Aldeyra Therapeutics Azioni (NASDAQ: ALDX)

Ultime notizie per Aldeyra Therapeutics (NASDAQ:ALDX) Azioni

Aldeyra Therapeutics

Aldeyra Therapeutics Inc is a biotechnology company engaged in developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated and metabolic diseases. The company's product candidate, Reproxalap, is a treatment in late-stage development for dry eye disease and allergic conjunctivitis. In addition, it also has additional product candidates in development for proliferative vitreoretinopathy, primary vitreoretinal lymphoma and other retinal diseases, autoimmune disease, and cancer. Company products includes ADX248, ADX743, ADX631, ADX246, ADX629, ADX2191.

Aldeyra Therapeutics, Inc. - Common Stock

Aldeyra Therapeutics Inc

BTIG analyst Thomas Shrader maintains Aldeyra Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) with a Buy and lowers the price target from $11 to $9.

News

Price Target

Analyst Ratings

ALDX

BTIG Maintains Buy on Aldeyra Therapeutics, Lowers Price Target to $9

<h3>Gainers</h3>
<ul>
<li>Impact BioMedical (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IBO#AMEX">IBO</a>) stock increased by 73.1% to $0.8 during Friday's regular session. The company's market cap stands at $9.2 million. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) stock rose 43.62% to $34.9. The market value of their outstanding shares is at $454.1 million. </li>
<li>Reshape Lifesciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RSLS#NASDAQ">RSLS</a>) stock rose 37.05% to $0.52. The company's market cap stands at $1.7 million. </li>
<li>Aldeyra Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) shares rose 32.04% to $1.88. The company's market cap stands at $111.6 million. </li>
<li>Universe Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPC#NASDAQ">UPC</a>) stock moved upwards by 23.95% to $3.57. The market value of their outstanding shares is at $54.3 million. </li>
<li>Kairos Pharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/KAPA#AMEX">KAPA</a>) shares moved upwards by 22.34% to $1.15. The company's market cap stands at $15.7 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>NeuroOne Medical Tech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NMTC#NASDAQ">NMTC</a>) stock declined by 44.3% to $0.48 during Friday's regular session. The market value of their outstanding shares is at $14.7 million. </li>
<li>Aptevo Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APVO#NASDAQ">APVO</a>) shares fell 32.16% to $1.35. The market value of their outstanding shares is at $1.9 million. </li>
<li>Lifecore Biomedical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LFCR#NASDAQ">LFCR</a>) stock fell 22.62% to $5.27. The company's market cap stands at $195.1 million. As per the press release, Q3 earnings came out yesterday. </li>
<li>ProPhase Labs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRPH#NASDAQ">PRPH</a>) stock fell 22.2% to $0.27. The company's market cap stands at $8.1 million. As per the news, the Q4 earnings report came out 4 days ago. </li>
<li>NewGenIvf Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NIVF#NASDAQ">NIVF</a>) stock declined by 22.11% to $0.44. The market value of their outstanding shares is at $2.3 million. </li>
<li>Adaptimmune Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADAP#NASDAQ">ADAP</a>) shares decreased by 20.6% to $0.26. The market value of their outstanding shares is at $66.1 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Friday's Intraday Session

HC Wainwright &amp; Co. analyst Matthew Caufield reiterates Aldeyra Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) with a Buy and maintains $10 price target.

Reiteration

HC Wainwright & Co. Reiterates Buy on Aldeyra Therapeutics, Maintains $10 Price Target

