Theseus Pharmaceuticals Inc【THRX】株式ニュース

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Form SC 14D9 - Solicitation, recommendation statements

Form SC TO-T - Tender offer statement by Third Party

Form SC14D9C - Written communication relating to third party tender offer

Form 8-K - Current report

Theseus Pharmaceuticals Enters into Agreement to Be Acquired by Concentra Biosciences for between $3.90 and $4.05 in Cash per Share Plus a Contingent Value Right

Theseus Pharmaceuticals Enters into Agreement to Be Acquired by Concentra Biosciences for between $3.90 and $4.05 in Cash per Share Plus a...

Form 8-K - Current report

Theseus Pharmaceuticals Confirms Receipt of Unsolicited Expression of Interest from Foresite Capital, LLC and OrbiMed Advisors LLC and Unsolicited Proposal from Concentra Biosciences LLC

Theseus Pharmaceuticals Confirms Receipt of Unsolicited Expression of Interest from Foresite Capital, LLC and OrbiMed Advisors LLC and...

Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend]

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB

Theseus Pharmaceuticals Announces Process to Explore Strategic Alternatives

Theseus Pharmaceuticals Announces Process to Explore Strategic Alternatives PR Newswire CAMBRIDGE, Mass., Nov...

Theseus Pharmaceuticals to Participate in the Stifel 2023 Healthcare Conference

Theseus Pharmaceuticals to Participate in the Stifel 2023 Healthcare Conference PR Newswire CAMBRIDGE, Mass., Nov. 7, 2023 CAMBRIDGE, Mass., Nov...

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Monksdream 1年前

Early Barchart Top 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

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subslover 1年前

Theseus Pharmaceuticals explores strategic options; cuts workforce by 72%

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TheFinalCD 2年前

under the radar today https://finviz.com/quote.ashx?t=THRX&p=d

9:02AM Theravance and GlaxoSmithKline (GSK) announce BREO ELLIPTA is now available to pharmacies throughout the U.S.; THRX agreed to make a milestone payment of $30 mln to GSK (THRX) :

GlaxoSmithKline plc (GSK) and Theravance (THRX) announced that BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), is now available to pharmacies throughout the U.S.
BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2-agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg). It is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. BREO ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
Under the terms of its 2002 LABA collaboration agreement with GSK, Theravance agreed to make a milestone payment of $30 mln (USD) to GSK following the launch of BREO ELLIPTA in the U.S.

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surf1944 11年前

3:18AM Theravance and GlaxoSmithKline (GSK) announce that RELVAR ELLIPTA gains approval in Japan for the treatment of asthma (THRX) 41.20 : GlaxoSmithKline (GSK) and Theravance (THRX) announce that the Japanese Ministry of Health, Labour and Welfare has approved RELVAR ELLIPTA for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required). Relvar Ellipta is not indicated for the treatment of chronic obstructive pulmonary disease in Japan.

Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $10 mln to GSK following MHLW approval of Relvar Ellipta in Japan.

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surf1944 11年前

7:18AM Theravance halted; FDA Advisory Committee to review ANORO ELLIPTA NDA (THRX) 37.79 : Co announced that NASDAQ halted trading of Theravance common stock this morning, Sep 10, 2013. The Pulmonary-Allergy Drugs Advisory Committee to the FDA meets today to discuss the new molecular entity New Drug Application (NDA) 203975 for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO ELLIPTA), sponsored by Glaxo Group (GSK) (d/b/a GSK) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. UMEC/VI is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide, a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group and Theravance.

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JD400 11年前

GSK shares hit as Advair generics edge closer in U.S.

LONDON (Reuters) - The threat of generic copies of GlaxoSmithKline's (GSK.L) best-selling lung drug Advair finally making it to market in the United States hit confidence in the drug maker on Tuesday, sending the stock down more than 3 percent.

Fears of cheaper versions of the $8 billion-a-year seller being launched in the world's biggest market were fuelled by a draft guidance document from the Food and Drug Administration setting out the requirements for generic versions of the inhaled drug.

Bernstein analyst Tim Anderson said the requirements looked "fairly benign" for generic firms seeking to make copies that could be automatically substituted for Advair when patients have their prescriptions filled.

Citigroup said its worst-case scenario for an accelerated U.S. Advair sales decline, following the FDA document, could slice up to 5 percent off GSK's valuation.

http://finance.yahoo.com/news/gsk-shares-hit-advair-generics-082354075.html?l=1

Advair, which is marketed as Seretide outside the United States, is used to treat both asthma and chronic lung disease caused by smoking.

Although patents on the active ingredients used in the medicine have expired, it remains protected by U.S. patents on the Diskus inhaler device that run until 2016, after which copies may reach the market.

