Organon

ObsEva Evidences Compliance with Nasdaq’s Stockholder’s Equity Rule and Announces Moratorium Dismissal Request Filing

Retrieved on: 
Wednesday, December 14, 2022
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Nasdaq Listing Rule 5450(b)(1)(A) requires listed companies listed on the Nasdaq Global Select Market to maintain stockholders’ equity of at least $10.0 million.

Key Points: 
  • Nasdaq Listing Rule 5450(b)(1)(A) requires listed companies listed on the Nasdaq Global Select Market to maintain stockholders’ equity of at least $10.0 million.
  • In July 2021, ObsEva granted a license to Organon for the global development, manufacturing, and commercial rights to Ebopiprant.
  • The Company therefore believes that as of the date hereof the Company has regained compliance with Nasdaq Listing Rule 5450(b)(1)(A).
  • There can be no assurance that the Company will be able to maintain compliance with the minimum stockholders’ equity requirement.

ONK Therapeutics Boosts Drug Development Experience and Expands US Presence with the Appointment of Bruce McCreedy Ph.D. as Chief Scientific Officer

Retrieved on: 
Tuesday, December 6, 2022
Virology, CD96, DR4, GMP, NK, McCreedy, DR5, Tumor microenvironment, Research, Lymphatic system, SAN, LNP, School, Medicine, Cancer, TNF, Microbiology, CD38, Hope, Doctor of Philosophy, CISH, Drug development, WEHI, Intellia Therapeutics, Patient, JLab Audio, CSO, IND, CRISPR, Gilead Sciences, Therapy, University, Management, Pharmaceutical industry, Organon, Hematology

He has been responsible for leading research organizations through the design and execution of highly successful drug development programs including currently marketed products.

Key Points: 
  • He has been responsible for leading research organizations through the design and execution of highly successful drug development programs including currently marketed products.
  • He joins ONK Therapeutics from Myeloid Therapeutics, Inc., where as CSO his responsibilities included all IND-enabling pre-clinical studies.
  • Bruce McCreedy Ph.D., CSO of ONK Therapeutics said, “I am excited to be joining ONK Therapeutics at a pivotal time in its development as it navigates its path towards clinical trials.
  • ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned USA subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego.

Organon To Present at the 41st Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Thursday, December 15, 2022
Health, Consumer, Women, General Health, Pharmaceutical, Vitamins, Supplements, Biotechnology, OGN, NYSE, Health, Woman, Investment, Conference, Organon

Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10th, 2023 at 7:30 a.m. PT.

Key Points: 
  • Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10th, 2023 at 7:30 a.m. PT.
  • Organon is a global healthcare company formed to focus on improving the health of women throughout their lives.
  • Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas.
  • Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

Organon Appoints Kirke Weaver as General Counsel and Corporate Secretary

Retrieved on: 
Monday, December 12, 2022
Vitamins, Supplements, General Health, Pharmaceutical, Health, MSD, Security (finance), Corporation, College, Commercial, Pennsylvania Office of General Counsel, General counsel, Employment, NYSE, Woman, Investment, Senior, Multimedia, OGN, Merck, Health, Ethics, Yale Law School, Management, Organon

Organon (NYSE: OGN), a global womens healthcare company, today announced that Kirke Weaver has been appointed General Counsel and Corporate Secretary, and will continue as a member of Organons executive leadership team, effective January 1, 2023.

Key Points: 
  • Organon (NYSE: OGN), a global womens healthcare company, today announced that Kirke Weaver has been appointed General Counsel and Corporate Secretary, and will continue as a member of Organons executive leadership team, effective January 1, 2023.
  • Mr. Weaver was named as the interim head of the Office of General Counsel and Corporate Secretary in July 2022.
  • Prior to serving as interim General Counsel and Corporate Secretary, Mr. Weaver served as Senior Vice President, Commercial, Regulatory, Securities, Employment and Deputy Corporate Secretary at Organon.
  • I am excited to continue to lead Organons Office of General Counsel as we build a company to serve an important purpose in womens health, said Kirke Weaver.

