Orexo

Orexo Interim Report Q1 2023

Retrieved on: 
Thursday, April 27, 2023
New Drug Application, NDA, EBITDA, FDA, SEK, Orexo, Pharmaceutical industry

EBITDA of SEK -41.1 m (2.8), EBITDA excluding legal costs and costs for non-repeating clinical trials, SEK 20.9 m (32.2)

Key Points: 
  • EBITDA of SEK -41.1 m (2.8), EBITDA excluding legal costs and costs for non-repeating clinical trials, SEK 20.9 m (32.2)
    New Drug Application (NDA) submitted with the FDA for OX124, high-dose rescue medication for opioid overdose
    Due to issues in the outsourced packaging line FDA has requested Orexo to resubmit the NDA, which is planned to take place in Q3, 2023

Orexo Interim Report Q1 2023

Retrieved on: 
Thursday, April 27, 2023
New Drug Application, NDA, EBITDA, FDA, SEK, Orexo, Pharmaceutical industry

EBITDA of SEK -41.1 m (2.8), EBITDA excluding legal costs and costs for non-repeating clinical trials, SEK 20.9 m (32.2)

Key Points: 
  • EBITDA of SEK -41.1 m (2.8), EBITDA excluding legal costs and costs for non-repeating clinical trials, SEK 20.9 m (32.2)
    New Drug Application (NDA) submitted with the FDA for OX124, high-dose rescue medication for opioid overdose
    Due to issues in the outsourced packaging line FDA has requested Orexo to resubmit the NDA, which is planned to take place in Q3, 2023

Report from Orexo AB's annual general meeting

Retrieved on: 
Tuesday, April 18, 2023
LTIP, Tax, Acquisition, SEK, Speech, Holding company, Management, Orexo

The annual general meeting also resolved on fees to the board of directors in accordance with the nomination committee's proposal.

Key Points: 
  • The annual general meeting also resolved on fees to the board of directors in accordance with the nomination committee's proposal.
  • The annual general meeting resolved to adopt procedures for the appointment of the nomination committee for the annual general meeting 2024 substantially in accordance with the same procedure as the preceding year.
  • The annual general meeting resolved, in accordance with the board's proposal, to adopt a new long-term incentive program for not more than 130 selected employees within the Orexo group, LTIP 2023.
  • LTIP 2023 substantially corresponds with LTIP 2022, a performance based long-term incentive program adopted at the annual general meeting 2022.

Report from Orexo AB's annual general meeting

Retrieved on: 
Tuesday, April 18, 2023
LTIP, Tax, Acquisition, SEK, Speech, Holding company, Management, Orexo

The annual general meeting also resolved on fees to the board of directors in accordance with the nomination committee's proposal.

Key Points: 
  • The annual general meeting also resolved on fees to the board of directors in accordance with the nomination committee's proposal.
  • The annual general meeting resolved to adopt procedures for the appointment of the nomination committee for the annual general meeting 2024 substantially in accordance with the same procedure as the preceding year.
  • The annual general meeting resolved, in accordance with the board's proposal, to adopt a new long-term incentive program for not more than 130 selected employees within the Orexo group, LTIP 2023.
  • LTIP 2023 substantially corresponds with LTIP 2022, a performance based long-term incentive program adopted at the annual general meeting 2022.

Orexo shares new timeline for the high-dose rescue medication for opioid overdose, OX124

Retrieved on: 
Monday, April 3, 2023
US Foods, Life, NDA, ORX, Orexo, Documentation, FDA, Food, Pharmaceutical industry, Medical device

As a result, FDA has requested Orexo to resubmit a New Drug Application (NDA), when Orexo has completed the qualification and can confirm the packaging process is ready for FDA inspection.

Key Points: 
  • As a result, FDA has requested Orexo to resubmit a New Drug Application (NDA), when Orexo has completed the qualification and can confirm the packaging process is ready for FDA inspection.
  • I am disappointed with the delay in the process of bringing this life saving medication to the US market.
  • When solved, this will even further strengthen the supply chain for our future rescue medications, such as OX640 and OX125."
  • On February 3, 2023, Orexo submitted the NDA with the FDA for OX124.

