Shares of Applied Therapeutics Inc. (APLT) have been struggling lately and have lost 46.8% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about th ...

U.S. stocks traded mixed this morning, with the Dow Jones index gaining more than 100 points on Friday.Following the market opening Friday, the Dow traded up 0.24% to 48,819.22 while the NASDAQ fell 0.34% to 23,514.76. The S&P 500 also fell, dropping, 0.13% to 6,892.15.Check This Out: Jim Cramer Rejects MicroStrategy: ‘I Just Want Bitcoin’Leading and Lagging SectorsMaterials shares jumped by 0.9% on Friday.In trading on Friday, information technology stocks fell by 0.9%.Top HeadlineLululemon Athletica Inc. ...

NEW YORK--(BUSINESS WIRE)--Halper Sadeh LLC, an investor rights law firm, is investigating whether the sale of Applied Therapeutics, Inc. (NASDAQ: APLT) to Cycle Group Holdings Limited for $0.088 per share in cash plus one non-transferrable contingent value right entitling the holder to receive potential additional payments under certain conditions is fair to Applied shareholders. Halper Sadeh encourages Applied shareholders to click here to learn more about their legal rights and options or co. ...

Applied Therapeutic’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseasesNEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT; “Applied”), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced a definitive agreement for Cycle Group Holdings Limited (“Cycle”) to acquire Applied Therapeutics. Applied Therap ...

Core Insights - Applied Therapeutics Inc. (APLT) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates [1][4][11] Earnings Estimates and Stock Price Impact - The Zacks rating system is primarily driven by changes in a company's earnings estimates, which are crucial for stock price movements [2][5] - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, influencing their buying or selling decisions [5][6] Recent Performance and Projections - The Zacks Consensus Estimate for Applied Therapeutics has increased by 11.9% over the past three months, with expectations of -$0.52 earnings per share for the fiscal year ending December 2025, showing no year-over-year change [9] - The upgrade to Zacks Rank 2 places Applied Therapeutics in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11] Zacks Rating System Overview - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a strong historical performance of Zacks Rank 1 stocks averaging a +25% annual return since 1988 [8] - The system maintains a balanced distribution of ratings, ensuring that only the top 5% of stocks receive a "Strong Buy" rating, while the next 15% are rated as "Buy" [10]

Core Viewpoint - Applied Therapeutics has initiated a process to explore strategic alternatives to maximize shareholder value, which may include mergers, acquisitions, partnerships, and other strategic transactions [1][2][3] Strategic Alternatives - The Board is evaluating a broad range of opportunities to enhance shareholder value, including potential mergers, acquisitions, partnerships, joint ventures, and licensing arrangements [2] - There is no set timetable for the completion of this strategic review process, and the company will not provide further public comments unless necessary [3] Workforce Reduction - The company is reducing its workforce by approximately 46% as part of cost-containment and cash conservation measures [4] Commitment to Patients - The interim CEO emphasized the company's commitment to advancing govorestat for patients with rare diseases while maximizing shareholder value [5] Regulatory Updates - The company completed a Type C meeting with the FDA regarding govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and plans to submit a request for an additional Type C meeting to discuss a potential Phase 3 trial design [6] - Feedback from the FDA regarding govorestat for Classic Galactosemia is being evaluated, with potential discussions for a Phase 3 trial design to follow [7] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases, with its lead candidate being govorestat, aimed at treating CNS rare metabolic diseases [8]

