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  • Orexo
    Box 303 751 05 Uppsala
    +46 (0)18 780 88 00
    +46 (0)18 780 88 88
    http://www.orexo.com

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    With the acquisition of the rights to two digital health products from GAIA and the appointment of Dennis, a thought leader in the digital health industry in the US, we are well positioned to lead this development within the complementary disease areas of our pharmaceutical business.
    Nikolaj Sørensen, President and CEO
    Our strategy is to focus on solutions with scientifically proven therapeutic effect which will benefit the healthcare system as a whole and more importantly patients.
    Nikolaj Sørensen, CEO, about Digital Therapies
    I am convinced that DTx will become an integral and natural part of addiction treatment in the future. This digital therapy for OUD patients is perfectly positioned with Orexo’s competences and commercial organization in the US.
    Nikolaj Sørensen, President and CEO
    Mundipharma Australia has been a good partner in the approval process and we are confident that their experience and infrastructure will create a strong foundation for a successful launch of Zubsolv®
    Nikolaj Sørensen, President and CEO
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    Orexo announces positive topline data from clinical study of OX640 in subjects with and without allergic rhinitis

    · OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of allergic reactions (incl. anaphylaxis) and is based on the proprietary AmorphOX® technology · The clinical study, OX640-002, evaluated both pharmacokinetic and pharmacodynamic effects of OX640 in subjects with and without allergic rhinitis · OX640 treatments achieved clinically relevant plasma levels of epinephrine more rapidly than the intramuscular reference product · Absorption from OX640 under allergic rhinitis conditions was significantly faster than under normal conditions, supporting

    Orexo enters into collaboration with Abera to develop nasal powder vaccines based on the AmorphOX technology

    · The collaboration is in line with Orexo's strategy to broaden the use of its powder-based drug delivery technology AmorphOX®. · Abera is a developer of mucosal vaccines and has several preclinical vaccine candidates based on Abera's innovative vaccine platform. · The AmorphOX technology has the potential to improve the stability and efficacy of Abera's vaccine candidates.  Uppsala, December 17, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), continues to develop its innovative powder-based drug delivery technology AmorphOX to improve the properties of new or existing drugs. The

    Orexo Interim Report Q3 2024

    Q3 2024 highlights ›  Total net revenues of SEK 136.5 m (156.1) ›  EBITDA of SEK -0.7 m (-9.5) ›  Net earnings of SEK -41.9 m (-33.3) ›  US Commercial segment net revenues of SEK 131.0 m (140.4), in local currency USD 12.6 m (13.0) ›  Cash flow from operating activities of SEK -13.4 m (-21.9), cash and cash equivalents of SEK 114.9 m (184.2) ›  Earnings per share before and after dilution amounted to SEK -1.21 (-0.97) ›  Orexo AB´s sustainability work ranked among the top five percent of all 70,000 businesses worldwide reviewed by EcoVadis ›   For OX124, our high

    Orexo: Salem Tewolde, Head of Supply Chain, on solving real problems

    News Release  Salem shares her experiences of heading up the supply chain at Orexo, ensuring timely delivery of Zubsolv® and preparing to launch OX124. Furthermore, her passion for enabling sustainability. Hi Salem, how would you describe your role as Head of Supply Chain? I work with my team to make sure we have everything in place to maintain an uninterrupted supply of our commercial products to distribute. Right now, one of our primary focuses is on ensuring a sustainable supply chain for OX124, our high-dose rescue medication. A large part of my role is ensuring that the supply

    Orexo´s Nomination Committee for the Annual General Meeting 2025

    Uppsala, Sweden – October 4, 2024 – The members of the Nomination Committee for the Annual General Meeting (AGM), that takes place on May 8, 2025, have been appointed and comprises of the following members:   •        Henrik Kjaer Hansen, (Chairman, appointed by Novo Holdings A/S) •        Claus Berner Møller, (appointed by The Danish Labour Market Supplementary Pension, ATP) •        Stefan Hansson, (private investor) •        James Noble, (Chairman of the Board of Orexo)   The Nomination Committee represents approximately 34 percent of the number of votes in the

    Orexo to participate in Pareto Securities´ 15th Annual Healthcare Conference 2024

    Uppsala, Sweden – September 3, 2024 – Orexo AB (Publ.), (STO:ORX) (OTCQX:ORXOY), today announces the company will participate in Pareto Securities´ 15th Annual Healthcare Conference, that takes place on September 19, at Downtown Camper by Scandic, Brunkebergstorg 9, Stockholm, Sweden.   On the day, between 2:25-2:45 CET (room Event Small), Robert Rönn, SVP and Head of R&D, will give a company presentation. Robert Rönn and Lena Wange, Investor Relations, will also be available for 1-1 meetings. For more information, please contact: Orexo AB (publ.) Lena Wange, IR &