Orexo shares new timeline for the high-dose rescue medication for opioid overdose, OX124

Retrieved on: 
Monday, April 3, 2023
US Foods, Life, NDA, ORX, Orexo, Documentation, FDA, Food, Pharmaceutical industry, Medical device

As a result, FDA has requested Orexo to resubmit a New Drug Application (NDA), when Orexo has completed the qualification and can confirm the packaging process is ready for FDA inspection.

Key Points: 
  • As a result, FDA has requested Orexo to resubmit a New Drug Application (NDA), when Orexo has completed the qualification and can confirm the packaging process is ready for FDA inspection.
  • I am disappointed with the delay in the process of bringing this life saving medication to the US market.
  • When solved, this will even further strengthen the supply chain for our future rescue medications, such as OX640 and OX125."
  • On February 3, 2023, Orexo submitted the NDA with the FDA for OX124.

Orexo postpones publication of the Annual Report

Retrieved on: 
Wednesday, March 15, 2023
Annual report, ORX, Orexo, Online shopping, Auction, ESEF

UPPSALA, Sweden, March 15, 2023 /PRNewswire/ -- Orexo AB (publ), (STO:ORX) (OTCQX:ORXOY), has resolved to postpone the publication of the Annual Report for 2022 to March 28, 2023.

Key Points: 
  • UPPSALA, Sweden, March 15, 2023 /PRNewswire/ -- Orexo AB (publ), (STO:ORX) (OTCQX:ORXOY), has resolved to postpone the publication of the Annual Report for 2022 to March 28, 2023.
  • The previously announced date for publication was March 24, 2023.
  • The change in date is due to prolonged audit of the financial reporting in the European Single Electronic Format, ESEF.
  • For further information please contact:

Orexo postpones publication of the Annual Report

Retrieved on: 
Wednesday, March 15, 2023
Annual report, ORX, Orexo, Online shopping, Auction, ESEF

UPPSALA, Sweden, March 15, 2023 /PRNewswire/ -- Orexo AB (publ), (STO:ORX) (OTCQX:ORXOY), has resolved to postpone the publication of the Annual Report for 2022 to March 28, 2023.

Key Points: 
  • UPPSALA, Sweden, March 15, 2023 /PRNewswire/ -- Orexo AB (publ), (STO:ORX) (OTCQX:ORXOY), has resolved to postpone the publication of the Annual Report for 2022 to March 28, 2023.
  • The previously announced date for publication was March 24, 2023.
  • The change in date is due to prolonged audit of the financial reporting in the European Single Electronic Format, ESEF.
  • For further information please contact:

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

Retrieved on: 
Friday, February 3, 2023
OTC, NDA, Orexo, Opioid overdose, Opioid use disorder, Fentanyl, Patient, Drug, File, Food, Absorption, FDA, Consciousness, US Foods, Naloxone, ORX, Cereal, Pharmaceutical industry

), (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.

Key Points: 
  • ), (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.
  • Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression.
  • The large need for potent and longer-lasting overdose rescue medications will most likely propel the prescription market.
  • In addition, the on-going expansion of mandatory co-prescription of naloxone rescue medication will much likely also benefit the market for prescription products.

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

Retrieved on: 
Friday, February 3, 2023
OTC, NDA, Orexo, Opioid overdose, Opioid use disorder, Fentanyl, Patient, Drug, File, Food, Absorption, FDA, Consciousness, US Foods, Naloxone, ORX, Cereal, Pharmaceutical industry

), (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.

Key Points: 
  • ), (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.
  • Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression.
  • The large need for potent and longer-lasting overdose rescue medications will most likely propel the prescription market.
  • In addition, the on-going expansion of mandatory co-prescription of naloxone rescue medication will much likely also benefit the market for prescription products.