Phase 2 Trial

Galecto Inc (NASDAQ: GLTO) has entered into a clinical trial supply agreement with Roche Holdings AG (OTC: RHHBY) to explore the combination of GB1211 in a planned Phase 2a trial in non-small-cell lung cancer (NSCLC).  Under the agreement terms, Galecto will fund and...

Metacrine Inc (NASDAQ: MTCR) reported topline results from its Phase 2a trial of MET409 in combination with Eli Lilly And Co's (NYSE: LLY) Jardiance (empagliflozin) in type 2 diabetes and non-alcoholic steatohepatitis (NASH).   LDL-cholesterol increases with...

Cocrystal Pharma Inc (NASDAQ: COCP) has submitted a pre-Investigational New Drug (IND) briefing package to the FDA for its broad-spectrum protease inhibitor CDI-45205 in COVID-19. FDA's response is expected to provide greater clarity and guidance on designing Phase 1 and Phase 2 trials...

ATAI Life Sciences NV (NASDAQ: ATAI) announced interim data from the first 8-patient cohort of its Phase 2a trial of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). Related Link: Peter Thiel Backed Atai Life Launches New Mental Health Disorders-Focused...

MedImmune Limited, a unit of AstraZeneca Plc (NASDAQ: AZN), has notified Inovio Pharmaceuticals Inc (NASDAQ: INO) to terminate the DNA cancer vaccine development program agreement. Under the agreement, MedImmune acquired exclusive rights to INO-3112 immunotherapy,...

The Data and Safety Monitoring Committee (DSMC) has completed a pre-specified interim analysis for ARCA biopharma Inc's (NASDAQ: ABIO) ASPEN-COVID-19 Phase 2b trial evaluating rNAPc2, a small recombinant protein for COVID-19. Based on the review of approximately 75% of the projected...

Inventiva (NASDAQ: IVA) announced the design of Phase 2a combination trial of lanifibranor in patients with type 2 diabetes (T2D) and non-cirrhotic non-alcoholic steatohepatitis (NASH). The trial will assess lanifibranor combined with Eli Lilly And Co's (NYSE: LLY)...

The FDA has signed off BioVie Inc's (NASDAQ: BIVI) Phase 2 study assessing NE3107's potential pro-motoric impact in Parkinson's disease patients. The NM201 study is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson's...

4D Molecular Therapeutics Inc (NASDAQ: FDMT) has announced interim data from the Phase 1/2 trial of intravenous 4D-310 in Fabry disease patients. The Company said that 4D-310 demonstrated a manageable safety profile with the initial evidence of clinical activity. The Company said...

Less than a year ago, Ventyx Biosciences Inc (NASDAQ: VTYX) emerged from stealth mode, then last month, it sprinted to Wall Street with a $100 million IPO ticket. This week Ventyx nabbed an upsized $152 million by offering 9.5 million shares at $16, within the range of $15 to $...

PDS Biotechnology Corporation (NASDAQ: PDSB) has temporarily suspended recruitment in the National Cancer Institute (NCI)-led Phase 2 trial of PDS0101 combo trial in advanced HPV cancers The issue is not specific to the PDS0101 trial and is unrelated to the triple combination's...

Stealth BioTherapeutics Corp (NASDAQ: MITO) has received a Refusal to File letter from the FDA regarding its marketing application for elamipretide, a mitochondria-targeted therapy for Barth syndrome. Barth syndrome is an ultra-rare genetic condition characterized by cardiac...

Rocket Pharmaceuticals Inc (NASDAQ: RCKT) has announced interim data updates from seven patients from the RP-L201 Phase 1/2 trial for Leukocyte Adhesion Deficiency-I (LAD-I). Data were shared at the Annual Congress of the European Society of Gene & Cell Therapy (ESGCT). RP-L201...

ImmunityBio Inc (NASDAQ: IBRX) has announced that Papillary disease (Cohort B) of its Phase 2/3 study of intravesical BCG plus Anktiva met its primary endpoints with disease-free survival of 57% at 12 months.  Non-muscle invasive bladder cancer (NMIBC) makes up 75%-85% of all...

Edesa Biotech Inc (NASDAQ: EDSA) has announced additional results from the Phase 2 part of an ongoing Phase 2/3 study of EB05 as a single-dose treatment for hospitalized COVID-19 patients. Related: Edesa Biotech Provides Update For COVID-19 Antibody Trial. Overall, EB05 + Standard of...