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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's AmorphOX technology may pave the way for intranasal GLP-1 medication

    · A preclinical pharmacokinetic in-vivo study has been conducted in which the AmorphOX® technology was used to develop three powder-based intranasal formulations with semaglutide, which were compared with an oral and an injectable formulation. · AmorphOX formulations demonstrated significantly higher plasma concentrations and higher bioavailability than the oral tablet. · The data further demonstrate the ability of the AmorphOX powder-based intranasal formulation technology to develop formulations for large molecules that are well absorbed through mucosal membranes. Uppsala, Sweden,

    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 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 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 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: 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 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,

    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 announces FDA acceptance of New Drug Application filing for OX124, a high-dose rescue medication for opioid overdose

    · OX124 is based on Orexo´s world-class drug delivery platform, amorphOX®, and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl · Synthetic opioids are behind 91 percent of all fatal opioid overdoses in the US[1] · Prescription Drug User Fee Act date (PDUFA) set to July 15, 2024. If approved, US launch is expected to be initiated late 2024.   Uppsala, Sweden – November 28, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug

    Orexo announces changes in the company´s Board of Directors

    Uppsala, Sweden – October 27, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), announces that Robin Evers, Senior Vice President, Head of Global Regulatory Affairs & Global Safety, Medical Writing and R&D Quality, at Novo Nordisk A/S has become a member of the company´s Board of Directors. Robin Evers replaces Henrik Kjaer Hansen, who has announced he will resign after having represented Orexo´s largest shareholder, Novo Holdings A/S, since 2018. Henrik Kjaer Hansen will continue to work closely with Orexo as chairman of Orexo´sNomination Committee.   Robin Evers has more than 25

    Orexo to participate in Pareto Securities´ 14[th] Annual Healthcare Conference 2023

    Uppsala, Sweden – September 5, 2023 – Orexo AB (Publ.), (STO:ORX) (OTCQX:ORXOY), today announces the company will participate in Pareto Securities´ 14th Annual Healthcare Conference, that takes place on September 14, at Hotel At Six, Brunkebergstorg 6, Stockholm, Sweden.   On the day, between 3:25-3:45 CET (room Event Large), 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 & Communications Director

    Orexo submits New Drug Application to FDA for OX124, a high-dose rescue medication for opioid overdose

    · OX124 is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl · Nine out of ten fatal opioid overdoses in the US involve synthetic opioids · If approved, the US launch is expected to be initiated in H1 2024   Uppsala, Sweden – February 3, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose. OX124, is based on Orexo´s drug delivery platform

    Orexo appoints Fredrik Järrsten as new CFO

    Uppsala, Sweden – March 11, 2022 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), announces today that the company has appointed Fredrik Järrsten as new Chief Financial Officer (CFO) and a member of the management team, starting at latest in early September, 2022. Fredrik Järrsten will succeed Joseph DeFeo.   Fredrik Järrsten has a long and successful career as CFO of several Swedish life science companies, most recently Oasmia Pharmaceutical AB and Karolinska Development AB. Fredrik Järrsten also has an extensive experience from corporate development such as business development and M&A,

    Orexo develops a nasal adrenaline medication based on the novel amorphOX[TM] platform

    · The development pipeline is broadening with a nasal adrenaline medication, targeting a global and growing unmet medical need · If approved, the medication would provide important benefits to patients and health care systems ensuring the correct adrenaline dose is both reliably and conveniently available when needed · Development and commercial partnerships will be considered Uppsala, Sweden – December 2, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces it has initiated a new pharmaceutical development project, OX640, a nasal adrenaline product for the emergency

    Orexo provides information about its new proprietary drug delivery platform – amorphOX[TM]

    · amorphOXTM is a novel and inventive drug delivery platform that can be used to develop highly differentiated products with various active ingredients and administration routes                · The amorphOXTM platform provides for excellent chemical and physical stability, commonly a significant problem for amorphous drug compositions · Development of products based on amorphOXTM will be conducted by Orexo or in partnership with other pharmaceutical companies Uppsala, Sweden – November 26, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today provides information about its new

    Orexo announces positive results from pivotal trial for its leading pharmaceutical pipeline asset OX124