Core Insights - Several small-cap biotech and therapeutics companies experienced significant gains in after-hours trading, driven by earnings updates, financial guidance, and regulatory developments [1] Company Summaries - Inotiv, Inc. (NOTV) saw a 36.61% increase in after-hours trading to $0.94, recovering from a 33.20% decline at the close, following preliminary Q4 revenue expectations of $137.5 million to $138.5 million and full-year revenue projections of $512.5 million to $513.5 million [2] - Applied Therapeutics, Inc. (APLT) rose 16.89% to $0.33 after a 30.19% gain at the close, with investors reacting positively to a narrower Q3 net loss of $19.0 million, or $0.13 per share, compared to a $68.6 million loss, or $0.48 per share, in the same quarter last year [3] - Alumis Inc. (ALMS) advanced 7.09% to $5.97, despite reporting a Q3 net loss of $110.8 million, wider than the $93.1 million loss in the prior year, with $2.1 million in collaboration income potentially boosting investor confidence [4] - TELA Bio, Inc. (TELA) increased 7.89% to $1.23 after a 14.08% gain at the close, reporting a reduced Q3 net loss of $8.6 million compared to $10.4 million a year earlier, with revenue growth of 9% to $20.7 million and revised 2025 guidance projecting at least 16% revenue growth over 2024 [5] - Corcept Therapeutics Inc. (CORT) gained 4.90% to $78.80, reflecting continued investor interest despite no specific news released [6] - BioRestorative Therapies, Inc. (BRTX) jumped 8.06% to $1.34, rebounding from a 6.77% decline at the close, following the announcement of a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application pathway for its BRTX-100 program [7]

Core Insights - The after-hours trading session on November 14, 2025, saw significant movements in biotech and therapeutics stocks due to various corporate updates and financial results [1] Company Summaries - Repare Therapeutics Inc. (RPTX) experienced a 30.32% increase, closing at $2.15, following the announcement of a definitive agreement for acquisition by XenoTherapeutics, with shareholders set to receive $1.82 per share plus a contingent value right. The company reported cash and cash equivalents of $112.6 million as of September 30, 2025, up from $109.5 million at the end of June [2] - Senti Biosciences, Inc. (SNTI) rose 7.45% to $1.73 after reporting a net loss of $18.1 million, or $0.69 per share, for Q3 2025. Cash and cash equivalents decreased to $12.2 million from $48.3 million at year-end 2024 [3] - Applied Therapeutics, Inc. (APLT) advanced 8.15% to $0.24, reporting a net loss of $19.0 million, or $0.13 per share, for Q3 2025, an improvement from a net loss of $68.6 million, or $0.48 per share, in the same period of 2024. Cash and cash equivalents totaled $11.9 million, down from $79.4 million at the end of 2024 [4] - RenovoRx, Inc. (RNXT) climbed 6.28% to $0.80, reporting revenues of approximately $266,000 for Q3 2025, with a net loss of $2.9 million compared to $2.5 million in the same period of 2024 [5] - Nuvalent, Inc. (NUVL) gained 9.33%, closing at $105.50, and announced plans for a webcast to discuss pivotal data for its investigational ALK-selective inhibitor in patients with advanced ALK-positive non-small cell lung cancer [6]

Core Viewpoint - Applied Therapeutics, Inc. is experiencing a significant decline in stock price while providing updates on its regulatory strategy for Govorestat related to Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) following a Type C meeting with the FDA [1][4]. Regulatory Strategy - The company received official meeting minutes from the FDA regarding Govorestat for CMT-SORD, which is a genetic defect that leads to toxic sorbitol buildup in cells, damaging peripheral nerves [2]. - Key open issues discussed in the meeting included the need for conclusive evidence on the pathophysiology of CMT-SORD, the use of sorbitol levels as a surrogate endpoint, selection of a primary endpoint for a potential Phase 3 trial, and carcinogenicity testing [3]. - The company plans to request an additional Type C meeting with the FDA to further discuss the design of a potential Phase 3 trial [3]. Financial Position - As of September 30, 2025, the company reported cash and cash equivalents totaling $11.9 million [4]. - The stock price of APLT has decreased by 58.8%, trading at $0.37 during the latest check [4].

