Progress, partnerships and milestones.

The U.S. Patent and Trademark Office issued U.S. Patent No. 12,734,136, “Intranasal Administration of Ketamine to Cluster Headache Patients.” The AFYX-owned patent covers intranasal ketamine methods for chronic and episodic cluster headache, including intranasal esketamine (S-ketamine hydrochloride).

AFYX said the grant strengthens its U.S. intellectual-property position for its intranasal esketamine program. The release said a Phase 2B clinical study was expected to begin in 2027. It also described an earlier Phase 2A study in which pain reduction was reported for 60% of patients within approximately 20–30 minutes.

The announcement describes cluster headache as a severely debilitating neurological condition involving recurrent attacks of intense pain, often around one eye or one side of the head, and notes that some patients continue to have unmet treatment needs.

Dr. Claus Møller-San Pedro, CEO and co-founder, said: “The issuance of this U.S. patent represents an important milestone for AFYX and further strengthens the foundation for our esketamine programme.”

For further information, the release lists Dr. Claus Møller-San Pedro at cm@afyxtx.com and +45 40 53 98 94.

Download the original AFYX press release (PDF) ↗

Original AFYX announcement ↗

AFYX announced regulatory approval, following completion of a decentralized procedure, for its proprietary 25 microgram oral misoprostol tablet in 20 European Union countries and Northern Ireland.

The company describes the tablet as a ready-to-use standardized oral formulation designed to avoid off-label low-dose dispensing through manual tablet fractioning or pharmacy compounding. In its release, AFYX cites WHO recommendations and extensive clinical experience with misoprostol.

AFYX estimated approximately 1.2 million labour inductions are performed annually in the EU. It said commercialization would proceed stepwise with selected local and regional partners, following national pricing and reimbursement processes, and that it was preparing regulatory submissions beyond Europe.

Claus Møller-San Pedro, CEO, said: “This approval marks an important milestone for AFYX and, more importantly, for women and clinicians across Europe.”

Clinical use must follow the locally approved Summary of Product Characteristics, local protocols and qualified healthcare professionals’ judgement.

For further information, the release lists Dr. Claus Møller-San Pedro at cm@afyxtx.com and +45 40 53 98 94.

Download the original AFYX press release (PDF) ↗

Original AFYX announcement ↗

AFYX announced an exclusive distribution partnership with Adcock Ingram Critical Care (AICC) for South Africa and ten additional countries in Sub-Saharan Africa. AFYX described AICC as a South African provider of hospital and specialty medicines.

Products named in the announcement

• Gefena (misoprostol 25 µg oral tablet): a ready-dose labour-induction product. The release describes it as a non-refrigerated oral tablet and reports completed bioequivalence studies.
• Nimorazole: a radiosensitizer used as an adjunct to radiotherapy for head and neck cancer. AFYX cites DAHANCA 5 and DAHANCA 29 study data in the release, describing a reduction in three-year relapse from 33.8% in the control group to 20.7% with nimorazole.

The release describes Gefena as not requiring refrigeration and summarizes expected use of labour-induction medicines in Europe and Africa. Those statements are AFYX’s company-reported product and market claims.

Claus Møller-San Pedro, CEO, said: “We are proud to enter this partnership with Adcock Ingram Critical Care. It marks an important step in our global expansion strategy.”

For further information, the release lists Dr. Claus Møller-San Pedro at cm@afyxtx.com.

Download the original partnership press release (PDF) ↗

Original AFYX announcement ↗

A multicentre randomized study presented at the European Society for Radiotherapy and Oncology (ESTRO) 2025 examined AFYX’s nimorazole product as a hypoxic radiosensitizer alongside accelerated chemoradiotherapy for locally advanced HPV-negative head and neck squamous cell carcinoma.

• Study population: 194 patients with stage III–IV laryngeal, hypopharyngeal or HPV-negative oropharyngeal squamous cell carcinoma.
• Regimen described: IMRT, 70 Gy over six weeks, with cisplatin and oral nimorazole or placebo before each radiation fraction.
• Primary endpoint: three-year locoregional failure; the release reports 18% with nimorazole versus 30% with placebo (p=0.04; hazard ratio 0.63).
• Other outcomes: the release reports no significant difference in disease-specific or overall survival and similar treatment compliance.

The company notes that the trial closed early and describes its results as supporting continued investigation of hypoxic modification. The original report discusses trial results; it is not a treatment recommendation.

For further information, the release lists Dr. Claus Møller-San Pedro at cm@afyxtx.com and +45 40 53 98 94.

Original AFYX announcement ↗

Lunatus and AFYX announced a distribution and sales collaboration for Gefena, AFYX’s 25 µg oral misoprostol tablet for induction of labour. Lunatus was to distribute, commercialize and supply the product in the United Arab Emirates, Qatar, Kuwait, Oman, Saudi Arabia, Bahrain, Iraq and Jordan.

At the time of the announcement, EU regulatory approval was expected in Q4 2025. That was a historical forecast; the subsequent May 2026 approval is described separately above.

The original release lists Lunatus contacts Mina Ashraf (Mina.ashraf@lunatus.com) and Maricel Magtibay (Maricel@lunatus.com; +971 4 399 4755 / +971 4 208 9333), and AFYX contact Pia Laursen (pcl@afyxtx.com; +45 23 20 19 14).

Original AFYX announcement ↗

AFYX Group reported Q4 2024 revenue of DKK 12.9 million, up from DKK 8.9 million in Q4 2023. The company attributed the increase primarily to Diaphine sales and growth in Nimorazole sales, particularly in Norway.

Development costs were nearly DKK 4 million, compared with DKK 4.4 million in Q4 2023; the company said the earlier period included the closing payment for its Nimorazole acquisition.

Reported EBITDA including R&D was DKK -0.9 million versus DKK -5.1 million in the prior-year quarter. Excluding R&D, AFYX reported EBITDA of DKK 3 million, compared with DKK -0.7 million.

The report described continued investment in the Rivelin patch, esketamine and Gefena programs for the U.S. market and preparation for a planned Nimorazole registration filing. These were plans stated at the time of publication.

Original AFYX announcement ↗

AFYX Therapeutics and Cevidra announced a strategic partnership aimed at bringing treatments for head and neck cancer to the French market. The release identifies Cevidra as local pharmaceutical Exploitant and distribution partner.

Cevidra’s described support includes price and reimbursement, local pharmacovigilance, CRO services for data collection, distribution and tailored promotional activities. The original release also outlines AFYX’s “Reversed Innovation” approach.

The original release lists Helle Heidensleben at AFYX (hh@afyxtx.com; +45 31 62 77 98) and Loïc Fiévet at Cevidra (l.fievet@cevidra.com; +33 4 93 70 58 31).

Original AFYX announcement ↗

The mutual sales and distribution collaboration named Gefena and Nimox for Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, Slovenia, Turkey and Ukraine.

The announcement described Gefena for labour induction and Nimox (nimorazole) as a hypoxic radiosensitizer for head and neck cancer. The release’s references to expected approval timings were forecasts made in January 2025.

Original AFYX announcement ↗

AFYX announced a DKK 25 million funding round led by existing investors and employees, intended to support development of its pipeline, operations and international expansion.

The announcement named the clobetasol patch for oral lichen planus and esketamine for cluster headache among the programs to be advanced. It also described the company’s 2024 formation through a merger and its distribution partnerships.

Original AFYX announcement ↗