Alderya (ALDX) Stock Declines on Getting CRL for PVRL Candidate
Alderya’s ALDX shares nosedived almost 27% on Jun 21, after receiving a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for ADX-2191.
ADX-2191 (methotrexate) is an investigational candidate, being developed as an intravitreal injection for the treatment of primary vitreoretinal lymphoma (PVRL).
The FDA stated that while there were no safety or manufacturing concerns in the CRL, there was a "lack of substantial evidence of effectiveness" due to the absence of adequate and well-controlled investigations in the NDA submission.
Alderya stated that it did not conduct any clinical studies of the drug in PVRL.
Although the company acknowledges FDA's stance on the need for evidence from rigorous clinical studies, it argues that conducting randomized clinical studies for ADX-2191 in PVRL is currently unfeasible.
PVRL is a rare and fatal cancer without approved therapy. The median survival rate of the disease is less than five years. The compounded intravitreal injection of methotrexate currently serves as the standard treatment for this condition. However, there is a shortage of this medication according to the FDA Drug Shortages database.
In light of these circumstances, Alderya intends to engage in discussions with the FDA about the possibility of offering ADX-2191 to PVRL patients through an Expanded Access Program. This program facilitates access to treatment options for serious diseases when no other therapies are available.
Shares of Alderya have risen 33.9% year to date against the industry’s 7.3% decline.
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ADX-2191 is also being developed for the treatment of proliferative vitreoretinopathy and retinitis pigmentosa. ALDX expects to announce results from a phase II study of ADX-2191 in retinitis pigmentosa later this month.
The company also plans to hold a Type C meeting with the FDA later in 2023 to discuss the completion of the clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy.
Successful development and subsequent commercialization of the candidate would be a huge boost for the company.
Aldeyra Therapeutics, Inc. Price and Consensus
Aldeyra Therapeutics, Inc. price-consensus-chart | Aldeyra Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Alderya currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics AKRO, ADMA Biologics, Inc. ADMA and Omega Therapeutics OMGA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 3.8% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
The consensus estimate for ADMA Biologics has narrowed from a loss of 19 cents per share to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have risen 1.8% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.51 per share to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 24.8% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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