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

Earlier in the year, Dynavax Technologies Corp. (NASDAQ: DVAX) reported that a third pivotal study had met both co-primary endpoints. The company plans to resubmit the HEPLISAV-B biologics license application to the FDA by the end of this month. Based on the expectation of a six-month review, if the application is approved Dynavax expects to launch this product in the fourth quarter of this year. For some background, HEPLISAV-B is a Phase 3 investigational adult hepatitis B vaccine.

Shares of Dynavax were trading up 0.7% at $16.26, with a consensus price target of $45.50 and a 52-week range of $15.80 to $32.49.

Puma Biotechnology

This company is expecting to continue to return value to shareholders in 2016 with neratinib. Puma Biotechnology Inc. (NYSE: PBYI) is submitting a New Drug Application (NDA) to the FDA in the first quarter of 2016. It is also reporting additional data from the Phase 2 trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using loperamide prophylaxis during the first half of 2016. Expect even more data when the company reports its Phase 2 data from an investigator sponsored trial of neratinib in patients with HER2-negative breast cancer who have a HER2 mutation in mid-2016.

Shares of Puma were trading down 7% at $38.85, with a consensus price target of $112.83 and a 52-week range of $34.71 to $252.92.

Durect

In 2015, Durect Corp. (NASDAQ: DRRX) completed five Phase 1 clinical trials, dosed over 75 healthy volunteers with either oral or injectable formulations, and saw no serious or treatment-related adverse events, enabling it to start 2016 by initiating its first DUR-928 patient trial. In November 2015, the company began recruiting patients in Persist, its Posimir pivotal Phase 3 clinical trial, which is designed to generate the data required for a resubmission of the NDA. In addition, Durect understands that Pain Therapeutics is in the later stages of completing the resubmission of the Remoxy NDA, which should lead to a six-month review by the FDA, which should come out in the late first quarter or early second quarter of 2016.

Shares of Durect were trading up 3% at $1.30, with a consensus price target of $4.00 and a 52-week range of $0.99 to $3.42.