Inside information: Positive Feedback from UK MHRA Scientific Advice Meeting regarding Nanoenzalutamide
Nanoform Finland Plc | Inside Information | August 05, 2026 at 12:00:00 EEST
Helsinki, Finland – Nanoform Finland Plc (“Nanoform”), the medicine performance-enhancing company, announced today that it has been notified by its development partners of positive feedback from a recent UK MHRA scientific advice meeting. The purpose of the meeting was to receive advice on the applicability of the hybrid application pathway for a marketing authorization application for nanoenzalutamide in the UK with the existing clinical data package.
A key outcome from the scientific advice was that a future UK marketing authorization application may be pursued via the hybrid application pathway (HMR Regulation 52B), supported by the existing single dose bioequivalence studies and pharmacokinetic modelling. The UK MHRA will consider the totality of the evidence package, including clinical, modelling and literature data when reviewing the final dossier.
Scientific advice given is not legally binding with regard to any future application for the product concerned, neither on the part of UK MHRA/Commission on Human Medicines (CHM) nor on the applicant. Furthermore, advice cannot be taken as indicative of any future agreed position.
Edward Hæggström, Chief Executive Officer of Nanoform, commented:
“We are encouraged by the UK MHRA’s feedback, which provides support for the regulatory strategy of our nanoenzalutamide program. We are on track to submit our first marketing authorization application for a Nanoformed medicine with our partners in 2026.”
Christian Jones, Chief Commercial Officer of Nanoform, commented:
“The UK MHRA’s feedback is an important step forward for nanoenzalutamide and reinforces our belief in the potential of Nanoform’s technology to enable differentiated medicines that can benefit patients. From a commercial perspective, it also highlights the broader opportunity to apply our platform to support partners in bringing products to market.”
For further information, please contact:
Albert Hæggström, CFO
albert.haeggström@nanoform.com
+358 29 370 0150
Henri von Haartman, DIR
+46 (0)7686 650 11
This information is inside information that Nanoform is obliged to disclose pursuant to the EU Market Abuse Regulation (EU) No 596/2014. The information was submitted for publication through the agency of the contact person set out above, on August 5th, 2026, at 12.00 EEST.
About Nanoform
Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services, from pre-clinical to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: DNB Carnegie Investment Bank AB, +46 8 588 685 70, certifiedadviser@dnbcarnegie.se. For more information, please visit www.nanoform.com.
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