Technical Analysis
Positive Uptrend      Previous Resistance: ~$21      Current Support: ~$16

Though Clinuvel is currently carries high volatility, the positive uptrend is appealing for short-term swing trades. Clinuvel is currently near its previous resistance. From a technical analysis, I don’t believe it is currently in the “good buy” territory. However, if Clinuvel continues to make “higher highs and higher lows,” that break the resistance, Clinuvel might offer a substantial profit. I have not taken a position; however, this company has been on my watch list.

Clinuvel is seeking US approval for their product, SCENESSE® (afamelanotide 16mg). The Prescription Drug User Fee Act (PDUFA) date is 8 July 2019. The promise for US approval is supported with the product already being approved in Europe. I will be discussing the mechanism of action within this post.

SCENESSE® (afamelanotide) is an alpha-melanocyte stimulating hormone (α-MSH), seeking the indication for erythropoietic protoporphyria (EPP).

Erythropoietic protoporphyria is a rare, autosomal recessive inborn error of metabolism that typically manifests in early childhood as severe painful photosensitivity. The pain occurs 1 to 20 minutes after direct exposure to the sun. Patients have severe burning pain, typically on the hands and face, and this pain is often followed by swelling and redness.^1,2

SCENESSE® (afamelanotide): Mechanism of Action

Alpha-Melanocyte Stimulating Hormone (α-MSH)
Alpha-Melanocyte Stimulating Hormone (α-MSH) is a naturally occurring peptide hormone which is released by skin cells in response to stimulation by ultraviolet radiation (UVR). Though α-MSH has a very short half-life (seconds) in the bloodstream, it is sufficient enough to reach and stimulate other skin cells, such as melanocytes. The melanocytes produce and release melanin, a dark brown pigment, which is known for its photoprotective effect.³

SCENESSE® (afamelanotide)
SCENESSE® is a chemical analogue of α-MSH and is a linear peptide with 13 amino acids. Two amino acids present in α-MSH have been changed and amplified to produce afamelanotide. These changes create a more stable molecule with increased potent biologic effects and a longer half-life (minutes). SCENESSE® works in a similar way to the natural hormone, α-MSH, by stimulating melanocytes to produce and release melanin within the body. SCENESSE® increases melanin content of the skin without exposure of the skin to the damaging effects of UVR. The increase in melanin allows an increase in tolerance to sunlight and assist in delaying the onset of pain due to skin photosensitivity in adults with confirmed erythropoietic protoporphyia (EPP).^3,4

REFERENCES:

1. JG Langendonk et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med 2015; 373:48-59.
2. Lecha M, Puy H, Deybach JC. Erythropoietic protoporphyria. Orphanet J Rare Dis 2009;4:19-19
3. SCENESSE® (afamelanotide 16mg).; (2019) Available at https://www.clinuvel.com/pharmaceutical/scenesse/scenesse
4. SCENESSE® (afamelanotide) [Package Leaflet, 2015]. Clinuvel (UK) Limited, London, UK.

Disclosure: I have no positions in the stock mentioned. I wrote this article myself, and it expresses my own opinions and not of those of my employer. I am not receiving compensation for it. I have no business relationship with the company whose stock is mentioned in this article.