Dec. 24, 2014, 12:13 PM
- United Therapeutics (UTHR +2.4%) submits a Pre-Market Approval (PMA) application to the FDA for the use of Medtronic's (MDT +0.7%) SynchroMed II implantable drug infusion system with Remodulin (treprostinil) to deliver the drug intravenously to patients with pulmonary arterial hypertension.
- The company plans to submit a supplemental New Drug Application (sNDA) in January to amend Remodulin's label to include the use of the drug with the device.
Dec. 17, 2014, 9:12 AM
- Effective January 1, United Therapeutics (NASDAQ:UTHR) President & COO Roger Jeffs, Ph.D., is promoted to President & Co-CEO. Chairman & CEO Martine Rothbaltt, Ph.D will also be Co-CEO and will continue as Chairman. Chief Manufacturing Officer and EVP, Pharmaceutical Development David Zaccardelli, Pharm.D, is promoted to EVP and COO.
Dec. 15, 2014, 7:54 AM
- The Q-50 Index houses those companies next-eligible for inclusion into the Nasdaq 100 (NASDAQ:QQQ). Amid the Nasdaq 100's annual changes which added and dropped three from the index, the Q-50's quarterly re-ranking adds and drops eleven.
- Added: Ainylam Pharma (NASDAQ:ALNY), Expedia (NASDAQ:EXPE), F5 Networks (NASDAQ:FFIV), JD.com (NASDAQ:JD), MercadoLibre (NASDAQ:MELI), Maxim Integrated (NASDAQ:MXIM), Old Dominion Freight Line (NASDAQ:ODFL), Shire (NASDAQ:SHPG), Splunk (NASDAQ:SPLK), Stratasys (NASDAQ:SSYS), United Therapeutics (NASDAQ:UTHR).
- Dropped: Avis Budget (NASDAQ:CAR), Cree (NASDAQ:CREE), First Solar (NASDAQ:FSLR), Golar LNG (NASDAQ:GLNG), Methanex (NASDAQ:MEOH), Melco Crown (NASDAQ:MPEL), Nuance (NASDAQ:NUAN), SolarCity (NASDAQ:SCTY). Also dropped are the three Nasdaq 100 additions: American Airlines, Lam Research, and Electronic Arts.
- Source: Press Release
- Previously: Who's in, who's out in annual change to Nasdaq 100 (Dec. 13, 2014)
Dec. 3, 2014, 3:36 PM
- Actelion Ltd (OTCPK:ALIOF) (OTC:ALIOY) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension (PAH).
- Selexipag is selective IP prostacyclin receptor agonist. Prostacyclin activates the IP receptor inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells. If approved, it will be the first such drug cleared for use in PAH.
- In April 2008, the company signed a license agreement with Nippon Shinyaku under which Actelion has global development and commercialization rights to selexipag outside of Japan. The firms will be partners in Japan.
- Actelion plans to submit an NDA to the FDA shortly.
- PAH-related tickers: (GSK -0.8%)(GILD -1.9%)(MSTX -1.5%)(ARNA +1.7%)(OTCPK:BAYRY -1.8%)(UTHR -1.2%)
Oct. 28, 2014, 10:53 AM
- United Therapeutics (UTHR -6%) Q3 results: Revenues: $330M (+9.2%); Net Product Sales: $328.3M (+9.4%); R&D Expense: $118.9M (+63.5%); SG&A: $202.5M (+115.2%); Operating Loss: ($32.2M) (-130.8%); Net Loss: ($25.2M) (-140.2%); Loss Per Share: ($0.53) (-145.3%).
- Product Sales: Remodulin: $142.9M (+8.0%); Tyvaso: $119.7M (-0.5%); Adcirca: $51.2M (+8.0%); Orenitram: $14.5M (+100.0%).
- No guidance given.
Oct. 28, 2014, 6:18 AM
Oct. 21, 2014, 11:37 AM
Aug. 29, 2014, 12:45 PM
Aug. 29, 2014, 11:52 AM
- Shares of United Therapeutics (UTHR +23.1%) jump on 5x surge in volume after a court rules that Sandoz (NVS +0.3%) failed to prove that United's '007 and '117 Remodulin (treprostinil) patents are invalid and that United proved that Sandoz's ANDA will infringe on patent '117.
- Remodulin accounted for almost 45% of United's 1H sales of $612.2M.
Jul. 29, 2014, 6:52 AM
- United Therapeutics (NASDAQ:UTHR) Q2 results: Total Revenues: $322.8M (+15.0%), Net Product Sales: $321.3M (+15.8%); R&D Expense: $39.7M (-27.3%); SG&A Expense: $68.0M (-4.8%); Operating Income: $176.3M (+44.2%); Net Income: $111.9M (+40.1%); EPS: $2.10 (+38.2%).
- Product Sales: Remodulin: $138.2M (+11.1%), Tyvaso: $121.2M (+10.8%), Adcirca: $55.3M (+26.5%).
- No guidance given.
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Feb. 25, 2014, 12:05 AM
Feb. 24, 2014, 5:30 PM
Dec. 24, 2013, 10:18 AM
- "Surprisingly, after two previous CRLs on unsuccessful Phase 3 programs, Orenitram was FDA approved," Jefferies' Eun Yang says, lifting the price target on United Therapeutics (UTHR -0.2%) to $91 from $76.
- Sales projection: <$300M "unless FREEDOM-EV success."
- "The new price target is still sharply below the current market price," Yang cautions.
UTHR vs. ETF Alternatives
United Therapeutics Corp is a biotechnology company, which is focused on the development and commercialization of products to address the medical needs of patients with chronic and life-threatening conditions.
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