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.

Novavax Shares Shoot 65% Higher on Phase 3 COVID-19 Vaccine Trial's 89.3% Effectiveness
Source: Streetwise Reports (01/29/2021)

Novavax Inc. shares established a new 52-week high after the firm's COVID-19 vaccine demonstrated an 89.3% efficacy rate in a Phase 3 trial in the U.K. and also showed efficacy against the South African variant in a Phase 2b trial.

Abiomed Shares Gain 8% After Firm Announces Record Q3 Revenue of $232 Million
Source: Streetwise Reports (01/28/2021)

Shares of cardiac medical device maker Abiomed Inc. traded higher after the company reported record revenue for Q3/21 despite the impact from COVID-19.

Sorrento Shares Rise 35% After Firm Posts Positive Data from Phase 1b ICU COVID-19 Trial
Source: Streetwise Reports (01/27/2021)

Shares of Sorrento Therapeutics traded higher after the company released positive preliminary results from it of Phase 1b COVI-MSC™ Study for treatment of hospitalized ICU COVID-19 patients.

Life Sciences Co. Receives Large Livestock Feed Order from New Client in Mexico
Source: Streetwise Reports (01/27/2021)

Avivagen Inc. reported it has secured a six tonne order for OxC-beta™ Livestock from a new customer in Queretaro City, Mexico.

Coverage Initiated on Biotech 'Improving Drugs Via Prodrug'
Source: Streetwise Reports (01/27/2021)

KemPharm's key near-term catalyst, lead value driver and other pipeline drug candidates are discussed in a ROTH Capital Partners report.

Vir Shares Climb 48% on Initial Phase 1 Chronic Hepatitis B Trial Data
Source: Streetwise Reports (01/26/2021)

Vir Biotechnology shares traded higher after the company reported data from its Phase 1 Chronic Hepatitis B Study that showed VIR-3434 significantly and rapidly reduced hepatitis B surface antigen.

Aurinia Pharma Shares Open at 52-Week High as FDA Approves Adult Lupus Nephritis Drug
Source: Streetwise Reports (01/25/2021)

Shares of Aurinia Pharmaceuticals traded 30% higher after the company reported that the U.S. Food and Drug Administration approved its LUPKYNIS™ (voclosporin) for use in treating adults with active lupus nephritis.

AzurRx Doses First Two People in Expanded Phase 2b Trial of Cystic Fibrosis Patients
Source: Streetwise Reports (01/22/2021)

AzurRx BioPharma shares traded 45% higher after the firm advised it had dosed the first two patients in its Phase 2b OPTION 2 Extension Study of MS1819 for treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.

Imagin Medical Is Bringing Cystoscopy into the 21st Century
Source: Dr. KSS, MD, PhD, for Streetwise Reports (01/21/2021)

Dr. KSS, MD, PhD, editor-in-chief of PubBio.co, profiles a small cap that "is poised to bring to clinic a next-generation of must-have cystoscopy equipment."

A Solace to the Stress of the SolarWinds Hack
Source: Jack Hurley for Streetwise Reports (01/21/2021)

Against the backdrop of the massive SolarWinds hack, value investor Jack Hurley discusses his investment thesis for Leonovus Inc, whose products provide an "ironclad level of cybersecurity."