Organon & Co. - OGN STOCK NEWS

Organon (NYSE: OGN) announced FDA approval of VTAMA® (tapinarof) cream, 1% for treating atopic dermatitis in adults and children aged 2 and older. The approval came ahead of the March 2025 target date. In pivotal studies ADORING 1 and 2, up to 46% of patients achieved treatment success at Week 8 versus 18% on vehicle.

The drug demonstrated powerful skin clearance with patients remaining treatment-free for ~80 consecutive days in the 48-week long-term extension study. VTAMA showed rapid itch relief within 24 hours and maintained a favorable safety profile. Common side effects included upper respiratory tract infection (12%) and folliculitis (9%).

The FDA has extended its review period for VTAMA® (tapinarof) cream, 1% for atopic dermatitis treatment in adults and children aged 2 and older by three months. The new target date is March 12, 2025, moved from December 12, 2024. The extension follows FDA's request for final datasets from the long-term extension study. The FDA has not raised safety, efficacy, or approvability concerns. Organon projects $125 million in VTAMA revenue for 2025, with an approximate 75 basis point headwind to Adjusted EBITDA margin.

Organon (OGN) reported strong Q3 2024 results with revenue of $1.582 billion, up 4% as-reported and 5% at constant currency. The company achieved net income of $359 million and diluted EPS of $1.38. Women's Health revenue grew 5%, Biosimilars increased 16%, and Established Brands rose 2%. The company narrowed its full-year 2024 revenue guidance to $6.375-$6.425 billion and revised Adjusted EBITDA margin to 30.0-31.0%. Nexplanon showed strong performance with 11% growth, positioning it to deliver $1 billion in revenue next year. The Board declared a quarterly dividend of $0.28 per share.

Shanghai Henlius Biotech and Organon (NYSE: OGN) announced the US FDA's acceptance of their Biologics License Application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab). The application is supported by comprehensive head-to-head studies, including analytical comparisons and two clinical trials. Under a 2022 license agreement, Organon holds exclusive commercialization rights for HLX14 in the US, EU, and Canada, excluding China. The clinical program included a phase 1 study in healthy males and a phase 3 trial in postmenopausal women with high-risk osteoporosis.

Organon (NYSE: OGN) has completed its acquisition of Dermavant Sciences from Roivant, expanding its dermatology portfolio with VTAMA® (tapinarof) cream. VTAMA is a novel nonbiologic, non-steroidal topical therapy FDA-approved for plaque psoriasis in adults, with no safety label warnings or use restrictions. The FDA is reviewing VTAMA for atopic dermatitis treatment in adults and children, with a decision expected in Q4 2024. The acquisition strengthens Organon's dermatology capabilities, particularly in treating chronic inflammatory skin conditions that affect millions globally, with psoriasis and atopic dermatitis having significant impact on quality of life.

Organon (NYSE: OGN), a global healthcare company focusing on women's health, will release its third quarter 2024 financial results on October 31, 2024, before a webcast and conference call at 8:30 a.m. EDT. The company anticipates recording $51 million in milestone expenses for Q3 2024, impacting both GAAP and non-GAAP earnings per share by approximately $0.16. Of this, $50 million relates to a denosumab biosimilar candidate progressing under an agreement with Shanghai Henlius Biotech, Inc.

Organon notes that IPR&D and milestones are not included in their financial guidance due to uncertainty in timing. The Q3 2024 results are preliminary and subject to finalization. Interested parties can access the live call via webcast on Organon's website, with a replay available approximately two hours after the event.

Shanghai Henlius Biotech and Organon (NYSE: OGN) have announced that their phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) biosimilar HLX11 has met its primary endpoint. The study compared HLX11 with reference Perjeta® as a neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer.

The trial (NCT05346224) was a multicenter, randomized, double-blind, parallel-controlled study. Patients received either HLX11 or reference Perjeta® combined with trastuzumab and docetaxel. The primary endpoint was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee. Secondary endpoints included various response rates, survival measures, safety, pharmacokinetics, and immunogenicity.

In 2022, Henlius granted Organon exclusive global commercialization rights for HLX11, except for China. Pertuzumab is approved in various countries for neoadjuvant, first-line, and adjuvant treatment of certain advanced HER2-positive breast cancers.

Organon (NYSE: OGN) has agreed to acquire Dermavant Sciences , a Roivant company, for up to $1.2 billion. The deal includes Dermavant's VTAMA® (tapinarof) cream, a novel, non-steroidal topical therapy for plaque psoriasis in adults. VTAMA is also under FDA review for atopic dermatitis treatment. The acquisition aims to extend Organon's international dermatology capabilities to the U.S.

Key points:

• Upfront payment of $175 million
• $75 million milestone payment upon regulatory approval for atopic dermatitis
• Up to $950 million for commercial milestones
• Tiered royalties on net sales
• Expected closing in Q4 2024
• Transaction subject to Hart-Scott-Rodino Antitrust Improvements Act review

Organon (NYSE: OGN) has expanded its agreement with Eli Lilly to become the sole distributor and promoter for the migraine medicine Emgality® (galcanezumab) in 11 additional markets. This builds on Organon's existing role as distributor in Europe since February 2024. Emgality is a CGRP antagonist for migraine prevention in adults and, in some markets, for episodic cluster headache treatment.

The expansion highlights Organon's focus on women's health, as women are three times more likely to experience migraines than men. The agreement includes an upfront payment of $22.5 million to Lilly, plus sales-based milestone payments. Lilly will remain the marketing authorization holder and manufacturer of Emgality.