    Orexo Q2 2024 Interim Report

    Making progress, while the OX124 review time extended Q2 2024 highlights›     Total net revenues of SEK 154.0 m (157.7)›     EBITDA of SEK 5.0 m (5.6) ›     Net earnings of SEK -35.9 m (-12.6)›     US Commercial segment net revenues of SEK 147.9 m (145.4), in local currency USD 13.9 m (13.8)›     Cash flow from operating activities of SEK -6.5 m (-12.7), cash and cash equivalents of SEK 139.7 m (251.1)›     Earnings per share before and after dilution amounted to SEK -1.04 (-0.37)›     Second patent in the US granted for OX640, a nasal epinephrine powder product ›     The

    Orexo shares new information on OX124, a high-dose naloxone rescue medication in development for opioid overdose

    Uppsala, Sweden – July 16, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces that the company has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication in development for opioid overdose. The NDA was submitted to the FDA on September 18, 2023. The CRL indicates the need for an additional Human Factors (HF) study, which is in line with previous communication. Furthermore, additional technical data on the final commercial product has been requested. The

    Orexo AB´s sustainability work ranked among top 5% by EcoVadis

    Uppsala, Sweden – July 10, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) announces that it has received a Gold Sustainability Rating by EcoVadis, one of the world´s most trusted provider of business sustainability ratings. The highly revered award places the company in the top 5 percent of all 70,000 businesses worldwide that are reviewed by EcoVadis each year.    This top rating is based on Orexo AB’s first year of reporting to EcoVadis and mainly includes sustainability data related to the business in Sweden, covering Group headquarters functions, R&D, Regulatory Affairs, Quality

    Orexo: invitation to presentation of the Q2 2024 Interim Report

    Uppsala, Sweden – Juli 8, 2024 – As previously communicated Orexo will announce the Interim Report for the second quarter of 2024 on July 17 at 8 am CET. The same day at 2 pm, analysts, investors, and media are invited to attend a presentation where Nikolaj Sørensen, CEO, and Fredrik Järrsten, CFO, will present the latest development and host a Q&A. To attend via teleconference where you can ask questions verbally use this link:  https://conference.financialhearings.com/teleconference/?id=50048737 

    Orexo publishes prospectus and applies for admission to trading of social bonds on Nasdaq Stockholm

    Uppsala, Sweden – May 10, 2024. On March 28, 2024, Orexo AB (publ), (“Orexo” or the “Company”) (STO:ORX) (OTCQX:ORXOY) successfully issued senior secured callable floating rate social bonds in an amount of SEK 500 million and with a tenor of four years (the “Bonds”). Pursuant to the terms and conditions for the Bonds, Orexo has undertaken to apply for admission to trading of the Bonds on the sustainable bond list of Nasdaq Stockholm. For this purpose, the Company has prepared a listing prospectus, which today has been approved by the Swedish Financial Supervisory Authority (Sw.

    Orexo Q1 2024 Interim Report

    Starting 2024 with a positive EBITDAQ1 2024 highlights›     Total net revenues of SEK 139.3 m (158.8)›     EBITDA of SEK 15.9 m (-41.1) ›     Net earnings of SEK -8.9 m (-63.9)›     US Commercial segment net revenues of SEK 129.3 m (140.3), in local currency USD 12.4 m (13.5)›     Cash flow from operating activities of SEK -18.9 m (-61.6), cash and invested funds of SEK 198.0 m (278.9)›     Earnings per share before and after dilution amounted to SEK -0.26 (-1.86)›     MODIA® and Vorvida® were reimbursed within the US Veterans Affairs Federal Supply Schedule as of January 1,

    Fentanyl awareness day: The synthetic opioid fentanyl increasingly poisons young Americans

    In 2023, the Drug Enforcement Agency seized 74.5 million pills containing fentanyl.[i] This record-breaking number helps to explain why so many young people are experiencing unintended fentanyl poisonings. This article explores the risks and why young people are more susceptible to the dangers of taking, and dying from, illicitly manufactured fentanyl pills.   Charlie, was just 22 when he overdosed and died after taking what he thought was a Percocet that he’d bought over the internet. It turned out to be a fake pill that contained illicit fentanyl.[ii] The opioid epidemic began as a

    Invitation to presentation of Orexo´s Q1 2024 Interim Report

    Uppsala, Sweden – May 2, 2024 – As previously communicated Orexo will announce the Interim Report for the first quarter of 2024 on May 8 at 8 am CET. The same day at 1 pm, analysts, investors, and media are invited to attend a presentation where Nikolaj Sørensen, CEO, and Fredrik Järrsten, CFO, will present the latest development and host a Q&A. To attend via teleconference where you can ask questions verbally use this link: https://conference.financialhearings.com/teleconference/?id=50048736 

    Report from Orexo AB’s annual general meeting, 26 April 2024

    Election of the board of directors and auditor The annual general meeting in Orexo AB (publ) on 26 April 2024 resolved, in accordance with the nomination committee’s proposal, that the number of board members shall be five with no deputy board members. James Noble, Staffan Lindstrand, Fred Wilkinson, Christine Rankin and Robin Evers were re-elected as ordinary board members. James Noble was elected as chairman of the board. Ernst & Young Aktiebolag was re-elected as auditor.   Fees to the board of directors and the auditor The annual general meeting also resolved on fees to the

