Press Releases and News

Orexo is celebrating 10 years on the US Pharma market - Interview with Robert DeLuca, President of Orexo US Inc.

News Release – Uppsala, Sweden, September 29, 2023
The year of 2023 marks 10 years on the US Pharma market for Orexo. In September 2013, after conscientious preparations and an FDA approval, ZUBSOLV®, became available for patients across the US. A big achievement and the start of a journey that is making a difference to the people whose lives are affected by the US opioid epidemic. In this interview, Robert DeLuca, President of Orexo US Inc., reflects on these exciting years and how he and his team are committed to tackling the opioid crisis from broad and holistic perspective.

• NEWS_Orexo is celebrating 10 years on the US Pharma market_Sep 29 2023

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

• Orexo Press Release Orexo submits NDA to FDA for OX124 Published Sep 18 2023

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

• NEWS_Orexo to participate in Paretos Securities 14th Annual Healthcare Conference 2023

Orexo secures patent protection in the US for OX640, a nasal epinephrine powder product

Uppsala, Sweden – August 29, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces that the United States Patent and Trademark Office (USPTO) has granted the first US patent specifically related to OX640, Orexo’s nasal epinephrine powder product based on the amorphOX® drug delivery platform.

• Orexo_Press_release_First Patent issued for OX640 in the US_Aug_29 2023

Orexo’s patent win for ZUBSOLV® appealed

• Orexo PR_Orexos patent win for ZUBSOLV appealed_July 24 2023

Invitation to presentation of Orexo´s Interim Report Q2 2023

OX640: Shaping the future of nasal powder epinephrine using the innovative amorphOX platform

• Orexo News Release_Interview Robert Ronn on OX640_June 19 2023

Invitation to presentation of Orexo´s Q1 Interim Report

Orexo postpones publication of the Annual Report

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

• Orexo Press Release Orexo submits NDA to FDA for OX124 Published Feb 3 2023

Invitation to presentation of Orexo´s Interim Report Q4 2022 incl. Full Year Report

Orexo initiates exploratory feasibility studies of amorphOX[®] with two leading biopharmaceutical and vaccine companies

• Orexo initiates exploratory feasibility studies of amorphOX® with two leading biopharmaceutical and vaccine companies

Edward Kim, M.D., Chief Medical Officer: “I joined Orexo to make a difference in the lives of people suffering from opioid use disorder”

• NEWS_Orexo Interview with Edward Kim CMO Orexo_Published Dec 22 2022

Digital Therapeutics: the future of healthcare is happening now

• Orexo Interview with Megan Coder DTx Alliance

Orexo announces last patient enrolled in pivotal study evaluating the efficacy of MODIA® in combination with sublingual buprenorphine/ naloxone for the treatment of OUD

• Orexo_Press Release_Last patient enrolled in MODIA clinical study_Published Oct 28

Orexo appoints Edward Kim, M.D., as new Chief Medical Officer

• Orexo Press Release Orexo appoints Edward Kim MD as new CMO_Published October 26 2022

Invitation to presentation of the Q3 Interim Report, on November 3 at 2 pm CET

Orexo’s partner Gesynta Pharma prepares phase 2 study for OX-MPI aiming to develop an innovative treatment for endometriosis

• PM Gesynta endometrios-data 2022-10-20 eng_FINAL

Orexo´s Nomination Committee for the Annual General Meeting 2023

Orexo’s partner Gesynta Pharma has announced phase II study results from the OX-MPI (GS-248) project

• PM Gesynta Phase II 2022-09-08 eng FINAL

Orexo’s partner Trinity Health today announces the availability of vorvida® and deprexis® to patients

• Orexo_Press_release_Trinity Health ND will offer vorvida and deprexis to patients_published Sep 7_ 2022

First patent issued in Europe for Orexo’s adrenaline product OX640

• Orexo_Press_release_First Patent issued for OX640 in Europe_ Published Sep 1 2022

Orexo to participate in Pareto Securities´ 13th Annual Healthcare Conference

Invitation to presentation of the Q2 Interim Report, on July 14 at 2 pm CET

Orexo’s nasal adrenaline rescue medication OX640 enters clinical development

• Orexo Press Release_ First clinical study initiated for OX640_Published Juli 5 2022

