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Apogee Therapeutics, Inc. Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares for Gross Proceeds of $345 Million
Globenewswire· 2025-10-10 20:01
SAN FRANCISCO and BOSTON, Oct. 10, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced the closing of its previously announced underwritten public offering of 8,048,782 shares of its common stock, including the full exercise of the underwriters’ option to purchase up to 1,097,561 additional shares, at a ...
Apogee Therapeutics, Inc. Announces Pricing of $300 Million Underwritten Public Offering
Globenewswire· 2025-10-09 01:52
Core Viewpoint - Apogee Therapeutics, Inc. has announced a public offering of 6,951,221 shares of common stock priced at $41.00 per share, aiming to raise approximately $300 million before expenses [1]. Group 1: Offering Details - The offering includes pre-funded warrants for certain investors to purchase up to 365,853 shares at a price of $40.99999 per warrant, with an exercise price of $0.00001 per share [1]. - The offering is expected to close on October 10, 2025, subject to customary closing conditions [1]. - Underwriters have an option to purchase an additional 1,097,561 shares at the public offering price within 30 days [1]. Group 2: Underwriters - Jefferies, BofA Securities, Guggenheim Securities, and TD Cowen are acting as joint book-running managers for the offering, while BTIG serves as a passive bookrunner [2]. Group 3: Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including treatments for Atopic Dermatitis, asthma, Eosinophilic Esophagitis, and Chronic Obstructive Pulmonary Disease [5]. - The company's lead program, APG777, targets Atopic Dermatitis, which is noted as a large and under-penetrated market [5]. - Apogee aims to achieve best-in-class profiles through its antibody programs by addressing limitations of existing therapies and optimizing properties such as half-life [5].
Apogee Therapeutics, Inc. Announces Proposed Underwritten Public Offering
Globenewswire· 2025-10-08 20:01
SAN FRANCISCO and BOSTON, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced that it has commenced an underwritten public offering of shares of its common stock or, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. In additi ...
RBC Capital Initiates Coverage of Apogee Therapeutics (APGE) With an Outperform Rating
Yahoo Finance· 2025-09-30 08:00
Apogee Therapeutics Inc. (NASDAQ:APGE) is one of the best strong buy stocks to invest in according to Wall Street. On September 25, RBC Capital initiated coverage of Apogee Therapeutics Inc. (NASDAQ:APGE) with an Outperform rating and a $60 price target. Is Exact Sciences Corporation (NASDAQ:EXAS) the Gene Therapy Stock with the Greatest Potential? The firm expressed optimistic sentiments regarding the company’s potential to deliver clinically differentiated biologics, telling investors in a research not ...
BofA Raises Apogee Therapeutics (APGE) PT to $87 Following Positive Phase 2 APEX Trial Results for Atopic Dermatitis
Yahoo Finance· 2025-09-15 13:09
Company Overview - Apogee Therapeutics Inc. (NASDAQ:APGE) is a clinical-stage biotechnology company focused on developing novel biologics for treating atopic dermatitis, asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications [4] Financial Performance - As of the end of Q2 2025, Apogee Therapeutics reported a strong cash position of $621.2 million in cash, cash equivalents, and marketable securities, which is expected to support operations into Q1 2028 [2] Recent Developments - BofA analyst Tim Anderson raised the price target for Apogee Therapeutics to $87 from $78, maintaining a Buy rating, following positive changes in estimates after the Q2 2025 results [1] - The company announced positive topline data from Part A of its Phase 2 APEX trial for APG777, a potential best-in-class treatment for moderate-to-severe atopic dermatitis, achieving a 71% reduction in the Eczema Area and Severity Index from baseline, compared to 33.8% for placebo [3]
Apogee Therapeutics Announces Late-Breaker Presentation of 16-Week Data from Phase 2 APEX Trial of APG777 for Moderate-to-Severe Atopic Dermatitis at the Upcoming European Academy of Dermatology and Venereology (EADV) 2025 Congress
Globenewswire· 2025-09-11 11:30
