2009 News Releases

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12/11/09GTx Announces Reduction in Force
Company Realigns Cost Structure Following Delay in Potential Commercialization of Toremifene 80 mg MEMPHIS, Tenn.--(BUSINESS WIRE)--Dec. 11, 2009-- GTx, Inc. (Nasdaq: GTXI) today announced a reduction in force reflecting the delay in the potential commercialization of toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy (ADT). “The delay of the commercialization of toremifene 80 mg ha... 
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11/11/09GTx Announces Corporate Presentation at Lazard Capital Markets Annual Healthcare Conference
MEMPHIS, Tenn.--(BUSINESS WIRE)--Nov. 11, 2009-- GTx, Inc. (NASDAQ: GTXI), announced today that management will present a company overview on November 17 at the Lazard Capital Markets 6th Annual Healthcare Conference in New York City. The GTx presentation will begin at 4:10 p.m. Eastern Time. A simultaneous webcast of the presentation will be accessible from the investor relations section of the GTx website at www.gtxinc.com. An archived repla... 
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11/09/09GTx, Inc. Reports Third Quarter 2009 Corporate Results
MEMPHIS, Tenn.--(BUSINESS WIRE)--Nov. 9, 2009-- GTx, Inc. (Nasdaq: GTXI) today reported financial results for the third quarter of 2009. The net loss for the third quarter and nine months ended September 30, 2009 was $12.8 million and $35.4 million, respectively, compared with a net loss of $11.9 million and $37.9 million for the same periods in 2008. At September 30, 2009 GTx had cash, cash equivalents and short-term investments of $55.5 million. ... 
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11/04/09GTx, Inc. Announces Third Quarter 2009 Corporate Results Conference Call and Webcast
MEMPHIS, Tenn.--(BUSINESS WIRE)--Nov. 4, 2009-- GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to discuss the Company’s third quarter 2009 corporate results on Monday, November 9 at 9:00 a.m. Eastern. The call and webcast will follow the release of the third quarter 2009 results earlier that day. To listen to the conference call, please dial: 866-515-2911 from the United State... 
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11/02/09GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application
MEMPHIS, Tenn.--(BUSINESS WIRE)--Nov. 2, 2009-- GTx, Inc. (NASDAQ: GTXI) today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT). The FDA identified two deficiencies in the Complete Response Letter and recommended... 
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10/30/09GTx to Host Conference Call and Webcast to Provide Update on Status of Toremifene 80 mg New Drug Application
MEMPHIS, Tenn.--(BUSINESS WIRE)--Oct. 30, 2009-- GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast on Monday, November 2, 2009 to provide an update regarding the New Drug Application for toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy. Conference Call GTx will host the conference call and webcast on Monday, November 2, 2009 at 9:00 a.m. ... 
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09/14/09GTx Announces Phase III Clinical Development of Toremifene 20 mg on Course Following Planned Safety Review
MEMPHIS, Tenn.--(BUSINESS WIRE)--Sep. 14, 2009-- GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate. ... 
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09/02/09GTx Announces Corporate Presentation at Rodman & Renshaw Annual Global Investment Conference
MEMPHIS, Tenn.--(BUSINESS WIRE)--Sep. 2, 2009-- GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on September 9 at the Rodman & Renshaw Annual Global Investment Conference in New York City. The GTx presentation will begin at 10:00 a.m. Eastern. A simultaneous webcast of the presentation will be accessible from the investor relations section of the GTx website at www.gtxinc.com. An archived replay of the pre... 
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08/10/09GTx, Inc. Reports Second Quarter 2009 Corporate Results
MEMPHIS, Tenn.--(BUSINESS WIRE)--Aug. 10, 2009-- GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2009. The net loss for the second quarter and six months ended June 30, 2009 was $11.3 million and $22.6 million, respectively, compared with a net loss of $13.2 million and $26.0 million for the same periods in 2008. At June 30, 2009 GTx had cash, cash equivalents and short-term investments of $68.9 million. ... 
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07/29/09GTx, Inc. Announces Second Quarter 2009 Corporate Results Conference Call and Webcast
MEMPHIS, Tenn., Jul 29, 2009 (BUSINESS WIRE) -- GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to discuss the Company's second quarter 2009 corporate results on Monday, August 10 at 9:00 a.m. Eastern. The call and webcast will follow the release of the second quarter 2009 results earlier that day. To listen to the conference call, please dial: - 866-711-8198 from the United States and Canada or - 617-597-5327 (Inter... 
