Articles from Apogee Therapeutics, LLC

Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025

Continued advancement of pipeline and execution towards expected milestones, including APG777 16-week proof-of-concept data from the Phase 2 Part A trial in 2H 2025, APG808 interim Phase 1 data in 4Q 2024, and APG990 Phase 1 trial initiation in healthy volunteers accelerated to 3Q 2024

SAN FRANCISCO and WALTHAM, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today announced that Lisa Bollinger, MD, has been appointed to the company’s board of directors. Dr. Bollinger most recently served as Vice President, Regulatory Affairs, Global Regulatory Affairs and Clinical Safety (GRACS) at Merck, where she led the general medicine therapeutic area in regulatory affairs. Dr. Bollinger’s over 30 years of experience in drug development, with deep regulatory experience gained both within the U.S. FDA and multinational biotechnology and pharmaceutical companies contributed to the Apogee board of directors’ selection decision.

SAN FRANCISCO and WALTHAM, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, COPD, asthma and other inflammatory and immunology indications, today announced that members of management will participate at the following upcoming investor conferences:

Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile

Initiated a Phase 2 clinical trial of APG777, a subcutaneous half-life extended monoclonal antibody targeting IL-13, in patients with moderate-to-severe atopic dermatitis, with 16-week proof-of-concept data from Part A of the trial expected in 2H 2025

SAN FRANCISCO and WALTHAM, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, COPD, asthma and other inflammatory and immunology indications, today announced that Michael Henderson, M.D., Chief Executive Officer and Jane Pritchett Henderson, Chief Financial Officer, will participate in a fireside chat at the 2024 Bank of America Healthcare Conference on Wednesday, May 15, 2024 at 3:40 p.m. P.T. / 6:40 p.m. E.T.

Preclinical data with APG808 demonstrate the potential for improved dosing over other treatment options in development, including the potential for dosing every six- or eight- weeks compared to dosing every two weeks for other biologics in development

SAN FRANCISCO, Calif. and WALTHAM, Mass., March 12, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology indications (Apogee or the Company), today announced the closing of its previously announced upsized public offering of 7,790,321 shares of common stock, including the full exercise of the underwriters’ option to purchase up to 1,016,128 additional shares, at a public offering price of $62.00 per share. The aggregate gross proceeds to Apogee from the offering were approximately $483.0 million before deducting underwriting discounts and commissions and other offering expenses payable by Apogee. All of the shares were offered by Apogee.

SAN FRANCISCO and WALTHAM, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology indications (Apogee or the Company), today announced the pricing of its upsized previously announced underwritten public offering of 6,774,193 shares of common stock at a public offering price per share of $62.00. The aggregate gross proceeds to Apogee from the offering are expected to be approximately $420.0 million before deducting underwriting discounts and commissions and other offering expenses payable by Apogee, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on March 12, 2024, subject to the satisfaction of customary closing conditions. In addition, Apogee has granted the underwriters a 30-day option to purchase up to an additional 1,016,128 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Apogee.

SAN FRANCISCO and WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology indications (Apogee or the Company), today announced that it has commenced an underwritten public offering of approximately $350.0 million of shares of its common stock. In addition, Apogee expects to grant the underwriters a 30-day option to purchase up to an additional $52.5 million of shares of common stock at the public offering price, less underwriting discounts and commissions. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the securities are being offered by Apogee.

Positive interim results from APG777 Phase 1 healthy volunteer clinical trial exceeded objectives with approximately 75-day half-life which supports the potential for higher exposures leading to potential for improved clinical responses in induction than currently available biologic therapies and the potential for maintenance dosing of every 3- or 6-months

Pharmacokinetic data support potential best-in-class profile with potential for improved clinical responses from greater exposures in induction than currently available biologic therapies and maintenance dosing of every 3- or 6-months

SAN FRANCISCO and WALTHAM, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology (I&I) indications, today announced it will report interim results from the Phase 1 APG777 healthy volunteer trial on Tuesday, March 5, 2024. Following the announcement, the Company will host a conference call and webcast at 7:00am ET to discuss the results.

SAN FRANCISCO and WALTHAM, Mass., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today announced that Michael Henderson, M.D., Chief Executive Officer of Apogee, will present at the 42nd Annual J.P. Morgan Conference on Tuesday, January 9, 2024 at 7:30 a.m. P.T. / 10:30 a.m. E.T.

Phase 1 clinical trial of APG777, a fully optimized, subcutaneous, extended half-life anti-IL-13 antibody, initiated ahead of schedule with initial PK and safety data from healthy volunteers expected mid-2024; on track to begin Phase 2 in moderate-to-severe atopic dermatitis in 2024

SAN FRANCISCO and WALTHAM, Mass., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, asthma, chronic obstructive pulmonary disease and other inflammatory and immunology indications, today announced that management will present at the following upcoming investor conferences:

SAN FRANCISCO, CA and WALTHAM, Mass., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease and other inflammatory and immunology (I&I) indications, today announced two abstracts co-written with Apogee’s research partner, Paragon Therapeutics, Inc., highlighting the company’s lead product candidate, APG777, a fully optimized and half-life extended antibody targeting IL-13 for the treatment of AD, have been accepted as e-posters at the upcoming 2023 European Academy of Dermatology and Venereology (EADV) Congress, held October 11-14, 2023, in Berlin, Germany and virtually.

SAN FRANCISCO and WALTHAM, Mass., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today announced that members of its management will participate in a fireside chat at the 2023 Stifel Virtual I&I Day on Wednesday, September 20th, 2023 at 9:30 a.m. ET.

$345 million in gross proceeds raised in upsized IPO, providing a projected operating runway into 4Q 2026

SAN FRANCISCO and WALTHAM, Mass., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease and other inflammatory and immunology (I&I) indications, today announced the appointment of Mark C. McKenna as Chairman of its board of directors. Mr. McKenna’s knowledge and successful track record in the I&I space as well as his significant development, commercial and executive management experience contributed to the Apogee board of directors’ selection decision.

Preclinical data with APG777 demonstrate the potential for significantly improved dosing over standard of care, including the potential for every two- or three-month dosing

SAN FRANCISCO and WALTHAM, Mass., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications, today announced that management will participate in the following upcoming investor conferences:

SAN FRANCISCO and WALTHAM, Mass., July 18, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications (“Apogee” or the “Company”), today announced the closing of its previously announced upsized initial public offering of 20,297,500 shares of common stock, including the full exercise of the underwriters’ option to purchase up 2,647,500 additional shares, at a public offering price of $17.00 per share. The aggregate gross proceeds to Apogee from the offering were approximately $345 million before deducting underwriting discounts and commissions and other offering expenses payable by Apogee. All of the shares were offered by Apogee.

SAN FRANCISCO and WALTHAM, Mass., July 13, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications (“Apogee” or the “Company”), today announced the pricing of its upsized initial public offering of 17,650,000 shares of common stock at a public offering price of $17.00 per share. The aggregate gross proceeds to Apogee from the offering are expected to be approximately $300 million before deducting underwriting discounts and commissions and other offering expenses payable by Apogee.   In addition, Apogee has granted the underwriters a 30-day option to purchase up to an additional 2,647,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Apogee.