XOMA Acquires Royalty and Milestone License to Ebopiprant, a Preterm Labor Asset, Being Developed by Organon

Retrieved on: 
Tuesday, November 22, 2022
COVID-19, IP, Incidence, Economics, Merck Group, Acquisition, Biotechnology, Drug Quality and Security Act, Preterm birth, Atosiban, Standard of care, Parent, Security (finance), Form 10-K, Health, Woman, Safety, Pharmaceutical industry, Organon

EMERYVILLE, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, announced today it has acquired all rights and title to ebopiprant held by ObsEva for $15 million plus certain earn-out payments.  XOMA has assumed the ebopiprant intellectual property (IP) estate and all license agreements, including the 2021 exclusive license agreement from ObsEva to Organon related to the development and commercialization of ebopiprant. 

Key Points: 
  • XOMA has assumed the ebopiprant intellectual property (IP) estate and all license agreements, including the 2021 exclusive license agreement from ObsEva to Organon related to the development and commercialization of ebopiprant.
  • The economics in the ebopiprant license acquisition have the potential to deliver significant returns to XOMA and our stockholders from the clinical development milestones alone.
  • XOMA will now be entitled to receive up to $475 million in development, regulatory, and sales-based milestone payments under the ObsEva/Organon license agreement.
  • As of the date of this press release, all assets in XOMAs milestone and royalty portfolio, except Vabysmo, are investigational compounds.

ObsEva Announces Sale of Ebopiprant License Agreement to XOMA for up to $113 Million

Retrieved on: 
Tuesday, November 22, 2022
Report, Pharmacokinetics, Risk, Merck Group, Female, SIX Swiss Exchange, Consent, Birth certificate, Inflammation, Drug development, Security (finance), Center for Drug Evaluation and Research, Letter, Sale, Fertilisation, Coronavirus, Woman, Cleveland Cultural Gardens, Pregnancy, Amendment, Safety, Form 6-K, JGB, Life insurance, Pharmaceutical industry, Organon

The sale of the Ebopiprant license agreement both strengthens our immediate financial position, while providing the potential for future upside for shareholders,said Brian OCallaghan, CEO of ObsEva.

Key Points: 
  • The sale of the Ebopiprant license agreement both strengthens our immediate financial position, while providing the potential for future upside for shareholders,said Brian OCallaghan, CEO of ObsEva.
  • ObsEva retains worldwide, exclusive, commercial rights for nolasiban, except for the Peoples Republic of China.
  • In addition to the $15 million received in upfront proceeds, ObsEva is eligible to receive up to $98 million upon the achievement of certain development and regulatory milestones and sales milestones under the Companys license agreement with Organon for Ebopiprant that was sold to XOMA in the transaction.
  • In July 2021, ObsEva granted a license to Organon for the global development, manufacturing, and commercial rights to Ebopiprant.

Daré Bioscience Announces Grant to Develop Novel Hydrogel Formulation for Delivery of Live Biotherapeutics to Support Vaginal Health

Retrieved on: 
Tuesday, November 15, 2022
Cream, COVID-19, Doctor of Philosophy, SAN, Recurrence, Fertility, Health minister, Infection, Food, Menopause, Risk, Female, Safety, Social media, Bill, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, Birth certificate, Bacterial vaginosis, Birth, Sale, 8-K, Health, Therapy, Progesterone, Intellectual property, Form, Failure, Bill & Melinda Gates Foundation, Woman, FDA, Pharmaceutical industry, Birth control, Bayer, Organon

SAN DIEGO, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has received a grant from the Bill & Melinda Gates Foundation (the foundation) of $584,986 to support activities related to development of a vaginal thermosetting gel formulation for the delivery of live biotherapeutics that can be reconstituted at the point of care. If successful, the formulation could be carried forward for further development as a delivery vehicle with potential to enhance the availability of novel therapeutics for vaginal health in the United States and worldwide, including in countries with varying climatic conditions and/or where extended storage may be required.

