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United Therapeutics Announces FDA Acceptance of Tyvaso sNDA

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United Therapeutics UTHR announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval to include data from the INCREASE study on the label of its pulmonary arterial hypertension (PAH) drug, Tyvaso for review. The pivotal phase III INCREASE study evaluated Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), a lung disease for which no treatments are presently approved. Tyvaso is presently approved to treat PAH to improve exercise ability.

The FDA granted standard review to the sNDA and so a decision is expected in April 2021. If approved, the label update will increase Tyvaso's eligible U.S. population by more than 30,000 patients, which should drive sales of the drug higher.

The stock has risen 25.8% this year so far against the industry’s decrease of 6.3%.



In February, United Therapeutics had announced that the INCREASE study met its primary efficacy endpoint by showing that Tyvaso improved six-minute walk distance by 21 meters compared to placebo after being administered for 16 weeks. The study also met its key secondary endpoints.

Other than Tyvaso, which is an inhaled version of treprostinil, United Therapeutics markets three other PAH medicines in the United States: Remodulin, an injectable formulation of treprostinil; Orenitram, an oral version of treprostinil; and Adcirca tablets. Remodulin is approved for both subcutaneous (SC) and intravenous (IV) use. Please note that United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for PAH in the United States from Eli Lilly LLY in November 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction. Adcirca/Cialis lost exclusivity in 2018 and generic versions are available.

United Therapeutics is working on several late-stage PAH studies. Key phase III programs include autologous cell therapy (PAH - phase II/III SAPPHIRE study), Treprostinil Technosphere dry powder inhaler (PAH — phase III BREEZE study), Tyvaso in PAH patients who have COPD (phase III PERFECT study), and Ralinepag (PAH — phase III ADVANCE outcomes studies). Success in these studies may open up attractive market opportunities and address significant unmet clinical needs.

United Therapeutics currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A couple of top-ranked small drugmakers include Pacira BioSciences PCRX and Actinium Pharmaceuticals ATNM. While Pacira has a Zacks Rank of 1, Actinium has a Zacks Rank #2 (Buy).

Pacira’s stock has risen 37.4% this year so far. Its earnings estimates for 2020 have increased 6.2% while that for 2021 have risen 5.5% over the past 30 days.

Actinium’s stock has risen 65.3% this year so far.

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