Evgen Pharma PLC (AIM:EVG)’s positive interaction with regulators in the US and UK have been described as ‘significant value inflexion points’ by City broker finnCap.
Here in the UK, Evgen met with the Medicines and Healthcare products Regulatory Agency (MHRA) to discuss protocols for a phase I study of the new tablet form of SFX-01, its lead asset.
Approval for the evaluation, which will assess safety, tolerability and the way the drug interacts with the body, is expected this month.
Researchers will also take the opportunity to generate data on dose escalation and target pathway engagement.
In the US, the company will submit a ‘package’ of information ahead of a meeting with the Food & Drug Administration.
Evgen wants to secure investigational new drug meeting status for SFX-01 so it can carry out a phase I/II study in people with glioblastoma, a type of brain tumour with a very poor prognosis.
“These represent significant value inflexion points for the company,” finnCap said.
“Evgen has a sufficient cash runway into the third quarter of 2023, which will enable it to deliver on value-enhancing milestones including potential clinical data sets.”
The broker repeated its 18p a share price target on stock in the group, which is developing treatments for cancer and inflammation. Mid-afternoon, the share were up 2.6% at 5.8p.