Financial Performance - Total revenue for the three months ended September 30, 2025, was $1,000,000, compared to $122,000 for the same period in 2024, representing a significant increase[20]. - The net loss for the three months ended September 30, 2025, was $18,990,000, compared to a net loss of $68,591,000 for the same period in 2024, reflecting an improvement of approximately 72%[20]. - For the nine months ended September 30, 2025, the company reported a net loss of $62.1 million, compared to a net loss of $149.6 million for the same period in 2024, indicating a 58.5% improvement year-over-year[27]. - The company reported a net cash used in operating activities of $67.4 million for the nine months ended September 30, 2025, compared to $64.8 million for the same period in 2024[27]. - The company reported a net loss of $62.1 million for the nine months ended September 30, 2025, with an accumulated deficit of $636.4 million[153]. Cash and Liquidity - Cash and cash equivalents decreased to $11,945,000 as of September 30, 2025, from $79,398,000 as of December 31, 2024, a decline of approximately 85%[18]. - The company had cash and cash equivalents of $11.9 million as of September 30, 2025, down from $98.9 million at the beginning of the period, reflecting a net decrease of $67.5 million in cash[27]. - As of September 30, 2025, cash and cash equivalents were $11.9 million, indicating a need for substantial additional funding for ongoing operations[188]. - The company has not generated any product revenue since inception and is dependent on debt and equity financing[188]. Expenses - Research and development expenses for the nine months ended September 30, 2025, were $27,361,000, down from $37,049,000 in the same period in 2024, indicating a reduction of approximately 26%[20]. - Total research and development expenses for the three months ended September 30, 2025 were $9.6 million, a decrease of $5.2 million (35%) from $14.8 million in 2024[174]. - General and administrative expenses for the three months ended September 30, 2025 were $8.2 million, down $6.9 million (46%) from $15.0 million in 2024[174]. - General and administrative expenses increased to $39.0 million for the nine months ended September 30, 2025, from $34.7 million in 2024, representing a $4.3 million increase[184]. - Legal and professional fees rose by $15.7 million, primarily due to securities class action and shareholder derivative litigation[184]. Assets and Liabilities - The total assets decreased to $34,374,000 as of September 30, 2025, from $86,691,000 as of December 31, 2024, a decline of approximately 60%[18]. - Total current liabilities increased to $32,902,000 as of September 30, 2025, from $27,296,000 as of December 31, 2024, representing an increase of about 21%[18]. - The total stockholders' equity showed a deficit of $(561,000) as of September 30, 2025, compared to a positive equity of $57,006,000 as of December 31, 2024[18]. - The accumulated deficit increased to $(636,355,000) as of September 30, 2025, from $(574,210,000) as of December 31, 2024, indicating a worsening of approximately 11%[18]. Financing and Capital Raising - The company is actively pursuing long-term financing options, including equity capital and debt, to support its operations and has engaged in discussions with potential partners for business development opportunities[33]. - The Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald, allowing for the sale of up to $75.0 million in common stock[97]. - The March 2024 Private Placement raised approximately $92.3 million from the sale of 12,285,714 shares at $7.00 each and 2,000,000 Pre-Funded Warrants[99]. - The Company sold an aggregate of 20,615,976 shares of common stock under the Leerink ATM Agreement, resulting in net proceeds of $49.3 million[96]. Research and Development - The company operates in a single segment focused on research and development activities related to rare diseases[37]. - The FDA accepted the New Drug Application (NDA) for AT-007 for Classic Galactosemia in February 2024, but issued a Complete Response Letter on November 27, 2024, citing deficiencies in the clinical application[146]. - The company initiated a clinical development program for AT-007 in PMM2-CDG, a rare pediatric disease affecting an estimated 14,000 patients in North America and Europe[149]. - AT-007 reduced blood sorbitol levels by approximately 66% from baseline in a pilot study involving eight CMT-SORD patients[148]. Legal and Regulatory Matters - A settlement loss of $15.4 million was recognized within General and Administrative Expense due to a securities class action lawsuit, which includes a $15.0 million cash settlement and $0.4 million for warrant liability[137]. - The Company expects to recover $16.7 million from insurance related to the settlement loss, which includes $15.0 million for the cash settlement and $1.7 million for legal expenses[137]. - The Company is involved in multiple derivative actions seeking corporate governance reforms and recovery for alleged misconduct by current and former officers and directors[138]. - As of September 30, 2025, the Company assessed the probability of loss from the derivative lawsuits as reasonably possible, but does not believe any potential exposure will be material to its operations[142]. Internal Controls and Compliance - Management has identified a material weakness in internal control over financial reporting related to communication deficiencies, which has been addressed through enhanced controls and resources[215][216]. - The company has implemented a rigorous disclosure review process involving the executive team and legal counsel to improve communication and compliance[216]. - Management believes that enhanced resources and control activities will support the functioning of information and communication processes[216]. - The company has evaluated its disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of September 30, 2025[214].