Up until now, many investors had assumed that fully substitutable generic versions of Advair were unlikely in the United States and instead generics would have to compete as separate brands. The FDA pathway to permitting "true" generics therefore represents a heightened threat.

Shares in GSK were down 3.3 percent at 15.85 pounds by 0805 GMT (3:05 EDT).

The uncertainty over Advair comes on the same day that a U.S. advisory panel is due to consider a new lung drug called Anoro from GSK and Theravance (THRX).

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surf1944 11年前

8:05AM Theravance Announces Reintroduction of VIBATIV (telavancin) to the U.S. Market (THRX) 36.80 : Co announces that it has commenced shipments of VIBATIV (telavancin) into the US wholesaler channel. VIBATIV is approved in the US for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable, and for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

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surf1944 12年前

12:38PM Theravance and GlaxoSmithKline (GSK) confirm BREO ELLIPTA gains U.S. approval for the treatment of COPD (THRX) 34.59 +3.28 : GlaxoSmithKline plc (GSK) and Theravance (THRX) announced that the FDA has approved BREO ELLIPTA as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2 agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg). Following this approval by the FDA, it is anticipated that BREO ELLIPTA will be available in the US during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of BREO ELLIPTA.

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starbuxsux 12年前

Theravance to Split Into Two Companies, Swings to 1st-Quarter Loss

Apr 25, 2013 17:23:34 (ET)

By Nathalie Tadena

Theravance Inc. (THRX) said it plans to create two independent publicly traded companies, separating its late-stage partnered respiratory assets from its biopharmaceutical operations.

Shares of the company, which had been halted ahead of the news, jumped 8.3% to $33.50 after hours. Through the close, the stock has climbed 45% over the past three months.

Theravance said one company will focus on managing the rights to potential respiratory product royalty revenues under its collaboration with GlaxoSmithKline PLC (GSK, GSK.LN). This company is expected to retain Theravance's net operating loss carryforwards and intends to return capital to shareholders.

The other company will be a separate biopharmaceutical company focusing on the development and commercialization of small-molecule medicines. Theravance said it plans to capitalize this company with about $300 million at separation, which is expected to fund operations over the following two to three years.

Theravance's current Chief Executive Rick Winningham will initially serve as CEO of the royalty management company. Most of Theravance's current employees are expected to become employees of the biopharmaceutical operations-focused company.

The separation is expected to be completed by late 2013 or early 2014.

Theravance also reported it swung to a first-quarter loss of $37.4 million, or 39 cents a share, from a year earlier profit of $84.6 million. Revenue from collaborative arrangements declined 99% to $1.3 million, primarily due to the termination of its collaboration with Astellas Pharma for the development and commercialization of Vibativ in January 2012.

Analysts polled by Thomson Reuters had expected a per-share loss of 38 cents and revenue of $2 million.

Write to Nathalie Tadena at nathalie.tadena@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

(END) Dow Jones Newswires

April 25, 2013 17:23 ET (21:23 GMT)

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gixxer11 12年前

Agreed - possibly a couple gap fills in the short term

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surf1944 12年前

Most all the good news is in THRX, on Sell list

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surf1944 12年前

4:00PM Theravance confirms FDA Advisory Committee recommends approval of BREO ELLIPTA for the treatment of COPD (stock halted) (THRX) 28.01 : Co and GlaxoSmithKline (GSK) announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO ELLIPTA as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against). BREO ELLIPTA, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long acting bronchodilator (LABA) vilanterol "VI" (FF/VI). The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against). The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for FF/VI is 12 May 2013.

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gixxer11 12年前

What link do you have - Tia

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John Q Trader 12年前

LOL I am watching this FDA hearing, and cant make sense from any of this clinical mumbo jumbo. JUST GIVE ME THE BOTTOM LINE PLEASE :)

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surf1944 12年前

7:09AM Theravance shares halted; The Pulmonary-Allergy Drugs Advisory Committee to the FDA meets today to discuss the new drug application 204275, for fluticasone furoate and vilanterol dry powder inhaler, sponsored by GlaxoSmithKline (GSK) (THRX) :

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surf1944 12年前

CORRECTED-UPDATE 2-FDA reviewers give mixed views on Glaxo lung drug

FDA reviewers say data for Glaxo's BREO not consistent
8:30am EDT

Mon Apr 15, 2013 11:30am EDT
(Changes headline to reflect that FDA reviewers, not advisory panel, gave opinion on drug)

* FDA reviewers: efficacy data not entirely consistent

* Say safety data generally consistent with other products

* Analysts interpret FDA reviewer opinions positively

* Theravance shares up 22 pct; Glaxo up 3.7 pct

By Toni Clarke

WASHINGTON, April 15 (Reuters) - Reviewers for the U.S. Food and Drug Administration said on Monday that efficacy data for an experimental drug made by GlaxoSmithKline Plc and Theravance Inc was somewhat inconsistent but that its overall safety appears consistent with similar drugs, a relief to investors.

