APGE

Apogee Therapeutics revealed mixed results for its experimental eczema treatment Wednesday, and the stock dropped.

APEX Part B met all primary and secondary endpoints with high statistical significance; mid-dose zumilokibart planned to advance into Phase 3 trials in moderate-to-severe atopic dermatitis (AD) in 2H 2026 Zumilokibart was well tolerated with a safety profile consistent with other agents in class Strategic financing collaboration with Blackstone Life Sciences announced today expected to provide funding through commercialization of zumilokibart in AD, asthma, and EoE Results support pipeline-in-a-product potential for zumilokibart with asthma and eosinophilic esophagitis (EoE) trial plans shared today Management to host conference call today at 8:00 a.m. ET SAN FRANCISCO and BOSTON, May 27, 2026 (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 positive 16-week data from Part B of the Phase 2 APEX clinical trial of zumilokibart (APG777), a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe AD. The trial met its primary and secondary endpoints with high statistical significance including 65.9% of patients treated with mid-dose zumilokibart achieving EASI-75 (41.9% placebo adjusted). Based on these dose optimization results and subject to regulatory interactions, Apogee plans to move forward with the mid-dose, which achieved the best clinical activity of the three doses tested and was well-tolerated, in its Phase 3 trials. "We are thrilled by the strength and consistency that zumilokibart demonstrated across all endpoints from today's APEX Part B induction results, which we believe could set a new standard of care for patients. Today’s results help clear our path to advance zumilokibart into the Phase 3 trials planned for the second half of this year and we look forward to engaging with regulatory agencies.” said Michael Henderson, M.D., Chief Executive Officer of Apogee. "Zumilokibart has the potential to move the bar on disease control and dosing based on both today's data as well as the robust APEX Part A maintenance results that showed continued improvement in efficacy over 52 weeks with every 3- and 6- month dosing. Beyond AD, we are excited to develop zumilokibart's pipeline-in-a-product potential and plan to commence Phase 2...

Zumilokibart advancing across multiple indications, with Phase 3 initiation in atopic dermatitis (AD) expected later this year: - APEX Phase 2 Part A 52-week data demonstrated durable maintenance and improved efficacy over time with every 3- and 6-month dosing in moderate-to-severe AD - APEX Phase 2 Part B 16-week data in AD expected in Q2 2026 - Following positive Phase 1b asthma results earlier this year, expansion plans are underway with additional trial details for asthma and eosinophilic esophagitis (EoE) expected later this year Strong cash position of $1.3B following successful public equity offering extending runway into 2029, through planned BLA filing for AD, subject to regulatory alignment SAN FRANCISCO and BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with the potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today provided pipeline progress and reported first quarter 2026 financial results. “We are off to a rapid start in 2026, reflecting the team’s relentless focus on execution. Most notably, the APEX Phase 2 Part A 52-week results exceeded our expectations and reinforced the potentially best-in-class profile of zumilokibart as well as the central role of IL-13 as the master cytokine in AD. Zumilokibart demonstrated durable maintenance of response with 3- and 6-month dosing and improved efficacy of responses across all lesional and itch endpoints with meaningfully fewer doses than current therapies, representing a potentially transformational opportunity as a first-line product for AD patients,” said Michael Henderson, M.D., Chief Executive Officer of Apogee Therapeutics. “Based on these results, together with the positive Phase 1b asthma data shared in January 2026, we remain confident in the pipeline-in-a-product potential for zumilokibart and plan to outline broader expansion into asthma and EoE trials later this year. Following our recent successful financing, Apogee is well capitalized with cash runway into 2029, supporting advancement towards a BLA filing for AD and continued execution across our development programs, including the APEX Phase 2 Part B readout expected this quarter and initiation of our Phase 3 trials in AD expected later this year.” Pipeline Progress, Corporate Highl...

Zumilokibart (APG777) trials continue to advance in atopic dermatitis (AD) with plans for expansion indications underway: - APEX Phase 2 Part A 52-week data expected this month - APEX Phase 2 Part B 16-week data expected in Q2 2026 - Phase 3 trial initiation in AD anticipated in 2H 2026 - Successful expansion of zumilokibart beyond AD demonstrated in asthma Phase 1b trial; details on asthma and eosinophilic esophagitis (EoE) trials expected later this year Phase 1b head-to-head trial of APG279 (zumilokibart + APG990) vs. DUPIXENT underway, with interim AD data anticipated in 2H 2026 Strong total cash position of $902.9 million with runway into 2H 2028 supports advancement toward potential launch of zumilokibart in 2029 SAN FRANCISCO and BOSTON, March 02, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with the potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today provided pipeline progress and reported fourth quarter and full year 2025 financial results. “In the last 12 months we made meaningful progress across our pipeline, including advancing zumilokibart with positive APEX Phase 2 Part A results, as well as proof-of-concept data from our Phase 1b trial in asthma,” said Michael Henderson, M.D., Chief Executive Officer of Apogee Therapeutics. “We are now focused on proving out the potential of zumilokibart in AD with the APEX Phase 2 Part A 52-week maintenance readout expected in March, followed by the APEX Phase 2 Part B dose optimization readout expected in the second quarter and Phase 3 initiation targeted by year end. Later this year, we plan to provide additional details on development for expansion indications including asthma and EoE, further advancing our vision for zumilokibart as a pipeline-in-a-product. In the second half of 2026, our expected head-to-head readout of APG279 compared to DUPIXENT has potential to be the first proof-of-concept for Apogee’s combination programs in AD. With cash runway into the second half of 2028, we believe we are well positioned to work toward launching a transformative therapy this decade as we build a leading I&I biotech.” Pipeline Highlights and Upcoming Milestones APEX Phase 2 clinical trial of zumilokibart for AD progressing, with 52-week Part A data anticipated this mon...

