Good day everyone,
Genprex, Inc. (NASDAQ: GNPX) is a clinical-stage gene therapy company focused on developing therapies for patients with cancer and diabetes.
Current price $2.36/share (as of market close 1-10-22)
In the Monday session GNPX shares seemed to move in tandem with the NASDAQ index, lagging throughout the morning and finishing with a rally to end up +8.75% from the opening price of $2.17/share.
The latest news regarding the two FDA fast track designations for their clinical trials in combination with Merck’s Keytruda and AstraZeneca’s Tagrisso could prove to be major catalysts for the company’s value. In H1 of 2021, when the news of these two forthcoming clinical trials was being discussed the company shares hovered in the $4.00 – $7.00/share range, and justifiably so.
In my view, the fast-track designation is far bigger news than the announcement of an upcoming clinical trial. The potential for milestones and catalysts can come at a fast and furious pace under FTD. Let’s remember what FTD means:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval.
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers.
Eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
GNPX may rise to a new high in value as the benefits of the FTD come into play.
The Traders News Group