Aankondiging • May 21
Orexo AB Announces Positive Outcome from In-Vivo Study of OX390 Orexo AB (publ.) announced positive data from a pre-clinical in-vivo study on the nasal absorption of atipamezole when delivered with Orexo's AmorphOX drug delivery technology. The study results mark an important milestone in the development of OX390, an emergency treatment to reverse overdoses involving xylazine and medetomidine, alpha-2 agonists often referred to as "Tranq" and "Rhino Tranq", respectively. The study demonstrated rapid and substantial intranasal absorption of atipamezole, successfully establishing proof-of-concept across multiple formulations. The results support that a single nasal dose of OX390 achieves exposure within the targeted therapeutic range. The next milestone in the project is an upcoming type C meeting with the FDA to agree on the non-clinical development plan that will enable human clinical trials. This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50125C00010. OX390 is designed to reverse respiratory depression associated with adulterated illicit opioid overdoses. Emerging evidence indicates that opioid-induced respiratory suppression (OIRD) may be greatly magnified in the presence of increasingly common adulterants, and that opioid antagonists such as naloxone and nalmefene may not be sufficient to revive victims of these overdoses. OX390 will be developed as a rapidly acting intranasal powder using Orexo's proprietary powder-based drug delivery technology AmorphOX for community-based use by first responders and laypersons. OX390 is an investigational compound, containing atipamezole, and is not approved for human use by the FDA. 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. Aankondiging • Mar 07
Orexo AB (publ.) Announces Executive Changes Orexo AB (publ.) on March 6, 2026 announced changes to its organizational structure and management team. The changes are a result of the divestment of Zubsolv in the US market and focus on advancing development programs and the AmorphOX technology. Lisa Moore, who has been part of Orexo's US leadership team since May 2024, will assume a new responsibility as Senior Vice President, Products and Portfolio Strategy. In her new role, she will be responsible for driving the long-term product vision for the development candidates, ensuring that the portfolio meets customer needs and that investment decisions support business growth. Lisa Moore is a biopharma industry leader with more than 25 years of experience in commercial, new product planning, and strategy roles. Prior to joining Orexo in 2024, she was Vice President, Global Commercial Strategy at Emergent, where she also led the commercial valuation of M&A opportunities. She has previously held management positions at MedImmune, Parke-Davis, Baxter International, and Merck. Lisa Moore will be a part of Orexo´s management team and report directly to the CEO. She will participate in Orexo's R&D Day on March 24, 2026 in Stockholm. Robert DeLuca, President of Orexo US Inc. since the launch of the US commercial organization in 2013, has been instrumental in building the US business, leading the successful commercialization of Zubsolv and advancing Orexo's mission to help curb the US opioid epidemic. Robert DeLuca will retire from his role at the company. Robert DeLuca will continue in his role as President of Orexo US Inc. through May 2026. He will also, after May continue to support the company with strategic projects and with the transition of Zubsolv US to Dexcel Pharma USA in an advisory role. Aankondiging • Jan 23
Orexo AB (publ) to Report Fiscal Year 2025 Results on Feb 05, 2026 Orexo AB (publ) announced that they will report fiscal year 2025 results at 7:00 AM, Central European Standard Time on Feb 05, 2026 Aankondiging • Jan 02
Dexcel Pharma USA, LLC acquired Zubsolv US business from Orexo AB (publ) (OM:ORX). Dexcel Pharma USA, LLC signed an asset purchase agreement to acquire Zubsolv US business from Orexo AB (publ) (OM:ORX) for approximately $110 million on December 22, 2025. The consideration includes a cash payment of $91 million will be paid and a contingent payment of up to $16.8 million based on future Zubsolv net sales during 2026 and 2027. Of this amount, $3 million will be deposited into an escrow account and $4–5 million relating to the acquired inventory. As part of consideration, $107.8 million is paid towards assets of Zubsolv US business of Orexo.
The Zubsolv US business had net sales LTM of $49 million and EBIT of $17 million. The transaction is expected to close by January 31, 2026.
Leerink Partners LLC acted as financial advisor for Orexo AB. Steptoe LLP acted as legal advisor for Orexo AB.
