Is no news good news at Dyax Corp. (DYAX)?
Today's Financial News - Posted March 26, 2009
There’s been no news at all on Dyax Corp’s (NASDAQ:DYAX) approval of DX-88 through the FDA. What to do now?
***Breaking news: Expect a Dyax press release later today!
by J. Christoph Amberger
Baltimore—TFN: Tuesday afternoon, I posted an article called “Dyax Corp. (DYAX) could soar on FDA approval for DX-88 HAE drug” at our TFN news portal. TFN’s stock guru Andrew Snyder and I had been watching this stock the way vultures ogle small furry mammals heading into the Painted Desert. Because it had all the hallmarks of a volume spike winner.
The catalyst for a powerful upward surge in Dyax Corp. (NASDAQ:DYAX) was FDA approval for its hereditary angioedema (HAE) drug DX-88. It was expected fist for Monday, March 23, and then corrected to March 25.
Both days came and went with nary a peep.
I had recommended two weeks ago that subscribers to our premium service HotStockConfidential position themselves early. They did, at $2.55 per share. For the more venturesome TFN Strategic Traders, Andrew had chiseled out a call options position. A bit more risky than my stock pick… but with a multiple of the profit potential than my prognosticated 20% short-term blip potential.
On no news at all, the stock touched $3 a share in yesterday’s trading before falling back substantially. Andy’s Strategic Traders were nimble enough to take a lightning-fast 70% gain off the table and scram.
Meanwhile, silence regarding possible FDA approval is all we heard, until the Dyax investor relations department informed me to expect a press release to be issued “later today”. I assume that means “after market close”… but that’s just me.
So far, we’re not doing poorly. At $2.80 a share right now, we’re sitting on a modest profit of 25 cents a share.
Given the volatility of market and stock price, I’m hesitant to set a stop loss. And I still think chances are good that approval may bag us our 20-30% gains we went for.
That’s why I say hold on to your position until news comes out! Probably tonight… with a powerful up- or downdraft in the stock price in early morning trading.
Next Article: Brilliance China Automotive (BCAHY) ready for Europe?
2 Responses to “Is no news good news at Dyax Corp. (DYAX)?”
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March 26th, 2009 at 5:29 pm
Hi Christoph
Thanks for the articles.
Any objective ideas about the requirements in that “response letter” FDA??
I meant and stay wondering here if DYAX already has the data for that “Risk Evaluation and Mitigation Strategy” and that wasn’t properly presented or if It needs to come up with the whole new set of data for the FDA compliance.
I guess it may get one, two or more months for a definitive FDA response. Any clue about this??
Thanks in advance.
Marcio
March 27th, 2009 at 10:14 am
The FDA’s response letter contained two key parts, a clarification of testing analytics and the request for more CMC (packaging and manufacturing) information. Of the two, the prior will be the easiest to fulfill as it merely requires the company to submit informationin in a different format with a few more details.
During last night’s conference call, the company refused to give a timeline for submitting to either request. I believe we will not see an approval for several months. Dyax should be able to fulfill its obligation quickly as it has a “rapid response” team on the case. It will be up to the FDA to either speed up the process or slow it down. Regardless, Dyax has enough cash to get it through 2009.