Health and Healthcare

4 More Key FDA Decisions in March

Chris Lange

Published: March 16, 2016 12:50 pm

Last Updated: January 13, 2020 11:52 am

24/7 Wall St. has collected a few more U.S. Food and Drug Administration (FDA) decisions coming up in March. Generally, companies in the pharmaceutical industry are involved in the lengthy process of getting their drug candidates to market through clinical trials.

There is a fair amount of risk involved should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside. FDA rulings can make or break these companies. A single failed clinical trial can mean disaster for a stock.

We have added some color, along with the trading range and price target. Note that, due to many outside and internal factors, there are no assurances that the dates will not change.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

BioLineRx

BioLineRx Ltd. (NASDAQ: BLRX) has enhanced and expanded the development strategy for its BL-8040 cancer therapy platform, which is currently being investigated for multiple cancer and hematological indications. These include a Phase 2 study for treating relapsed and refractory acute myeloid leukemia patients, top-line results of which are expected by the end of this month. Results from the first part of this trial continue to demonstrate substantial mobilization of leukemic cells from the bone marrow to the peripheral blood and robust induction of cancer cell apoptosis, which, combined with the reported 38% composite remission rate, strongly suggest that BL-8040 has potent anti-leukemic activity.

Shares of BioLineRx were last seen trading up 4% at $1.05, with a consensus analyst price target of $4.67 and a 52-week trading range of $0.85 to $2.80.

24/7 Wall St.
5 Key FDA Decisions Expected in March