<h3>Gainers</h3>
<ul>
<li>Impact BioMedical (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IBO#AMEX">IBO</a>) shares increased by 94.6% to $0.9 during Thursday's after-market session. The company's market cap stands at $10.3 million. </li>
<li>Entero Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENTO#NASDAQ">ENTO</a>) shares moved upwards by 85.35% to $0.81. The market value of their outstanding shares is at $3.8 million. </li>
<li>Sangamo Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGMO#NASDAQ">SGMO</a>) shares rose 29.54% to $0.81. The market value of their outstanding shares is at $180.9 million. </li>
<li>Aldeyra Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) shares rose 15.19% to $1.63. The market value of their outstanding shares is at $97.0 million. </li>
<li>Ernexa Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ERNA#NASDAQ">ERNA</a>) shares moved upwards by 10.49% to $0.2. The company's market cap stands at $10.4 million. </li>
<li>Coya Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COYA#NASDAQ">COYA</a>) shares increased by 8.19% to $6.6. The company's market cap stands at $110.3 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>NeuroOne Medical Tech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NMTC#NASDAQ">NMTC</a>) stock declined by 36.2% to $0.55 during Thursday's after-market session. The company's market cap stands at $16.9 million. </li>
<li>Virpax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRPX#NASDAQ">VRPX</a>) stock fell 28.95% to $0.47. </li>
<li>Genprex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNPX#NASDAQ">GNPX</a>) shares declined by 15.16% to $0.37. The market value of their outstanding shares is at $3.1 million. </li>
<li>Bone Biologics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBLG#NASDAQ">BBLG</a>) stock fell 13.37% to $0.75. The market value of their outstanding shares is at $1.8 million. </li>
<li>Portage Biotech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTG#NASDAQ">PRTG</a>) stock declined by 9.28% to $5.67. The company's market cap stands at $9.3 million. </li>
<li>Aditxt (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADTX#NASDAQ">ADTX</a>) stock declined by 7.53% to $5.16. The company's market cap stands at $5.3 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Thursday's After-Market Session

<h3>Gainers</h3>
<ul>
<li>Protagenic Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTIX#NASDAQ">PTIX</a>) shares rose 85.8% to $0.42 during Thursday's regular session. The market value of their outstanding shares is at $3.0 million. As per the news, the Q4 earnings report came out 3 days ago. </li>
<li>OSR Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OSRH#NASDAQ">OSRH</a>) shares moved upwards by 59.18% to $2.34. The market value of their outstanding shares is at $45.1 million. </li>
<li>Aptevo Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APVO#NASDAQ">APVO</a>) shares rose 45.67% to $2.01. The company's market cap stands at $2.9 million. </li>
<li>Alaunos Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TCRT#NASDAQ">TCRT</a>) shares rose 38.75% to $3.88. The market value of their outstanding shares is at $6.2 million. </li>
<li>Genprex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNPX#NASDAQ">GNPX</a>) shares moved upwards by 31.33% to $0.39. The market value of their outstanding shares is at $3.2 million. </li>
<li>Tivic Health Systems (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) shares increased by 30.76% to $4.25. The company's market cap stands at $2.6 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Aldeyra Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) stock declined by 73.7% to $1.4 during Thursday's regular session. The company's market cap stands at $83.3 million. </li>
<li>Virpax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRPX#NASDAQ">VRPX</a>) shares decreased by 61.61% to $0.47. </li>
<li>RxSight (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RXST#NASDAQ">RXST</a>) stock fell 39.29% to $15.86. The market value of their outstanding shares is at $642.1 million. </li>
<li>Impact BioMedical (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IBO#AMEX">IBO</a>) stock decreased by 18.3% to $0.47. The market value of their outstanding shares is at $5.3 million. </li>
<li>CervoMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares decreased by 17.75% to $11.17. The market value of their outstanding shares is at $97.2 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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11 Health Care Stocks Moving In Thursday's Intraday Session