Key Points: 
  • However, there remains a clear and unmet need for products that can be administered following effective treatment of the primary vaginal infection to then rebalance the vaginal microbiota and promote continued improved vaginal health.
  • This grant will enable us to investigate the use of a novel hydrogel technology to deliver live biotherapeutics to address this challenge that affects women everywhere.
  • We are grateful for the foundations support in advancing this technology with the goal of making such therapies available to women worldwide.
  • Dar cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.

Daré Bioscience Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study

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Monday, November 14, 2022
Cream, Trial of the century, Tablet, Breast cancer, Intravaginal administration, Safety, Disease, Fertility, Risk, Plasma, Prevalence, Organon, Birth, PK, Form, Aromatase, Social media, Vaginal discharge, Survivor, Personal lubricant, Progesterone, Inflammation, Intellectual property, Pain, Tamoxifen, COVID-19, Health, Vulvar cancer, FDA, Failure, SERM, Quality of life, Female, Pharmacokinetics, Bacterial vaginosis, Recurrence, Food, Woman, Oncology, 8-K, Health minister, Dyspareunia, PD, Menopause, Tissue, History, Patient, Birth control, Pharmaceutical industry, VVA, Bayer

SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced topline data from its Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed for the treatment of moderate to severe vulvar and vaginal atrophy. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA. The topline data from the study demonstrated safety and tolerability of DARE-VVA1, as well as improvement in the vaginal cytology parameters and the bothersome vaginal symptoms associated with VVA. DARE-VVA1 has the potential to be the first therapeutic specifically approved for the treatment of VVA in U.S. patients with HR+ breast cancer. There are currently no FDA-approved products labeled for VVA treatment in HR+ breast cancer patients.

Key Points: 
  • We are highly encouraged by the positive topline results of the Phase 1/2 study of DARE-VVA1 as this study is a critical step in developing a potential non-hormonal treatment alternative for VVA, said Dr. Annie Thurman, Medical Director of Dar Bioscience.
  • The Phase 1/2 study evaluated different doses of DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women with VVA.
  • The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluated the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1.
  • Dar plans to submit data from the Phase 1/2 clinical study of DARE-VVA1 for publication in a peer-reviewed publication.

Organon To Present at the Piper Sandler 34th Annual Healthcare Conference

Retrieved on: 
Tuesday, November 15, 2022
Health, Consumer, Women, Managed Care, General Health, Pharmaceutical, Biotechnology, Investment, EST, OGN, Woman, Piper Sandler Companies, Conference, Health, NYSE, Pharmaceutical industry, Organon

Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29th, 2022 at 9:00 a.m. EST.

Key Points: 
  • Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29th, 2022 at 9:00 a.m. EST.
  • Organon is a global healthcare company formed to focus on improving the health of women throughout their lives.
  • Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas.
  • Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

The Estée Lauder Companies, Organon & Co., and Apex Logic Receive "Tell Awards" for their business investments in Switzerland

Retrieved on: 
Monday, November 21, 2022
FDI, Acquisition, Environment, Government, Water, The Walt Disney Company, Software, Organon, ELC, Merck, Merck & Co., Consul, Fine chemical

NEW YORK, Nov. 21, 2022 /PRNewswire/ -- The Este Lauder Companies, Organon & Co., and Apex Logic have each won a 2022 Tell Award from the Swiss authorities, recognizing their significant foreign direct investment in Switzerland, reports Daniel Bangser, Trade Commissioner of Switzerland.

Key Points: 
  • NEW YORK, Nov. 21, 2022 /PRNewswire/ -- The Este Lauder Companies, Organon & Co., and Apex Logic have each won a 2022 Tell Award from the Swiss authorities, recognizing their significant foreign direct investment in Switzerland, reports Daniel Bangser, Trade Commissioner of Switzerland.
  • Ambassador Niculin Jger, The Consul General of Switzerland in New York, and Ambassador Balz Abplanalp, The Consul General of Switzerland in San Francisco, are presenting the awards to the leadership teams of each company.
  • Organon attributes its decision to set up in Lucerne to the opportunities offered in this growing environment for biopharmaceutical innovation.
  • Apex Logic is a privately-owned developer of software for e-commerce and for automating the acquisition process in government that established a European Headquarters in Fribourg in 2020.