Dexcel Pharma USA, LLC completed the acquisition of Zubsolv US business from Orexo AB (publ) (OM:ORX) on December 31, 2025. Aankondiging • Oct 18
Orexo AB (publ), Annual General Meeting, Mar 02, 2026 Orexo AB (publ), Annual General Meeting, Mar 02, 2026. Aankondiging • Sep 06
Orexo AB (Publ) Announces Positive Pharmacokinetic In-Vivo Data for A Powder-Based Intranasal Semaglutide Formulation Developed with the Amorphox Technology Orexo AB (publ.) announced positive pharmacokinetic in-vivo data for a powder-based intranasal semaglutide formulation developed with the AmorphOX technology. In the in-vivo study, three different formulations of powder semaglutide were administered intranasally. For comparison, Rybelsus®?, a semaglutide tablet, was administered orally, and Wegovy®?, injectable semaglutide, was administered subcutaneously. At the median values, two of the AmorphOX powder formulations had a sevenfold increase in plasma values when compared to the oral tablet, although as expected they had lower values than the injectable. In addition to higher exposure than the oral route, the AmorphOX formulations exhibited lower variability in plasma concentration. The data generated further supports the ability of the AmorphOX technology to formulate large molecules into powders that could be delivered intranasally. An AmorphOX-formulated intranasal semagLutide may provide needle-free delivery with improved convenience, potentially better adherence, and would not require refrigeration. Dosing schedules, depending on intranasal dosage strength and therapeutic levels achieved, may also be extended to require less frequent dosing than the oral route. Aankondiging • Apr 10
Orexo Announces Positive In-Vivo Proof-Of-Concept Data for Powder-Based Intranasal Vaccine Formulated with the Amorphox Technology Orexo AB (publ.) announced positive in-vivo proof-of-concept data for a powder-based intranasal vaccine candidate formulated with the AmorphOX technology. The data was generated under the collaboration between Orexo and Abera Biosciences ("Abera") entered in December 2024. The proof-of-concept study was conducted in rats where Abera's influenza vaccine candidate was administered intranasally, either formulated as a liquid nasal solution or as an intranasal powder using Orexo's AmorphOX technology. Both formulations induced strong systemic antibody response in serum (IgG) as well as locally in the nose and lungs (IgA). No difference in immune response was seen between the liquid nasal solution and the intranasal powder. An intranasal influenza vaccine has the potential to easily and effectively help reduce the spread of infections and prevent disease, which could play an important role in a potential future pandemic. Formulating vaccines in powder form using the AmorphOX technology provides the potential to develop cost-efficient, thermostable vaccines with no need for cold chain requirements. Aankondiging • Apr 03
Orexo AB (publ), Annual General Meeting, May 08, 2025 Orexo AB (publ), Annual General Meeting, May 08, 2025, at 16:00 W. Europe Standard Time. Location: at rapsgatan 28 in uppsala, Sweden Aankondiging • Mar 26
Orexo AB (publ) to Report Fiscal Year 2024 Final Results on Mar 28, 2025 Orexo AB (publ) announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Mar 28, 2025 Aankondiging • Jan 10
Orexo AB (publ) Announces Positive Topline Results from the Clinical Study OX640-002 Orexo AB (publ.) announced positive topline results from the clinical study OX640-002. The study evaluated the performance in subjects with and without allergic rhinitis when treated with Orexo's nasal rescue medication including powder-based epinephrine, OX640. The study was a cross-over study in 30 subjects assessing absorption and pharmacodynamic effects of epinephrine from two doses of OX640, with one of the doses also administered during ongoing allergic rhinitis symptoms. Exposure was compared to a commercial intramuscular injection. Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. Absorption under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with significant airway symptoms. OX640 formulations typically produced more pronounced increases in blood pressure and heart rate than the intramuscular injections, which are key effects for treatment of anaphylaxis. Systemic safety was in line with the known pharmacology of epinephrine and local effects were transient and tolerated. There were no severe or serious adverse events. Aankondiging • Dec 16
Orexo Resolves Zubsolv US Patent Litigation with Sun Pharmaceutical Industries Orexo AB (publ.) announced that it has entered into a settlement agreement with Sun to resolve the patent litigation regarding Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII), for the treatment of opioid use disorder in the US. The agreement resolves the patent litigation commenced in 2020 by Orexo following Sun's filing of an Abbreviated New Drug Application ("ANDA") seeking approval to market generic versions of Zubsolv in the US prior to the expiration of Orexo's patents listed in FDA's Orange Book for Zubsolv. The agreement allows Sun to enter the US market with its generic versions of Zubsolv in September 2030. Zubsolv is protected by ten patents in the US with expiration dates ranging from 2027 to 2032. This settlement agreement does not implicate its patent protection. Aankondiging • Oct 23