Anaphylaxis: symptoms, causes and treatment challenges

One Pill Can Kill – Fentanyl Awareness Day May 10

• Orexo News Release Fentanyl Awareness Day May 10_2022

Orexo´s partner Gesynta Pharma granted Orphan Drug Designation by the FDA for OX-MPI (GS-248) for the treatment of systemic sclerosis

• Orexo Press Release Orexos partner Gesynta Pharma granted Orphan Drug Designation by FDA for OX_MPI (GS248)_ April 27

Orexo appoints Fredrik Järrsten as new CFO

• Orexo Press Release Orexo appoints Fredrik Järrsten as new CFO_Published March 11 2022

Orexo's lead product ZUBSOLV® added to NY State Medicaid MAT Preferred Drug List

• Orexo Press Release ZUBSOLV on NY State Medicaid MAT Formulary_Feb 24 2022

Invitation to presentation of the Q4 Interim Report, on January 27 at 2 pm CET

Robert Rönn, SVP and Head of R&D: “My vision is to develop several new drugs based on amorphOX™”

• Orexo News Release_Interview Robert Rönn SVP and Head of RnD_Pulished Dec 22 2021

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

• Orexo develops a nasal adrenalin medication based on the novel amorphOX platform

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

• Orexo informs about the novel proprietary amorphOX platform_Nov 26 2021

Orexo´s Nomination Committee for the Annual General Meeting 2022

• Orexo´s Nomination Committee for the Annual General Meeting 2022

Invitation to presentation of Orexo´s Q3 Interim Report, on November 3 at 1 pm CET

MODIA™ paper published in the Journal of Medical Internet Research Mental Health

• Orexo Press Release MODIA paper published in JMIR Mental Health Oct 18 2021

Synthetic opioids drive record-high surge in fatal overdoses

International Overdose Awareness Day, tomorrow on 31 August, is an opportunity for people across the globe to reflect on the many lives being destroyed by opioids, and the grief of their loved ones. Synthetic opioids are driving a record-high surge in fatal overdoses. With deaths caused by opioid misuse climbing to greater than 92,000[i] last year, it’s more important than ever to consider how we can prevent more broken lives.  

[i] https://www.cdc.gov/ 

• Orexo News Article_Synthetic opioids driving a worsening of the overdose epidemic_Published Aug. 30

Orexo’s flagship pharmaceutical pipeline asset OX124 enters pivotal trial

• Orexo Press Release Orexo enters pivotal study with OX124_Published July 16 2021

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

• Orexo Group_PR_Orexo signs commercial partnership agreement with Sober Grid incl access to vorvida and deprexis_Published July 12 2021

Sober Grid Users to Gain Access to Clinically Proven Digital Therapeutics Through New Commercial Partnership with Orexo

Invitation to presentation of Orexo´s Q2 Interim Report, on July 15 at 3 pm CET

Orexo announces first patient enrolled in pivotal study evaluating the efficacy of modia™ in combination with sublingual buprenorphine/ naloxone for the treatment of OUD

• Orexo Group_PR_First Patient enrolled in pivotal modia study

Orexo’s Partner Gesynta Pharma announces progresses in phase II study of OX-MPI and submits IND with FDA

• Orexo’s Partner Gesynta Pharma announces progresses in phase II study of OX-MPI and submits IND with FDA

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

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

Invitation to presentation of Orexo´s Q1 Interim Report, on April 29 at 2 pm CET

Orexo continues to strengthen IP rights for ZUBSOLV®

• Orexo continues to strengthen IP rights for ZUBSOLV®

Orexo starts to test modia™ on patients in collaboration with ApexB.io and Magellan Rx Management

• Orexo starts to test modia™ on patients in collaboration with ApexB.io and Magellan Rx Management

Orexo expects FDA filing of OX124 mid 2022

• OX124 is designed to reverse the effect of the most powerful synthetic opioids
• Synthetic opioids are behind the majority of fatal overdoses in the US, a development expected to increase due to Covid-19
• New Drug Application (NDA) filing expected mid 2022

• Orexo expects FDA filing of OX124 mid 2022

Orexo strengthens IP rights for overdose rescue drug OX124

• Orexo strengthens IP rights for overdose rescue drug OX124

Orexo’s Partner Gesynta Pharma Initiates Phase II Study of OX-MPI in Systemic Sclerosis

• Release

Invitation to presentation of Orexo´s Full Year Report 2020, incl. Q4, on January 28 at 2 pm CET

