Orexo Ab Stock Price, News & Analysis

Orexo AB (STO: ORX, OTCQX: ORXOY) announced positive topline results from clinical study OX640-002, evaluating their nasal rescue medication OX640, a powder-based epinephrine treatment for allergic reactions including anaphylaxis. The cross-over study involved 30 subjects and compared two doses of OX640 against an intramuscular injection reference product.

Key findings showed that OX640 treatments achieved clinically relevant epinephrine plasma levels faster than the intramuscular reference. Notably, absorption was significantly faster under allergic rhinitis conditions compared to normal conditions, demonstrating efficacy in patients with airway symptoms. The treatment produced more pronounced increases in blood pressure and heart rate compared to intramuscular injection. Safety profiles aligned with known epinephrine pharmacology, with only transient and tolerable local effects reported.

Orexo AB (STO: ORX, OTCQX: ORXOY) has entered into a collaboration with Abera Bioscience to develop nasal powder vaccines using Orexo's AmorphOX® technology. The partnership aims to develop mucosal vaccines, initially focusing on Abera's influenza vaccine candidate. The AmorphOX technology has demonstrated potential to improve stability and efficacy of various active ingredients, from small molecules to larger biomolecules like vaccines.

The collaboration is funded through Abera's previously received grants, primarily from CEPI (Coalition for Epidemic Preparedness Innovation). The partnership represents a strategic step in leveraging AmorphOX's scalability, combining Orexo's powder formulation expertise with Abera's 30+ years of vaccine development experience.

Orexo has initiated a new clinical study (OX640-002) for OX640, an intranasal rescue medication for severe allergic reactions using powder-based epinephrine. The study will evaluate OX640's performance in 30 participants with allergic rhinitis through a cross-over design with four treatment periods. This follows positive phase 1 results where OX640 showed comparable absorption and effects to intramuscular auto-injectors.

The study will assess epinephrine absorption with and without allergic symptoms, comparing it to a commercial intramuscular product. The study cost is estimated at SEK 11 million, with completion expected in 2024 and results in early 2025.

Orexo reported Q3 2024 financial results with total net revenues of SEK 136.5m, down from SEK 156.1m in Q3 2023. The company posted a negative EBITDA of SEK -0.7m, improving from SEK -9.5m last year. US Commercial segment revenues declined to SEK 131.0m from SEK 140.4m. Net earnings deteriorated to SEK -41.9m from SEK -33.3m. The FDA requested additional technical data for OX124, their high-dose naloxone rescue medication. Despite challenges, including higher legal costs and lower Zubsolv sales, the company maintained its 2024 financial guidance and initiated a phase 1 study for OX640 in allergic rhinitis patients.

Orexo has announced the formation of its Nomination Committee for the Annual General Meeting (AGM) scheduled for May 8, 2025. The committee comprises four 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), and James Noble (Chairman of the Board of Orexo).

The Nomination Committee represents approximately 34 percent of the company's voting rights as of August 31, 2024. Their responsibilities include preparing proposals for the AGM regarding the Chairman of the meeting, Chairman of the Board, Board members, fees, auditor fees, and principles for the Nomination Committee's composition. Shareholders can submit proposals to the committee via email by March 7, 2025.

Orexo AB (STO: ORX) (OTCQX: ORXOY) has announced its participation in Pareto Securities' 15th Annual Healthcare Conference on September 19, 2024, at Downtown Camper by Scandic in Stockholm, Sweden. The company's SVP and Head of R&D, Robert Rönn, will deliver a company presentation from 2:25-2:45 CET in the Event Small room.

Additionally, Robert Rönn and Lena Wange, Investor Relations, will be available for one-on-one meetings during the conference. This event provides an opportunity for Orexo to showcase its developments and engage with investors and industry professionals in the healthcare sector.

Orexo AB (ORXOY) released its Q2 2024 interim report, showing total net revenues of SEK 154.0 million, slightly down from SEK 157.7 million in Q2 2023. The company reported an EBITDA of SEK 5.0 million and net earnings of SEK -35.9 million. US Commercial segment net revenues increased to SEK 147.9 million. Notably, Orexo received a complete response letter from the FDA for OX124, its high-dose naloxone rescue medication for opioid overdose, requesting additional data. The company successfully conducted a new human factor study in early July. Orexo's CEO highlighted a strong recovery in Zubsolv sales and the company's focus on bringing OX124 to the US market, despite the delay in FDA approval.

Orexo AB (STO: ORX) (OTCQX: ORXOY) has received a complete response letter (CRL) from the FDA regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication for opioid overdose. The FDA requires an additional Human Factors (HF) study and more technical data on the final commercial product. No additional clinical or non-clinical studies are needed.

Orexo has already completed a new HF study successfully. The company will work quickly to address the unexpected request for additional technical data. The NDA resubmission review period will be up to six months. OX124 aims to meet the growing need for more powerful medications to reverse overdoses caused by synthetic opioids like fentanyl, which account for 92% of all fatal opioid overdoses.

Orexo AB has achieved a Gold Sustainability Rating from EcoVadis, placing it in the top 5% of the 70,000 businesses reviewed annually. This recognition is based on the company's sustainability efforts in Sweden, covering headquarters functions, R&D, Regulatory Affairs, Quality & SHE, and Supply Chain. The rating highlights Orexo's success in environmental, labor and human rights, ethics, and sustainable procurement areas. CEO Nikolaj Sørensen emphasized that the company will continue to set ambitious sustainability goals to benefit patients, investors, the company, and society.