Teligent Inc. (NASDAQ: TLGT) watched its shares make a solid gain on Wednesday after the firm announced a key approval from the U.S. Food and Drug Administration (FDA). While Teligent has suffered over the past year, this approval could be the turnaround that this company has been waiting for.
The FDA approved Teligent’s abbreviated new drug application (ANDA) of Clobetasol Propionate Cream USP, 0.05%.
For some quick background: Clobetasol Propionate Cream is a topical steroid used to treat the inflammation and itching caused by a number of skin conditions, such as allergic reactions, eczema and psoriasis.
Based on recent data, the total addressable market for this product is approximately $125.4 million.
Also note that this is Teligent’s fourth approval for 2018, and its 23rd approval from its internally developed pipeline of topical generic pharmaceutical medicines.
Jason Grenfell-Gardner, president and CEO of Teligent, commented:
Clobetasol Propionate Cream USP, 0.05% is Teligent’s fourth FDA approval in 2018. This shows the continued success of our R&D team and pipeline. We look forward to launching this product in the second quarter of 2018.
We now have twenty-eight topical generic pharmaceutical products in the US portfolio, in addition to our four US injectable products.
Excluding Wednesday’s move, Teligent had underperformed the broad markets with its stock down 62% in the past 52 weeks. In just 2018 alone, the stock was down closer to 17%.
Shares of Teligent were last seen up 20% at $3.63, with a consensus analyst price target of $5.50 and a 52-week range of $2.43 to $9.54.