Orexo announces new US patent for ZUBSOLV®

• Orexo announces new US patent for ZUBSOLV®

Orexo Enters Exclusive License and Supply Agreement with Accord Healthcare for ZUBSOLV[® ]in Europe

• Orexo Enters Exclusive License and Supply Agreement with Accord Healthcare for ZUBSOLV® in Europe

Accenture, Orexo Team to Offer Digital Therapeutics through INTIENT™ Platform

Invitation to presentation of the Interim Report Q3 2020, on November 4 at 2 pm CET

Orexo and Lyfebulb Announce the Winner of the 2020 Innovation Challenge in Substance Use Disorders

Orexo´s Nomination Committee for the Annual General Meeting 2021

• Orexo´s Nomination Committee for the Annual General Meeting 2021

Invitation – Orexo Digital Therapeutics business update October 1

• Invitation – Orexo Digital Therapeutics business update October 1

Orexo commences patent infringement litigation against Sun Pharmaceutical

• Orexo commences patent infringement litigation against Sun Pharmaceutical

Orexo and GoGoMeds Partner to Bring Digital Therapies to Populations Battling Addiction and Depression with Limited Support Options

Orexo and Lyfebulb Announce the Finalists and Jury for the 2020 Innovation Challenge in Substance Use Disorders

Invitation to presentation of the Interim Report Q2 2020, on July 16 at 3 pm CET

Gesynta Pharma raises SEK 190 million and will initiate a phase 2 study for OX-MPI in Q4

• Release

Invitation to attend a teleconference on July 2, 1.30 pm CET - DTx US commercialization plan

Positive results from human PK study assessing Orexo’s intranasal nalmefene formulations for opioid overdose reversal

• Orexo Press Release Positive results from OX125 human PK study

Orexo and Lyfebulb Announce Call for Digital Solutions to Treat Substance Use Disorder

Interview with Geri Lynn Utter, Medical Science Liaison at Orexo - with marks of wisdom she continues to inspire us all

• News Release Interview with Geri Lynn Utter, Medical Science Liaison at Orexo

Orexo and Lyfebulb Partner During Unprecedented Times to Help Those Struggling with Alcohol and Opioid Use Disorders

• Release

Orexo´s partner Gesynta Pharma announces positive results from phase 1 study for OX-MPI

• Orexo´s partner Gesynta Pharma announces positive results from phase 1 study for OX-MPI

James Noble appointed as Chairman of the Board

• James Noble appointed as Chairman of the Board

The board of directors of Orexo withdraws proposal on incentive program

• The board of directors of Orexo withdraws proposal on incentive program

Orexo has repurchased 14 percent of own corporate bonds

• Orexo has repurchased 14 percent of own corporate bonds

Orexo presents sales potential of the pharmaceutical pipeline and digital therapies during the Capital Markets Day

• Orexo presents sales potential of the pharmaceutical pipeline and digital therapies during the Capital Markets Day

Invitation to attend Orexo´s Capital Markets Day via teleconference

• Invitation to attend Orexo´s Capital Markets Day via teleconference

Orexo submits application for vorvida® to the FDA to enable commercialization in the US

• Orexo submits application for vorvida® to the FDA to enable commercialization in the US

Invitation – Orexo Capital Markets Day, Stockholm, Sweden, March 17

• Invitation – Orexo Capital Markets Day, Stockholm, Sweden, March 17

Promising results from human PK study assessing novel ketorolac formulations for treatment of pain

• Promising results from human PK study assessing novel ketorolac formulations for treatment of pain

Invitation to presentation of the Full Year Report 2019, incl. Q4, on January 30

Save the date: Orexo to host Capital Markets Day focusing on Digital Health, on March 17, 2020

• Save the date: Orexo to host Capital Markets Day focusing on Digital Health, on March 17, 2020

Orexo appoints Dennis Urbaniak as Executive Vice President Digital Health

• Orexo appoints Dennis Urbaniak as Executive Vice President Digital Health

Orexo to Present at Jefferies 2019 Healthcare Conference

• Orexo to Present at Jefferies 2019 Healthcare Conference

Invitation to presentation of Orexo´s Q3 2019 Interim Report, on October 24

Orexo´s Nomination Committee for the Annual General Meeting 2020

• Orexo´s Nomination Committee for the Annual General Meeting 2020

Orexo signs partnership agreement with GAIA to develop and commercialize a new digital therapy for the treatment of Opioid Use Disorder

