Apogee Therapeutics Inc Stock Price, News & Analysis

Apogee Therapeutics (NASDAQ: APGE) reported Q1 2025 financial results and pipeline updates. The company's lead candidate APG777 is advancing in Phase 2 APEX trial for atopic dermatitis, with interim data expected mid-2025. Recent market research shows strong preference for APG777's quarterly dosing, with 96% of current biologic patients likely to switch. The company reported $681.4 million in cash reserves, extending runway into Q1 2028. Key developments include: first patient dosed in APG777's Phase 1b asthma trial, positive interim results for APG808 in asthma showing 53% FeNO reduction, and plans to initiate APG279 head-to-head trial vs DUPIXENT in 2025. Financial results showed R&D expenses of $46.4 million and a net loss of $55.3 million for Q1 2025.

Apogee Therapeutics (NASDAQ: APGE) announced positive interim results from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody, in patients with mild-to-moderate asthma. The trial, involving 22 adult patients, demonstrated that APG808 achieved a 53% maximal decrease in FeNO (a biomarker of Type 2 inflammation) from baseline, with a sustained 50% decrease at 12 weeks. The drug showed a favorable safety profile with no Grade 3 TEAEs or severe adverse events. Most common side effects included headache, injection site erythema, and upper respiratory tract infections. Notably, APG808's optimized formulation and pharmacokinetic profile support potential dosing every 2 months or longer, compared to the current biweekly standard of care, potentially offering a significant advancement in asthma treatment.

Apogee Therapeutics (NASDAQ: APGE) has announced its participation in the upcoming Bank of America Health Care Conference. The company's management team will deliver a presentation on Tuesday, May 13, 2025, at 1:40 p.m. PT / 4:40 p.m. ET. Interested parties can access both the live and archived versions of the presentation through the News & Events page in the Investors section of Apogee Therapeutics' website.

Apogee Therapeutics (NASDAQ: APGE) reported significant pipeline progress and 2024 financial results. The company's Phase 2 APEX clinical trial for APG777 has exceeded enrollment in Part A, with Part B initiated ahead of schedule. Topline Part A 16-week data is expected mid-2025.

Key financial highlights include $731.1 million in cash and equivalents, providing runway into Q1 2028. R&D expenses increased to $167.9 million in 2024 (vs $68.4M in 2023), while G&A expenses rose to $49.0 million (vs $24.6M in 2023). Net loss widened to $182.1 million in 2024 from $84.0 million in 2023.

The company reported positive interim results for APG990, with a 60-day half-life supporting three- and six-month dosing potential. APG279 (APG777 + APG990) head-to-head study versus DUPIXENT is planned, with readout expected in H2 2026. Additional pipeline developments include progress in respiratory indications and positive interim data for APG808.

Apogee Therapeutics (NASDAQ: APGE) announced positive interim Phase 1 results for APG990, their novel half-life extended OX40L antibody. The trial demonstrated an approximately 60-day half-life, supporting potential maintenance dosing every three and six months.

Key findings include:

• APG990 showed favorable tolerability across all five cohorts up to 1,200mg doses
• 53% of participants experienced at least one TEAE, with headache being most common
• No Grade 3 TEAEs or severe adverse events related to study drug
• No study discontinuations due to adverse events

The company plans to initiate a Phase 1b head-to-head study of APG279 (APG777 + APG990 combination) versus DUPIXENT in 2025, with data expected in second half of 2026. The combination therapy could potentially offer improved clinical outcomes by addressing multiple inflammation pathways with a single 2 mL coformulated injection administered 2-4 times per year.

Apogee Therapeutics (Nasdaq: APGE) has scheduled a conference call and webcast for March 3, 2025, at 8:30 a.m. ET to present interim results from its Phase 1 healthy volunteer trial of APG990. The clinical-stage biotechnology company, which focuses on developing novel biologics for inflammatory and immunology (I&I) conditions, will also discuss combination strategy plans for APG777 + APG990.

The company's therapeutic pipeline targets major I&I markets, including:

• Atopic dermatitis (AD)
• Asthma
• Eosinophilic esophagitis (EoE)
• Chronic obstructive pulmonary disease (COPD)

The live webcast will be accessible through the company's investor relations website, with a replay available after the call.

Apogee Therapeutics (Nasdaq: APGE) has announced that its management team will be participating in two major investor conferences in March 2025. The company will attend the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025, at 2:30 p.m. ET, followed by the Leerink Global Healthcare Conference on Tuesday, March 11, 2025, at 8:40 a.m. ET.

For interested parties, both events will feature fireside chats that will be available through live and archived webcasts. These webcasts can be accessed via the News & Events page in the Investors section of the Apogee Therapeutics website, providing an opportunity for investors to gain insights into the company's developments and strategies.

Apogee Therapeutics (NASDAQ: APGE) announced significant progress in its Phase 2 APEX clinical trial of APG777 for moderate-to-severe atopic dermatitis (AD). The company has completed Part A enrollment ahead of schedule with 123 patients, exceeding the target of 110 patients, and has begun dosing patients in Part B.

The trial evaluates APG777, a novel subcutaneous extended half-life monoclonal antibody targeting IL-13. Part A randomized patients 2:1 to APG777 versus placebo, with APG777 patients receiving 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12. Part B will involve approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo.

Key upcoming milestones include Part A 16-week data in mid-2025, maintenance data in H1 2026, and Part B 16-week data in H2 2026. The company also plans to initiate Phase 1b trials in asthma and a combination study with APG990 in 2025.

Apogee Therapeutics (Nasdaq: APGE) has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company's management team will engage in a fireside chat scheduled for Wednesday, February 5, 2025, at 1:00 p.m. E.T. Interested parties can access both live and archived versions of the presentation through the News & Events page in the Investors section of the Apogee Therapeutics website.