U.S. stocks traded lower midway through trading, with the Nasdaq Composite dipping more than 800 points on Thursday.
The Dow traded down 3.07% to 40,929.87 while the NASDAQ fell 4.83% to 16,750.33. The S&amp;P 500 also fell, dropping, 3.73% to 5,459.39.
Check This Out: <a href="https://www.benzinga.com/analyst-ratings/price-target/25/04/44625270/top-3-tech-and-telecom-stocks-youll-regret-missing-this-month">Top 3 Tech And Telecom Stocks You&#8217;ll Regret Missing This Month</a>
Leading and Lagging Sectors Consumer staples shares rose by 0.4% on Thursday.
In trading on Thursday, energy shares tumbled by 5.6%.
Top Headline
The ISM services PMI dipped to 50.8 in March versus a reading of 53.5 in February, and down from market estimates of 53.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Lamb Weston Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LW#NYSE">LW</a>) shares shot up 10% to $59.60 after the company reported better-than-expected third-quarter financial results and issued FY25 sales guidance above estimates.</li>
<li>Shares of NewGenIvf Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NIVF#NASDAQ">NIVF</a>)got a boost, surging 95% to $1.15 after the company announced it secured $5.2 million in funding to drive international expansion.</li>
<li>The Goodyear Tire &amp; Rubber Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GT#NASDAQ">GT</a>) shares were also up, gaining 12% to $10.19.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Aldeyra Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) shares dropped 76% to $1.2750 after the company received a response letter from the FDA for the Reproxalap new drug application for the treatment of signs and symptoms of dry eye disease.</li>
<li>Shares of RH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RH#NYSE">RH</a>) were down 41% to $147.59 after the company reported weaker-than-expected fourth-quarter financial results.</li>
<li>Wayfair Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/W#NYSE">W</a>) was down, falling 22% to $26.30. Shares of specialty retailers in the furniture and home goods space traded lower following disappointing earnings from RH.</li>
</ul>
Commodities In commodity news, oil traded down 7.1% to $66.64 while gold traded down 1.8% at $3,110.80.
Silver traded down 7.1% to $32.205 on Thursday, while copper fell 3.4% to $4.8705.
Euro zone
European shares were lower today. The eurozone's STOXX 600 fell 2.19%, Germany's DAX 40 dipped 2.11% and France's CAC 40 fell 2.93%. Spain's IBEX 35 Index fell 1.32%, while London's FTSE 100 fell 1.30%.
Asia Pacific Markets
Asian markets closed lower on Thursday, with Japan's Nikkei 225 dipping 2.77%, China's Shanghai Composite Index falling 0.24%, Hong Kong's Hang Seng Index falling 1.52% and India's BSE Sensex falling 0.42%.
Economics
<ul>
<li>U.S. initial jobless claims fell by 6,000 to 219,000 in the week ending March 29, compared to market estimates of 225,000.</li>
<li>The U.S. trade deficit shrank to $122.7 billion in February compared to $130.7 billion in the previous month and versus market estimates of a $123.5 billion gap.</li>
<li>The S&amp;P Global services PMI was revised higher to 54.4 in March compared to a preliminary reading of 54.3.</li>
<li>The S&amp;P Global composite PMI climbed to 53.5 in March versus 51.6 in the previous month.</li>
<li>The ISM services PMI dipped to 50.8 in March versus a reading of 53.5 in February, and down from market estimates of 53.</li>
</ul>
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<li> <a href="https://www.benzinga.com/news/earnings/25/04/44622367/acuity-rh-and-3-stocks-to-watch-heading-into-thursday">Acuity, RH And 3 Stocks To Watch Heading Into Thursday</a> </li>
</ul>
Photo via Shutterstock

Earnings

Equities

Eurozone

Commodities

Intraday Update

Markets

Trading Ideas

Crude Oil Dips 7%; ISM Services PMI Falls In March

U.S. stocks traded lower this morning, with the Dow Jones index dipping more than 1,100 points on Thursday.
Following the market opening Thursday, the Dow traded down 2.64% to 41,110.44 while the NASDAQ fell 4.15% to 16,870.74. The S&amp;P 500 also fell, dropping, 3.14% to 5,492.92.
Check This Out: <a href="https://www.benzinga.com/analyst-ratings/price-target/25/04/44625270/top-3-tech-and-telecom-stocks-youll-regret-missing-this-month">Top 3 Tech And Telecom Stocks You&#8217;ll Regret Missing This Month</a>
Leading and Lagging Sectors Consumer staples shares rose by 0.8% on Thursday.
In trading on Thursday, information technology shares tumbled by 5.1%.
Top Headline
U.S. initial jobless claims fell by 6,000 to 219,000 in the week ending March 29, compared to market estimates of 225,000.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Protagenic Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTIX#NASDAQ">PTIX</a>) shares shot up 125% to $0.5068.</li>
<li>Shares of NewGenIvf Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NIVF#NASDAQ">NIVF</a>)got a boost, surging 112% to $1.25 after the company announced it secured $5.2 million in funding to drive international expansion.</li>
<li>Tivic Health Systems, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) shares were also up, gaining 52% to $4.9299.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Aldeyra Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) shares dropped 76% to $1.30 after the company received a response letter from the FDA for the Reproxalap new drug application for the treatment of signs and symptoms of dry eye disease.</li>
<li>Shares of RxSight, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RXST#NASDAQ">RXST</a>) were down 42% to $15.15 after the company issued FY25 revenue guidance below estimates.</li>
<li>American Rebel Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AREB#NASDAQ">AREB</a>) was down, falling 38% to $3.93.</li>
</ul>
Commodities In commodity news, oil traded down 7.3% to $66.45 while gold traded down 2.8% at $3,077.00.
Silver traded down 7.8% to $31.95 on Thursday, while copper fell 3.3% to $4.8735.
Euro zone
European shares were lower today. The eurozone's STOXX 600 fell 2.3%, Germany's DAX 40 dipped 2.3% and France's CAC 40 fell 3%. Spain's IBEX 35 Index fell 1.5%, while London's FTSE 100 fell 1.5%.
Asia Pacific Markets
Asian markets closed lower on Thursday, with Japan's Nikkei 225 dipping 2.77%, China's Shanghai Composite Index falling 0.24%, Hong Kong's Hang Seng Index falling 1.52% and India's BSE Sensex falling 0.42%.
Economics
<ul>
<li>U.S. initial jobless claims fell by 6,000 to 219,000 in the week ending March 29, compared to market estimates of 225,000.</li>
<li>The U.S. trade deficit shrank to $122.7 billion in February compared to $130.7 billion in the previous month and versus market estimates of a $123.5 billion gap.</li>
</ul>
Now Read This: 
<ul>
<li><a href="https://www.benzinga.com/news/earnings/25/04/44622367/acuity-rh-and-3-stocks-to-watch-heading-into-thursday">Acuity, RH And 3 Stocks To Watch Heading Into Thursday</a> </li>
</ul>
Photo via Shutterstock

