Morphic Medical – FDA approval of study amendments
Source: RNS
4 June 2024
Crystal Amber Fund Limited
("Crystal Amber Fund", the "Company" or the "Fund")
Investee company update:
Morphic Medical Inc - FDA approval of study amendments brings forward US revenue target
Crystal Amber is pleased to announce that Morphic Medical Inc ("Morphic"), the creator of RESET, a medical device designed to target the underlying cause of diabetes, has received approval from the U.S. Food and Drug Administration ("FDA") for Morphic's application for amendments to certain requirements for its pivotal study, which is approved as a staged study. The FDA has also referenced that there are no subject protection concerns.
These changes are expected to accelerate access to the key US markets for the treatments of diabetes and obesity by 18 months. Morphic is now seeking to target sales in the US market in 2026, subject to, inter alia, successful completion of the study and trials.
The Fund owns 81.5% of Morphic's fully diluted share capital and also owns interest bearing loan notes in Morphic.
Christopher Waldron, Chairman of Crystal Amber commented:
"I am delighted to report on this important development at Morphic, which is expected to accelerate the pathway to revenues in the key US market. Following returns of capital by the Fund of more than £55 million since the start of 2022 as a result of several successful realisations, Morphic has become the Fund's largest holding by value. It is therefore encouraging to note that our substantial efforts and focus on Morphic's growth opportunities are now providing visibility of success."
For further enquiries please contact:
Crystal Amber Fund Limited
Chris Waldron (Chairman)
Tel: 01481 742 742
Allenby Capital Limited - Nominated Adviser
Jeremy Porter/ Dan Dearden-Williams
Tel: 020 3328 5656
Winterflood Investment Trusts - Broker
Joe Winkley/Neil Langford
Tel: 020 3100 0160
Crystal Amber Advisers (UK) LLP - Investment Adviser
Richard Bernstein
Tel: 020 7478 9080
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