Orexo AB (publ) Initiates New Study of OX640 in Participants with Allergic Rhinitis Orexo AB (publ.) announced the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine, in a new study in subjects with allergic rhinitis (hay fever). The study will be completed during 2024 with results available early in 2025. Following the positive results from the phase 1 clinical study, OX640-001, where OX640 showed absorption of epinephrine and effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector, Orexo now advances the development of OX640. In the new study, OX640-002, the epinephrine absorption from OX640 will be investigated in participants with and without allergic symptoms in the nose. As patients may experience allergic symptoms in the nose during anaphylaxis, it is critical to understand the absorption of epinephrine from Orexo's unique powder formulation under these conditions. The study is a cross-over study in 30 participants with allergic rhinitis and involves four treatment periods. In one of the periods, a small dose of an allergen will be sprayed into the nose of the participants to trigger an allergic reaction before being treated with OX640. This will be compared with absorption of epinephrine from OX640 without the allergen, and a commercial intramuscular epinephrine product. The fourth period will be used to document dose proportionality of OX640. In addition to the absorption of epinephrine, effects on blood pressure and heart rate will be measured as relevant parameters to understand the effect of OX640 in case of an anaphylaxis. Aankondiging • Oct 04
Orexo AB (publ) Announces Nomination Committee for the Annual General Meeting 2025 Orexo AB (publ) announced 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% of the number of votes in the company as of August 31, 2024. The Nomination Committee will prepare proposals to the AGM regarding Chairman of the meeting, Chairman of the Board, Board members, Board member fees, any remuneration for committee work, and fees to the auditor, as well as principles for the composition of the Nomination Committee. Aankondiging • Apr 17
Orexo Extends Patent Protection for Its Nasal Epinephrine Powder Product OX640 in the US Orexo AB 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 patent applications filed on a global basis and expects to continuously strengthen the patent portfolio for OX640. Aankondiging • Mar 22
Orexo AB (Publ) Announces Board Resignations Orexo AB (publ) announced the board members Mary Pat Christie, Charlotte Hansson and Michael J Matly have declined re-election. Aankondiging • Feb 08
Orexo AB (publ) to Report Q4, 2024 Results on Feb 06, 2025 Orexo AB (publ) announced that they will report Q4, 2024 results at 8:00 AM, Central European Standard Time on Feb 06, 2025 Aankondiging • Nov 29
Orexo AB (Publ) Announces FDA Acceptance of New Drug Application Filing for OX124 Orexo AB (publ.) announced the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo's world-classdrug delivery platform, amorphOX. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay. OX124 will meet the growing need for more powerful medications to improve the possibility of reviving individuals experiencing an overdose caused by use of synthetic opioids, such as fentanyl, which cause 91% of all fatal opioid overdoses. OX124 is a potent medication and, in combination with rapid absorption and high bioavailability, this makes it capable of reversing an overdose or sustaining consciousness in a patient who has taken synthetic opioids. A MorphOX is an innovative powder-based technology that, in addition to rapid absorption and high bioavailability., improves stability and reduces sensitivity related to temperature changes. For users and lay-people OX124 has the potential to become an efficient and reliable rescue medication independent of temperature variations during storage, for example its efficacy is not affected at freezing temperatures. OX124 is protected by patents until 2039. Driven by the need to increase access to overdose medication, low-dose products, including the market leader, have recently been approved by the FDA as non-prescription over-the-counter (OTC) products. Historically, OTC products in the US have had limited reimbursement from insurance companies and, when applying similar industry analogues going forward, this may provide an advantage to high-dose prescription naloxone products, such as OX124. In addition, high-dose prescription products are expected to benefit from the continued expansion of mandatory co-prescription of naloxone when prescribing opioids to at-risk patients suffering from pain. Aankondiging • Oct 24
