This section highlights FDA-related milestones and regulatory updates for drugs developed by Apogee Therapeutics (APGE).
Over the past two years, Apogee Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
APG333, APG777, APG808, and APG990. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
APG333 FDA Regulatory Events
APG333 is a drug developed by Apogee Therapeutics for the following indication: Treatment of Respiratory and Broader I&I Conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- APG333
- Announced Date:
- December 10, 2024
- Indication:
- Treatment of Respiratory and Broader I&I Conditions
Announcement
Apogee Therapeutics, Inc., announced that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions.
AI Summary
Apogee Therapeutics, Inc. has started dosing healthy volunteers in its Phase 1 clinical trial of APG333. This novel drug is a subcutaneous, half-life extended monoclonal antibody designed to target thymic stromal lymphopoietin (TSLP), a key protein involved in triggering inflammation. The trial will explore the safety, tolerability, and pharmacokinetics of APG333 and is primarily aimed at developing a new treatment for respiratory diseases.
Initially, APG333 is being evaluated for treating asthma and chronic obstructive pulmonary disease (COPD), with hopes that it could later be used for a broader range of inflammatory and immunology conditions. Researchers expect to have interim data on the trial in the second half of 2025, marking an important step in Apogee’s pipeline as they work toward innovative combination therapies for respiratory diseases.
Read Announcement
APG777 FDA Regulatory Events
APG777 is a drug developed by Apogee Therapeutics for the following indication: For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- APG777
- Announced Date:
- July 6, 2025
- Indication:
- For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc 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.
AI Summary
Apogee Therapeutics, Inc. announced that it will report the Part A 16‐week results from its Phase 2 APEX trial of APG777 on Monday, July 7, 2025. This data release is key to understanding the potential effectiveness and safety of APG777, the company’s leading biologic under development aimed at addressing inflammatory and immunology conditions.
Following the announcement, Apogee Therapeutics will host a conference call and live webcast at 8:00 a.m. ET to discuss the results in detail. Stakeholders and interested parties can join the webcast online or via the company’s website to obtain further insights, ask questions, and learn about the implications of the trial outcomes for future treatment options in conditions like atopic dermatitis.
Read Announcement- Drug:
- APG777
- Announced Date:
- February 3, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc announced that Part A 16-week proof-of-concept data anticipated in mid-2025.
AI Summary
Apogee Therapeutics, Inc. recently completed enrollment for the Phase 2 Part A trial of its novel therapy, APG777, ahead of schedule by enrolling 123 patients, exceeding the initial target. This milestone reflects strong support from both patients and investigators for the treatment of moderate-to-severe atopic dermatitis and other inflammatory conditions.
Significantly, the company announced that the 16-week proof-of-concept data from Part A is anticipated in mid-2025. This data will provide important insights into the safety and potential efficacy of APG777. The trial is designed to evaluate whether APG777 can offer improved drug exposure and clinical responses while reducing the number of necessary injections compared to existing therapies, potentially easing the treatment burden on patients.
Read Announcement- Drug:
- APG777
- Announced Date:
- February 3, 2025
- Indication:
- For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc. announced the first patient has been dosed in the Part B portion of the Phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe AD, as well as enrollment completion in the Part A portion of the trial.
AI Summary
Apogee Therapeutics, Inc. announced that the first patient has been dosed in the Part B portion of its Phase 2 APEX clinical trial for APG777 in patients with moderate-to-severe atopic dermatitis (AD). This marks an important step in their study designed to evaluate a novel subcutaneous monoclonal antibody that targets IL-13, a key driver of inflammation in AD.
In addition, the Part A portion of the trial has already completed enrollment ahead of schedule, with 123 patients recruited—surpassing the initial target. This rapid enrollment reflects strong interest and support from both patients and investigators. The streamlined transition between Part A and Part B underscores the company’s commitment to efficient clinical development, which could accelerate the availability of a safe and effective treatment option for AD.
Read Announcement
APG808 FDA Regulatory Events
APG808 is a drug developed by Apogee Therapeutics for the following indication: In Patients with Mild-to-Moderate Asthma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- APG808
- Announced Date:
- May 12, 2025
- Indication:
- In Patients with Mild-to-Moderate Asthma
Announcement
Apogee Therapeutics, Inc announced positive interim data from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody, in patients with mild-to-moderate asthma.
AI Summary
Apogee Therapeutics, Inc. announced positive interim results from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody for patients with mild-to-moderate asthma. The trial demonstrated that multiple doses of APG808 rapidly and robustly suppressed FeNO—a key biomarker of Type 2 inflammation linked to asthma exacerbations—with a maximal decrease of 53% from baseline. Importantly, this reduction was maintained at around 50% even at 12 weeks, pointing to the antibody’s potential for durable disease control. The drug also showed an optimized formulation and promising pharmacokinetic profile, suggesting that patients could eventually benefit from less frequent dosing—every two months or longer—compared with the current biweekly standard of care. Additionally, the treatment was well tolerated, with a favorable safety profile and no severe adverse events reported during the trial.
