FDA accepts United Therapeutics' ralinepag NDA for PAH

United Therapeutics (UTHR) shares are under scrutiny after the FDA accepted its NDA for ralinepag, a treatment for pulmonary arterial hypertension, with a target action date set for June 24, 2027. The company's stock has seen a 1-year return of 67.69% and a 5-year return of 141.31%, but has dipped 9.15% in the past 90 days. Analysts suggest potential undervaluation, with a narrative fair value of $665.23 compared to the recent close of $518.53, citing its pipeline and long-term growth prospects.

United Therapeutics (NASDAQ: UTHR) reported Q2 2026 revenues of $783.3 million, down 2% year over year, and net income per diluted share of $7.27 versus $6.41. Tyvaso DPI sales were $326.6 million, while nebulized Tyvaso fell 18% to $126.0 million. Management discussed a path to a $4 billion 2027 revenue run rate amid competitive pressure and upcoming IPF and PAH launches.

Three Connecticut firms outlined different financing paths. New Silver said it acquired Mayflower Venture Partners to expand lending in New England, with deal terms undisclosed. American Battery Materials filed to raise about $16.3M for Utah lithium and magnesium exploration, targeting production in 2029. MannKind raised $50M after FDA approval of Furoscix ReadyFlow, funding a $45M milestone payment and aiming for U.S. sales by end-August.

MANNKIND CORP (MNKD) filed an SEC Form 8-K — Results of Operations and Financial Condition. MannKind Reports Second Quarter 2026 Financial Results and Provides Business Update • Achieved three major catalysts to drive future growth: o Launched the pediatric indication of Afrezza ® following FDA approval o FUROSCIX ReadyFlow™ autoinjector approved for treatment of edema

United Therapeutics Corporation reported Q2 2026 sales of $783.3M versus $798.6M a year earlier. Net income was $333.0M versus $309.5M. Basic EPS from continuing ops was $7.82 versus $6.86, and diluted EPS was $7.27 versus $6.41. For six months, sales were $1,564.8M versus $1,593.0M; net income $607.9M versus $631.7M.

United Therapeutics (NASDAQ: UTHR) reported Q2 CY2026 revenue of $783.3 million, down 1.9% year over year but 2.3% above Wall Street estimates, according to the company. GAAP EPS was $7.27, up from $6.41 and 5.9% above consensus. Analysts expect revenue to decline 20.9% over the next 12 months.