GSK's shares were up 3.7 percent at 1,628 pence on Monday while shares of the smaller Theravance were up 22 percent at $28.98.

The drug, Breo, treats a lung disease that causes breathing difficulties and includes chronic bronchitis, emphysema, or both.

The reviewers' opinions were posted on the FDA's website ahead of a meeting scheduled for Wednesday in which a panel of expert advisers will discuss the drug and recommend whether it should be approved. Their views were interpreted in a generally positive way by investment analysts.

"The FDA review is benign and a relief given the issues that emerged in this clinical trial programme," said Alistair Campbell, an analyst at Berenberg Bank in a research note.

Breo is made up of 100 micrograms of a corticosteroid, fluticasone furoate (FF), and 25 micrograms of a long-acting beta-agonist, or LABA, called vilanterol (VI). The drug is administered via a new dry powder inhaler called Ellipta.

The FDA's advisory panel will be examining whether the benefits of Breo outweigh the risks, and whether the drug combination confers additional benefit over and above the LABA component alone.

"On the positive side, the FDA appears happy with the dosing for Breo, which has marginally increased the probability of approval in our opinion," said Jeffrey Holford, an analyst at Jefferies, in a research note. He estimates peak annual sales of the drug in COPD of $1.5 billion.

COPD refers to a group of lung diseases that block airflow and make breathing difficult. Emphysema, which is most frequently caused by smoking, and chronic bronchitis, an inflammation of the lining of the bronchial tubes, are the two most common conditions that make up COPD.

COPD became the third-leading cause of death in the United States in 2008, according to the U.S. Centers for Disease Control and Prevention, affecting more than 12 million Americans.

The reviewers questioned the contribution of the corticosteroid in improving lung function, saying the data was inconsistent, though they suggested the data appears to support a benefit in limiting COPD exacerbations.

They said the drug's safety profile appears generally consistent with that of similar drugs, though they pointed out an increase in cases of pneumonia and fractures.

"The main question mark appears to be the relative benefit of adding a steroid onto the bronchodilator," said Berenberg's Campbell.

He said he expects the advisory panel meeting "may be less contentious than feared and this should give Breo a very good chance of a positive recommendation."

Glaxo owns 27 percent of Theravance and speculation has risen that Glaxo might buy the remaining 73 percent in order to gain full control of their portfolio of jointly developed respiratory drugs.

The market for COPD drugs has until now been dominated by Glaxo's Advair and Pfizer Inc's Spiriva. Glaxo is seeking a successor to Advair, its twice-daily medication for COPD and asthma which generates some $8 billion a year. (Editing by Maureen Bavdek and Matthew Lewis)

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surf1944 12年前

7:02AM Theravance and GlaxoSmithKline (GSK) announce FDA acceptance of New Drug Application submission in the US for ANORO ELLIPTA for COPD (THRX) 22.13 : Co and GlaxoSmithKline (GSK) announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 18 December 2013.

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surf1944 12年前

7:11AM Theravance Announce and GlaxoSmithKline plc (GSK) regulatory submission for UMEC/VI (LAMA/LABA) in the US (THRX) 22.08 : GlaxoSmithKline plc (GSK) and Theravance (THRX) announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist, administered using the ELLIPTA inhaler.

US Submission:
A New Drug Application for UMEC/VI (62.5/25mcg and 125/25mcg doses) with the proposed proprietary name ANORO ELLIPTA has been submitted to the US Food and Drug Administration, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

Future Regulatory Submissions:
Regulatory filings for UMEC/VI are planned in the European Union imminently and in other countries during the course of 2013. In addition, GSK intends to commence global regulatory submissions for UMEC monotherapy in the ELLIPTA inhaler for COPD patients in 2013.

THRX FDA PanelThu, November 29, 12am – Fri, November 30, 12am
Calendar
FDA Calendar

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surf1944 12年前

I am currently in about 75 small cap biotech stocks & looking to add on any weakness in the weeks. Hopeful for a major bounce in many beaten down stocks, but the whole sector should do well into Jan/Feb, this bounce has taken place since I have been following the group. Most are less than $10/share, but again THRX will rise with the sector....

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hm36tm 12年前

Which stocks are you looking for an year end bounce?

