Latest news with #APG777
Yahoo
5 days ago
- Business
- Yahoo
Canaccord Genuity Reiterated a Buy Rating on Apogee Therapeutics (APGE)
Apogee Therapeutics, Inc. (NASDAQ:APGE) is one of the . On July 7, analyst Edward Nash of Canaccord Genuity reiterated a Buy rating on Apogee Therapeutics, Inc. (NASDAQ:APGE) with a price target of $89. The reiterated bullish sentiment comes after the company released promising results from its APEX study for its drug APG777. The drug is an IL-13 monoclonal antibody aimed at treating atopic dermatitis. The Phase II study met its primary and secondary goals, showing a significant reduction in the Eczema Area and Severity Index score, which is a key measure of disease severity. Notably, improvement was seen as early as Week 2, indicating a strong drug effect. A scientist in a white lab coat working at a bench with biopharmaceutical equipment. Analyst Nash also highlights the ongoing Part B of the APEX study and expects 52-week maintenance data in early 2026. These data are important for confirming the drug's long-term benefits and dosing schedule, which could be quarterly to semi-annual. Apogee Therapeutics, Inc. (NASDAQ:APGE) is a clinical-stage biotech company developing novel biologic drugs for inflammatory and immunology diseases. While we acknowledge the potential of APGE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
10-07-2025
- Business
- Yahoo
Apogee Therapeutics (APGE) Falls 17%, Positive Trial Results Fail to Impress Investors
Apogee Therapeutics, Inc. (NASDAQ:APGE) is one of the . Apogee Therapeutics fell by 17.32 percent on Monday to end at $39.24 apiece as investors disposed of positions amid the broader market pessimism, shunning positive results from the company's clinical trial for the treatment of eczema. On Monday, Apogee Therapeutics, Inc. (NASDAQ:APGE) said the phase 2 clinical trial of the APG777 antibody met all primary and key secondary endpoints and exceeded trial objectives. At the 16th week of the trial, Apogee Therapeutics, Inc. (NASDAQ:APGE) said that APG777 demonstrated a 66.9-percent improvement in the Eczema Area and Severity Index-75 (EASI-75) score, the highest topline and placebo-adjusted efficacy of any biologic in a global study. A close-up of a biotechnology machine working on an oncology therapy. 'APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing, benefitting patients, providers, and payers. Today's results bring us closer to that vision, and we believe further de-risks APG777's path to approval,' said Apogee Therapeutics, Inc. (NASDAQ:APGE) CEO Michael Henderson. While we acknowledge the potential of APGE as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the . READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
07-07-2025
- Business
- Associated Press
Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis
APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including71.0%decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposureswith readout accelerated and now anticipated mid-2026, enabling planned Phase 3 initiation in 2026 APEX Part A testing potentially best in class 3- or 6-month maintenance dosing with 52-week readout anticipated 1H 2026 APG777 was well tolerated with a favorable safety profile consistent with other agents in class First patient dosed in APG279 (IL-13 + OX40L) Phase 1b head-to-head trial versus DUPIXENT with readout expected in 2H 2026 Management will host a conference call today at 8:00 a.m. ET SAN FRANCISCO and BOSTON, July 07, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, today announced positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD). 'With two out of every three patients treated with APG777 achieving EASI-75 response at Week 16 in the Phase 2 APEX Part A trial, APG777 demonstrated the highest EASI-75 response rate both on a topline and placebo-adjusted basis for any biologic in a global study to date, reinforcing its potential best-in-class profile for patients with moderate-to-severe atopic dermatitis,' said Michael Henderson, M.D., Chief Executive Officer of Apogee. 'APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing — benefitting patients, providers, and payers. Today's results bring us closer to that vision, and we believe further de-risks APG777's path to approval. In addition, I am excited for our two upcoming readouts to potentially even further improve on efficacy results — the accelerated APEX Part B testing higher exposures that is now expected to readout mid-2026, and the ongoing APG279 (IL-13 + OX40L) head-to-head trial against DUPIXENT expected to readout in the second half of 2026.' 'Today's results from APEX Part A demonstrate strong efficacy results across all key endpoints,' said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. 