Apogee is aiming to shift atopic dermatitis treatment from an every-two-to-four-week regimen to an every-three-to-six-month dosing paradigm, with Part A maintenance data due this quarter, a fully optimized AD dose next quarter, Phase III initiation planned this year, and a target 2029 launch supported by more than $900 million in cash runway into H2 2028. Phase 1b asthma results in 19 patients showed up to a 60% reduction in FeNO with durable effects through 16 weeks (and follow-up to eight months), supporting pursuit of an asthma label that could materially expand the AD opportunity given ~30% comorbidity and potential payer advantages versus competitors. Commercial strategy includes a fixed-dose co‑formulation APG279 (IL‑13 + OX40L) positioned to compete head‑to‑head with Dupixent and a plan to use combination partners for second‑line patients, with manufacturing optimized for low single‑digit COGS and a planned launch force of about 150 reps. Interested in Apogee Therapeutics Inc.? Here are five stocks we like better. IPO watch 2024: Which new stocks will hit the market? Executives from Apogee Therapeutics (NASDAQ:APGE) outlined their development and commercialization priorities at Guggenheim’s Emerging Outlook Biotech Conference, emphasizing plans to shift treatment for atopic dermatitis (AD) toward substantially less frequent dosing while expanding the company’s reach into respiratory indications and combination therapies. Chief Executive Officer Michael Henderson said Apogee was founded roughly four years ago with the goal of improving options for patients with AD and related conditions. He pointed to Phase II data discussed as showing rapid itch relief and lesional benefits, and he framed the next near-term milestone as demonstrating that the company can move dosing from an every-two- to four-week paradigm to an every-three- to six-month paradigm without sacrificing efficacy. → No Rally? Coca-Cola’s Results Still Look Like a Sweet Deal Henderson said the company expects to report Part A maintenance data “this quarter,” to deliver a “fully optimized dose” in AD next quarter, and to initiate Phase III studies this year. He also said the broader pipeline strategy is aimed at best-in-class monotherapy and fixed-dose combinations targeting Type 2 inflammation across dermatology and respiratory diseases. Chief Medical Officer Carl Dambkowski reviewed Apogee...

Webcast to be held Tuesday, January 6th at 8:00 a.m. ET SAN FRANCISCO and BOSTON, Jan. 05, 2026 (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 it will report interim results from its Phase 1b trial of APG777 in patients with mild-to-moderate asthma on Tuesday, January 6, 2026. 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 APG777 Phase 1b asthma interim results will begin on Tuesday, January 6th 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 https://investors.apogeetherapeutics.com/news-events/events. 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 best-in-class profiles 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 https://apogeetherapeutics.com. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB [email protected]

Phase 1b interim results of zumilokibart (APG777) in asthma demonstrated rapid and durable suppression of FeNO (key biomarker of Type 2 inflammation) through 16 weeks for all patients - Suppression of FeNO through 32 weeks for patients with available follow up - Results reinforce continued development in asthma testing every 3- or 6-month dosing Successful expansion of zumilokibart beyond dermatology confirms its pipeline-in-a-product potential across I&I indications Zumilokibart in atopic dermatitis (AD) advancing in Phase 2 APEX trials with goal of Phase 3 initiation by end of 2026: - Part A maintenance (52-week) data readout expected in Q1 2026 with potential to establish best-in-class every 3- or 6-month dosing profile - Part B enrollment completed ahead of schedule and exceeded enrollment target with a total of 347 patients; 16-week induction data readout on track for Q2 2026 Serial innovation in AD advances with APG279 Phase 1b expanded to approximately 80 patients with readout on track for 2H 2026 based on strong enrollment Strong cash position of $913 million with runway into 2H 2028 supports advancement toward potential launch of zumilokibart in 2029 Management will host a conference call at 8:00 a.m. ET SAN FRANCISCO and BOSTON, Jan. 06, 2026 (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 positive interim data from the Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma and highlighted upcoming 2026 milestones. The company recently received approval for the International Non-proprietary Name (INN) of zumilokibart for APG777. Zumilokibart is a novel, half-life extended anti-IL-13 antibody. “2025 was a foundational year for Apogee, setting the stage for a potentially transformational 2026 as we plan to deliver multiple significant clinical data readouts for our monotherapy and combination programs and enter Phase 3 development,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “With today’s positive readout in patients with mild-to-moderate asthma, we are excited to advance zumilokibart in asthma and seek to further derisk its pipeline-in-a-product potential. We look forward to reporting three clinical...