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starbuxsux 12年前

I would love to see some of those tickers that apply to that statement and compare them with mine lol

I play tax selling plays this time of the year, stocks that have been killed with likely moves of over 100% into Jan

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surf1944 12年前

THRX may trend higher into Jan, but the risk reward is not in it for me with the large number of other biotech stocks starting to move move up. I play tax selling plays this time of the year, stocks that have been killed with likely moves of over 100% into Jan, THRX doesn't fit that line of thinking for me....

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starbuxsux 12年前

Your thoughts on this one?

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surf1944 12年前

THRX FDA Panel
Thu, November 29, 12am – Fri, November 30, 12am
Calendar
FDA Calendar

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surf1944 12年前

4:04AM Theravance and GlaxoSmithKline (GSK) receive FDA acceptance of FF/VI New Drug Application submission in the US for COPD (THRX) 25.76 : GlaxoSmithKline plc (GSK) and Theravance (THRX) announce that the New Drug Application for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" for patients with chronic obstructive pulmonary disease, has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act goal date has also been confirmed as 12th May 2013. GSK also submitted a Japanese New Drug Application for FF/VI for patients with COPD and asthma on 25th September 2012.

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surf1944 12年前

September 7, 2012
07:14 EDT THRX, GSK Theravance recent weakness a buying opportunity, says Piper Jaffray
Piper Jaffray recommends using the recent weakness in shares of Theravance (THRX) as a buying opportunity as it believes Phase III data for Breo/Relvar and LAMA/LABA support regulatory approval and an eventual takeout by partner GlaxoSmithKline (GSK). Piper reiterates an Overweight rating on Theravance with a $35 price target.

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surf1944 13年前

:58AM GSK and Theravance (THRX) announced the results of Phase III studies of investigational LAMA/LABA; for the first treatment comparison showed a statistically significant improvement (GSK) 45.58 : GlaxoSmithKline (GSK) and Theravance (THRX) announced the results of four pivotal phase III studies of investigational LAMA/LABA involving over 4,000 patients with chronic obstructive pulmonary disease. These four studies include two 24-week efficacy studies that compared the combination LAMA/LABA, its components and placebo and two 24-week active comparator studies that compared the combination with the LAMA tiotropium, a widely prescribed maintenance bronchodilator for COPD. The second 24-week, randomised, double-blind, double-dummy, parallel-group study compared the efficacy and safety of UMEC/VI 62.5/25mcg and 125/25mcg with UMEC 125mcg and tiotropium 18mcg. This study randomised 872 patients. The pre-specified primary endpoint was trough FEV1 at the end of the treatment period. For the first treatment comparison, UMEC/VI 125/25mcg showed a statistically significant improvement of 74mL compared with tiotropium. For the second comparison, UMEC/VI 125/25mcg showed a numerical but not statistically significant improvement compared with UMEC 125mcg. UMEC/VI 62.5/25mcg showed a numerical difference from tiotropium of 60mL and a numerical difference from UMEC 125mcg of 22mL in trough FEV1.

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surf1944 13年前

7:08AM Theravance disclosed earlier that it signed a Technology Transfer and Supply Agreement with Hospira (HSP) relating to VIBATIV (THRX) 21.83 : The Agreement provides for the co to transfer certain manufacturing technology to Hospira (HSP) related to its VIBATIV (telavancin for injection) drug product, and make technology transfer payments to Hospira as Hospira undertakes and completes technology transfer and validation activities. Once regulatory approval for Hospira to manufacture VIBATIV has been obtained, Hospira will manufacture and sell VIBATIV to the co pursuant to the Agreement. The Agreement has a five-year term, subject to earlier termination following bankruptcy, uncured breaches or inability to perform. Theravance has agreed, subject to certain conditions and exceptions, to purchase from Hospira more than a majority of its VIBATIV 750 mg dosage form requirements during the term.

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mlkrborn 13年前

GSK ups lung drug bet by buying more of Theravance

GSK ups lung drug bet by buying more of Theravance
7:48am EDT
Novartis lung drug meets goals in late-stage trials
4:10am EDT
UPDATE 2-Novartis lung drug meets goals in late-stage trials
4:04am EDT
GSK's new once-daily HIV drug matches Merck rival
3:16am EDT
Insight: Chasing cheaper cancer drugs
Sun, Apr 1 2012

LONDON | Mon Apr 2, 2012 9:09am EDT

(Reuters) - GlaxoSmithKline (GSK.L) bet another LONDON 12.9 million on the success of lung drug Relovair on Monday by raising its stake in U.S. biotech firm Theravance (THRX.O) - its partner on the new medicine - to 26.8 percent.

Britain's biggest drugmaker has been working with Theravance for 10 years to develop Relovair, an inhaled therapy combining two ingredients, which is a potential successor to GSK's $8 billion-a-year top-seller Advair.