    Orexo extends patent protection for its nasal epinephrine powder product OX640 in the US

    Uppsala, Sweden – April 17, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces that the United States Patent and Trademark Office (USPTO) has granted another US patent specifically related to OX640, Orexo’s nasal epinephrine powder product based on the AmorphOX® drug delivery platform.   In August 2023, the USPTO granted the first patent for OX640 in the US, providing protection until May 2041. The newly issued patent, US Patent No. 11,957,647, provides both expanded scope of protection as well as longer patent term, now extending until November 2042. Orexo has multiple

    Orexo announces that the condition for early redemption of its existing bonds has been fulfilled

    Uppsala, Sweden – April 2, 2024. On March 13, 2024, Orexo AB (publ), (“Orexo” or the “Company”) (STO:ORX) (OTCQX:ORXOY) announced that the Company intends to redeem early the Company’s existing senior unsecured bonds with maturity in February 2025 (ISIN SE0015193958) (the “Existing Bonds”). The early redemption was conditional upon that settlement of the Company’s issue of new senior secured social bonds with a tenor of four years has occurred, which is further described in the Company’s press release on March 13, 2024. This condition has been fulfilled and the early redemption is

    Orexo publishes the Annual and Sustainability Report for 2023

    Uppsala, Sweden - March 28, 2024 – Orexo’s Annual and Sustainability Report for 2023 has been published and can be downloaded at, www.orexo.com. The Swedish version of the Report is also available on the company´s website in European Single Electronic Format (ESEF). A PDF version is attached to this press release.   Nikolaj Sørensen, President and CEO, said: “In 2023, we continued our path to make a difference for patients with opioid dependence. I am particularly pleased with the NDA filing of OX124, a high-dose rescue medication for opioid overdose. In addition, we saw a recovery in

    Correction: Notice of Annual General Meeting of Orexo

    The correction concerns the proposal regarding the number of board members as stated in the Swedish language version of the notice, which shall be five with no deputy members.   The shareholders in Orexo AB (publ), reg. no. 556500-0600, registered office Uppsala, are summoned to the annual general meeting, to be held on Friday 26 April 2024, at 16.00 pm in Orexo’s facilities at Rapsgatan 7E in Uppsala, Sweden.   Participation, etc.   Shareholders who wish to participate in the meeting must be recorded in the share register maintained by Euroclear Sweden AB on Thursday 18

    Notice of Annual General Meeting of Orexo

    The shareholders in Orexo AB (publ), reg. no. 556500-0600, registered office Uppsala, are summoned to the annual general meeting, to be held on Friday 26 April 2024, at 16.00 pm in Orexo’s facilities at Rapsgatan 7E in Uppsala, Sweden.   Participation, etc.   Shareholders who wish to participate in the meeting must be recorded in the share register maintained by Euroclear Sweden AB on Thursday 18 April 2024, and notify Orexo of their intention to attend the meeting not later than on Monday 22 April 2024 by post to Orexo AB, P.O. Box 303, SE-751 05 Uppsala, Sweden, by telephone

    Orexo successfully issues senior secured callable floating rate social bonds of SEK 500 m and announces results of the tender offer for its existing bonds

    Uppsala, Sweden – March 13, 2024. Orexo AB (publ), (“Orexo” or the “Company”) (STO:ORX) (OTCQX:ORXOY) has successfully issued new senior secured callable floating rate social bonds in an amount of SEK 500 million and with a tenor of four years (the “New Social Bonds”). The New Social Bonds carry a floating rate interest of 3m STIBOR + 650 basis points per annum and the net proceeds will be applied in accordance with the principles set out in Orexo’s social financing framework, including but not limited to, refinancing of Orexo’s existing senior unsecured callable floating rate bonds of SEK

    Leading with purpose: Why Cecilia Coupland became an Orexo executive

    News Release – Uppsala, Sweden, Mars 8, 2024   In this interview to mark International Women’s Day 2024, Cecilia Coupland, SVP and Head of Operations, shares her values-led approach to leadership, why she’s stayed with Orexo for 18 years and what motivates her each day.   Our people make it easy for me to be a leader Since the first International Women’s Day was celebrated in 1911, gender equality has come a long way. It’s a privilege to work with the brilliant and competent people we have at Orexo, and I’m a leader here not because I’m a woman, but because I’m good at my job.

    Orexo contemplates issuance of senior secured callable floating rate social bonds and announces a conditional tender offer for its existing bonds

    Uppsala, Sweden – March 8, 2024 - Orexo AB (publ), (“Orexo” or the “Company”) (STO:ORX) (OTCQX:ORXOY) has mandated ABG Sundal Collier and Carnegie Investment Bank as arrangers and joint bookrunners to arrange a series of fixed income investor meetings commencing on March 11, 2024, to explore the possibility to issue new senior secured callable floating rate social bonds in an expected amount of SEK 500,000,000 and with a tenor of four years (the “New Social Bonds”). Subject to, inter alia, market conditions, a capital markets transaction may follow. The net proceeds from the contemplated

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