AREB

Dow Tumbles Over 1,100 Points; US Initial Jobless Claims Fall

The U.S. Food and Drug Administration (FDA) on Thursday issued a Complete Response Letter for Aldeyra Therapeutics, Inc.&#8217;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">dry eye disease</a>.
The FDA stated that the NDA &#8220;failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes&#8221; and that &#8220;at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of a dry eye&#8221; <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44625448/aldeyra-therapeutics-receives-complete-response-letter-from-the-u-s-food-and-drug-administration-f" rel="noreferrer noopener">should be conducted</a>.
The letter identified concerns with the trial data submitted to the NDA that may have affected the interpretation of the results.
The FDA stated that these concerns may be related to methodological issues, including a difference in baseline scores across treatment arms.
The agency said no manufacturing or safety issues with reproxalap were identified.
Per draft FDA dry eye disease guidance, to be considered for regulatory approval in the United States, efficacy in dry eye disease may be demonstrated with two symptom and two sign trials.
Among other clinical trials of reproxalap, Aldeyra previously conducted two trials for ocular redness (a dry eye disease sign) in a dry eye chamber and two dry eye disease symptom field (environmental exposure) trials, which were submitted as part of an initial NDA in November 2022.
In November 2023, the FDA issued a Complete Response Letter to the initial NDA stating that at least one additional <a target="_blank" href="https://www.benzinga.com/general/biotech/23/11/35980906/fda-rejects-aldeyra-therapeutics-dry-eye-disease-candidate-asks-for-additional-study" rel="noreferrer noopener">symptom trial was required</a>.
Aldeyra initiated three clinical trials assessing dry eye disease symptoms: a dry eye chamber trial, a clinical trial in a different dry eye chamber, and a six-week field trial.
In August 2024, Aldeyra announced the achievement of the primary endpoint in the first dry eye chamber clinical trial of reproxalap, and the NDA was <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40260741/aldeyras-new-eye-drug-shows-positive-results-in-fda-approved-study-stock-jumps-over-30" rel="noreferrer noopener">resubmitted in October 2024</a>.
Aldeyra expects to announce topline results from the ongoing dry eye disease field trial and the chamber clinical trial in the second quarter of 2025.
Aldeyra intends to resubmit the NDA by mid-year 2025. The review period for the potential NDA resubmission is expected to be six months.
As of December 31, 2024, Aldeyra reported $101 million in cash, cash equivalents, and marketable securities.
Price Action: ALDX stock is down 74.5% at $1.36 during the premarket session at the last check Thursday.
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Image: Shutterstock

Biotech

Health Care

General

FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns

WIIM

Aldeyra Therapeutics shares are trading lower after the company received a response letter from the FDA for the Reproxalap new drug application for the treatment of signs and symptoms of dry eye disease.

