Phase 2 trial, VLA15-221, compared the immunogenicity of VLA15 after administration of two or three primary series doses....

The FDA has cleared Altimmune Inc's (NASDAQ: ALT) Investigational New Drug (IND) application for its Phase 2 trial of pemvidutide for obesity.  Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development to treat obesity and nonalcoholic...

Kaleido Biosciences Inc (NASDAQ: KLDO) halted work on a planned phase 2 trial in chronic obstructive pulmonary disease (COPD) and terminated its agreement with the COPD Foundation to realign resources. The Company had announced the COPD agreement in August 2021. The Phase 2...

Taysha Gene Therapies Inc (NASDAQ: TSHA) reported initial serum β-hexosaminidase A (Hex A) enzyme activity data for TSHA-101 in patients with Sandhoff and Tay-Sachs diseases, two forms of GM2 gangliosidosis.  According to Taysha, TSHA-101 is the first bicistronic vector in...

4D pharma plc (NASDAQ: LBPS) has announced additional clinical data from Part A of its Phase 1/2 trial of MRx-4DP0004, an orally-delivered single strain Live Biotherapeutic for asthma.  As previously announced, Part A met the primary endpoint, and the safety profile of MRx...

TYME Technologies Inc (NASDAQ: TYME) will discontinue SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC). The trial's sponsor, Pancreatic Cancer Action Network (PanCAN), terminated the arm due to futility compared to the control of the standard...

The Alzheimer's Drug Discovery Foundation (ADDF) and The Association for Frontotemporal Degeneration (AFTD) will support Wave Life Sciences Ltd's (NASDAQ: WVE) amyotrophic lateral sclerosis (ALS) and frontotemporal degeneration (FTD) program. The organizations will...

The FDA signed off Imara Inc's (NASDAQ: IMRA) investigational new drug (IND) application for tovinontrine (IMR-687) in heart failure with preserved ejection fraction (HFpEF). The Company plans to initiate a Phase 2 trial in Q2 of 2022 to evaluate tovinontrine in patients 45...

The FDA has issued a hold, pending Chemistry, Manufacturing & Controls (CMC) clearance, on Mustang Bio Inc's (NASDAQ: MBIO) Investigational New Drug (IND) application for MB-207 in patients with X-linked severe combined immunodeficiency (XSCID). The application was submitted...

89bio Inc (NASDAQ: ETNB) announced topline results from a cohort of 20 patients (Cohort 7) in the Phase 1b/2a proof-of-concept study evaluating pegozafermin (formerly BIO89-100) for nonalcoholic steatohepatitis (NASH). The results show that 63% of patients achieved a two-point or...

The FDA has cleared Tango Therapeutics Inc's (NASDAQ: TNGX) Investigational New Drug (IND) application for its lead program, TNG908. TNG908 is a synthetic lethal small molecule inhibitor of protein arginine methyltransferase 5 (PRMT5) designed to kill cancer cells with a...

SAB Biotherapeutics Inc (NASDAQ: SABS) has reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required to move to Phase 3 in the National Institutes of Health (NIH) COVID-19 ACTIV-2 Trial. SAB-185 is a fully human, specifically targeted,...

MediWound Ltd (NASDAQ: MDWD) has posted topline results from its U.S. Phase 2 study of EscharEx for the debridement (removal of dead or infected skin tissue for wound healing) of venous leg ulcers (VLUs).  The study randomized 120 patients, of which 119 patients were treated by...

Mirati Therapeutics Inc (NASDAQ: MRTX) has announced data from a Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib at the 600mg BID dose in pretreated patients with pancreatic ductal adenocarcinoma and other gastrointestinal (GI) tumors. As of September 10, 2021, the subset...

Provention Bio Inc (NASDAQ: PRVB) has initiated the Phase 2a PREVAIL-2 study evaluating PRV-3279 in systemic lupus erythematosus (SLE). PRV-3279 is a humanized bispecific DART molecule targeting the B-cell surface proteins CD32B & CD79B, which can intercept the pathophysiology...