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Shares of United Therapeutics UTHR rose 15% on Apr 1, following FDA approval for label expansion of its pulmonary arterial hypertension (PAH) drug, Tyvaso. Tyvaso Inhalation Solution is now approved to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.
The approval was based on data from the INCREASE study,which showed that Tyvaso improved six-minute walk distance by 21 meters compared to placebo after being administered for 16 weeks.
The company also launched Tyvaso with the expanded label following the approval. PH-ILD is a serious, life-threatening lung disease for which Tyvaso is currently the only FDA-approved treatment.
Tyvaso is already approved for treating pulmonary arterial hypertension patients and is one of the key drugs in United Therapeutics’ commercial portfolio, generating almost a third of total revenues. The drug showed promising growth in 2020. The label update of the drug will likely increase Tyvaso's eligible U.S. population by more than 30,000 patients, which should drive sales of the drug higher. The company has already expanded its field-based teams to support the launch of the drug in the expanded label and it expects to double the number of patients on Tyvaso therapy by the end of next year.
An expanded targeted patient-population with almost no competition and the company’s immediate launch following the label expansion are likely to have driven investors’ enthusiasm.
United Therapeutics’ stock has risen 26.7% this year so far against the industry’s decrease of 1.1%.
Meanwhile, the company is also developing Tyvaso in two late-stage studies — TETON and PERFECT — as a potential treatment for patients with idiopathic pulmonary fibrosis and pulmonary hypertension associated with chronic obstructive pulmonary disease, respectively. The company is also developing a new formulation, inhaled dry powder via pre-filled, single-use cartridges, for the drug. The company has successfully completed a late-stage study and an NDA is expected to be filed in the first half of 2021.
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 Eli Lilly LLY markets Adcirca as Cialis and the drug has lost patent protection and several generic versions are available.
United Therapeutics has also developed an Implantable System for Remodulin (ISR), an implantable pump for delivering Remodulin intravenously in collaboration with Medtronic MDT. The launch of the ISR is expected in late 2021.
United Therapeutics Corporation Price
United Therapeutics Corporation price | United Therapeutics Corporation Quote
United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked small drugmaker is Catalent, Inc. CTLT, which has a Zacks Rank of 2 (Buy). Cassava Sciences’ stock price has surged 103.4% in the past year. The consensus estimate for 2021 has improved from earnings of $3.00 per share to $3.27 per share over the past 60 days.
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