Latest news with #Orexo
Yahoo
02-06-2025
- Business
- Yahoo
Orexo to present clinical data for OX640 at the EAACI Congress
OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of severe allergic reactions (including anaphylaxis) and is based on the proprietary AmorphOX® technology EAACI is a leading global association devoted to allergic and immunology diseases Orexo´s advisor Dr. Anne K Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University, Ontario, CA, will present data from the OX640-002 clinical study. UPPSALA, Sweden, June 2, 2025 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), announces the company will attend the 2025 EAACI Congress in Glasgow, UK, on June 13-16. The European Academy of Allergy and Clinical Immunology (EAACI) is a leading global association for the treatment of allergic and immunology diseases, including members representing over 16,000 clinicians, researchers, and health professionals from 125 countries. On June 15, Dr. Anne K. Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University (Kingston, Ontario, Canada) and advisor to Orexo will present on behalf of the company. Dr. Anne K. Ellis will present data from the OX640-002 clinical study, which, among other findings, demonstrated that epinephrine was absorbed significantly faster under allergic rhinitis conditions compared to normal conditions. These results support a rapid onset of action, even in patients experiencing airway symptoms. In addition to the oral presentation, Orexo's SVP and Head of R&D, Robert Rönn, will present a scientific poster demonstrating detailed stability data for OX640. "We look forward to attending this important congress. Thanks to our powder-based drug-delivery technology, AmorphOX®, we are able to present strong data from the second clinical study of OX640, along with a leading stability profile. I am confident that OX640 has the potential to become a convenient, effective, and reliable rescue medication for people at risk of severe allergic reactions," said Robert Rönn, SVP and Head of R&D. For further information contact:Nikolaj Sørensen, President and CEOLena Wange, IR & Communications Director+46 (0)18 780 88 00ir@ About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to SEK 590 million, and the number of employees 110. Orexo is listed on Nasdaq Stockholm's main list and is available as ADRs (ORXOY) on the OTCQX market in the US. For more information on Orexo, visit You can also follow Orexo on X, LinkedIn, and YouTube. About AmorphOX® Orexo's proprietary drug-delivery platform, AmorphOX, is a powder made up of particles that are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. About OX640 OX640 is a nasal epinephrine powder-based product for the acute treatment of severe allergic reactions, including anaphylaxis. The product is based on the proprietary AmorphOX drug-delivery platform providing rapid and extensive systemic drug absorption after nasal administration as well as excellent physical and chemical stability. Thanks to its unique properties, OX640 has the potential to provide allergic patients with a needle-free, convenient, and rapidly acting allergy rescue product that also has a long shelf-life and allows for flexible storage, both in hot and cold temperatures. About the OX640-002 study The study was a 4-period cross-over study in 30 otherwise healthy subjects with seasonal allergic rhinitis. The study was conducted during allergy season with no ongoing allergy symptoms in subjects. Epinephrine plasma levels, blood pressure and heart rate were collected after administration of two different doses of OX640 and 0.3 mg intramuscular epinephrine. In one treatment period, one of the OX640 doses was administered following nasal administration of allergens, producing acute allergic rhinitis symptoms in the subjects. #EAACI2025 #TogetherForAllergy The information was submitted for publication at 8.00 am CET on June 2, 2025. This information was brought to you by Cision The following files are available for download: Orexo PR Orexo to present clinical data for OX640 at the EAACI Congress Publ June 2 View original content: SOURCE Orexo Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-06-2025
- Business
- Yahoo
Orexo to present clinical data for OX640 at the EAACI Congress
OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of severe allergic reactions (including anaphylaxis) and is based on the proprietary AmorphOX® technology EAACI is a leading global association devoted to allergic and immunology diseases Orexo´s advisor Dr. Anne K Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University, Ontario, CA, will present data from the OX640-002 clinical study. UPPSALA, Sweden, June 2, 2025 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), announces the company will attend the 2025 EAACI Congress in Glasgow, UK, on June 13-16. The European Academy of Allergy and Clinical Immunology (EAACI) is a leading global association for the treatment of allergic and immunology diseases, including members representing over 16,000 clinicians, researchers, and health professionals from 125 countries. On June 15, Dr. Anne K. Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University (Kingston, Ontario, Canada) and advisor to Orexo will present on behalf of the company. Dr. Anne K. Ellis will present data from the OX640-002 clinical study, which, among other findings, demonstrated that epinephrine was absorbed significantly faster under allergic rhinitis conditions compared to normal conditions. These results support a rapid onset of action, even in patients experiencing airway symptoms. In addition to the oral presentation, Orexo's SVP and Head of R&D, Robert Rönn, will present a scientific poster demonstrating detailed stability data for OX640. "We look forward to attending this important congress. Thanks to our powder-based drug-delivery technology, AmorphOX®, we are able to present strong data from the second clinical study of OX640, along with a leading stability profile. I am confident that OX640 has the potential to become a convenient, effective, and reliable rescue medication for people at risk of severe allergic reactions," said Robert Rönn, SVP and Head of R&D. For further information contact:Nikolaj Sørensen, President and CEOLena Wange, IR & Communications Director+46 (0)18 780 88 00ir@ About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to SEK 590 million, and the number of employees 110. Orexo is listed on Nasdaq Stockholm's main list and is available as ADRs (ORXOY) on the OTCQX market in the US. For more information on Orexo, visit You can also follow Orexo on X, LinkedIn, and YouTube. About AmorphOX® Orexo's proprietary drug-delivery platform, AmorphOX, is a powder made up of particles that are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. About OX640 OX640 is a nasal epinephrine powder-based product for the acute treatment of severe allergic reactions, including anaphylaxis. The product is based on the proprietary AmorphOX drug-delivery platform providing rapid and extensive systemic drug absorption after nasal administration as well as excellent physical and chemical stability. Thanks to its unique properties, OX640 has the potential to provide allergic patients with a needle-free, convenient, and rapidly acting allergy rescue product that also has a long shelf-life and allows for flexible storage, both in hot and cold temperatures. About the OX640-002 study The study was a 4-period cross-over study in 30 otherwise healthy subjects with seasonal allergic rhinitis. The study was conducted during allergy season with no ongoing allergy symptoms in subjects. Epinephrine plasma levels, blood pressure and heart rate were collected after administration of two different doses of OX640 and 0.3 mg intramuscular epinephrine. In one treatment period, one of the OX640 doses was administered following nasal administration of allergens, producing acute allergic rhinitis symptoms in the subjects. #EAACI2025 #TogetherForAllergy The information was submitted for publication at 8.00 am CET on June 2, 2025. This information was brought to you by Cision The following files are available for download: Orexo PR Orexo to present clinical data for OX640 at the EAACI Congress Publ June 2 View original content: SOURCE Orexo
Yahoo
07-05-2025
- Business
- Yahoo
Orexo AB (LTS:0H19) Q1 2025 Earnings Call Highlights: Navigating Challenges and Optimizing Growth
Q : Can you provide more details on the transition to the new device for OX124 and the timeline for this process? A : Nikolaj Sorensen, CEO: The transition to the new device for OX124 involves minimal changes, primarily in the handling of the device. We are starting the manufacturing switch now and do not anticipate major work. The timeline depends on FDA discussions, but we are using the delay in receiving the original device component to prepare for the new device. We expect minimal commercial implications and will update once we have FDA feedback. The company experienced a decline in volumes for its main product, Subsol, particularly due to high deductibles and Medicare policy changes. There are ongoing uncertainties with the FDA, causing delays in drug approvals and impacting timelines for product launches. The strengthening of the SEK against the US dollar negatively impacted the company's cash position. Orexo AB ( LTS:0H19 ) faced challenges due to changes in Medicare policies in the US, impacting volume and pricing. The company is optimistic about reaching a partnership agreement for OX640 later this year, which could enhance future growth prospects. Orexo AB ( LTS:0H19 ) has a natural hedge against currency fluctuations due to a significant portion of expenses being in US dollars. Orexo AB ( LTS:0H19 ) reported stable revenue in both SEK and US dollars compared to last year, with a slight increase driven by lower inventory decline. For the complete transcript of the earnings call, please refer to the full earnings call transcript. Financial Outlook for 2025: Subsol net sales expected between USD50 to USD55 million; Group EBITDA expected to be positive for the full year. Story continues Q: Is there any ongoing work for OX640, and what are the next steps for partnering? A: Nikolaj Sorensen, CEO: We are adjusting the manufacturing process for OX640 based on recent study results and preparing to upscale production. We aim to have a partner in place before starting full-scale manufacturing, as some partners may want more control over the supply chain. Discussions with potential partners are ongoing. Q: Can you elaborate on the market position of Suboxone and the reasons for the volume decline? A: Nikolaj Sorensen, CEO: The volume decline is mainly due to United Health Group's high deductibles and Humana's changes in Medicare policy. These factors have historically impacted Q1 volumes. Despite a slight market share decrease, our market position remains stable, and we expect volumes to recover in subsequent quarters. Q: How is the strategic overview of Orexo affected by market volatility, and what are the plans for potential partnerships? A: Nikolaj Sorensen, CEO: We are focusing on optimizing our R&D pipeline and exploring partnering strategies for Amorphox. While the market is volatile, we are not in a hurry to make strategic moves. We are open to discussions with companies interested in partnerships, but we are satisfied with our current US business performance. Q: What is the outlook for Orexo's financial performance and cash flow management? A: Fredrik Jarrsten, CFO: We have a stable financial position with a focus on cash flow optimization. Our US business is profitable, and we are continuously improving cost efficiency. We expect positive cash flow from operations and are comfortable with our working capital position. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