• Orexo signs partnership agreement with GAIA to develop and commercialize a new digital therapy for OUD published Aug 20 2019

Orexo signs license and supply agreement with Mundipharma for Zubsolv® in Australia and New Zealand

• Orexo signs license and supply agreement with Mundipharma for Zubsolv® in Australia and New Zealand

Orexo prepays part of the corporate bond loan

• Orexo prepays part of the corporate bond loan

Invitation to presentation of Orexo´s Q2 2019 Interim Report, on July 11

Orexo’s closest upcoming presentations at conferences

• Press release (PDF)

Invitation to presentation of Orexo´s Q1 2019 Interim Report, on May 2

Issues of shares following the vesting of 2016/2019 incentive plan

• Issues of shares following the vesting of 2016/2019 incentive plan

Report from Orexo AB’s annual general meeting

• Orexo Pressrelease Report from the Annual General Meeting April 11 2019

Orexo´s partner Gesynta Pharma secures 6 MEUR in financing round led by Industrifonden

• Release

District Court of Delaware rules that Actavis does not infringes with their Suboxone® and Subutex® generics

• District Court of Delaware rules that Actavis does not infringes with their Suboxone® and Subutex® generics

Invitation to presentation of Orexo´s Full Year Report incl. Q4 2018, on January 30

Actavis infringes Orexo’s long term Zubsolv® US patent ´330

• Actavis infringes Orexo’s long term Zubsolv® US patent ´330

Orexo hosts Capital Markets Day today in Stockholm, Sweden

• Orexo hosts Capital Markets Day today in Stockholm, Sweden

US Court of Appeals denies Actavis’s petition for rehearing regarding validity of the Zubsolv® patent

• US Court of Appeals denies Actavis’s petition for rehearing regarding validity of the Zubsolv patent

Agenda – Orexo Capital Markets Day, Stockholm, Sweden, Dec. 6

• Agenda Orexo Capital Markets Day, Stockholm, Sweden, Dec. 6

Orexo to host a Capital Markets Day on Dec. 6 with the US president´s former advisor as keynote speaker

• Invitation: Orexo to host a Capital Markets Day on Dec. 6 with the US president´s former advisor as keynote speaker

Save the date: Orexo to host Capital Markets Day on Dec. 6 with the US president´s former advisor as key note speaker

• Orexo to host Capital Markets Day on Dec. 6 with the US president´s former advisor as key note speaker

Invitation: “The successful defence of Zubsolv® – Experiences from pharmaceutical patent litigation in the US”

Invitation to presentation of Orexo´s Interim Report Q3 2018 on October 25

Orexo internalizes contract field force in the US to further strengthen the commercial organization

• Orexo internalizes contract field force in the US to further strengthen the commercial organization

Due to the patent decision Orexo invites to a teleconference

Invitation to presentation of Orexo´s Interim Report Q2 2018 on July 11

Invitation to presentation of Orexo´s Interim Report Q1 2018 on April 26

Orexo participating in new project concerning R&D for Drug Delivery technologies in collaboration with Uppsala University

Invitation to presentation of Orexo´s Q4 and Full Year Report 2017

Orexo discloses more information about the improved market access position for Zubsolv® US in 2018

• Release

Orexo publishes prospectus and applies for listing of bonds on Nasdaq Stockholm

• Release

Orexo completes early redemption of existing bond loan

• Release

Zubsolv® receives authorization for treatment of opioid dependence in Europe

• Release

Orexo issues bonds of SEK 325 million and confirms fulfilment of condition under notice of early redemption

• Release

Invitation to presentation of Orexo´s Q3 2017 Interim Report on Oct. 19

Orexo, together with Malmö University, receives research grant

Zubsolv® gains preferred position on CVS Caremark 2018 formulary

• Release

Invitation to presentation of Orexo´s Q2 2017 Interim Report on July 11

• Release

Orexo Completes Bond Buyback Program

• Release

Orexo Completes Bond Buyback Program

• Release

Orexo to Present at the Annual Biotech Showcase Conference, San Francisco

• Release

Orexo completes 1,080 patient REZOLV study and reports on improved treatment of opioid dependent patients

• Release

Orexo welcomes increased access to treatment for patients with opioid dependence in the US

• Release