BASEL, Switzerland and LONDON and NEW YORK, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms. V ...

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Organon & Co OGN has agreed to acquire Roivant Sciences Ltd's ROIV Dermavant Sciences Ltd, which is focused on developing and commercializing therapeutics in immunodermatology. Dermavant's novel product, Vtama (tapinarof) cream, 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the FDA in May 2022. Vtama cream is a once-daily, steroid-free, topical therapy applied to affected areas. Also Read: JP Morgan Shows Most Interest In Teva, Organon As Specialty P ...

Core Insights - Organon has entered into a definitive agreement to acquire Dermavant Sciences for up to approximately $1.2 billion, enhancing its dermatology capabilities in the U.S. market [2][6] - Dermavant's VTAMA cream, a non-steroidal treatment for plaque psoriasis, has been approved by the FDA and is under review for atopic dermatitis, with a decision expected in Q4 2024 [3][6] Company Overview - Organon is a global healthcare company focused on improving women's health, with a diverse portfolio of over 60 medicines and products [12][13] - Dermavant Sciences specializes in developing innovative therapeutics in immuno-dermatology, with a focus on unmet medical needs in skin conditions [17] Product Details - VTAMA cream is a once-daily, steroid-free topical treatment for plaque psoriasis, approved for mild to severe cases, and has no safety label warnings [3][9] - The FDA is currently reviewing VTAMA for atopic dermatitis, with positive results from Phase III clinical trials [3][17] Market Impact - Psoriasis affects over 8 million Americans and 125 million people globally, while atopic dermatitis impacts approximately 16.5 million adults and over 9.6 million children in the U.S. [4] - The acquisition is expected to leverage Organon's market access capabilities and regulatory expertise to enhance the reach of VTAMA cream [5][6] Financial Terms - The acquisition includes an upfront payment of $175 million, a $75 million milestone payment upon regulatory approval for atopic dermatitis, and up to $950 million for achieving commercial milestones [6][7] - Organon will also pay tiered royalties on net sales of VTAMA cream, which Dermavant owns globally except for China [6] Strategic Goals - The acquisition aligns with Organon's objective to invest in treatments that address conditions affecting women differently, enhancing its portfolio in dermatology [5] - The deal is structured to focus on success-based milestones and royalties, reflecting a disciplined approach to capital allocation [5][6]

Roivant Sciences Ltd. (ROIV) closed the last trading session at $12.50, gaining 11.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16.89 indicates a 35.1% upside potential. The mean estimate comprises nine short-term price targets with a standard deviation of $2.62. While the lowest estimate of $12 indicates a 4% decline from the current price level, the most optimistic analyst ...

Mosliciguat, a potential first-in-class and best-in-category inhaled soluble Guanylate Cyclase (sGC) activator with targeted delivery to the lungs and once-daily administration, is being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), which affects ~200,000 patients in the U.S. and Europe; PH-ILD prevalence is meaningfully greater than that of pulmonary arterial hypertension (PAH) with limited to no treatment options In the Phase 1b ATMOS study, presented today at th ...

Core Insights - Mosliciguat is a potential first-in-class inhaled soluble Guanylate Cyclase (sGC) activator designed for once-daily administration, showing promise in treating pulmonary hypertension (PH) [1][10] - The Phase 1b ATMOS study demonstrated a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38% in PH patients, indicating significant efficacy [1][4] - The upcoming Phase 2 "PHocus" study will evaluate mosliciguat in approximately 120 patients with PH associated with interstitial lung disease (PH-ILD), a condition affecting around 200,000 patients in the U.S. and Europe [1][6] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on developing innovative therapies for pulmonary diseases, with mosliciguat as its lead program [10] - The company aims to provide a convenient once-daily inhaled treatment option for patients suffering from pulmonary hypertension [10] Clinical Development - The Phase 1b ATMOS study was a non-randomized, open-label trial involving 38 patients, which showed that mosliciguat led to clinically meaningful reductions in PVR [4][5] - Mosliciguat has been characterized in a robust Phase 1 program with 170 participants, demonstrating a favorable safety profile and dose-dependent increases in cGMP [2][5] - The Phase 2 PHocus study is set to begin imminently, targeting a patient population with high unmet medical needs and limited treatment options [6][8] Mechanism of Action - Mosliciguat acts as an sGC activator, independent of heme and nitric oxide (NO), which may allow it to retain efficacy in oxidative environments typical of PH [2] - The drug's mechanism may lead to increased vasodilation, reduced inflammation, and anti-fibrotic effects, differentiating it from existing therapies [2][5] Market Opportunity - PH-ILD represents a significant commercial opportunity due to its higher prevalence compared to pulmonary arterial hypertension (PAH) and the lack of approved treatment options [6][9] - The high morbidity and mortality associated with PH-ILD underscores the need for effective therapies, positioning mosliciguat as a potentially transformative treatment [8][9]

