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Noticias de ALDX
Eventos de ALDX
Aldeyra Submits Formal Dispute Resolution Request to FDA
Aldeyra Therapeutics announced intent to submit to the U.S. Food and Drug Administration a Formal Dispute Resolution Request for reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The FDRR, which is expected to be reviewed by the FDA's Office of New Drugs, is designed to appeal the March 16, 2026 Complete Response Letter that denied approval of a New Drug Application for reproxalap for the treatment of dry eye disease. Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026. Following an NDA submission and two NDA resubmissions of reproxalap for the treatment of dry eye disease, Aldeyra has received three Complete Response Letters, the first two of which recommended an additional clinical trial to "demonstrate a positive effect on the treatment of ocular symptoms of dry eye" and the most recent of which did not request further clinical trials but stated that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product." Over the course of the three NDA submissions, Aldeyra has provided data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints, consistent with or greater than the success rates of clinical trials conducted for approved dry eye disease products. The decision to submit the FDRR is based on the outcome of recent Type A and Type D meetings with the FDA Division of Ophthalmology and the Office of Specialty Medicine. Per Prescription Drug User Fee Act target timelines established for the FDRR process, Aldeyra expects to hold a meeting with OND in the fourth quarter of 2026. The timing of the OND FDRR decision will depend on a number of factors, including whether the deciding official requests additional information or determines there is a need to discuss the FDRR with internal or external experts or convene an advisory panel, the occurrence and timing of which are uncertain. "We remain steadfast in our commitment to working with the FDA to provide a novel therapeutic approach for the treatment of dry eye disease, a condition often regarded by patients and physicians as inadequately addressed by available therapies," stated Todd Brady, CEO. "Based on the activity of reproxalap across a number of clinical trial designs, and against a backdrop of FDA dry eye disease product approvals that have applied considerable discretion, we are optimistic in the outcome of the FDRR."
Aldeyra Updates Financial Guidance, Cash Runway Extended to 2029
Based on reported cash and cash equivalents of $45.1M as of June 30, 2026, Aldeyra updated financial guidance to include extension of operational cash runway into 2029.
Aldeyra Receives Complete Response Letter from FDA, reproxalap NDA Rejected
Aldeyra announced receipt of a complete response letter, or CRL, from the FDA for the new drug application, or NDA, of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The CRL stated that there is "a lack of substantial evidence consisting of adequate and well-controlled investigations ... that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling" and that "the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease." The letter also stated that the "inconsistency of study results raises serious concerns about the reliability and meaningfulness of the positive findings" and that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product." Consistent with prior NDA reviews of reproxalap, no safety or manufacturing concerns were identified. During the NDA review, label drafts were provided by the FDA in December 2025 and again in March 2026. Aldeyra does not believe that label negotiations were completed. The FDA recommended that the reasons for failure in certain trials be explored, and that populations or certain conditions in which reproxalap may be effective be identified. The FDA did not recommend conducting additional trials or request submission of additional confirmatory evidence. As such, Aldeyra does not currently expect to pursue additional clinical trials, and intends to expeditiously request a Type A meeting to understand the actions needed for NDA approval. Per Prescription Drug User Fee Act goals, the target Type A meeting date is within 30 days of receipt of the meeting request. As of December 31, 2025, Aldeyra reported cash, cash equivalents, and marketable securities of $70M, which are expected to support operations into 2028.