Relovair will be submitted to regulators for approval as a treatment for chronic obstructive pulmonary disease (COPD) in mid-2012.

The new drug has had mixed results in clinical trials, showing superiority to Advair in some tests but not others. Still, GSK remains confident and hopes the convenience of once-daily dosing will appeal to patients, helping Relovair carve out good sales as a replacement for twice-daily Advair.

Current consensus forecasts point to annual Relovair sales of $1.46 billion by 2016, according to Thomson Reuters Pharma.

The success of Relovair is critical to GSK's future business in lung disease as Advair is set to lose patent protection in key markets, although it is not certain it will face immediate generic competition as respiratory drugs are difficult to copy.

GSK, which previously had an 18.3 percent holding in its U.S. partner, said it was paying $21.2887 per share for 10 million Theravance shares, a 7.5 percent premium to the five-day average price up to March 30.

(Reporting by Ben Hirschler; Editing by Keith Weir and Erica Billingham)

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surf1944 13年前

7:36AM GlaxoSmithKline to increase its ownership in Theravance (THRX) (GSK) 19.50 : Co announced that they have entered into a stock purchase agreement, under which THRX will issue, and GSK will acquire, 10 mln shares of Theravance common stock at a price of $21.2887 per share, for a total investment of $212.8 mln Following this purchase, GSK would own ~25.8 mln shares of THRX common stock, which would increase GSK's ownership from ~18.3% to ~26.8% of the total outstanding capital stock of THRX.

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surf1944 13年前

8:11AM Theravance and GlaxoSmithKline (GSK) announce topline results from Relovair vs Advair Phase 3 studies in COPD (THRX) 18.62 : Two replicate 12-week superiority studies evaluated the 24-hour lung function profile of once-daily FF/VI 100/25mcg (Relovair) compared with twice-daily Advair 250/50mcg (fluticasone propionate "FP"/salmeterol "SAL" (FP/SAL)) in patients with COPD. Each study randomised approximately 500 patients. In the first study, FF/VI demonstrated superiority over FP/SAL on the predefined primary endpoint of 0-24 hour weighted mean FEV1 (p<0.001). In the second study, FF/VI demonstrated numerical improvements but not statistical superiority over FP/SAL on the predefined primary endpoint of 0-24 hour weighted mean FEV1 (p=0.267).

GSK has also completed the phase III registrational programme for FF/VI, following the completion of a study to evaluate the efficacy and safety of FF and FP compared to placebo in the treatment of persistent asthma in adults and adolescents. In this 24-week multi-centre study of approximately 330 patients, FF met the primary endpoint of a statistically significant change from baseline in trough evening FEV1 at the end of the 24-week treatment period (p=0.009) compared to placebo. FP also met this primary endpoint when compared to placebo (p=0.011).

For COPD, GSK continues with its plans to submit regulatory applications for FF/VI in the US and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a US asthma indication

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Penny Roger$ 13年前

~ Thursday! $THRX ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $THRX ~ Earnings expected on Thursday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.

http://stockcharts.com/h-sc/ui?s=THRX&p=D&b=3&g=0&id=p88783918276&a=237480049

http://stockcharts.com/h-sc/ui?s=THRX&p=W&b=3&g=0&id=p54550695994

~ Google Finance: http://www.google.com/finance?q=THRX
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~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=THRX+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=THRX
Finviz: http://finviz.com/quote.ashx?t=THRX
~ BusyStock: http://busystock.com/i.php?s=THRX&v=2

<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=THRX >>>>>>

http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

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surf1944 13年前

Theravance to Present at Investor Conferences in February 2012
MarketwirePress Release: Theravance, Inc. – Wed, Feb 1, 2012 4:05 PM EST

SOUTH SAN FRANCISCO, CA--(Marketwire -02/01/12)- Theravance, Inc. (NASDAQ: THRX - News) announced today that Rick E Winningham, Chief Executive Officer, is scheduled to present at the following investor conferences in February 2012:

Leerink Swann Global Healthcare Conference
Waldorf Astoria, New York, NY
Thursday, February 16, 2012
9:30 a.m. EST

RBC Capital Markets' Global Healthcare Conference
New York Palace, New York, NY
Tuesday, February 28, 2012
8:30 a.m. EST

Citi Global Healthcare Conference
Waldorf Astoria, New York, NY
Wednesday, February 29, 2012
9:30 a.m. EST

All webcast information will be available on Theravance's web site at www.theravance.com. Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software.

