Mayne Pharma (ASX:MYX) receives FDA approval for contraceptive pill

Company News

by Michael Luu

Specialty pharmaceutical company Mayne Pharma (ASX:MYX) has successfully received approval from the US Food and Drug Administration (FDA) for its product NEXTSTELLIS.

NEXTSTELLIS is a novel contraceptive pill containing a new estrogen - Esterol (E4). This is the first new estrogen introduced in the US for contraceptive use in nearly half a century and has the potential to reduce environmental impact. The company has scheduled the commercial launch of the oral contraceptive for June this year.

The encouraging news has come as a timely boost for Mayne Pharma (ASX:MYX), following recent blows from COVID-19 and generic drug sales to profits last year. Reduced patient visits have resulted in clinic and medical practice closures, leading to a decline in prescriptions. Asset impairments associated with the Mayne’s generics department contributed to a loss of $19.3 million last year.

The pharmaceutical researcher is in the process of diversifying into more sustainable markets in dermatology, women’s health, infectious diseases and contract services. Mayne is planning to reapply for FDA approval for its generic Nuvaring drug this year.

Shares in Mayne Pharma (ASX:MYX) last traded at 46 cents

Are you a 708 sophisticated investor?

A sophisticated investor is defined under Section 708 of the Corporations Act (net assets of $2.5 million or annual incomes in excess of $250,000).

They are eligible to receive information regarding wholesale investment opportunities that are not available to regular or retail investors.

Please subscribe if you would like to be alerted to these types of opportunities.