Core Insights - Apogee Therapeutics, Inc. announced that data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis will be presented at the EADV Congress 2025 in Paris, highlighting its potential as a best-in-class treatment [1][2] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease [4][5] - The company aims to create best-in-class profiles through advanced antibody engineering and targeting established mechanisms of action [4][5] Clinical Trial Highlights - The APEX trial demonstrated that APG777 met both primary and secondary endpoints, reinforcing its potential as a leading treatment option for moderate-to-severe atopic dermatitis [2] - APG777 is notable for being the only biologic tested with maintenance dosing every 3 and 6 months [2] - The combination of APG777 with APG990, which targets OX40L, is expected to broaden the treatment scope for various inflammatory conditions [2] Presentation Details at EADV Congress 2025 - A late-breaker oral presentation titled "APG777, a Novel, Half-Life Extended Anti-IL-13 Antibody, Demonstrates Safety and Efficacy in Moderate-to-Severe Atopic Dermatitis: 16-Week Results from the Phase 2 APEX Study" will be presented by Dr. Emma Guttman-Yassky on September 19, 2025 [3] - Multiple poster presentations will also be featured, including studies on APG777 and APG990, showcasing their safety profiles and efficacy [3]
Apogee Therapeutics to Participate at the Stifel 2025 Virtual Immunology and Inflammation Forum
Globenewswire· 2025-09-03 11:30
Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing optimized, novel biologics for immunology and inflammation (I&I) markets, including treatments for Atopic Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), and Chronic Obstructive Pulmonary Disease (COPD) [2] - The company aims to create best-in-class therapies by targeting established mechanisms of action and utilizing advanced antibody engineering to enhance properties such as half-life [2] - APG777 is the most advanced program, targeting AD, which is identified as the largest and least penetrated market within I&I [2] Pipeline and Strategy - Apogee has four validated targets in its portfolio and is pursuing both monotherapies and combinations of its novel antibodies to achieve best-in-class profiles [2] - The company believes its broad pipeline and expertise can provide significant value and benefits to patients who are underserved by current standard care [2] Upcoming Events - Management will participate in a fireside chat at the Stifel 2025 Virtual Immunology and Inflammation Forum on September 16, 2025, at 11:30 a.m. E.T., with a live and archived webcast available on the company's website [1]
Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-11 11:00
Core Insights - Apogee Therapeutics reported positive results from the 16-week Phase 2 Part A APEX trial for APG777, an anti-IL-13 antibody, which met all primary and key secondary endpoints for moderate-to-severe atopic dermatitis [1][2][3] - The company is advancing its pipeline with ongoing trials, including a Phase 1b head-to-head study of APG279 against DUPIXENT, with results expected in the second half of 2026 [1][2][3] - Apogee has a strong cash position of $621.2 million, which is projected to support operations into Q1 2028 [1][6][8] Pipeline Progress - APG777 demonstrated a 71.0% reduction in the Eczema Area and Severity Index (EASI) from baseline compared to 33.8% for placebo (p < 0.001) in the APEX Part A trial [3][4] - The APEX Part A maintenance phase is testing dosing every 3- and 6-months, potentially allowing for 2-4 injections per year versus 26 for standard care [3][7] - The readout for APEX Part B has been accelerated to mid-2026 due to strong enrollment [1][2][3] Financial Performance - Research and development expenses increased to $55.7 million for Q2 2025, up from $33.2 million in Q2 2024, primarily due to the development of APG777 [6][8] - General and administrative expenses rose to $17.5 million in Q2 2025 from $10.9 million in Q2 2024, driven by increased personnel-related costs [6][8] - The net loss for Q2 2025 was $66.1 million, compared to a net loss of $33.8 million in Q2 2024, reflecting higher operating expenses [8][15]
创新药周报:全球首个口服HAE急性发作按需治疗药物获批上市-20250713
Huachuang Securities· 2025-07-13 14:22
