Aldeyra Therapeutics Inc (NASDAQ: ALDX) is flying early on in the trading session this morning, and for good reason. The company announced positive late-stage clinical data, exciting investors and sending the stock screaming for the top. Today, we’ll talk about:
- The positive clinical data;
- what we’re seeing from ALDX stock as a result; and
- what we’ll be watching for ahead.
ALDX Announces Positive Clinical Data
As mentioned above, Aldeyra Therapeutics is flying early on in the trading session this morning after announcing positive late-stage data. The data came by way of press release early this morning.
In the release, the company provided positive results from the Phase e ALLEVIAT Trial. Through the trial, the company assessed the safety and efficacy of 0.25% and 0.5% reproxalap topical opthalmic solution in patients with allergic conjunctivitis.
ALDX announced through the release that the clinical trial met its primary endpoint as well as the key secondary endpoint for both concentrationso f the drug. The trial was a double-masked, randomized, vehicle-controlled, multi-center, parallel-group conjunctival allegen challenge clinical study.
The primary efficacy endpoint was the evaluation of ocular itch score area under the curve from 10 to 60 minutes after allergen challenge. The key secondary endpoint was two-point responder rate, a measure of clinical relevance. Both of these endpoints were successfully met. Not to mention, safety and tolerability data proved promising.
In a statement, Todd C. Brady, M.D., Ph.D., President and CEO at ALDX, had the following to offer:
We are thrilled to announce positive results from ALLEVIATE, our first completed Phase 3 clinical trial. Consistent with positive results from five prior Phase 2 clinical trials in ocular inflammation, today’s announcement confirms the potential of reproxalap as a novel and clinically meaningful approach for the treatment of allergic conjunctivitis. Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 program in dry eye disease.
The above statement was followed up by David J. Clark, M.D., M.R.C.P., CMO at ALDX. Here’s what he had to say:
There is a large allergic conjunctivitis patient population that is underserved by currently available medications. The ALLEVIATE results suggest the potential of topical ocular reproxalap as a novel, safe, and effective therapeutic option that could be used to complement existing therapy before resorting to corticosteroids, which can lead to serious ocular toxicity.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. When it comes to Aldeyra Therapeutics, the news proved to be overwhelmingly positive.
After all, the positive data from this late-stage study will likely lead to a New Drug Application being submitted to the FDA relatively soon. Should the application be approved, it will provide the company with the ability to start generating revenue from the sales of this treatment.
So, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:23), ALDX is trading at $11.90 per share after a gain of $4.76 per share or 66.67% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ALDX. In particular, we’re interested in following the story surrounding the company’s continued work to bring reproxalap to market as the data is overwhelmingly promoising. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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