There are no gains like biotech gains, a fact Biora Therapueutics (BIOR) investors can happily attest to following this week’s market action. Shares of the micro-cap surged by over 200% after the company provided an encouraging update.
Following a Type C meeting with the FDA regarding its PGN-600 Targeted Therapeutics program, which is focused on the treatment of ulcerative colitis (UC), the company said the regulatory body has provided positive feedback. And this means the company remains on course to file an IND (investigational new drug) application for the PGN-600 program, which will be followed by the initiation of clinical studies. Biora anticipates a trial will kick off in Q2, with data readouts expected in Q3.
H.C. Wainwright analyst Joseph Pantginis is confident development will go according to plan.
“Subsequent to the disclosure of positive FDA engagement and conversations with management, we believe the agency is becoming increasingly on board with the Targeted Therapeutics platform,” the analyst opined. “We remind investors that, while the Targeted Therapeutics employs a novel delivery device, the therapeutic payloads are well studied, validated, and safe. Biora’s own independent investigations have further corroborated these observations. This due diligence, in our opinion, has helped build a compelling case to the FDA to move PGN-600 forward in a rapid manner.”
The Targeted Therapeutics program makes use of a smart capsule that is ingested and designed to accurately deliver therapies to the gastrointestinal tract so to help with treating IBD (inflammatory bowel disease), with the company focused on ulcerative colitis to begin with.
Biora also plans on presenting results from the program at the Crohn’s & Colitis Congress this month (January 19-21). These will show successful function of the device when provided with food, which could “potentially allow non-fasted administration.”
If you think you’re late for the party following this week’s mighty gains, don’t fret. Pantginis gives Biora shares a $65 price target, suggesting the shares will deliver incredible upside of 879% over the coming year. (To watch Pantginis’ track record, click here)
This stock appears to be flying under Wall Street’s radar right now; Pantginis’ review is the sole one to be made over the past 3 months. (See Biora stock forecast)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
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