May 26, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Three developmental stage biotech companies seem to be, without much fanfare, rising on the market. Zachs gives us a head’s-up.
Fort Washington, Pennsylvania-based Vitae Pharmaceuticals focuses on rare diseases and utilizes its drug design platform called Contour. At the company’s recent first-quarter earnings report, Jeff Hatfield, company president and chief executive officer, said in a statement, “The highlight of the first quarter was the positive top-line results from Vitae’s Phase IIa proof-of-concept clinical trial of VTP-43742, our wholly owned, first-in-class ROR?ß inhibitor, in psoriatic patients. We believe these results have validated a potentially paradigm-changing therapeutic. We now anticipate reporting results for VTP-38543, our wholly owned, potential first-in-class LXRß selective agonist being developed for atopic dermatitis, in the second half of 2016. In addition, Vitae recently completed a follow-on offering, providing us with sufficient resources to continue to develop our proprietary pipeline.”
Vitae is currently trading for $9.51. Zacks points out that since March 16 the company’s stock shares have gained 129 percent, and “beat our EPS consensus estimate last quarter by 12 percent.”
GlycoMimetics , headquartered in Rockville, Maryland, is a clinical-stage biotech company focused on sickle cell anemia, cancer, and other diseases. The key to its approach is treating diseases in which carbohydrate biology plays a significant role.
In its May 4, first-quarter earnings report Rachel King, the company’s chief executive officer, said in a statement, “In February 2016, we announced the topline readout of data from the first two cohorts in our ongoing Phase I/II clinical trial evaluating our drug candidate GMI-1271 in relapsed/refractory acute myeloid leukemia (AML) patients. Of the first 13 evaluable patients dosed with GMI-1271 in combination with chemotherapy, investigators observed clinical responses in eight patients, for an overall response rate of 62 percent. … In addition, we plan soon to initiate clinical development of BMI-1359, our third product candidate, also with a novel mechanism of action targeting E-selectin and CXCR4, an important target believed to play a key role in cancer cell migration and infiltration. Here our initial indications will likely also be hematological cancers, but in the future we may expand into solid tumors as well. We anticipate filing an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for GMI-1359 in the third quarter of 2016.”
GlycoMimetics is currently trading for $8.10. Zachs wrote, “GLYC is a Zacks Rank #2 (Buy). Since the 10th of May, shares have gained 30.95 percent in value. Over the last week, shares have appreciated by 26.92 percent. The surge stems from news that GlycoMimetics’ drug candidate, GMI-1271, inhibits breast cancer metastasis. The drug candidate was also found to have a possible new application towards treating solid tumors. GLYC’s GMI-1359 was also found to have possible uses for the treatment of certain cancers.”
Cambridge, Massachusetts-based Dimension Therapeutics , is working on novel, liver-directed gene therapy treatments for severe, rare genetic disorders. Its lead program focuses on hemophilia B, which started clinical trials in January. It has additional programs in OTC deficiency, GSDla, citrullinemia type 1, Wilson disease, and a collaboration deal with Bayer HealthCare in hemophilia A.
At its May 12 first-quarter earnings report, the company also described an expansion of its research collaboration and license deal with the University of Pennsylvania to focus on citriullinemia type 1, phenylketonuria (PKU) and Wilson disease. And the company’s DTX301 for OTC deficiency received U.S. FDA orphan drug designation for OTC deficiency, and a positive opinion from European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP), recommending it receive orphan medicinal product designation. It also plans filing an IND for DTX401 for GSDla.
Dimension is currently trading for $7.84. Zacks writes, “DMTX shares are a Zacks Rank #2 (Buy), and shares have gained 20.54 percent in share value over the last week. The surge is stemming from a major earnings beat by the company posted on the 12th of May. Since then, shares have picked up a whopping 34.12 percent in value.”