Apogee Therapeutics (APGE) said Tuesday that interim results from a Phase 1b trial showed that zumil

Apogee Therapeutics (APGE) said Monday that interim phase 1 data for its APG333 antibody "exceeded t

Pipeline programs continue to advance, with four clinical data readouts anticipated in 2026; APG777 trial readout timelines accelerated, with Phase 1b in asthma and APEX 52-week Part A data in AD anticipated in Q1 2026, APEX 16-week Part B data in AD in Q2 2026, and APG279 Phase 1b head-to-head readout against DUPIXENT in AD in 2H 2026 Interim Phase 1 results of APG333 in healthy volunteers reported today exceeded trial objectives, demonstrated a half-life of approximately 55 days, and suppressed key biomarkers for 6 months following a single dose, supporting potential 3- and 6-month dosing and the development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications Completed $345 million public offering; $913 million cash, cash equivalents and marketable securities pro forma as of September 30th supports runway into 2H 2028 SAN FRANCISCO and BOSTON, Nov. 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 provided pipeline progress and reported third quarter 2025 financial results. “Apogee is gearing up for a potentially transformative 2026 from a position of strength. With four key readouts coming in 2026 and the recent financing providing us runway through Phase 3 topline data for our lead program, APG777 in atopic dermatitis, we believe we are well positioned to advance our therapies to patients as quickly as possible,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “In conjunction with our third quarter results, we are pleased to share first-in-human data for APG333, which, together with APG777, we believe could prove to be a best-in-class combination approach for respiratory indications, with the potential for dosing every three months or even less frequently. As we move into 2026, we look forward to advancing APG777’s pipeline-in-a-product potential, beginning with the Phase 1b proof-of-concept readout in patients with asthma, followed by the Phase 2 Part A maintenance data in AD in the first quarter; Phase 2 Part B data in AD in the second quarter; and results from the APG279 Phase 1b head-to-head readout against DUPIXENT in AD in the second half of the year.” Corporate & Pipeline Hi...

Interim Phase 1 results for APG333 exceeded trial objectives, demonstrated a half-life of approximately 55 days, and suppressed key biomarkers for 6 months following a single dose, supporting potential 3- and 6- month dosing Results support development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications APG333 was well tolerated across all cohorts with doses of up to 1,000 mg SAN FRANCISCO and BOSTON, Nov. 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 positive interim Phase 1 results from its first-in-human study of APG333, which demonstrated data supporting potential 3- and 6-month dosing based on a half-life of approximately 55 days across doses tested. Additionally, APG333 was well tolerated across all cohorts, with doses up to 1,000 mg. “Today’s positive results show that our engineered antibody approach continues to deliver durable activity, which may enable less frequent dosing versus currently available agents, potentially improving adherence and outcomes for patients. This milestone represents another important step forward for our pipeline in the evolution of I&I treatments,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “The extended PK and favorable tolerability profile of APG333 underscores Apogee’s potential to advance a quarterly or better dosing combination of APG777 and APG333, designed to address key drivers of respiratory diseases more broadly than a monotherapy.” The APG333 Phase 1 clinical trial was designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose study in healthy volunteers. It evaluated the safety, tolerability and PK of APG333 in 32 healthy adults across four cohorts. Key results include: APG333 demonstrated an optimized PK profile, including a half-life of approximately 55 days, supporting potential for APG273 (APG777+APG333) every 3-month or better dosing. Key biomarkers of eosinophils and IL-5 showed depth of suppression in line with TSLP analogs and durability out to 6 months (limit of available follow up). APG333 was well tolerated across the four cohorts, with doses of up to 1,000 mg. The most common treat...

Apogee Therapeutics Inc. (NASDAQ:APGE) is one of the best up and coming stocks with huge upside potential. On August 28, BofA analyst Tim Anderson raised the firm’s price target on Apogee Therapeutics to $87 from $78, while keeping a Buy rating on the shares, citing estimate changes following Q2 2025 results. The Q2 2025 financial results showed that Apogee Therapeutics had a strong cash position of $621.2 million in cash, cash equivalents, and marketable securities at the end of the quarter. The financial runway is expected to support operations into Q1 2028. Apogee announced positive 16-week topline data from Part A of its Phase 2 APEX trial for APG777, which is a potential best-in-class treatment for moderate-to-severe atopic dermatitis/AD. The trial met all primary and key secondary endpoints, with APG777 demonstrating a 71% reduction in Eczema Area and Severity Index/EASI from baseline, compared to 33.8% for placebo. Apogee Therapeutics Inc. (NASDAQ:APGE) is a clinical-stage biotechnology company that develops novel biologics for the treatment of atopic dermatitis/AD, asthma, eosinophilic esophagitis/EoE, chronic obstructive pulmonary disease/COPD, and other inflammatory and immunology indications. 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.