#ALDX

Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease Aldeyra Therapeutics (Nasdaq: ALDX) announced the FDA extended the PDUFA target action date for the reproxalap NDA for dry eye disease to March 16, 2026. The NDA was submitted on June 16, 2025 and accepted as a complete class 2 response on July 16, 2025 with an original PDUFA date of December 16, 2025.On December 12, 2025 the FDA requested the Clinical Study Report (CSR) for a field trial that did not meet its primary symptom endpoint; the CSR was submitted the same day and considered a major amendment. The FDA previously received safety data on August 21, 2025 and shared a draft prospective label, to which Aldeyra responded. The FDA said it plans to communicate proposed labeling requests and possible postmarketing requirements by February 16, 2026 if no major deficiencies are found.Aldeyra will host a conference call and webcast on December 16, 2025 at 8:00 a.m. ET to discuss the PDUFA extension.

2 months ago

#ALDX Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease

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3 months ago

🎯 #UnusualOptionsActivity trade ideas! Strong census from institutions on #options with short expir

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3 months ago

🚀 Institutions taking big swings on #UnusualOptionsActivity with short expirations! PM Top Unusual

🚀 Institutions taking big swings on #UnusualOptionsActivity with short expirations!

PM Top Unusual Activity from 🔥 INSIDERFINANCE.COM 🔥
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Aldeyra Therapeutics Announces Positive Results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, Focuses RASP Product Candidate Pipeline on Next-Generation Molecules Aldeyra Therapeutics (Nasdaq: ALDX) reported Phase 2 proof-of-concept results for orally administered RASP modulator ADX-629 in four patients with mild-to-moderate alcohol-associated hepatitis showing statistically significant improvement versus baseline in liver function and inflammation: MELD score (P=0.001), triglycerides (P<0.0001), and C-reactive protein (P<0.0001). No serious adverse events were reported and no events were deemed related to ADX-629. Aldeyra is discontinuing clinical development of ADX-629 while advancing next-generation RASP candidates ADX-248 and ADX-246, with anticipated IND filings in 2026. Cash runway is extended into the second half of 2027.

4 months ago

#ALDX Aldeyra Therapeutics Announces Positive Results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, Focuses RASP Product Candidate Pipeline on Next-Generation Molecules

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Potential Breakthrough for 1M+ Patients: Aldeyra's Eye Drug Fast-Tracked for Untreated Blindness Condition FDA grants Fast Track designation for Aldeyra's ADX-2191 to treat retinitis pigmentosa, affecting 1M+ globally. Phase 2/3 trial planned for 2025 following positive Phase 2 results.

6 months ago

#ALDX Aldeyra Therapeutics Receives Fast Track Designation for ADX‑2191 for the Treatment of Retinitis Pigmentosa

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7 months ago

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7 months ago

🚨 Institutions #optionsvolume surge detected! AM Top Momentum Activity from 🔥 INSIDERFINANCE.COM

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AM Top Momentum Activity from 🔥 INSIDERFINANCE.COM 🔥
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FDA Reviews Breakthrough Dry Eye Drug: Aldeyra's Reproxalap Could Transform Treatment Landscape FDA sets December 2025 decision date for novel dry eye therapy reproxalap after successful clinical trials. First-in-class treatment shows promising results. Get details.

7 months ago

#ALDX Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease

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PRISM MarketView

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8 months ago

Aldeyra Receives FDA Protocol Agreement to Advance ADX-2191 in Rare Eye Cancer Aldeyra Therapeutics (Nasdaq: ALDX) announced that it has received a Special Protocol Assessment (SPA) Agreement Letter from the U.S. Food and Drug Administrati

#AldeyraTherapeutics (Nasdaq: #ALDX) secures FDA Special Protocol Assessment for ADX-2191 in rare eye cancer, paving the way for potential approval in primary vitreoretinal lymphoma. Trial expected to begin in 2H 2025. .
#AldeyraALDX
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PRISM MarketView

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8 months ago

Aldeyra Resubmits Reproxalap NDA for Dry Eye Disease, Raising Hopes for 2025 Approval Aldeyra Therapeutics (Nasdaq: ALDX) announced the resubmission of its New Drug Application (NDA) for reproxalap, a topical ocular therapy for dry eye disease, f

Dry eye breakthrough on the horizon?
#AldeyraTherapeutics (Nasdaq: #ALDX) has resubmitted its NDA for reproxalap after a positive Phase 3 trial hit the mark on reducing eye discomfort.
prismmarketview.com/aldeyra-resu...

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Aldeyra's Dry Eye Drug Hits Major Trial Goal (P=0.002), FDA Application Resubmitted After Previous Rejection New Phase 3 trial achieves primary endpoint for reproxalap dry eye treatment. FDA decision expected within 6 months. See complete resubmission details.

8 months ago

#ALDX Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

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Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Chamber Trial of Reproxalap and Plans NDA Resubmission Aldeyra Therapeutics (NASDAQ: ALDX) has announced positive results from its Phase 3 dry eye chamber trial for reproxalap ophthalmic solution. The trial achieved its primary endpoint, with reproxalap showing statistically significant superiority over vehicle (P=0.002) in reducing ocular discomfort. The company plans to resubmit its New Drug Application (NDA) to the FDA in mid-2025, following a Complete Response Letter received in April 2025. The new trial data, showing no notable baseline differences across treatment arms, potentially addresses the FDA's previous concerns. While a recent field trial was numerically supportive but didn't reach statistical significance, reproxalap has demonstrated both acute and chronic activity in reducing symptoms and is the first investigational drug showing pivotal data for acute activity in reducing ocular redness exacerbation. The drug has been studied in over 2,900 patients with a favorable safety profile.

10 months ago

#ALDX Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Chamber Trial of Reproxalap and Plans NDA Resubmission

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Critical Phase 3 Results: Aldeyra's Dry Eye Drug Reproxalap Data Release Tomorrow Key Phase 3 efficacy data for novel dry eye treatment reproxalap coming May 6. Join live webcast to discover trial outcomes in $5B+ market. Get insights.

10 months ago

#ALDX Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Topline Results from Phase 3 Dry Eye Disease Clinical Trials of Reproxalap

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Thiard News@F4F

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10 months ago

Investigation Launched into Aldeyra Therapeutics: A Deep Dive Into Securities Fraud Allegations Pomerantz Law Firm has initiated an investigation into Aldeyra Therapeutics to determine if there were any fraudulent activities affecting investors following recent FDA news.

Investigation Launched into Aldeyra Therapeutics: A Deep Dive Into Securities Fraud Allegations #USA #New_York #Pomerantz #Aldeyra #ALDX

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Small Cap Strategist

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11 months ago

SmCpStr Technicals – Technical Indicators for Small-cap Stocks

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Small Cap Strategist

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11 months ago

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Market Wire News

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1 year ago

News; ( NASDAQ: #ALDX ) Aldeyra Therapeutics Inc. (NASDAQ: ALDX) Sees Notable Increase in Monday Morning Market Activity

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Market Wire News

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1 year ago

Breaking News: ( NASDAQ: #ALDX ) Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option Agreement

#StockMarket #News

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1 year ago

#ALDX Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option Agreement

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