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mlkrborn 13年前

Lung drug deaths: dropped to $13
http://www.thestreet.com/_yahoo/story/11369952/1/theravance-shares-slide-on-lung-drug-deaths.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

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surf1944 13年前

2. Theravance Inc. (THRX): Engages in the discovery, development, and commercialization of small molecule medicines for various therapeutic areas, including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Market cap of $1.99B. Put/Call ratio changed from 0.60 to 0.18 between 10/31/11 and 11/14/11, a change of -70%. The stock is a short squeeze candidate, with a short float at 10.29% (equivalent to 17.85 days of average volume). The stock has had a good month, gaining 12.93%.

6 Biotech Stocks With Bullish Options Sentiment

http://seekingalpha.com/article/308696-6-biotech-stocks-with-bullish-options-sentiment?source=yahoo

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surf1944 13年前

3:10AM Theravance and Astellas receive European Marketing Authorization for VIBATIV for nosocomial pneumonia caused by MRSA (THRX) 20.45 : Astellas Pharma Europe and co announce that the European Commission has granted marketing authorization for VIBATIV, following the Committee for Human Medicinal Products' positive opinion in May 2011. VIBATIV, discovered by THRX is a bactericidal, once-daily injectable lipoglycopeptide antibacterial agent with a dual mechanism of action against Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureu

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surf1944 13年前

Theravance, Inc. (Nasdaq:THRX)
Total Insider buying: $2,019,604.88
SEC Filing
Latest Chart
GlaxoSmithKline Plc which is a 10% owner of the company purchased more shares at an average price of $19.71 in early August and shares saw a low of $16.59 before bouncing to $18.55, then finally settling at $17.50.

There are three upcoming milestones for the company highlighted in the calendar, including two separate approval decisions for Telavancin that are under review at the European Medicines Agency.

Theravance is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule medicines in therapeutic areas of respiratory disease, bacterial infections and central nervous system.

http://seekingalpha.com/article/288897-10-big-healthcare-stocks-being-snapped-up-by-insiders?source=yahoo

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surf1944 13年前

http://www.insidercow.com/history/company.jsp?company=thrx&B1=Search!

http://www.form4oracle.com/company/theravance-inc-thrx/company-transactions?id=9012

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surf1944 14年前

Theravance Remains Neutral
zacks

Zacks Equity Research, On Tuesday June 14, 2011, 10:15 am EDT

We have maintained our Neutral recommendation on Theravance, Inc. (NasdaqGM: THRX - News) with a target price of $24.00 per share following the announcement of first quarter 2011 financial results.

Theravance’s first quarter 2011 loss per share of 28 cents was in line with the Zacks Consensus Estimate, but narrower than the year-ago loss of 35 cents per share. Revenues at Theravance increased 10% year over year to $6.3 million. An increase in royalty revenues from Vibativ sales in the reported quarter was attributable for both the jump in revenues and the narrower year-over-year loss per share. However, total revenue was below the Zacks Consensus Revenue Estimate of $7 million.

Theravance has active collaborations with GlaxoSmithKline (NYSE: GSK - News) for the Relovair, LAMA/LABA (also called 719/VI) and MABA programs. The Relovair program holds the biggest potential in the company’s pipeline, which aims to replace one of Glaxo’s best selling drugs, Advair. It is being developed for the treatment of chronic obstructive pulmonary diseases (COPD) and asthma. The LAMA/LABA combination is also being developed for the treatment of COPD. Under the MABA collaboration, Theravance is making rapid progress with GSK961081, which could be another important option for the treatment of COPD. If successful, this portfolio of respiratory products could put Theravance in a very competitive position. Theravance is entitled to receive royalties on sales of Relovair, LABA/LAMA, and MABA without any cost obligations. We believe the revenue generated following the approval of any of the programs will ultimately lead the company to profitability.

Theravance, on its own, has a deep pipeline consisting of candidates like TD-5108 (chronic constipation), TD-1792 (cSSSI), and TD-1211 (opioid-induced constipation), which could boost future revenues. All these programs are solely owned by Theravance and it is looking for collaboration partners for the development and commercialization of these compounds.

Theravance’s lead drug, Vibativ (telavancin), is an injectable antibiotic approved for the treatment of complicated skin and skin structure infections (cSSSI), caused by gram-positive bacteria, including resistant pathogens such as methicillin-resistant staphylococcus aureus (MRSA). Vibativ is being marketed and sold by Astellas, while Theravance receives royalties, ranging from high teens to upper twenties depending on sales volume. The US Food and Drug Administration’s (FDA) approval to market Vibativ is a significant achievement for the company which will provide Theravance with much-needed funds.

