Latest news with #JuanCamiloArjonaFerreira
Yahoo
10-07-2025
- Business
- Yahoo
Organon & Co. (OGN) Announces Discontinuation of the OG-6219 Clinical Development Program
Organon & Co. (NYSE:OGN) is one of the 13 Cheap Healthcare Stocks with Huge Upside Potential. On July 2, Organon & Co. (NYSE:OGN) announced that its Phase 2 ELENA proof-of-concept study did not meet its primary efficacy endpoint. The study evaluated the investigational candidate OG-6219 in endometriosis-related pain, with OG-6219 being an oral 17β-hydroxysteroid dehydrogenase type 1 inhibitor. A pharmacist wearing a white lab coat and a face mask dispenses biosimilars at a pharmacy. Organon & Co. (NYSE:OGN) acquired OG-6219 through its 2021 acquisition of Forendo Pharma. The compound did not exhibit improvement in moderate-to-severe endometriosis-related overall pelvic pain in the study as compared to the placebo, which is why Organon & Co. (NYSE:OGN) plans to discontinue the clinical development program. Juan Camilo Arjona Ferreira, M.D., Head of Research and Development and Chief Medical Officer at Organon & Co. (NYSE: OGN), stated that while the study results were disappointing, the company remains committed to its focus on improving the lives of women with endometriosis. Organon & Co. (NYSE:OGN) is a global pharmaceutical company that develops and delivers innovative health solutions via a portfolio of prescription therapies within women's health, established brands, and biosimilars. While we acknowledge the potential of OGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Errore nel recupero dei dati Effettua l'accesso per consultare il tuo portafoglio Errore nel recupero dei dati Errore nel recupero dei dati Errore nel recupero dei dati Errore nel recupero dei dati
Yahoo
10-07-2025
- Business
- Yahoo
Organon & Co. (OGN) Announces Discontinuation of the OG-6219 Clinical Development Program
Organon & Co. (NYSE:OGN) is one of the 13 Cheap Healthcare Stocks with Huge Upside Potential. On July 2, Organon & Co. (NYSE:OGN) announced that its Phase 2 ELENA proof-of-concept study did not meet its primary efficacy endpoint. The study evaluated the investigational candidate OG-6219 in endometriosis-related pain, with OG-6219 being an oral 17β-hydroxysteroid dehydrogenase type 1 inhibitor. A pharmacist wearing a white lab coat and a face mask dispenses biosimilars at a pharmacy. Organon & Co. (NYSE:OGN) acquired OG-6219 through its 2021 acquisition of Forendo Pharma. The compound did not exhibit improvement in moderate-to-severe endometriosis-related overall pelvic pain in the study as compared to the placebo, which is why Organon & Co. (NYSE:OGN) plans to discontinue the clinical development program. Juan Camilo Arjona Ferreira, M.D., Head of Research and Development and Chief Medical Officer at Organon & Co. (NYSE: OGN), stated that while the study results were disappointing, the company remains committed to its focus on improving the lives of women with endometriosis. Organon & Co. (NYSE:OGN) is a global pharmaceutical company that develops and delivers innovative health solutions via a portfolio of prescription therapies within women's health, established brands, and biosimilars. While we acknowledge the potential of OGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Business Wire
07-07-2025
- Health
- Business Wire
Organon's VTAMA ® (tapinarof) cream, 1%, Granted Strong Recommendation in the American Academy of Dermatology Updated 2025 Guidelines for Adult Atopic Dermatitis
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global independent healthcare company with a focus on women's health, today announced that VTAMA ® (tapinarof) cream, 1%, was granted a strong recommendation by the American Academy of Dermatology (AAD) in their 2025 focused guideline update for the management of adults with moderate to severe atopic dermatitis (AD). The recommendation underscores VTAMA cream as an effective, steroid-free option for daily disease management, with no label warnings or precautions, no contraindications, and no restrictions on duration of use or percentage of body surface area affected. In AD, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. 'With 6.6 million adults in the US living with moderate to severe AD, innovative treatment options that meet the highest standards for efficacy, safety, and tolerability are necessary to help provide lasting relief. We are proud of the AAD's strong evidence-based recommendation from the ADORING 1 and ADORING 2 8-week clinical trials for VTAMA cream—a once daily, steroid-free topical with no label restrictions on use based on disease severity, percentage of body surface area affected, or duration of use,' said Juan Camilo Arjona Ferreira, Head of Research and Development and Chief Medical Officer at Organon. 'This strong recommendation, paired with the findings from our Phase 3 ADORING 3 48-week, open-label, long-term extension study which uncovered the possibility of a treatment-free interval lasting on average 80 days after treatment success, highlights how VTAMA cream has the potential to redefine the AD treatment landscape and provide lasting results.' The focused update incorporates topical and systemic therapies that have been recently approved by the US Food and Drug Administration (FDA) into the AAD's existing guidance on the management of AD in adults to ensure the dermatology community has access to the best available evidence. In December 2024, the FDA approved VTAMA cream for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was also approved by the FDA on May 24, 2022, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults. INDICATIONS: VTAMA ® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for: the topical treatment of plaque psoriasis in adults the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older SELECTED SAFETY INFORMATION Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Before prescribing VTAMA cream, please read the Prescribing Information. For more information about VTAMA (tapinarof) cream, 1%, visit About Atopic Dermatitis AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the US alone and up to 10% of adults worldwide. 1,2 AD occurs most frequently in children, affecting up to 20% worldwide. 1,2 The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck. 3 Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, which can disturb sleep. 1 About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes 'forward-looking statements' within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon's expectations about the potential impact of VTAMA as a treatment option for AD. Forward-looking statements may be identified by words such as 'potential,' 'mission,' 'expects,' 'will,' or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site ( Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. 1 Eczema stats. National Eczema Association. Accessed June 5, 2025. 2 Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies: 2022. Accessed February 25, 2025. 3 What is eczema? National Eczema Association. Accessed July 2, 2025.