Major US Averages Mixed as Unemployment Rate Rises to 4.6%
The major averages had a mixed day as traders reacted to delayed jobs data that could influence the Federal Reserve's interest-rate path next year. Though November's jobs report came in better-than-expected, with an increase of 64,000 jobs for the month, the Bureau of Labor Statistics also reported that 105,000 jobs were shed in October, with the unemployment rate climbing to 4.6%.Record highs earlier in December have given way to a softer backdrop as investors weigh the release of the delayed nonfarm payrolls and other indicators like retail sales and CPI inflation, which were postponed by the longest U.S. government shutdown in history.Looking to commodities, gold was mostly unchanged, while oil fell sharply ahead of API crude numbers set for release this afternoon.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Fordsaid it expectsto "rationalize" U.S. EV-related assetsPfizerreiterated its guidance for FY25 and provided aPayPalhas submitted applications toApplewill expand its iPhone lineup to seven models by 2027,The U.S. Trade Representative said it will use "every tool" to2. WALL STREET CALLS:Rokuto Overweight from Underweight at Morgan StanleyLockheed Martinto Equal Weight at Morgan StanleyOktato Buy at JefferiesStubHubto Market Perform at CitizensWells FargoGapto Overweight3. AROUND THE WEB:Apollo Globalis exploring a potential sale of Atlas Air,Trump is slated to interview Fed governor Christopher Waller on Tuesday for the position of Fed chair,Oraclesigned roughly $150B of data center leases in the three months ending November 30, raising its total data center and cloud capacity commitments to $248B,Metaearned more than $18B in annual ad sales from China in 2024, making up over 10% of its global revenue, with more than $3B linked to fraudulent ads, like for scams,The U.K. government wants Apple, Google, and others to block explicit images at the OS level by default to protect kids and have adults verify their ages,4. MOVERS:Cementos Pacasmayoincreases in New York after announcingof the Hochschild Group, which controls 50.01% of the companyRezolve AIgains in New York afterannual recurring revenue view of $500M or moreAldeyrahigher after announcing thetarget action date for the reproxalap New Drug ApplicationLightwave Logicfalls after announcing anNavanlower after announcing the departure of5. EARNINGS/GUIDANCE:Vestisreaffirmed itsVital Farmsfor FY25Organigram, with Executive Chair Peter Amirault calling fiscal 2025 "marked by purposeful growth"Humanafor FY25CSP Inc., with EPS and revenue higher year-over-yearINDEXES:The Dow fell 302.30, or 0.62%, to 48,114.26, the Nasdaq gained 54.05, or 0.23%, to 23,111.46, and the S&P 500 declined 16.25, or 0.24%, to 6,800.26.
Major Averages Broadly Lower as Traders Eye Jobs Report
The major averages were broadly lower near noon as traders eyed a key jobs report and additional economic data that could influence the Federal Reserve's interest-rate path next year. Though November's jobs report came in better-than-expected, with an increase of 64,000 jobs for the month, the Bureau of Labor Statistics also reported that 105,000 jobs were shed in October, with the unemployment rate climbing to 4.6%.Record highs earlier in December have given way to a softer backdrop as investors weigh the release of the delayed nonfarm payrolls and other indicators like retail sales and CPI inflation, which were postponed by the longest U.S. government shutdown in history.Looking to commodities, gold edged higher once again, while oil fell sharply ahead of API crude numbers set for release this afternoon.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Fordsaid it expectsto "rationalize" U.S. EV-related assetsPfizerreiterated its guidance for FY25 and provided aPayPalhas submitted applications toApplewill expand its iPhone lineup to seven models by 2027,Databricks said it is raising a greater than, valuing the company at $134B2. WALL STREET CALLS:Roku (ROKU)to Overweight from Underweight at Morgan StanleyLockheed Martinto Equal Weight at Morgan StanleyOktato Buy at JefferiesStubHubto Market Perform at CitizensWells FargoGapto Overweight3. AROUND THE WEB:Oraclesigned roughly $150B of data center leases in the three months ending November 30, raising its total data center and cloud capacity commitments to $248B,Metaearned more than $18B in annual ad sales from China in 2024, making up over 10% of its global revenue, with more than $3B linked to fraudulent ads, like for scams,The U.K. government wants Apple, Google, and others to block explicit images at the OS level by default to protect kids and have adults verify their ages,Stellantishas hired over 1,000 employees for its Windsor, Ontario plant, aiming for 1,500 new jobs for a third shift,Nasdaqis looking to submit paperwork with the U.S. Securities and Exchange Commission to roll out 24/7 stock trading,4. MOVERS:Cementos Pacasmayoincreases in New York after announcingof the Hochschild Group, which controls 50.01% of the companyRezolve AIgains in New York afterannual recurring revenue view of $500M or moreAldeyrahigher after announcing thetarget action date for the reproxalap New Drug ApplicationLightwave Logicfalls after announcing anNavanlower after announcing theAmy Butte5. EARNINGS/GUIDANCE:Vestisfor FY26Vital Farmsfor FY25Organigram, with Executive Chair Peter Amirault calling fiscal 2025 "marked by purposeful growth"Humanafor FY25CSP Inc., with EPS and revenue higher year-over-yearINDEXES:Near midday, the Dow was down 0.53%, or 254.20, to 48,162.36, the Nasdaq was down 0.27%, or 61.48, to 22,995.93, and the S&P 500 was down 0.49%, or 33.55, to 6,782.96.
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