The Approval Process in Action

Source: The Life Sciences Report and Visual Capitalist (5/1/13)

What catalysts in the drug development process move biotech company stocks? The savvy investor must know what steps in the U.S. Food and Drug Administration's approval process can propel a stock up or down. From drug discovery to the much-anticipated PDUFA date, The Life Sciences Report and the Visual Capitalist have collaborated on an infographic that describes both the process and related catalysts.

Cassava Shares Rise on Updated Phase 2b Alzheimer's Drug Trial Data
Source: Streetwise Reports (06/03/2020)

Shares of Cassava Sciences traded 70% higher after the firm provided updates from its Phase 2b study of PTI-125 for use in treating Alzheimer' disease.

AI Firm Receives Grant to Create Deep Learning Tools to Enhance Organ Donation Processes
Source: Streetwise Reports (06/03/2020)

Xtract AI has secured a CA$150,000 grant from the Innovative Solutions Canada program to utilize artificial intelligence to increase organ donations and improve transplant success rates.

Immunotherapy Firm Releases Data Showing Treatment Potential Against Sepsis
Source: Streetwise Reports (06/03/2020)

Recently presented results from Enlivex Therapeutics' Phase 1b study in sepsis and their implications are reviewed in an H.C. Wainwright & Co. report.

Micro-Cap Pharma Moving Ahead with Plans for Phase 3 US Trial of a Repurposed Drug for Covid-19
Source: Streetwise Reports (06/03/2020)

Revive Therapeutics is focused on infectious diseases as well as treatments using psilocybin-based formulations.

Myovant Sciences Shares Rise on NDA Filing for Uterine Fibroid Combination Therapy Drug
Source: Streetwise Reports (06/01/2020)

Shares of Myovant Sciences traded 40% higher after the company reported that it has submitted a New Drug Application to the FDA for once-daily relugolix combination tablet for the treatment of women with uterine fibroids.

AI Firm Develops Tool That Helps Radiologists Diagnose COVID-19
Source: Streetwise Reports (05/30/2020)

Patriot One Technologies and its partners create a model that automatically calculates, from a radiological scan, the degree of a patient's affected lungs, a COVID-19 indicator.

Mersana Therapeutics Trades 60% Higher on Positive Phase 1 Ovarian Cancer Trial Data
Source: Streetwise Reports (05/27/2020)

Shares of Mersana Therapeutics reached a new 52-week high price after the company reported positive interim data from the expanded portion of its Phase 1 study of XMT-1536 for treatment of ovarian cancer.

Biotech Identifies Antibody with 100% SARS-CoV-2 Inhibition
Source: Streetwise Reports (05/27/2020)

The goal of Sorrento Therapeutics to develop a Covid-19 antibody cocktail, including its progress, next steps and market opportunity, is reviewed in a Dawson James report.

Biotech's 'Multiple Sclerosis Therapy Shows Improvement in Disability'
Source: Streetwise Reports (05/27/2020)

Atara Biotherapeutics' clinical trial design and results are reviewed in a ROTH Capital Partners report.

Surgical Equipment Firm Delivers Innovative Imaging Systems to Leading Urologists
Source: Streetwise Reports (05/27/2020)

Imagin Medical delivered two functional i/Blue™ Imaging Systems for use in conducting in vivo studies and virtual demonstrations for evaluation by leading urologists.