Welcome to Business of Cannabis’ new weekly strategic digest tracking the financial health, market moves, and corporate developments shaping the European cannabis sector.
The frenetic pace of company updates across various cannabis-based sectors comes as the industry prepares to descend on Berlin and London for European Cannabis Week where the latest insights from the world’s leading voices will take centre stage across four separate events taking place from June 19-25.
For further real-time updates on market dynamics, market sizing and evolving regulations, pre-orders for the soon-to-be-launched digital report from Prohibition Partners are now available here.
Ananda Pharma
UK-based cannabis biotech firm Ananda Pharma has made a major step forward in the clinical development of its lead drug, as its CEO says ‘the behind-the-scenes work is now starting to show in the public arena’.
Ananda Pharma, now the leading force in pharmaceutical cannabis research in the UK, announced this week that its Phase 1 pharmacokinetic study for its lead compound, MRX1, has now been published on ClinicalTrials.gov, the US-based clinical trial registry and results database maintained by the US National Library of Medicine (NLM) at the National Institutes of Health (NIH).
This is a crucial step on the regulatory path for pharmaceutical drug development in the US, and demonstrates Ananda’s progress towards breaking into the lucrative but infamously difficult to access market.
For any drug that will support an FDA application (like an IND – Investigational New Drug application, or NDA – New Drug Application), registration on ClinicalTrials.gov is required under the FDA Amendments Act of 2007 (FDAAA 801).
MRX1, which is being developed to treat complex chronic inflammatory pain conditions, has also now achieved ‘two years of stability data’, according to a separate release from the company.
This now puts it inline with CH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, marking another incremental but no-less crucial step towards having the drug approved.
According to the company, the MRX1 formulation remained stable both under standard conditions and accelerated conditions, where the product was stored at elevated temperatures above 30°C. The latter is particularly important as the company prepares for a Phase 1 clinical trial in Australia, where warmer climates present additional regulatory scrutiny.
“This stability data is a key differentiator between MRX1 and any unlicenced product (including a cannabis-based medicine prescribed via a cannabis clinic or available via a dispensary), any UK Food Standards Agency approved CBD product, and any CBD product produced in accordance with the Farm Bill in the USA where the reliability of product is not verified,” the company stated.
EU Commission looks to improve conditions for biotech companies
Ananda’s aforementioned Australian clinical trials are emblematic of a far more widespread issue in the biotech sector, which has endured widespread job cuts, a significant slowdown of M&A activity, and public investment opportunities all but grind to a halt.
Last month Business of Cannabis reported on the collapse of another UK-based cannabis biotech firm, Oxford Cannabinoid Technologies (Octavian Therapeutics), which had failed to attain enough funding to continue its drug trials.
Pharmaceutical drugs are expensive and cumbersome to develop in Europe, driving many companies towards the Australian market, which is far more favourable for drug development thanks to generous subsidies.
Alongside Ananda, cannabinoid based companies including Kingdom Therapeutics and DeFloria have both recently announced plans to launch drug trials in the region.
In response to this growing exodus of promising biotech firms, the European Union has proposed a new Biotech Act, as part of ongoing efforts by the European Commission to strengthen the continent’s biotechnology and biomanufacturing sectors, which have struggled with fragmented rules and sluggish approval processes.
The Biotech Act is intended to streamline complex regulations across EU member states, speed up clinical trial approvals, and improve access to capital, all while maintaining strict safety and sustainability standards. The Act also aims to boost public trust in biotech and reduce time-to-market for innovative products.
A call for evidence was published by the European Commission in early May 2025, inviting stakeholders to weigh in on key challenges in the sector. These include regulatory delays, limited access to capital, a shortage of skilled workers, and the need for better integration of AI and data use in biotech development. The feedback window closes on 11 June, with a public consultation on the Act expected later in 2025.
Days later, however, the European Commission announced that the Biotech Act, initially expected by the end of 2025, will now not be introduced until the third quarter of 2026.
Despite the delay, the EU insists the Act remains a cornerstone of its ambitions to build a world-leading biotech ecosystem that is competitive, sustainable, and strategically autonomous.
Celadon remains on the brink
These widespread funding woes are also impacting medical cannabis producers like LSE-listed Celadon Pharmaceuticals, which has seen successive funding deals fall through over the past few months.
In a statement released on 30 May 2025, the company said it had “limited working capital” and that its continued operation was dependent on receiving funds from a new finance provider.
This follows news on 8 April 2025 that Celadon had terminated its existing committed credit facility, originally announced in February, and no longer expected to receive any funds from it. The company said it had requested the removal of the floating charge over its assets related to that facility.
The 30 May update confirmed that while due diligence had been completed by a new prospective lender, no capital had yet been received.
“In the event the Company cannot secure funds over the coming days, the directors will have to protect the interests of all stakeholders and the Company will be placed into administration,” the statement read.
Despite the cautious nature of its update, Celadon has seen its stock price spike since its publication.
These developments follow a dramatic governance shake-up and proposed delisting announced on 29 March 2025, when Celadon confirmed it would seek to cancel the trading of its shares on AIM.
At the time, CEO James Short—who owns just under 40% of the company—said the move was aimed at “significantly reducing operational costs” and gaining access to capital “on more attractive terms” in private markets.
The post EU Moves to Improve Conditions for Embattled Biotech Sector, Ananda’s Clinical Development Pushes On, & Celadon Remains on the Brink appeared first on Business of Cannabis.
Continue reading...