Vibativ is also being studied for hospital-acquired pneumonia (HAP) or nosocomial pneumonia (NP). Though the antibiotic has not been approved for NP in either Canada or the US, the drug received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the NP indication in late May 2011. If approved, this will be the first approval for the treatment of NP, which is associated with high mortality rates. In US, Theravance received a complete response letter (CRL) for the NP indication from the FDA requesting for additional data. The company is currently in discussions with the FDA and has no plans to conduct additional studies. Though we are encouraged by the positive CHMP opinion for Vibativ for NP, we are disappointed with the CRL received in the US.

In addition, we are concerned about competition from other drugs targeting gram-positive bacterial infections. Vibativ is competing with ViroPharma’s (VPHM) Vancocin, Cubist Pharmaceutical’s (NasdaqGS: CBST - News) Cubicin, Pfizer’s (NYSE: PFE - News) Xyvox and Tygacil and Forest Laboratories’ (NYSE: FRX - News) Teflaro. Consequently, we apprehend that Vibativ’s initial sales ramp would be slow. We, therefore prefer to remain on the sidelines on the stock.

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surf1944 14年前

Top Buys and Sells of Baupost's Star Manager Seth Klarman

Healthcare sector: Buy Theravance Inc. (THRX) and Alere Inc. (ALR). Baupost sold $390 million of its prior quarter $1.01 billion position in the healthcare sector. It sold out of its prior quarter $45 million position in biotech Regeneron Pharmaceuticals (REGN). The position was opened in the mid-$20s in the summer of 2010, and it probably sold out in the $40 range last quarter, so this was just profit-taking. Furthermore, Baupost added to its prior quarter positions in biotech PDL Biopharma Inc. (PDLI) and Aveo Pharmaceuticals (AVEO); both positions were opened at the end of 2010, and are indicative of Baupost’s conviction in its buy decision. Furthermore, Baupost holds a large $315 million position in biotech Theravance Inc. (THRX) that was opened in the mid-teens in early 2008, and a $120 million position in Alere Inc. (ALR), a developer of diagnostic products in the areas of infectious disease, cardiology, oncology, drug abuse and women’s health, that was opened in the $30 range in the summer of 2010. THRX traded in the high-$20s last quarter and ALR traded in the $40 range last quarter, so Baupost continuing to hold these positions without any profit-taking is indicative of Baupost’s conviction in its hold decision. Baupost holds a 17.4% of the outstanding shares of THRX and it is a large conviction holding for it. Furthermore, ALR is projected to exhibit strong double-digit revenue and earnings growth going forward and trades at a very attractive forward 12 P/E, near the low-to-mid-end of its historic P/E range.

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surf1944 14年前

7. Theravance Inc. (THRX): Biotechnology Industry. Market cap of $1.86B. Current price at $21.99 vs. target price of $27.8 (implies a potential upside of 26.42%). Net insiders purchases over the last 6 months is 5.19M shares, which represents 9.92% of the 52.32M share float. The stock is a short squeeze candidate, with a short float at 8.61% (equivalent to 14.23 days of average volume). The stock has performed poorly over the last month, losing 13.19%.

http://seekingalpha.com/article/276281-10-undervalued-biotech-stocks-with-insider-buying?source=yahoo

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surf1944 14年前

GSK and Theravance Announce Results of Two Pivotal Phase III Studies for Relovair(TM) in COPD
Results Support Continuation of Relovair Development Programme in COPD

Press Release Source: Theravance, Inc. On Thursday June 2, 2011, 7:00 am EDT

LONDON and SOUTH SAN FRANCISCO, CA--(Marketwire - 06/02/11) - GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ:THRX - News) today announced the results of two pivotal 6-month efficacy and safety phase III studies of Relovair for patients with chronic obstructive pulmonary disease (COPD). Results of both studies support the continuation of the Relovair development programme in the COPD patient population.

Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, comprising fluticasone furoate and vilanterol (FF/VI), currently under development for the treatment of COPD and asthma.

These data form part of the overall evaluation of the efficacy and safety of the Relovair combination in COPD that, together with data from ongoing 12-month exacerbation studies, will be included in regulatory submissions around the world.

For pre-specified co-primary endpoints analyses, both studies show statistically significant improvements for Relovair compared with placebo on 0-4 hour weighted mean FEV1 and trough FEV1. For the same endpoints, the studies also demonstrate statistically significant improvements for VI compared to placebo. In order to assess the contribution of VI to the performance of the combination, a further co-primary endpoint compared Relovair to FF on weighted mean FEV1; again this was statistically significant. In order to assess the contribution of FF to the performance of the combination, Relovair was compared to VI on trough FEV1. For this analysis, Relovair demonstrated numerical improvements but not consistent statistical significance compared with VI alone.

In both studies the most common adverse events across all treatment arms, including placebo, were nasopharyngitis, upper respiratory tract infection and headache. There were no clinically relevant effects seen in laboratory measures or vital signs.