Read Announcement
APG990 FDA Regulatory Timeline and Events
APG990 is a drug developed by Apogee Therapeutics for the following indication: For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- APG990
- Announced Date:
- March 3, 2025
- Indication:
- For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc. announced positive interim Phase 1 results from its first-in-human trial of APG990.
AI Summary
Apogee Therapeutics announced positive interim Phase 1 results from its first-in-human trial of APG990, a new antibody targeting OX40L. The study showed that APG990 has a half-life of about 60 days across different doses. This long half-life may allow for maintenance dosing every three to six months, even with a lower dose of 50 mg. The trial also indicated that APG990 was well tolerated by participants, with minimal side effects such as headaches and no severe adverse events or study discontinuations.
These encouraging results support APG990’s potential as a novel treatment option for inflammatory conditions like atopic dermatitis. The success of APG990 also provides key support for its future use in combination with APG777, in a coformulated product known as APG279, which aims to target multiple inflammation pathways.
Read Announcement- Drug:
- APG990
- Announced Date:
- February 28, 2025
- Estimated Event Date Range:
- March 1, 2025 - March 1, 2025
- Target Action Date:
- March 01, 2025
- Indication:
- For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc announced it will report interim results from the Phase 1 APG990 healthy volunteer trial on Monday, March 3, 2025.
AI Summary
Apogee Therapeutics, Inc. announced that it will share the interim results from its Phase 1 APG990 healthy volunteer trial on Monday, March 3, 2025. This clinical-stage biotechnology company is working on novel biologics for various inflammatory and immunology conditions. The interim results will help gauge the safety and initial effectiveness of APG990 as part of the company’s development process for new treatments.
Following the results announcement, Apogee Therapeutics will host a conference call and webcast at 8:30 a.m. ET to discuss the findings and its plans, including a potential combination approach involving APG777 and APG990. Interested parties can access the live webcast or view the replay later through the Investor section on the company’s website.
Read Announcement- Drug:
- APG990
- Announced Date:
- August 19, 2024
- Indication:
- For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc announced that Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases
AI Summary
Apogee Therapeutics, Inc. announced that it plans to start the first clinical trial combining APG777 and APG990 in 2025. This trial is designed to explore a new treatment approach for atopic dermatitis and other inflammatory and immunology diseases. The company believes that using the two therapies together may result in greater efficacy. APG777 targets IL-13, a key driver in inflammation, while APG990 targets OX40L, a protein involved earlier in the inflammatory pathway. By combining these two mechanisms, the treatment could offer a broader inhibition of the inflammation cascade that causes disease symptoms. This innovative approach aims to provide deeper and more sustained responses, potentially improving outcomes for patients who do not benefit from existing treatments.
The planned trial underscores Apogee’s commitment to delivering best-in-class dosing and effectiveness for patients with challenging inflammatory conditions.
Read Announcement- Drug:
- APG990
- Announced Date:
- August 19, 2024
- Indication:
- For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc announced that Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025
AI Summary
Apogee Therapeutics, Inc. announced that interim safety and pharmacokinetic data from its Phase 1 trial in healthy volunteers is expected in 2025. This trial is focused on APG990, a novel subcutaneous monoclonal antibody targeting OX40L, which is initially being developed for atopic dermatitis. The study is a double-blind, placebo-controlled, single-ascending dose trial designed to assess the safety, tolerability, and pharmacokinetics of APG990 in around 40 healthy adults divided into five cohorts.
In addition, the company plans to kick off the first clinical trial testing a combination of APG777 and APG990 in 2025. This combination aims to deliver a first-in-class approach by pairing two potent mechanisms, potentially expanding treatment options for patients with atopic dermatitis and other inflammatory and immunology disorders.
Read Announcement- Drug:
- APG990
- Announced Date:
- August 19, 2024
- Indication:
- For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Announcement
Apogee Therapeutics, Inc announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting OX40L, which is being developed initially as a treatment for people living with AD.
AI Summary
Apogee Therapeutics, Inc. announced that it has begun dosing healthy volunteers in its first clinical trial for APG990. APG990 is a new subcutaneous, half-life extended monoclonal antibody that targets OX40L and is being developed as a treatment for atopic dermatitis (AD). The trial is a first-in-human, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of APG990. Approximately 40 healthy adults will participate in the study across five different dosing groups, and the company expects to share interim results in 2025.
This early clinical advancement is a significant step for Apogee as it works to develop innovative treatments for AD and other inflammatory conditions. The company hopes that APG990 will offer a new option for patients who have not benefited from current therapies by providing a broader impact on the inflammatory cascade.
Read Announcement
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