Core Viewpoint - Corcept Therapeutics experienced a significant drop in share price, falling 50% on December 31, 2025, after receiving a complete response letter (CRL) from the FDA regarding its treatment relacorilant for hypercortisolism, indicating the need for additional evidence of effectiveness [1][2]. Company Summary - Corcept Therapeutics' relacorilant was previously promoted as having strong efficacy and commercial potential, with management expressing confidence in growing its hypercortisolism business to annual revenues between $3 billion and $5 billion within three to five years [2][3]. - The FDA's CRL indicated that the agency could not make a favorable benefit-risk assessment for relacorilant without further evidence, contrasting with Corcept's prior assurances about the drug's approval timeline [2][3]. - Following the announcement of the CRL, Corcept's market capitalization decreased by over $3.6 billion in a single day, reflecting the severe impact of the news on investor sentiment [1][2].

Core Insights - The "Catalyst Monitor: Q3 2025 Outlook" report provides forward-looking intelligence on significant catalyst events expected in Q3 2025, derived from interviews with key opinion leaders (KOLs) [1][3] - The report highlights 18 major catalyst events, including FDA approval decisions for various drugs targeting conditions such as adult growth hormone deficiency and wet age-related macular degeneration [2][4] Company and Industry Highlights - Ascendis Pharma's Skytrofa is under review for FDA approval for adult growth hormone deficiency [2] - PTC Therapeutics' sepiapterin is being evaluated for phenylketonuria, while Lenz Therapeutics' LNZ100 is aimed at treating presbyopia [2] - Eli Lilly's orforglipron is in ongoing clinical trials for obesity, and aTyr Pharma's efzofitimod is being studied for pulmonary sarcoidosis [3][4] - The report includes insights on the commercial impact of orforglipron in the GLP-1 market if approved, based on Phase III data [7] - KOLs assess the commercial potential of Lenz Therapeutics' LNZ100 in the context of existing non-pharmacological options for presbyopia [7] - Boehringer Ingelheim's Ofev is discussed regarding its potential expansion into pediatric interstitial lung disease amid safety concerns [7] Research Methodology - The report compiles predictive intelligence based on extensive research and exclusive interviews with KOLs, focusing on market-moving events expected in Q3 2025 [3][4] - It provides a comparative analysis of expected regulatory events, trial initiations, and completions in Q3 compared to the previous quarter [7]

Core Viewpoint - Aldeyra Therapeutics, Inc. experienced a significant decline in share price, dropping over 70% after receiving a Complete Response Letter from the FDA regarding its New Drug Application for reproxalap, a treatment for dry eye disease, leading to a loss of over $200 million in market capitalization [1][2][4]. Company Overview - Aldeyra Therapeutics, Inc. is focused on developing reproxalap for the treatment of dry eye disease, previously claiming successful Phase 3 trial results and assuring investors of imminent FDA approval [4][6]. - The FDA's Complete Response Letter indicated that the NDA did not demonstrate adequate efficacy and required at least one additional controlled study to validate the treatment's effectiveness [6]. Market Reaction - Following the announcement of the FDA's CRL, Aldeyra's share price plummeted, resulting in a substantial loss of shareholder value [2][4]. - The market's swift reaction reflects investor sentiment and confidence in the company's previous assurances regarding FDA approval [1][4]. Legal Investigation - Hagens Berman, a law firm, has initiated an investigation into potential securities law violations by Aldeyra, focusing on whether the company misrepresented the prospects of FDA approval [2][5]. - The firm is encouraging investors who suffered losses to come forward and assist in the investigation [3][5].