June 10, 2022 (Investorideas.com Newswire) Approval would be positive news for Aldeyra Therapeutics Inc. given the market for the indication is large and underserved, noted a BTIG report.
Aldeyra Therapeutics Inc.’s (ALDX:NASDAQ) reproxalap ophthalmic solution is likely to get U.S. Food and Drug Administration (FDA) approval for dry eye disease, based on new TRANQUILITY-2 trial data, reported BTIG analyst Thomas Shrader in a June 8 research note.
“From an FDA perspective, reproxalap is very safe, passes the Schirmer test with high significance, and has a novel mechanism of action in a field with underserved patients,” Shrader highlighted. “We think that will be enough for approval.”
Also of note for investors, the biotech offers a potentially significant return from its current $3.50 share price, reflected in BTIG’s $29 per share price target on it.
“We believe Aldeyra represents an attractive and derisked investment opportunity ahead of the company’s first new drug application filings,” Shrader wrote.
Massachusetts-based Aldeyra is developing reactive aldehyde species (RASP)-targeted therapies for immune-mediated diseases. Dry eye disease is one of its lead programs.
The TRANQUILITY-2, Phase 3 trial met, with high significance, one of the two primary endpoints. This was passing the Schirmer test, which determines if one’s eyes produce enough tears to keep them moist. This study result bodes well for FDA approval of reproxalap, as only one endpoint needed to be met to file a new drug application for the product candidate.
A greenlight for reproxalap would be great news for Aldeyra as dry eye disease is a large, currently underserved market. An estimated 15-plus million people in the U.S. have been diagnosed with the disorder.
TRANQUILITY-2’s second primary endpoint, improvement in ocular redness, was unexpectedly unmet as it had been achieved in the TRANQUILITY-1 and Phase 2 studies.
“The redness failure seen in the recent TRANQUILITY-2 readout was surprising as redness effects have been seen in the other trials, and improving redness seems very consistent with the drug’s mechanism, scavenging the irritant that drives dry eye disease,” wrote Shrader.
This efficacy shortfall cannot be overlooked, Shrader pointed out, as “redness is important, and the drug’s effect on this [disease] sign is likely the key to commercial uptake.”
The analyst added that reproxalap probably does reduce redness but may take longer than a day to do so. Proving this would require another trial with a different design, which is not part of the current development plan.
There is a chance, though, that reproxalap may demonstrate efficacy concerning redness in the chamber crossover trial now underway, in which that disease sign and the Schirmer test are the primary endpoints, Shrader noted. The results are due out in Q3/22.
Otherwise, “an understanding of how good the drug reproxalap is at controlling redness will come after launch,” Shrader wrote.
Before Aldeyra submits a new drug application for reproxalap in dry eye disease, the company will meet with the FDA, presumably in Q3/22.
BTIG rates the biotech Buy.
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.
Disclosures for BTIG Research, Aldeyra Therapeutics, June 8, 2022
Analyst Certification: I, Thomas Shrader, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report. I, Sung Jun Hong, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: Aldeyra Therapeutics (ALDX).
Research reports produced by BTIG LLC (“BTIG”) are published for and intended to be distributed solely to BTIG institutional and corporate clients. Recipients of BTIG reports will not be considered clients of BTIG solely because they may have received such BTIG report.
To the extent recipient accesses BTIG research, whether on a BTIG research website or through a third-party platform, BTIG is able to search, filter, download and review information on the readership of BTIG’s research, including the specific research consumed and the name, company name, email address and, in certain circumstances, the location of the individual who accessed the research (the “Readership Information”). Recipient consents to BTIG’s receipt of the Readership Information, including receipt of that information from a third party.
The research analyst(s) responsible for the preparation of this report receives compensation based upon a variety of factors, including the quality and accuracy of research, internal/client feedback, and overall Firm revenues. BTIG reports are based on public information and BTIG considers the same to be reliable, comprehensive information, but makes no representation or warranty that the reports are accurate or complete. BTIG opinions and information provided in this report are as of the date of the report and may change without notice. An issuer may be classified as “Under Review” or “Research Restricted”. In these cases, investors should consider any previous investment recommendation and/or rating to a subject company/issuer to no longer be current and should not be relied upon nor considered a solicitation.
This research report is not an offer to buy or sell or solicitation of an offer to buy or sell any security in any jurisdiction where such an offer or solicitation would be illegal. This research report was not drafted specifically for any particular individual or entity and is not a personal recommendation to participate in any particular trading strategy or transaction. Any recipient of this research report should obtain independent advice specific to their personal circumstances before undertaking any investment activity and must make their own independent evaluation of any securities or financial instruments.
Facts, views or opinions presented in this report have not been reviewed by, and may not reflect information known to, employees or other professionals in the “BTIG Group” (BTIG Group includes, but is not limited to, BTIG and its parents, subsidiaries and/ or affiliates). BTIG Group employees, including Sales Representatives and Traders, may provide oral or written commentary or advice that may be inconsistent with the opinions and/or views expressed in this research report. BTIG Group employees and/or its affiliates not involved in the preparation of this research report may have investments in securities or derivatives of securities of companies mentioned in this report that are inconsistent with the views discussed in this report.
Investors in securities products bear certain risks in conjunction with those investments. The value of, and income from, any investments may vary because of changes in interest rates or foreign exchange rates, securities prices or market indexes, operational or financial conditions of companies or other factors within or beyond the companies’ control. Recipient of the research reports should be aware that investments in securities may pose significant risks due to the inherent uncertainty associated with relying on forecasts of various factors that can affect the earnings, cash flow and overall valuation of a company.
Any investment in securities should be undertaken only upon consideration of issues relating to the recipient’s overall investment portfolio and objectives (such as diversification by asset class, industry or company) as well as time horizon and liquidity needs. Further, past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. There may be time limitations on the exercise of options or other rights in any securities transactions.
Investing in foreign markets and securities, including ADRs, is subject to additional risks such as currency fluctuation, limited information, political instability, economic risk, and the potential for illiquid markets. Investing in emerging markets may accentuate these risks. Non-U.S. reporting issuers of foreign securities, however, may not make regular or complete public disclosure relating to their financial condition or the securities that they issue.
This news is published on the Investorideas.com Newswire – a global digital news source for investors and business leaders
Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions.
More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com
BiotechIndustryStocks.com – investing ideas in biotechnology stocks, medical technology and life sciences
Like Biotech Stocks? View our Biotech Stocks Directory