<ul>
<li>Top-Line Data from Dry Eye Chamber Trial and Field Trial Expected in Q2 2025</li>
<li>Pending Positive Results and Discussions with the FDA, New Drug Application Resubmission Expected Mid-Year 2025</li>
</ul>
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.aldeyra.com%2F&amp;esheet=54232964&amp;newsitemid=20250403220331&amp;lan=en-US&amp;anchor=Aldeyra+Therapeutics%2C+Inc.&amp;index=1&amp;md5=231423ca5b7730a157e413b7ea8d690e">Aldeyra Therapeutics, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. Although no manufacturing or safety issues with reproxalap were identified, the FDA stated in the letter that the NDA "failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes" and that "at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye" should be conducted. The letter identified concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms.

Aldeyra Therapeutics Receives Complete Response Letter From The U.S. FDA For The Reproxalap New Drug Application For The Treatment Of Signs And Symptoms Of Dry Eye Disease

<h3>Gainers</h3>
<ul>
<li>Protagenic Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTIX#NASDAQ">PTIX</a>) shares moved upwards by 179.6% to $0.63 during Thursday's pre-market session. The company's market cap stands at $4.5 million. The company's, Q4 earnings came out 3 days ago. </li>
<li>Aptevo Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APVO#NASDAQ">APVO</a>) stock increased by 122.46% to $3.07. The company's market cap stands at $4.4 million. </li>
<li>Tivic Health Systems (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) stock increased by 62.76% to $5.29. The company's market cap stands at $3.2 million. </li>
<li>OSR Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OSRH#NASDAQ">OSRH</a>) stock moved upwards by 44.95% to $2.13. The company's market cap stands at $41.0 million. </li>
<li>Genprex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNPX#NASDAQ">GNPX</a>) stock increased by 21.08% to $0.36. The company's market cap stands at $3.0 million. </li>
<li>Longevity Health Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XAGE#NASDAQ">XAGE</a>) stock rose 13.64% to $0.15. The market value of their outstanding shares is at $4.5 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>RxSight (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RXST#NASDAQ">RXST</a>) stock fell 29.2% to $18.49 during Thursday's pre-market session. The market value of their outstanding shares is at $748.7 million. </li>
<li>bioAffinity Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIAF#NASDAQ">BIAF</a>) shares fell 24.18% to $0.67. The market value of their outstanding shares is at $10.5 million. As per the news, the Q4 earnings report came out 3 days ago. </li>
<li>Aldeyra Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) stock fell 23.01% to $4.1. The market value of their outstanding shares is at $244.1 million. </li>
<li>Quoin Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QNRX#NASDAQ">QNRX</a>) stock fell 22.95% to $0.23. The company's market cap stands at $4.6 million. </li>
<li>ITeos Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITOS#NASDAQ">ITOS</a>) stock fell 20.11% to $4.61. The market value of their outstanding shares is at $176.0 million. </li>
<li>Sunshine Biopharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBFM#NASDAQ">SBFM</a>) stock fell 19.56% to $1.81. The market value of their outstanding shares is at $4.9 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

BIAF

ITOS

QNRX

SBFM

Longevity Health Holdings, Inc. - Common Stock

XAGE

12 Health Care Stocks Moving In Thursday's Pre-Market Session

RGNX: 30% &#x7C; <a href="https://www.benzinga.com//node/42033259">REGENXBIO shares are trading higher after the company announced dosing the first patient in its pivotal trial for Duchenne gene therapy.</a>
&nbsp;
NIVF: 123% &#x7C; <a href="https://www.benzinga.com//node/42033041">NewGenIvf Inks Binding Term Sheet With California-Based Institutional Investor White Lion Capital, LLC, For $100M Equity Line Of Credit, Expandable To $500M</a>
&nbsp;
ALDX: 10% &#x7C; <a href="https://www.benzinga.com//node/42033306">Aldeyra Therapeutics shares are trading higher after the FDA accepted its resubmitted new drug application for Reproxalap for the treatment of dry eye disease, prompting the company to announce an expansion of its option agreement with AbbVie.</a>

RGNX

Market-Moving News for November 18th

Aldeyra Therapeutics shares are trading higher after the FDA accepted its resubmitted new drug application for Reproxalap for the treatment of dry eye disease, prompting the company to announce an expansion of its option agreement with AbbVie.