Orexo AB (publ), Annual General Meeting, Apr 26, 2024 Orexo AB (publ), Annual General Meeting, Apr 26, 2024. Aankondiging • Oct 11
Orexo AB (publ) Announces Data from the MODIA Study Evaluating Impact on Use of Illicit Opioids Orexo AB (publ) reported top line results after having completed a study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder (OUD) and reduction in use of illicit opioids. The study had unexpectedly high treatment response rates for both treatment arms, with no statistically significant difference in treatment response in the full population. No adverse events associated with the use of MODIA were reported. An exploratory analysis of patients randomized to MODIA found that those who completed all 24 modules had a significantly higher rate of treatment response than those who did not complete the entire program. A comprehensive Medication-Assisted Treatment (MAT) approach that combines medications for OUD with psychosocial support is recommended for optimal outcomes. Education of patients with OUD is critical to help them understand their disease, their treatment, and strategies to support their recovery. As a browser-based digital program that can be accessed remotely at any time, MODIA provides flexible access to educational content and exercises that are based on cognitive behavioral therapy principles. The study was a randomized, open-label, parallel-group study, enrolling patients aged 18 to 65 across the US who voluntarily sought treatment for documented moderate to severe OUD. Participants were inducted and stabilized on buprenorphine/naloxone during a brief screening period, then evaluated during weekly visits over the course of 24 weeks, with a primary endpoint defined as the subject having =80 percent of urine drug tests negative for illicit opioids and negative self-reports for illicit opioid use during the final 20 weeks of the study. Patients were randomized to receive weekly medication management i.e., background study care (BSC), or BSC in addition to MODIA. The study enrolled 437 patients at 36 centers across the US. Study completion rates were similar (55% BSC, 52% MODIA), as were treatment response rates (32% BSC, 31% MODIA). There was no statistically significant difference between treatment arms in any pre-specified endpoint of the study. These unexpectedly high treatment response rates exceeded those of similarly designed trials of long-acting injectable buprenorphine, which had 18 and 24 study visits (17% and 29%, respectively). An exploratory analysis of the 219 patients randomized to MODIA who subsequently completed the entire study (n=114), found that the 61 patients that completed all 24 modules of MODIA had a significantly higher treatment response rate of 61% than those that did not complete the entire program (n=53), who had a treatment response rate of 38% (p=0.0146). The difference in treatment response rate emerged after completion of 12 modules. In addition, the study showed indications of improved psychosocial outcome for those who completed MODIA which will be explored further in continued post hoc analysis. MODIA is designed to educate patients on behavioral changes that can support their recovery journey, and to empower them with techniques to help them cope with the challenges of everyday life. To support the patients’ healthy recovery, adherence to the program is important and Orexo will work with the developer of MODIA, GAIA AG to add functionality to MODIA to further improve adherence. In the study 38% of patients reported at least one adverse event. Overall reporting of adverse events was similar between treatment arms, and no adverse events associated with the use MODIA were reported. The company will continue to commercialize MODIA with limited changes as a mobile medical device subject to FDA enforcement discretion following the expected expiration of the COVID Public Health Emergency Guidance in November 2023. Under enforcement discretion MODIA will be positioned as a supportive resource for patients undergoing a clinician-directed treatment, rather than as a physician-prescribed treatment regimen. The study results indicate there is high value in the combination of high frequency interactions with health care providers and completion of the MODIA program, as well as MODIA’s strong safety profile. The company is continuing to analyze the study data and will continue to collect data to show the value of MODIA in supporting the patients with OUD to get their lives back. Aankondiging • Oct 05
Orexo AB (Publ) Announces Henrik Kjær Hansen Will Resign from the Board of Directors Orexo AB (publ) announced that the board member Henrik Kjær Hansen will resign from the board of directors in connection with the Extraordinary General Meeting. Aankondiging • Sep 18