Yahoo
03-07-2025
- Health
- Yahoo
Organon discontinues endometriosis drug after Phase II flunk
Organon is terminating development of its endometriosis drug after the Phase II trial failed to show any benefit. The ELENA proof-of-concept study (NCT05560646) was evaluating Organon's therapy, OG-6219, in endometriosis-related pain. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor. In the study, OG-6219 failed to demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo, the study's primary endpoint. As a result of the study, Organon said it will discontinue the OG-6219 clinical development program. The randomised, double-blind, placebo-controlled study aimed to evaluate the efficacy, safety, and tolerability of three dose levels of OG-6219 in pre-menopausal women aged 18 to 49 years who have been surgically diagnosed with endometriosis with moderate-to-severe endometriosis-related pain. Organon's research and development head Dr Juan Camilo Arjona Ferreira said: 'While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier everyday for all women, including those living with endometriosis.' Organon acquired the therapy as part of a $75m acquisition of Forendo Pharma in 2021. Current treatment options for endometriosis include pain relief medications, hormonal therapies or surgical options, which can include the removal of lesions or affected organs. GlobalData predicts that the endometriosis market will grow from $938m in 2024 to $2.5bn in 2034 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). The increase is partially due to new pipeline therapies, increased awareness and improved diagnostic tools. Some approved therapies used to treat endometriosis are Pfizer's Myfembree (relugolix/estradiol/norethisterone acetate), Myovant and Gedeon Richter's Ryeqo (relugolix/estradiol/norethisterone acetate) and Kissei Pharmaceutical and ObsEva's Yselty (linzagolix). While the pipeline is limited, GlobalData anticipates that three late-stage pipeline products will enter the endometriosis market by 2034: Kissei Pharmaceutical's linzagolix, Hope Medicine's HMI-115, and Fuji Pharma's Alyssa (drospirenone and estetrol). GlobalData is the parent company of Clinical Trials Arena. "Organon discontinues endometriosis drug after Phase II flunk" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Wire
02-07-2025
- Business
- Business Wire
Organon Provides Update on Phase 2 ELENA Proof-of-Concept Study Evaluating OG-6219 in Patients with Endometriosis-Related Pain
BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a focus on women's health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition of Forendo Pharma in 2021. In the study, OG-6219 did not demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo. Based on these results, the company plans to discontinue the OG-6219 clinical development program. 'While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women including those living with endometriosis,' said Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon. 'We are grateful to all the patients, caregivers, and investigators for their participation in and support of this study.' The randomized, double-blind, placebo-controlled, parallel-group, global multi-center Phase 2a/b study (NCT05560646) aimed to evaluate the efficacy, safety, and tolerability of three dose levels of OG-6219 in pre-menopausal women 18 to 49 years of age who have been surgically diagnosed with endometriosis with moderate-to-severe endometriosis-related pain. Eligible patients were randomized to receive one of three doses of OG-6219 or placebo orally twice a day. The primary efficacy endpoint was the change from the baseline cycle (placebo run-in cycle) to the last planned treatment cycle (third month of treatment exposure), in the mean endometriosis-related overall pelvic pain score (measured using an eleven-point numerical rating scale). About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon's future business efforts and prospects. Forward-looking statements may be identified by words such as 'plans', 'mission,' 'vision,' 'future,' 'may,' 'can,' 'will,' 'expects,' or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site (