Investment Rating - The report indicates a positive investment outlook for the hereditary angioedema (HAE) treatment sector, particularly following the approval of the first oral on-demand treatment, sebetralstat [14][21]. Core Insights - The report highlights the urgent need for effective HAE treatments due to the high risk of life-threatening episodes, with nearly half of HAE patients facing potential asphyxiation [10][16]. - Sebetralstat, approved by the FDA, is noted for its rapid onset of action, achieving near-complete inhibition of plasma kallikrein within 15 minutes of administration [21]. - The KONFIDENT trial results demonstrate that sebetralstat significantly reduces symptom relief time compared to placebo, with median relief times of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose [20][21]. Summary by Sections Section 1: HAE Overview - HAE is characterized by recurrent episodes of angioedema without urticaria, with a prevalence of approximately 1.5 per 100,000 individuals [7]. - The disease can lead to severe complications, including laryngeal edema, which has a mortality rate of up to 40% among patients [7][10]. Section 2: Current Treatment Landscape - Existing treatments include long-term preventive therapies (LTP) and on-demand treatments for acute episodes [10][11]. - The global HAE drug market reached $2.9 billion in 2022, with $2 billion attributed to long-term prevention and $900 million to acute on-demand treatments [13]. Section 3: Sebetralstat Approval and Efficacy - Sebetralstat is the first oral on-demand treatment for HAE, approved on July 7, 2025, and is expected to address unmet needs in the treatment landscape [21]. - The KONFIDENT trial, involving 136 patients across 20 countries, confirmed the efficacy and safety of sebetralstat, showing significant improvements in symptom relief and severity reduction compared to placebo [21]. Section 4: Future Developments - Pharvaris is developing deucrictibant, a competitive oral antagonist for HAE, with promising Phase II trial results indicating effective management of HAE attacks [26]. - The report anticipates further advancements in HAE treatments, with ongoing clinical trials expected to yield additional data in the coming years [26].
Gold Falls 1%; ProKidney Shares Spike Higher
Benzinga· 2025-07-08 17:25
Market Overview - U.S. stocks showed mixed performance with the Dow Jones index declining by 0.35% to 44,249.09, while the NASDAQ increased by 0.07% to 20,427.63 and the S&P 500 fell by 0.03% to 6,228.39 [1] - Energy shares experienced a notable increase of 2.1%, while utilities stocks decreased by 1.9% [1] Used Vehicle Market - The US Manheim Used Vehicle Value Index rose by 1.6% month-over-month for June, following a 1.4% decline in May [2][11] Commodity Market - Oil prices increased by 0.3% to $68.14, while gold prices decreased by 1.1% to $3,306.90. Silver fell by 0.8% to $36.625, and copper dropped by 0.5% to $5.0000 [5] European Market - European shares showed positive movement with the eurozone's STOXX 600 rising by 0.40%, Spain's IBEX 35 Index up by 0.10%, London's FTSE 100 gaining 0.46%, Germany's DAX 40 increasing by 0.68%, and France's CAC 40 rising by 0.46% [6] Asian Market - Asian markets closed higher, with Japan's Nikkei gaining 0.26%, Hong Kong's Hang Seng climbing 1.09%, China's Shanghai Composite increasing by 0.70%, and India's BSE Sensex rising by 0.32% [7] Company News - ENDRA Life Sciences Inc. saw its shares surge by 134% to $8.10 after announcing a US patent for a "Radio Frequency Applicator" [9] - ProKidney Corp. shares surged by 218% to $1.95 following positive topline results from its Phase 2 REGEN-007 trial for chronic kidney disease and diabetes [9] - Humacyte, Inc. shares increased by 20% to $2.5750 after receiving Electronic Catalog Listing approval from the US Defense Logistics Agency [9] - Blue Gold Limited shares dropped by 21% to $58.75 after announcing the formation of its inaugural Advisory Board for Blockchain Evolution [9] - Sunrun Inc. shares fell by 11% to $9.84 after President Trump signed an executive order to end clean-energy tax credits [9] - Apogee Therapeutics, Inc. shares decreased by 8% to $36.24 following the release of data from its Phase 2 APEX clinical trial for atopic dermatitis [9]