Dyax Corp. (NASDAQ: DYAX) is almost certain to dominate the biotech news flow on Wednesday. The company announced positive data on Tuesday evening from the Phase 1b clinical study of the company’s investigational product, DX-2930. This candidate is being developed for the prevention of hereditary angioedema (HAE) attacks.
A gain of close to 40% in the after-hours, and with more than a million shares trading in the after-hours session is almost certain to catch the eye of investors and speculators.
A total of 37 subjects were randomized to active drug or placebo in a 2:1 ratio across four dosing groups of 30, 100, 300 or 400 mg. Each subject received two doses of DX-2930 or placebo, separated by 14 days, and was followed for 15 weeks after the second dose.
The good news was that DX-2930 was well tolerated at all dose levels. There were no deaths or subject discontinuations due to an adverse event. There were no serious adverse events in subjects treated with DX-2930 and no evidence of dose-limiting toxicity.
Another big bit of news to note in this release was that Dyax received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of DX-2930 for HAE.
Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax, noted in simpler terms:
The study met all of its primary objectives, and notably, DX-2930 also demonstrated statistically significant reductions in attack rate compared to placebo, an important characteristic for a prophylactic treatment.
Gustav Christensen, president and CEO of Dyax, said:
The positive results from this trial are a significant milestone for Dyax and will be integral in guiding the future clinical development of DX-2930. If approved, we believe that DX-2930, with its unique profile, is well positioned as a potential preventive treatment option for patients suffering from HAE.
Analysts are looking for almost $93 million in 2015 revenues, followed by an expectation of $117.6 million in 2016 revenues. The company is expected to have losses of $0.19 per share in 2015 and $0.05 per share in 2016.
Dyax shares closed down 1.7% at $16.75 Tuesday, and its 52-week trading range is $6.05 to $18.07. The after-hours stock reaction was last seen up 38% at $23.30. If the after-hours trading holds up, this will be a new high for Dyax not seen for the past decade. The consensus analyst target price was last seen at $17.06, and the highest analyst target price is currently $19.00. Those analyst targets may be going up.
By the way, kudos to RBC Capital Markets for their very positive view on Dyax ahead of this news.
As far as why this stock will dominate the biotech news on Wednesday, it traded right at 2 .4 million shares on the day — 1.1 million of which were shares traded in the after-hours trading session.