Darrell Baker, SVP, Respiratory Portfolio Optimisation Leader at GSK said: "Successful completion of these two studies is an important milestone in the development of Relovair for COPD. These data will be reviewed together with the larger 12 month exacerbation studies still underway, to develop a complete evaluation of Relovair in treating patients with COPD."

These two six month FEV1 studies provide an initial insight into the pivotal programme for Relovair which is evaluating over 6,000 patients with COPD. Two larger 12-month exacerbation studies in over 3,000 patients are now fully recruited. The results of these additional studies will provide a fuller evaluation of the efficacy of Relovair compared with VI and FF on reduction of exacerbations and improvement in lung function. The full results of all the studies will be presented at future scientific meetings.

Relovair is also in Phase III clinical development for the treatment of asthma.

About the 6-month Efficacy and Safety Studies
The two studies were placebo-controlled, double-blind, parallel-group studies and randomised a total of approximately 2,200 patients with moderate to severe COPD. Patients (approximately n=200 per arm per study) received either FF alone (100mcg, 200mcg), VI alone (25mcg), a combination of FF and Vl (50mcg, 100mcg, or 200mcg FF plus Vl 25mcg) or placebo.

The studies evaluated two separate measures of lung function: improvements in lung function over the first four hours post dose on day 168 and the end of dose trough lung function on day 169.

Relovair™ is a trademark of the GlaxoSmithKline group of companies.

Theravance Analyst Conference Call and Webcast Information
Theravance has scheduled an analyst conference call to discuss this announcement today at 8:00 a.m. Eastern Daylight Time. Analysts who wish to participate in the live call by telephone, please dial (877) 837-3908 from the U.S., or (973) 890-8166 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting Theravance's web site at www.theravance.com. To listen to the live call, please go to Theravance's web site 15 minutes prior to its start to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance's web site for 30 days through July 2, 2011. An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on June 9, 2011 by dialing (800) 642-1687 from the U.S., or (706) 645-9291 for international callers, and entering confirmation code 72929617.

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Theravance -- is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance's key programs include: RELOVAIR™, LAMA/LABA ('719/vilanterol (VI)) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist (PµMA) program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance's web site at www.theravance.com.

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surf1944 15年前

7:01AM Theravance announces that EMEA has completed the validation phase for the Telavancin MAA for the treatment of nosocomial pneumonia and complicated skin and soft tissue infections (THRX) 13.13 : Co announces the European Medicines Agency (EMEA) has completed the validation phase for the Marketing Authorization Application for telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, and complicated skin and soft tissue infections in adults. Astellas Pharma Europe B.V., a European affiliate of Astellas Pharma Inc. submitted the MAA in October 2009 under the Centralized Procedure and applied for marketing authorization for telavancin in the Member States of the European Union, plus Iceland, Liechtenstein and Norway. The successful completion of the validation phase for a MAA signifies that the submission is administratively complete and that EMEA's scientific review process has begun.

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surf1944 16年前

THRX may have hit a near term top and sold some short as a hedge position in the sector. Mainly long the group going into Jan 09.

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surf1944 16年前

Theravance, Inc. Q2 2008 Earnings Call Transcript

http://seekingalpha.com/article/90286-theravance-inc-q2-2008-earnings-call-transcript?source=yahoo

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surf1944 16年前

Theravance Announces Regulatory Update on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Tuesday July 22, 8:00 am ET

SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Jul 22, 2008 -- Theravance, Inc. (THRX - News) announced today that the U.S. Food and Drug Administration (FDA) has not yet made a decision regarding the New Drug Application (NDA) for telavancin. The Prescription Drug User Fee Act (PDUFA) date for action by FDA was July 21, 2008, and as of that date, the company had not received an action letter from the FDA. Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic, for the proposed indication to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).

The company previously announced that the FDA had indicated that it did not expect to take final action on the telavancin NDA prior to completing its further evaluation of study site monitoring and study conduct in the ATLAS Phase 3 program, nor prior to resolution of the manufacturing issues not specifically related to telavancin that were cited in the approvable letter received in October, 2007.

"We continue to work diligently with the FDA to resolve the remaining issues on our cSSSI NDA," said Rick E Winningham, Chief Executive Officer of Theravance. "We remain confident in the data generated in this program and are committed to bringing the potential benefit of telavancin to those patients suffering from cSSSI and more serious infections such as hospital-acquired pneumonia."

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. The company's key programs include: telavancin for the treatment of serious Gram-positive bacterial infections with Astellas Pharma Inc., the Horizon program with GlaxoSmithKline plc, and the Gastrointestinal Motility Dysfunction program. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at www.theravance.com.

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