July 6, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Several biotech companies are facing catalysts this month—sometimes releasing interim data from a clinical trial, sometimes expecting a decision by the U.S. Food and Drug Administration (FDA). Chris Lange, writing for 24/7 Wall Street, provides some background on seven catalysts for July.
Headquartered in Philadelphia, Spark focuses on genetic diseases. The company is expected to announce interim data from a Phase I/II clinical trial of SPK-9001 for hemophilia B at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress in Berlin between July 8 and 13.
Spark Therapeutics is currently trading for $64.94. A consensus analyst price target is $70.44.
Based in The Netherlands, uniQure NV is focused on gene therapies, also in this case working on hemophilia B. The company is also presenting at ISTH.
“The data to be featured in an oral presentation at ISTH now demonstrate long-term safety, efficacy and the potential for broad application for AAV5 in hemophilia B,” said Matthew Kapusta, uniQure’s chief executive officer, in a statement. “We also look forward to the presentation of clinical data demonstrating successful and effective transduction in patients with pre-existing neutralizing antibodies to AAV5, further supporting our belief that our AAV5-based gene therapies may provide clinical benefits to nearly all patients suffering from hemophilia B and other severe diseases.”
uniQure is currently trading for $6.32. The consensus price target is $12.82.
Located in Novata, Calif., BioMarin focuses on rare diseases. And again, the company is presenting data at the ISTH, reporting interim data from a Phase I/II trial of BMN 270, an AAV5-FVIII Gene transfer in severe hemophilia. It will be presented on July 11.
“We are committed to further our ongoing clinical program with BMN 270,” said Hank Fuchs, BioMarin’s president of Worldwide Research and Development, in a statement, “which has the potential to change the course of hemophilia A treatment, the most common form of the disease, and look forward to sharing our latest findings.”
BioMarin is currently trading for $90.78. Consensus target price is
Based in Warrendale, Penn. and Brighton, Mass., Kadmon (KDMN) is a fully integrated biopharmaceutical company working on drug candidates for autoimmune and fibrotic diseases, oncology and genetic diseases. The company plans to release data on July 11 at its Research and Development day regarding its ongoing Phase II clinical trial of KD025 for previously treated patients with chronic graft-versus-host disease.
Kadmon Holdings is currently trading for $3.92. The consensus price target is $10.54.
Headquartered in Boston, Paratek focuses on infectious diseases. Last month, the company presented positive efficacy data in a Phase III trial in community-acquired bacterial pneumonia, comparing IV to once-daily oral omadacycline to moxifloxacin. Top-line data from a Phase III registration trial in acute bacterial skin and skin structure infection (ABSSSI) comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid is expected mid-July.
Paratek is currently trading for $23. Consensus price target is $3.80.
Based in Bedford, Mass., Ocular Therapeutix , not surprisingly, focuses on diseases of the eye. In February of this year, the company resubmitted its New Drug Application (NDA) for treatment of ocular pain after ophthalmic surgery by Dextenza, after it was rejected by the FDA. The FDA approved the resubmission and granted it as Class 2 review with a PDUFA date of July 19.
Ocular Therapeutix is currently trading for $10.06. Consensus price target is $22.25.
Headquartered in Woodcliff Lake, NJ, Eagle focuses on developing injectable products mostly in the areas of critical care, orphan diseases, and oncology. Generally, the company’s approach is to improve on already approved formulations.
It is awaiting a PDUFA date of July 23 for its NDA of Ryanodex (dantrolene sodium) for the treatment of exertional heat stroke (EHS). “There is currently no approved pharmacological treatment for EHS,” said Scott Tarriff, Eagle’s chief executive officer, in a statement. “If Ryanodex is approved, Eagle will be the first to market with a potentially transformational therapy. EHS can strike anyone, but athletes, our military and outdoor workers are especially vulnerable. We look forward to working with the FDA throughout the review process and to their expedited decision in July 2017.”
Eagle is currently trading for $82.73. The consensus price target is $91.75.