Financial Data and Key Metrics Changes - The company reported a net income of $57 million for the quarter, with net revenues of $55 million, including product revenues of approximately $18 million [21] - The company ended the quarter with $5.7 billion in cash and cash equivalents, reflecting a repurchase made in the previous quarter [21] - The carrying value of the company's debt has decreased due to renegotiations [21] Business Line Data and Key Metrics Changes - VTAMA generated $18.4 million in product revenue for the quarter, with script volumes up 20% year-over-year, indicating growth in the psoriasis market [18][19] - The company is preparing for the launch of VTAMA in atopic dermatitis (AD) after expected approval at the end of the year, which is anticipated to significantly increase market presence [19][53] Market Data and Key Metrics Changes - The anti-FcRn market has expanded significantly, with 23 indications in development for anti-FcRn antibodies, addressing a total patient population of 4 million [12] - The company is optimistic about the competitive positioning of its FcRn programs compared to other mechanisms in the autoimmune disease space [14][15] Company Strategy and Development Direction - The company is focused on growth and expansion, with plans to deliver clinical data across multiple franchises, including the anti-FcRn franchise and brepocitinib [3][4] - The company aims to prioritize capital allocation for share buybacks while expanding its pipeline with mid-late-stage programs [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the constructive interaction with the FDA regarding the Phase III design for brepocitinib in non-infectious uveitis (NIU) [24] - The company anticipates a busy catalyst calendar ahead, with significant data releases and program unveilings expected in the coming months [20][22] Other Important Information - The company achieved a $28 million milestone related to the Japanese approval of VTAMA and received $110 million from Roche for Telavant [9] - The company is actively involved in IP litigation regarding COVID vaccines, with a trial expected to begin in September 2025 [8] Q&A Session Summary Question: What is left to be worked out on the Phase III design for brepocitinib? - Management indicated that interactions with the FDA were constructive and that they are confident in the program's direction, with no major dependencies on the 52-week data [24] Question: How does the final enrollment of the VALOR study compare to original expectations? - The final enrollment of 241 patients exceeded the original plan of 225, providing a well-powered study [26] Question: What is the go/no-go decision for the Phase II namilumab data? - Management stated that the bar for progression is meaningful, focusing on consistency across primary and secondary endpoints [28] Question: How does the recent market sell-off affect the search for new assets? - Management noted that it depends on the specific opportunities available, but they remain focused on finding great opportunities at attractive prices [29] Question: Can you provide more color on the LNP litigation? - Management mentioned that they are in the discovery phase and expect a trial to begin in early next year [39] Question: What is the expected evolution of OpEx with new trials? - Management expects OpEx to increase due to the initiation of multiple pivotal studies, estimating costs for Phase 3 programs to range from $80 million to $120 million [45]

Financial Results and Business Update for the Quarter Ended June 30, 2024 roivant August 8, 2024 Speakers Matthew Gline Chief Executive Officer Richard Pulik Chief Financial Officer Frank Torti, MD Vant Chair Eric Venker, MD, PharmD President and Chief Operating Officer Mayukh Sukhatme, MD President and Chief Investment Officer roivant For investor audiences only 2 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that co ...

Roivant Sciences Ltd. (ROIV) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 14.29%. A quarter ago, it was expected that this company would post a loss of $0.25 per share when it actually produced a loss of $0.23, delivering a surprise of 8%. Over the last four quarters, the company has surp ...