'In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX Part B. Combined with a favorable safety profile, these findings reinforce APG777's potential to deliver meaningful and durable benefit to patients while significantly reducing dosing frequency compared with existing agents. On behalf of the entire Apogee team, I'd like to extend our gratitude to the patients and physicians for their support in the successful execution of this important trial.' APEX Phase 2 Part A Key 16-Week Results The Phase 2 APEX clinical trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12. Patients benefiting from treatment continued maintenance dosing, evaluating 3- or 6-month dosing of APG777. The primary endpoint of Part A is mean percentage change in Eczema Area Severity Index (EASI) score from baseline at Week 16. Secondary endpoints include EASI-75, EASI-90, Validated Investigator Global Assessment (IGA) 0/1 and Itch Numeric Rating Scale (NRS) at Week 16. Initial 16-week findings from APEX Part A include efficacy results, which compare favorably versus standard of care across endpoints as well as rapid onset of itch relief and lesion reduction, and a favorable safety profile consistent with its class: 'The Phase 2 Part A results are exciting, with APG777 demonstrating promising efficacy results from only four injection days over the initial 16-week induction period,' said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. 'Despite meaningful advances in atopic dermatitis treatment, there remains a significant unmet need to reduce the injection burden for patients while continuing to improve patient outcomes. I look forward to seeing the first half-life extended antibody in AD progress and I am excited about Apogee's studies that are bringing this therapy closer to patients.' APEX Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo. Part B continues to enroll participants with readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026. Webcast Details Apogee Therapeutics' live webcast of the Phase 2 APEX Part A results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company's website at A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic Esophagitis (EoE) and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the Company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the Company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Forward Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future product candidates and programs; the expected timing of and results from its clinical trials, including 52-week maintenance data from Part A and the initial readout from Part B of its Phase 2 trial of APG777 in AD and initial readout from its Phase 1b trial of APG279 in AD; its planned clinical trial designs; its plans for current and future clinical trials, including the timing of initiation of a Phase 3 trial of APG777 in AD and potential path to regulatory approval; the potential clinical benefit and half-life, PK profile, dosing regimen, and treatment outcomes of APG777 and APG279; and its planned business strategies. Words such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'develop,' 'plan' or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee's filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the Company's control and subject to change. Actual or final results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Apogee's preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee's clinical trials; the unpredictable relationship between preclinical study results and clinical trial results, including across different phases of clinical trials; the accuracy of cross-trial comparisons against products in the same class; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, and subsequent disclosure documents Apogee has filed and may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB Media [email protected]
Associated Press
07-07-2025
- Business
- Associated Press
Apogee Therapeutics to Host Conference Call to Report Part A 16-Week Data from the Phase 2 APEX Trial of APG777 in Patients with Moderate-to-Severe Atopic Dermatitis on July 7, 2025
SAN FRANCISCO and BOSTON, July 06, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced it will report Part A 16-week data from the Phase 2 APEX trial of APG777 on Monday, July 7, 2025. Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET to discuss the results. Webcast Details Apogee Therapeutics' live webcast of the Phase 2 APEX Part A results will begin on Monday, July 7th at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company's website at A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, COPD, EoE and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the Company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the Company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB [email protected]
Yahoo
29-05-2025
- Business
- Yahoo
Apogee Therapeutics to Participate at the Jefferies Global Healthcare Conference
SAN FRANCISCO and BOSTON, May 29, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), today announced that members of management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025, at 10:30 a.m. E.T. A live and archived webcast of the fireside chat will be available via the News & Events page in the Investors section of the Apogee Therapeutics website. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Investor Contact:Noel KurdiVP, Investor Relations Apogee Therapeutics, Media Contact:Dan Budwick 1AB dan@