Orexo AB (publ.) Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Over Overio Overio Overio Overio Orexo AB (publ.) announced the submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OX124, a high-dose rescue medication for opioid overdose with nasal delivery. 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. The submission is supported by data from the pivotal study in healthy volunteers, OX124-002, where OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In addition, development formulations of OX124 have in a previous exploratory clinical study (OX124-001) in healthy volunteers, demonstrated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator. OX124 is protected by patents until 2039. If approved OX124 will meet the significant and growing need of more powerful rescue medications improving the possibility to revive individuals who have got an overdose caused by use of synthetic opioids, such as opioid. During the latest 12-month period, ending April 2023, the predicted annual number of fatal overdoses in the US encountered for more than 110.000. The great majority, 76%, refers to opioid overdoses, and of these 91% involved synthetic opioids. The technical issues with the packaging process, which earlier this year gave rise to FDA's request for filing a new NDA, have now been solved in partnership with the contract manufacturer. To ensure the manufacturing process meets the reliability requirements, tests, and qualifications have successfully been conducted at the contract manufacturers site. FDA's review process is expected to take ten to thirteen months. Orexo is planning to initiate the US launch late in second half of 2024 or early 2025. Aankondiging • Feb 03
Orexo AB (publ) Submits New Drug Application to FDA for OX124, A High-Dose Rescue Medication for Opioid Overdose Orexo AB (publ.) announced 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 amorphOX® and contains a high-dose of naloxone. The submission is supported by data from the pivotal study in healthy volunteers, OX124-002, where OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In addition, development formulations of OX124 have in a previous exploratory clinical study (OX124-001) in healthy volunteers, demonstrated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator. OX124 is protected by patents until 2039. Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression. Opioid overdoses can be treated with the opioid antagonist naloxone. During the 12-month period ending August 2022, the predicted annual number of fatal opioid overdoses in the US exceeded 81,000. Nine out of ten opioid overdose deaths involved synthetic opioids, including fentanyl. The switch to highly potent synthetic opioids has led to more severe overdoses, prompting the need for high-dose naloxone products. Aankondiging • Jan 09
Orexo AB (publ.) Initiates Exploratory Feasibility Studies of amorphOX with Two Leading Biopharmaceutical and Vaccine Companies Orexo AB (publ.) announced the company has initiated two exploratory feasibility studies, applying the proprietary drug delivery platform amorphOX to protein based pharmaceuticals and vaccines in collaboration with leading international biopharmaceutical and vaccine companies. The feasibility studies follow successful formulation of the Covid-19 spike protein in amorphOX. Orexo has expanded the application of the amorphOX platform, from small molecules to also cover larger biomolecules. The company has tested enzymes, peptides and proteins in amorphOX and seen significant improvement in stability compared to other formulations in a wide range of storage temperatures. In the recent study with Covid-19 spike protein, Orexo measured the activity level of the protein after one month storage in both intermediate and high temperatures. Data showed formulations based on amorphOX managed to fully maintain activity levels after one month, even at high storage temperature. amorphOX has also been tested in multiple clinical studies with several different APIs (Active Pharmaceutical Ingredients) and consistently showed superior nasal absorption and bioavailability to competing drug delivery technologies. To test the ability of amorphOX as a platform for biopharmaceuticals, Orexo will work with companies having unique biomolecules or technologies. Today's announcement of collaborations with two leading international biopharmaceutical and vaccine companies is based on shared risk projects, where the parties will assess the feasibility of the biomolecules supplied by the partners in amorphOX formulations. Orexo will lead the formulation and manufacturing work, whereas the partner will be responsible for testing the product and to assessing future commercial opportunities of a partnership. Aankondiging • Jan 28
Orexo AB (publ) to Report Q4, 2022 Results on Jan 26, 2023 Orexo AB (publ) announced that they will report Q4, 2022 results at 8:00 AM, Central European Standard Time on Jan 26, 2023