Why Aldeyra Is A Must-Watch Stock: Exciting Catalysts On The Horizon

2023 is shaping up to be a pivotal year for Aldeyra Therapeutics Inc. (ALDX) as it continues to make significant progress in its pipeline of compounds targeting systemic and retinal immune-mediated diseases.

Two of the company’s drug candidates – ADX-2191 and Reproxalap – are under FDA review.

ADX-2191 is an intravitreal formulation of methotrexate for the potential prevention or treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa.
The FDA is reviewing ADX-2191 as a potential treatment for primary vitreoretinal lymphoma, and a decision is due on June 21, 2023.

Primary vitreoretinal lymphoma is a rare and aggressive type of cancer affecting the retina, which can be fatal. In the United States, it is diagnosed in around 300 to 600 patients annually. Unfortunately, the median survival rate for newly diagnosed patients is less than five years, and currently, there are no approved treatments available. However, intravitreal injection of compounded methotrexate is considered the current standard of care.

ADX-2191 is also being explored in a phase II trial for the treatment of retinitis pigmentosa. Topline results from this study are expected in the first half of this year.

Retinitis pigmentosa refers to a group of rare genetic eye diseases characterized by retinal cell death and loss of vision. There this no FDA-approved treatment for this disease.

— The company’s second drug candidate under FDA review is Reproxalap, a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.

The FDA decision on Reproxalap, proposed for the treatment of signs and symptoms of dry eye disease, is expected on November 23, 2023.

Dry eye disease includes a group of conditions that occur when the eyes fail to produce enough tears or produce tears of the wrong consistency. Age is a significant factor that contributes to the development of dry eye, affecting around 5% of adults aged 30-40 and 10-15% of those over 65, and women are more prone to this condition. If not treated promptly, severe dry eye can cause discomfort, ulcers, and corneal scarring.

Kala Pharma’s Eysuvis, Novartis’ Xiidra, Allergan’s Restasis, and Oyster Point’s Tyrvaya are some of the FDA-approved drugs for dry eye disease.

Reproxalap is also being explored in a phase III trial in patients with allergic conjunctivitis, dubbed INVIGORATE-2. Topline results from this study are anticipated in the first half of 2023.

Next in the pipeline is ADX 629, a novel, orally administered RASP modulator, which belongs to the same chemical class as Reproxalap.

ADX 629, is under a phase II trial for the treatment of chronic cough. Top-line results from this study are expected in the first half of 2023.

When a cough lasts for more than eight weeks, it is usually considered to be a chronic cough.

The company has two more investigational RASP modulators, namely ADX 246 and ADX 248.

A phase I clinical trial of orally administered ADX 246 for the treatment of systemic immune-mediated diseases, and a phase I/II clinical trial of intravitreally injected ADX 248 for the treatment of geographic atrophy, a sight-threatening retinal disease, are expected to be initiated in the second half of 2023 or early 2024.

Cash position

The company ended the year 2022 with cash, cash equivalents, and marketable securities of $174.3 million.

Aldeyra shares began trading on the NASDAQ Capital Market under the symbol “ALDX” on May 2, 2014, priced at $8 per share.

ALDX was trading around $3.90 when it was initially featured on our site on Mar.16, 2022, and it had risen to $4.55 when it was featured again on Jul.12, 2022.

In the last 1 year, ALDX has traded in a range of $2.36 to $10.03. The stock hit a new 52-high of $10.03 during intraday trading Friday (Mar.31, 2023), before closing at $9.93, up 4.53%.

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