Looking ahead: Antares Pharmaceuticals’ October PDUFA

It is an exciting period for Antares Pharmaceuticals, with the FDA decision date for its innovative drug-injector combo product Xyosted coming up on the 20th of October, as listed on our Catalyst Calendar.

Antares is primarily specialised in the design and manufacturing of both needle and needle-free self-injection devices. Thanks to their efficient delivery technologies, their products minimise the required drug dosage, and hence guarantee higher safety and reduced side effects.

Antares has developed 4 FDA approved products within the past 5 years, and the next in line is Xyosted (referred to as Quickshot T on their website). In simple terms, Xyosted is a medical testosterone “supplement” for male adults who suffer from hypogonadism (low testosterone levels), and will be offered in combination with an innovative auto-injector manufactured by Antares. Results from phases 2&3 have demonstrated that Xyosted offers a painless and low-risk alternative when compared with other drugs on the market.

Why we like $ATRS: Antares is a revenue generating company that currently has products offered through distributors in a variety of markets across the world. They have secured a funding of $35mn for the potential production and marketing of Xyosted, a product that has shown exceptional results in the previous phases. Additionally, a supplemental new drug application (sNDA) has been filed for the Makena auto-injector, a product developed with their partner AMAG, with the decision date expected to be in October.

The market for auto-injectors is expected to increase at a CAGR of 15% between 2016-2026, reaching a size of $6bn. The fact that Antares holds the intellectual property rights for several auto-injector technologies means that the company’s value could be unlocked in the near future.

The stock is currently trading at $3.02. A price range of $2.95-3.15 seems suitable for buying shares in anticipation of the Xyosted PDUFA on the 20th of October, and the upcoming decision date on Makena!

Be sure to check out our Catalyst Calendar and sign up with your e-mail address to be able to edit it yourself!

7 thoughts on “Looking ahead: Antares Pharmaceuticals’ October PDUFA

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