Phase 2 Trial

IMV Inc (NASDAQ: IMV) announced safety and preliminary efficacy data of the combination of its lead immunotherapy candidate, maveropepimut-S (MVP-S), with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) from a Phase 2 basket study in advanced, metastatic...

VYNE Therapeutics Inc (NASDAQ: VYNE) announced positive efficacy results from the Phase 1b segment of Phase 1b/2a trial of FMX114 in mild-to-moderate atopic dermatitis (AD). Mean Atopic Dermatitis Severity Index (ADSI) scores for FMX114 and vehicle-treated lesions were 7.8 and 8.0,...

Biophytis SA (NASDAQ: BPTS) said that it is currently assessing FDA comments and recommendations and preparing to submit Phase 2-3 trial designs for sarconeos (BIO101) trial in sarcopenia. Enrollment is expected to start in 2H of 2022 in the SARA Phase 2 trial. In October 2021,...

Adverum Biotechnologies Inc (NASDAQ: ADVM) received feedback via a Type C meeting written response from the FDA regarding its planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration (wet AMD).  Adverum requested the FDA's feedback to align with the...

Imara Inc (NASDAQ: IMRA) shares are falling after interim analyses of its Ardent Phase 2b trial of tovinontrine (IMR-687) in sickle cell disease (SCD) and Forte Phase 2b trial in beta-thalassemia.  Data from the sickle cell disease study interim analysis demonstrated that...

BridgeBio Pharma Inc (NASDAQ: BBIO) announced updated data from its ongoing Phase 2 open-label extension (OLE) study of acoramidis (AG10) in symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM).  Acoramidis was generally well-tolerated and resulted in sustained,...

Quantum Leap Healthcare Collaborative (QLHC) announced that the nebulized form of NRx Pharmaceuticals Inc's (NASDAQ: NRXP) Zyesami (Aviptadil) in the I-SPY COVID Trial of critical patients had been stopped.  The I-SPY COVID Trial is a phase 2 trial designed to rapidly...

Portage Biotech Inc (NASDAQ: PRTG) has updated its clinical development programs and announced its development goals for 2022, and it continues to work toward multiple clinical readouts in 2022. In 2021, clinical trials for Portage's lead invariant natural killer T cell (iNKT) agonist...

Immutep Limited (NASDAQ: IMMP) has announced new interim data from the Phase 2 TACTI002 trial of eftilagimod alpha (efti or IMP321), combined with Merck & Co Inc's Keytruda (pembrolizumab). The trial included 36 patients with PD-L1 unselected 2nd line PD-X...

In the partnership that spawned aducanumab, Eisai Co Ltd (OTC: ESALY) and Biogen Inc (NASDAQ: BIIB) have released more data on lecanemab, another anti-Alzheimer's drug.  The lecanemab's Phase 2b study data were presented at the annual AD/PD meeting. The ratio...

NLS Pharmaceutics Ltd (NASDAQ: NLSP) has announced interim topline data from its Phase 2a trial of its lead product candidate, Quilience (Mazindol ER), in narcolepsy.  For excessive daytime sleepiness (EDS), the trial's primary endpoint, patients on Mazindol ER exhibited a...

The FDA has lifted the clinical hold on AIM ImmunoTech Inc's (NYSE: AIM) investigational new drug (IND) application for a Phase 2 study of Ampligen for locally advanced pancreatic cancer (AMP-270). The AMP-270 clinical trial's primary objective compares the efficacy of...

The FDA has cleared Adagene Inc's (NASDAQ: ADAG) Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab).  The global trial (ADG126-P001 / KEYNOTE-C98) will...

AnaptysBio Inc's (NASDAQ: ANAB) Phase 2 ACORN trial of imsidolimab for moderate-to-severe acne did not demonstrate efficacy over placebo on primary or secondary endpoints. Imsidolimab was generally safe, well-tolerated, and no imsidolimab-related serious or severe adverse events...

GeoVax Labs Inc (NASDAQ: GOVX) has engaged CATO SMS to manage its two ongoing Phase 2 trials of its COVID-19 vaccine candidate, GEO-CM04S1. One is testing the safety and effectiveness of GEO-CM04S1 compared to the Pfizer Inc (NASDAQ: PFE) / BioNTech SE (NASDAQ:...