The Approval Process in Action

Life Sciences Tools & DiagnosticsMedical DevicesRegenerative MedicineBiotechnology / Pharmaceuticals

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.

GMP Production of Exosomes Slated for Later This Year
Source: Jason Kolbert (03/31/2025)

This is a next big step for the biotech in moving its investigational exosome therapy for chronic inflammation into the clinic, noted a D. Boral Capital report.

Biotech Advances Revolutionary Treatment for Neurodegenerative Diseases
Source: Streetwise Reports (03/28/2025)

Clinical-stage biotechnology company Coya Therapeutics Inc.'s (COYA:NASDAQ) regulatory T cell-derived exosome (Treg exosome) program is set to enter Good Manufacturing Production (GMP) late this year, paving the way for an initial clinical study. Find out why one analyst calls the company's work a "potential breakthrough."

Biotech Co. Advances AI-Generated Cancer Treatments
Source: Streetwise Reports (03/28/2025)

Rakovina Therapeutics Inc. (RKV:TSX.V) receives the first synthesized batch of artificial intelligence-generated ATR inhibitor compounds developed in collaboration with Variational AI. Find out why the technology could revolutionize the way we treat cancer.

Chen Highlights His Premium Silver, Gold Opportunities for Q2
Source: Streetwise Reports (03/25/2025)

Even with tariff chaos, asset manager Chen Lin of What is Chen Buying? What is Chen Selling? said he is still bullish in the near term for gold silver. Find out which stocks are his top picks for the coming quarter.

PDUFA Date Nearing for New PSVT Drug
Source: Patrick Trucchio (03/19/2025)

If approved, commercialization will start mid-year; the biopharma behind the treatment offers a potential return of 1,052%, noted an H.C. Wainwright & Co. report.