Announcement this morning:

PYC today announces the receipt of Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for this drug candidate (known as PYC-001) for the treatment of OPA1-associated vision loss. ODD is given to drug candidates designed to treat rare diseases. Benefits of an ODD include tax credits for qualified clinical trials, exemptions from some regulatory fees and the potential for 7 years of market exclusivity post approval

This announcement, whilst not unexpected is another step in the right direction and talks to the ability of PYC management to execute.

By way of background PYC has three RNA drugs and their associated carrier peptides for treatment of genetic conditions they are busy proving up. They are:

i) Retinitis Pigmentosa RP11. Drug VP-001. Est $1b annual market.

ii) Autosomal Dominant Optic Atrophy (ADOA). Drug PYC-001. Est $2b annual market.

iii) Autosomal Dominant Polycystic Kidney Disease (ADPKD). Drug PYC-003. Est $10b annual market.

What will drive the share price, either up or down is further clinical and pre-clinical readouts for all of the above drugs expected between now and the end of the calendar year.