Phase 2 Trial

Adaptimmune Therapeutics plc (NASDAQ: ADAP) will report updated data from its SPEARHEAD-1 Phase 2 trial with afamitresgene autoleucel (afami-cel, ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) at the Connective Tissue Oncology Society...

Cortexyme Inc (NASDAQ: CRTX) has presented additional data from its Phase 2/3 GAIN Trial at the Clinical Trials on Alzheimer's Disease Conference.  The 643-participant 48-week GAIN Trial failed to meet statistical significance on its co-primary cognitive and...

Freeline Therapeutics Holdings plc (NASDAQ: FRLN) gave an update on its investigational Fabry disease treatment FLT190, currently in a Phase 1/2 trial, saying the candidate proved durable in the second patient tested. Fabry disease is an inherited metabolic disorder resulting from...

Finch Therapeutics Group Inc (NASDAQ: FNCH) announced positive topline results from PRISM-EXT, an open-label extension of the PRISM3 Phase 2 trial evaluating CP101 to prevent recurrent C. difficile infection (CDI). PRISM-EXT was a 24-week trial in 132 participants who either rolled...

GeoVax Labs Inc (NASDAQ: GOVX) entered into an exclusive license agreement with City of Hope, a cancer research and treatment organization, for COH04S1, a synthetic, attenuated modified vaccinia Ankara vector expressing spike and nucleocapsid antigens of the SARS-CoV-2 virus. ...

Immutep Limited (NASDAQ: IMMP) has announced final overall survival data (OS) from its Phase 2b AIPAC trial. 227 patients with HER2-negative/HR-positive metastatic breast cancer (HR+ MBC) were 1:1 randomized in the AIPAC study.  The trial evaluated Immutep's eftilagimod...

​​​​​Compass Pathways plc (NASDAQ: CMPS) has announced results from Phase 2b trial of COMP360 psilocybin therapy for treatment-resistant depression. The study has achieved its primary endpoint for the highest dose, with a 25mg dose of COMP360 demonstrating a highly statistically...

The FDA has accepted Seelos Therapeutics Inc's (NASDAQ: SEEL) Investigation New Drug application to study SLS-005 (trehalose injection, 90.5 mg/mL) for spinocerebellar Ataxia (SCA).  The FDA has also granted the program Fast Track designation for SCA, and SLS-005 has...

MorphoSys AG (NASDAQ: MOR) presented interim results from the M-PLACE Phase 1b/2a study with felzartamab at the 2021 Annual Meeting of the American Society of Nephrology (ASN). Felzartamab is a fully human IgG1 monoclonal anti-CD38 antibody that can potentially deplete CD38-positive...

Calithera Biosciences Inc (NASDAQ: CALA) has decided to terminate its phase 2 KEAPSAKE trial based on a lack of clinical benefit observed in patients treated with telaglenastat in an interim analysis. The Phase 2 KEAPSAKE study was designed to evaluate the safety and anti-tumor...

Sangamo Therapeutics Inc (NASDAQ: SGMO) announced preliminary results from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a gene therapy candidate for Fabry disease.  As of the September 17, 2021 cutoff date, results from the four patients treated in...

Novartis AG (NYSE: NVS) has announced Phase 2 trial data of iptacopan, a selective factor B inhibitor, in patients with C3 glomerulopathy (C3G). In C3G, an overly-active alternative complement pathway causes deposits of C3 protein to build up in blood vessels that filter waste and remove...

The FDA has signed off Achieve Life Sciences Inc's (NASDAQ: ACHV) Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. In addition to the ongoing Phase 3 program for cytisinicline treatment in...

Aldeyra Therapeutics Inc's (NASDAQ: ALDX) reproxalap achieved the primary endpoint of ocular redness in the Phase 2 trial in patients with dry eye disease. The ocular redness scores in the reproxalap group were statistically lower than those of vehicle. Mean visual analog scale...

Clene Inc (NASDAQ: CLNN) has announced topline data from RESCUE-ALS phase 2 trial evaluating CNM-Au8 for early amyotrophic lateral sclerosis (ALS). The trial did not meet the primary or secondary endpoints, Motor Unit Number Index (MUNIX), and forced vital capacity (FVC) at week 36...