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Theravance, Inc. (THRX)

- NASDAQ
  • Wed, Jul. 29, 5:01 PM
    • Theravance (NASDAQ:THRX) declares $0.25/share quarterly dividend, in line with previous.
    • Forward yield 6.4%
    • Payable Sept. 30; for shareholders of record Sept. 10; ex-div Sept. 8.
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  • Wed, Jul. 29, 4:07 PM
    • Theravance (NASDAQ:THRX): Q2 EPS of -$0.07 misses by $0.01.
    • Revenue of $10.66M (+1046.2% Y/Y) misses by $0.24M.
    • Press Release
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  • Tue, Jul. 28, 10:08 AM
    • The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
    • Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
    • Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
    • Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
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  • Tue, May 26, 9:21 AM
    • The FDA approves privately-held Boehringer Ingelheim's once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or acute deterioration of COPD.
    • Tiotropium, a long-acting anticholinergic, is the active ingredient in Spiriva, the most prescribed COPD maintenance treatment worldwide. Olodaterol, a long-acting beta2-agonist that complements the efficacy of Spiriva, has a fast onset of action that improves airflow in five minutes after dosing.
    • COPD-related tickers: (NASDAQ:TBPH) (NYSE:GSK) (NASDAQ:THRX) (NYSE:AZN) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY) (NASDAQ:AQXP)
    | 2 Comments
  • Wed, May 6, 5:10 PM
    • Theravance (NASDAQ:THRX) declares $0.25/share quarterly dividend, in line with previous.
    • Forward yield 6.41%
    • Payable June 30; for shareholders of record June 12; ex-div June 10.
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  • Wed, May 6, 4:51 PM
    • Theravance (NASDAQ:THRX): Q1 EPS of -$0.09 misses by $0.01.
    • Revenue of $6.9M (+3958.8% Y/Y) misses by $2.85M.
    • Press Release
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  • Thu, Apr. 30, 4:46 PM
    • As expected, the FDA approves Breo Ellipta (fluticasone furoate and vilanterol powder) for the once-daily treatment of asthma in adult patients at least 18 years old. It is not approved for the treatment of acute bronchospasm.
    • Breo Ellipta, co-developed by Theravance (NASDAQ:THRX) and GlaxoSmithKline (NYSE:GSK) was previously approved for the treatment of chronic obstructive pulmonary disease.
    • Previously: PDUFA date approaches for expanded use of Breo Ellipta inhaler (April 28)
    | 1 Comment
  • Tue, Apr. 28, 12:19 PM
    • April 30 is the PDUFA date for the FDA's decision on the approval of the use of the Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) inhaler in adult patients with asthma. The Ad Comm vote last month was 18 - 2 in favor of the new indication. Breo Ellipta is currently cleared for the treatment of chronic obstructive pulmonary disease.
    • Breo Ellipta was co-developed by Theravance (THRX +3.3%) and GlaxoSmithKline (GSK +0.2%).
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  • Mon, Mar. 23, 4:26 PM
    • According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
    • 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
    | 20 Comments
  • Fri, Mar. 20, 9:23 AM
    | 2 Comments
  • Thu, Mar. 19, 7:24 PM
    • Theravance (NASDAQ:THRX) has fallen to $16.11 in AH trading after the FDA advisory committee backed the use of GlaxoSmithKline's Breo Ellipta inhaler for treating asthma in adults, but not in adolescents.
    • Theravance, which co-developed Breo Ellipta with Glaxo and receives royalties on its sale, was halted today in advance of the decision. CEO Michael Aguiar, discussing the decisions in a PR: "We remain committed to the ongoing review process and will be fully cooperating with the FDA to ensure it has all it needs to consider the sNDA for Breo Ellipta in asthma. We look forward to the final outcome expected in April."
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  • Thu, Mar. 19, 4:05 PM
    • The FDA joint advisory committee reviewing Glaxo's (NYSE:GSK) sNDA for the use of Breo Ellipta to treat asthma voted 17 - 3 in favor that the safety data was adequately demonstrated in adults with asthma.
    • It voted 18 - 2 in favor of its efficacy in adults at least 18 years old, but 16 - 4 against the data showing a benefit in adolescents ages 12 - 17 years.
    • Related ticker: (NASDAQ:THRX)
    • Previously: Ad Comm meeting approaches for expanded indication for Glaxo's COPD med (March 17)
    | 8 Comments
  • Thu, Mar. 19, 11:26 AM
    • The joint meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is in session today to review Glaxo's sNDA seeking approval for the use of Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) in patients with asthma.
    • Trading in development partner Theravance (THRX) has been halted pending news of the committees' decision.
    • Previously: Ad Comm meeting approaches for expanded indication for Glaxo's COPD med (March 17)
    | 5 Comments
  • Wed, Mar. 18, 7:45 AM
    • Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
    • PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
    • PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
    • The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
    • Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
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  • Mon, Feb. 23, 4:35 PM
    • Theravance (NASDAQ:THRX) declares $0.25/share quarterly dividend, in line with previous.
    • Forward yield 5.72%
    • Payable March 31; for shareholders of record March 12; ex-div March 10.
    | Comment!
  • Thu, Feb. 19, 10:39 AM
    • Theravance (THRX +1.8%) Q4 results: Revenues: $7.3M (+386.7%); Operating Expense: $7.2M (-19.1%); Operating Income: $0.1M (+101.4%); Net Loss: ($15.9M) (-78.7%); Loss Per Share: ($0.14) (-75.0%).
    • FY2014 results: Revenues: $8.4M (+86.7%); Operating Expense: $42.4M (+27.3%); Operating Loss: ($33.9M) (-17.7%); Net Loss: ($73.5M) (-140.2%); Loss Per Share: ($0.66) (-120.0%); Quick Assets: $283.4M (-45.6%).
    • No guidance given.
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Company Description
Theravance Inc provides is a royalty management company engaged in maximizing the potential value of the respiratory assets.
Sector: Healthcare
Industry: Biotechnology
Country: United States