Aldeyra Therapeutics Announces FDA Acceptance For Review Of The Resubmitted New Drug Application For Reproxalap In Treatment Of Dry Eye Disease; Based On FDA Acceptance, Co. Announces Expansion Of Option Agreement With AbbVie

Aldeyra Therapeutics Has Resubmitted New Drug Application To The FDA For Topical Ocular Reproxalap, An Investigational New Drug Candidate, For Signs And Symptoms Of Dry Eye Disease

Aldeyra Therapeutics Inc.&#8217;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) Phase 3 dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/b40247202/aldeyra-therapeutics-achieves-primary-endpoint-in-phase-3-dry-eye-disease-clinical-trial-of-reprox" rel="noreferrer noopener">achieves the primary endpoint</a>.
Reproxalap, an investigational new drug candidate for dry eye disease, was statistically superior to the vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), an FDA-accepted symptom of dry eye disease.
The company enrolled the first patient in the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/05/b38695423/aldeyra-therapeutics-enrolls-first-patient-in-phase-3-clinical-trial-designed-to-enable-potential-" rel="noreferrer noopener">trial in May 2024</a> and concluded the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/06/b39308148/aldeyra-therapeutics-completes-enrollment-in-phase-3-clinical-trial-of-reproxalap-in-dry-eye-disea" rel="noreferrer noopener">study in June</a>.
In the Phase 3 clinical trial, patients were administered vehicle (the drug product without the active ingredient) before and during exposure to a dry eye chamber in a manner that Aldeyra believes is consistent with the FDA&#8217;s dry eye disease draft guidance.
Qualifying patients were subsequently randomized to receive either reproxalap or vehicle before and during exposure to an additional dry eye chamber.
Of the 132 patients randomized, 66 patients received reproxalap, and 66 received vehicle.
The primary endpoint was ocular discomfort, an FDA-accepted symptom of dry eye disease, from 80 to 100 minutes in the chamber.
The dry eye chamber clinical trial was designed to satisfy the FDA&#8217;s New Drug Application resubmission requirement, identified in the previously received complete response letter, of &#8220;at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of <a target="_blank" href="https://www.benzinga.com/general/biotech/23/11/35980906/fda-rejects-aldeyra-therapeutics-dry-eye-disease-candidate-asks-for-additional-study" rel="noreferrer noopener">ocular symptoms of dry eye</a>.&#8221;
Aldeyra says that in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supporting acute and chronic activity in reducing symptoms and the first investigational drug for chronic administration with pivotal data supporting acute activity in reducing ocular redness.
The potential NDA resubmission is anticipated in 2024. Based on FDA guidance, the resubmission NDA review period is expected to be six months.
No safety signals were observed in the clinical trial, and reproxalap was well tolerated.
No treatment-related discontinuations were reported. Reproxalap has now been studied in over 2,500 patients.
Price Action: ALDX stock is up 34.8% at $4.40 at last check Thursday.
Read Next:
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Photo: Unsplash

Aldeyra's New Eye Drug Shows Positive Results In FDA-Approved Study, Stock Jumps Over 30%

Aldeyra Therapeutics shares are trading higher after the company achieved the primary endpoint in its Phase 3 trial for Reproxalap ophthalmic solution in treating dry eye disease. The company anticipates resubmitting its NDA in 2024.

Aldeyra Therapeutics Achieves Primary Endpoint In Phase 3 Trial For Reproxalap Ophthalmic Solution In Treating Dry Eye Disease; Statistically Superior For Ocular Discomfort; NDA Resubmission Anticipated In 2024

Press Releases

ALDX STOCK NOTIFICATION: Did Aldeyra Therapeutics, Inc. Violate the Securities Laws? Investors are Notified to Contact BFA Law (NASDAQ:ALDX)

Legal

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Aldeyra Therapeutics, Inc. - ALDX

ALDX STOCK REMINDER: The Aldeyra Therapeutics, Inc. Investigation is Ongoing – Investors are Urged to Contact BFA Law (NASDAQ:ALDX)

ALDX INVESTIGATION NOTICE: Suffer Losses on Aldeyra Therapeutics, Inc.? Contact BFA Law about the Securities Investigation (NASDAQ:ALDX)

Bragar Eagel & Squire, P.C. Is Investigating TechTarget and Aldeyra and Encourages Investors to Contact the Firm

Aldeyra Therapeutics Appoints Chip Clark to Board of Directors

ALDX INVESTOR INVESTIGATION: Aldeyra Therapeutics, Inc. Investors are Reminded of the Ongoing Securities Investigation – Contact BFA Law (NASDAQ:ALDX)

ALDX INVESTOR NEWS: Aldeyra Therapeutics, Inc. Investors may be able to Recover Losses in Class Action Investigation -- Contact BFA Law (NASDAQ:ALDX)

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