Now could be the time to pounce on Clinuvel Pharmaceuticals Limited (ASX: CUV) shares now if you want big returns for your portfolio.
That's the view of analysts at Bell Potter, which are feeling very positive about the ASX 300 share.
Why is it an ASX 300 share to buy?
In case you're not familiar with Clinuvel, it is a global specialty pharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders.
Its lead therapy is Scenesse, which is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world's first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP).
The ASX 300 share is also seeking to expand Scenesse's use into other treatment areas. It is this that is getting Bell Potter excited. It commented:
CUV are conducting two Phase 3 trials to expand the label of Scenesse to include patients with vitiligo. Following recent company announcements, we have revisited vitiligo development expectations and market forecasts. The first Phase 3 trial primary readout is expected in 2H CY25 and represents one of the next major catalysts for the company excluding financial results. Assuming the Phase 3 trials proceed smoothly, we expect submission to the FDA in late CY26 for potential approval by end-CY27.
Bell Potter notes that if successful, this expansion has the potential to be a huge boost to its sales. It adds:
With ~1% of the US population affected by vitiligo, the market size is far greater than the single rare disease for which Scenesse is currently approved. We estimate a directly addressable vitiligo market in the US of ~65-70k patients (vs. ~2k patients for EPP). This translates into legitimate potential for Scenesse to increase its annual sales several fold if the Phase 3 trials succeed and regulatory approval is granted.
Big return potential
In light of the above, the broker has reaffirmed its buy rating and $22.25 price target on the ASX 300 share. Based on its current share price of $14.60, this implies potential upside of 52% for investors over the next 12 months.
The broker concludes:
We view the first vitiligo Phase 3 readout in CY25 as a significant catalyst for the company and see the current CUV price as a good entry point for those willing to take on clinical risk with downside mitigated to a degree by the existing, profitable EPP franchise.
