2 Biotechs Face Potential Catalysts as Early as Next Week
October 27, 2016
By Mark Terry, BioSpace.com Breaking News Staff
This year’s fourth quarter has plenty of biotech companies facing major decisions, but two have potential catalytic events as early as next week.
Anthera Pharmaceuticals
Hayward, Calif.-based Anthera Pharmaceuticals has two products in development, sollpura, a pancreatic enzyme replacement therapy to treat exocrine pancreatic insufficiency in patients with cystic fibrosis (CF) and blisibimod, a BAFF inhibitor to treat systemic lupus erythematosus and IgA nephropathy.
The company is expected to release data from its blisibimod trial soon, and Market Exclusive expects next week. Mark Collins, writing for Market Exclusive, says, “Now, this one already failed to hit a primary endpoint of a Phase IIb trial back at the end of 2012, but the company pushed forward with this Phase III in the hope that a slightly altered protocol could alter the eventual outcome. Markets aren’t overly optimistic on its chances, but we’ve seen it happen many times before, and so we’re not writing the company off.”
Anthera is currently trading for $2.40.
Duncan Independent writes that, “Anthera Pharmaceuticals, Inc.’s performance this year to date is -45.9 percent. The stock has performed -9.06 percent over the last seven days, -20.57 percent over the last thirty, and =18.77 percent over the last three months.”
Theratechnologies
Theratechnologies , headquartered in Montreal, Quebec, focuses on medications related to HIV. On October 24, Theratechnologies and its partner, TaiMed Biologics, reported that the last patient had been enrolled in its Phase III trial of ibalizumab. The drug is used in combination with background treatment in patients with multi-drug resistant HIV-1. It is the last trial required by the U.S. Food and Drug Administration (FDA) to complete the Biologics License Application (BLA) for the drug.
The data is expected to be released in the next couple weeks, possibly as early as next week. Ibalizumab is essentially an adjuvant used to boost standard of care (SOC) background therapy. HIV patients are prone to developing resistance to various drug regimens, so generally a cocktail of antiviral drugs is used to overcome that resistance.
Collins writes, “Theratechnologies is hoping ibalizumab will be able to combine with current antivirals and—in doing so—both maximize their impact on viral load in HIV-1 and serve as a tool with which to extend the treatment (efficacy) life of the current options.”
Theratechnologies is currently trading for $3.28.
A number of firms have weighed in on Theratechnologies recently. Mackie cut its price target from $5.30 (Canadian) to $4.40 (Canadian) earlier this year, which seems pretty optimistic at the moment. Community Financial News writes, “Theratechnologies traded up 4.27 percent during trading on Tuesday, hitting $2.93. 74,297 shares of the company’s stock traded hands. Theratechnologies has a 52-week low of $1.26 and a 52-week high of $3.74.”
Other companies facing big decisions this quarter include Theravance , The Medicines Company ), which will be updating two programs on November 15, and Dynavax Technologies , which is waiting for the FDA to decide on its Heplisav-B treatment for hepatitis B in patients with type 2 diabetes on or before December 15.
Cempra Pharmaceuticals has two FDA PDUFA dates this quarter. The first is December 27, for an oral version of Solithera to treat community-acquired bacterial pneumonia (CABP), and on December 28, when the FDA decides on an injectable form of Solithera to treat CABP. France’s Advanced Accelerator Application has a PDUFA from the FDA on December 28 for Lutathera to treat gastroenterpancreatic neuroendocrine tumors (GEP-NETs).