    · The pivotal trial OX124-002 meets the primary endpoints in the 4-period crossover, comparative bioavailability study in healthy volunteers · OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product · OX124 is designed to help in the fight against overdoses caused by the most powerful synthetic opioids that are behind the vast majority of fatal overdoses in the US · Upon approval Orexo will, along with ZUBSOLV® and MODIA™, have the most comprehensive range of treatment options for people suffering

    Orexo Q3 2021 Interim Report

    Steady progression on our journey to build a broader and stronger Orexo Q3 2021 highlights · Total net revenues of SEK 145.9 m (150.3) · Net earnings of -52.0 SEK  m (-84.9) · EBITDA of SEK -47.4 m (-20.9) · US Pharma segment (ZUBSOLV® US) net revenues of SEK 136.4 m (143.8), in local currency USD 15.8 m (16.2), US Pharma EBIT of SEK 78.5 m (72.4) · Cash flow from operating activities of SEK -79.7 m (-12.9), cash balance of SEK 588.1 m (593.3) · Earnings per share before dilution amounted to -1.51 (-2.45) · Commercial partnership agreement signed with Sober Grid,

    Orexo’s flagship pharmaceutical pipeline asset OX124 enters pivotal trial

    · The first cohort of healthy volunteers has been dosed. New Drug Application (NDA) filing expected in the second half of 2022. · OX124 is designed to reverse the effect of overdoses caused by the most powerful synthetic opioids that today are behind the vast majority of fatal overdoses in the US · Upon approval Orexo will along with ZUBSOLV® and modia™ have the most comprehensive range of treatment options for people suffering from opioid use disorder on the US market Uppsala, Sweden – July 16, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces that the company has

    Orexo signs commercial partnership agreement with Sober Grid allowing community users access to clinically proven digital therapies vorvida® and deprexis®

    · With more than 300,000 users Sober Grid is the largest global social media network for people in recovery from addiction · Community users will gain access to Orexo´s digital therapies for alcohol misuse and depression, which are among the most clinically proven digital tools available Uppsala, Sweden – July 12, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) and Sober Grid, the largest social media network for those in addiction recovery, today announced thatSober Grid’s more than 300,000 users will gain access to Orexo’s clinically proven digital therapies vorvida®, for

    Orexo continues to strengthen ZUBSOLV´s patent portfolio with two new patents

    Uppsala, Sweden – June 2, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces that the US Patent and Trademark Office (USPTO) has issued another two patents relating to ZUBSOLV®, Orexo’s sublingual buprenorphine and naloxone tablet (CII) for the treatment of opioid use disorder.The new patents, US Patent Nos. 11,020,387 and 11,020,388, expire in September 2032. Orexo will now have nine patents listed in the Orange Book relating to ZUBSOLV®.Nikolaj Sørensen, President and CEO, said: “I am pleased that the USPTO continues to recognize the uniqueness of the technology behind

    Orexo Q1 2021 Interim Report

    Investing in future growth driversQ1 2021 summary · Total net revenues of SEK 132.3 m (175.0) · Net earnings of SEK -31.5 m (82.6) · EBITDA of SEK -23.9 m (39.1) · US Pharma segment (ZUBSOLV® US) net revenues of SEK 126.8 m (163.9), EBIT of SEK 66.1 m (75.9) · Cash flow from operating activities of SEK -47.8 m (48.1), cash balance of SEK 725.5 m (861.4) · A new patent for OX124, overdose rescue medication, was issued by the US Patent and Trademark Office (USPTO), protecting the technology until 2039 · Issued a new corporate bond amounting to a nominal value of SEK

    Report from Orexo AB’s annual general meeting, 13 April 2021

    Election of the board of directors and auditor The annual general meeting in Orexo AB (publ) on 13 April 2021 resolved, in accordance with the nomination committee’s proposal, that the number of board members shall be eight with no deputy board members. James Noble, Staffan Lindstrand, David Colpman, Henrik Kjær Hansen, Kirsten Detrick, Fred Wilkinson, Mary Pat Christie and Charlotte Hansson were re-elected as ordinary board members. James Noble was re-elected as chairman of the board. Ernst & Young Aktiebolag was re-elected as auditor. Fees to the board of directors and the auditor

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