Pipeline and regulatory updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Last week, Kythera Biopharmaceuticals, Inc. KYTH received positive news on the regulatory font when the FDA approved its lead candidate, Kybella, for improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults, commonly referred to as a double chin. Kybella is the first FDA-approved, non-surgical treatment for double chin.
Earlier this year, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to support the approval of Kybella.
We note that the company had regained all rights to Kybella outside the U.S. and Canada from the HealthCare segment of Bayer AG BAYRY in Mar 2014.
Meanwhile, Kythera has submitted marketing applications in Canada, Switzerland and Australia for Kybella.
According to the American Society for Dermatologic Surgery, 68% of consumers were affected by submental fullness in 2014.
There has been a widespread adoption of anti-aging and aesthetic treatments among the people in the U.S. According to the American Society for Aesthetic Plastic Surgery, U.S. citizens spent more than $12 billion on both surgical and non-surgical procedures in 2014. The company anticipates potential revenues from Kybella to exceed $500 million in the U.S. alone.
Kybella’s approval is a major positive for the company. We expect investor focus to remain on further updates on Kybella.
Kythera currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Aeterna Zentaris Inc. AEZS and Biogen BIIB. Both stocks sport a Zacks Rank #1 (Strong Buy).
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