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07/07/09GTx-758, an Oral LH Inhibitor for First Line Treatment of Advanced Prostate Cancer, Advances into Second Phase I Clinical Trial
MEMPHIS, Tenn.--(BUSINESS WIRE)--Jul. 7, 2009-- GTx, Inc. (Nasdaq: GTXI), today announced the initiation of a Phase I multiple ascending dose clinical trial evaluating GTx-758, an oral LH inhibitor for first line treatment of advanced prostate cancer. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June. In the completed Phase I single ascending dose clinical trial, GTx-758 was well tolerat... 
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06/11/09GTx Presents Phase II Ostarine (MK-2866) Cancer Cachexia Clinical Trial Results at Endocrine Society Annual Meeting
WASHINGTON--(BUSINESS WIRE)--Jun. 11, 2009-- GTx, Inc. (Nasdaq: GTXI) today announced results of a Phase II clinical trial evaluating Ostarine™ (MK-2866), an investigational selective androgen receptor modulator (SARM), in patients with cancer induced muscle loss, also known as cancer cachexia. In the study, Ostarine treatment led to statistically significant increase in lean body mass (LBM) and improvement in muscle performance measured by sta... 
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06/08/09GTx Announces Ostarine(TM) (MK-2866) Clinical Trial Data to be Presented at ENDO 2009
MEMPHIS, Tenn., Jun 08, 2009 (BUSINESS WIRE) -- GTx, Inc. (NASDAQ: GTXI), today announced that results of the Phase II clinical trial evaluating Ostarine(TM) (MK-2866) for the treatment of cancer cachexia will be presented at ENDO 2009, The Endocrine Society's Annual Meeting, being held in Washington, DC June 10-13 at the Walter E. Washington Convention Center. "The use of a selective androgen receptor modulator to improve lean body mass and muscle perfor... 
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06/02/09GTx Announces Webcast of Corporate Presentation at Goldman Sachs 30th Annual Global Healthcare Conference
MEMPHIS, Tenn.--(BUSINESS WIRE)--Jun. 2, 2009-- GTx, Inc. (NASDAQ: GTXI), announced today that management will participate in the Goldman Sachs 30th Annual Global Healthcare Conference on June 9, 2009. The GTx presentation will begin at 11:55 a.m. Eastern time. A live webcast of the presentation may be accessed by visiting the GTx website at www.gtxinc.com. An archived replay of the webcast will be available for two weeks beginning approximate... 
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06/01/09GTx's Toremifene 80 Mg Increased Bone Mineral Density in Multiple Clinically Relevant Subpopulations of Prostate Cancer Patients on Androgen Deprivation Therapy
ORLANDO, Fla.--(BUSINESS WIRE)--Jun. 1, 2009-- GTx, Inc. (Nasdaq: GTXI) announced the presentation yesterday of data demonstrating that toremifene 80 mg treatment compared to placebo increased bone mineral density (BMD) in multiple clinically relevant subpopulations of men with prostate cancer on androgen deprivation therapy (ADT). The data, an analysis of results of the recent Phase III clinical trial evaluating toremifene 80 mg for the prevention o... 
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05/28/09GTx Announces Toremifene 80 mg Phase III ADT Clinical Trial Data to be Presented at the Annual Meeting of the American Society of Clinical Oncology
MEMPHIS, Tenn.--(BUSINESS WIRE)--May. 28, 2009-- GTx, Inc. (NASDAQ: GTXI) today announced that data from the Phase III clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy will be presented at the 2009 Annual Meeting of the American Society of Clinical Oncology being held in Orlando, Florida May 29-June 2.   ... 
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05/11/09GTx, Inc. Reports First Quarter 2009 Results
MEMPHIS, Tenn.--(BUSINESS WIRE)--May. 11, 2009-- GTx, Inc. (NASDAQ: GTXI) today reported financial results for the first quarter of 2009. The net loss for the first quarter was $11.3 million compared with a net loss of $12.7 million for the same period in 2008. At March 31, 2009, GTx had cash, cash equivalents and short-term investments of $81.7 million. “This is an exciting period for GTx,” said Mitchell S. Steiner, MD, CEO ... 
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05/04/09GTx, Inc. Announces First Quarter 2009 Corporate Results Conference Call and Webcast
MEMPHIS, Tenn.--(BUSINESS WIRE)--May. 4, 2009-- GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to discuss the Company’s first quarter 2009 corporate results on Monday, May 11 at 9:00 a.m. Eastern. The call and webcast will follow the release of the first quarter 2009 results earlier that day. To listen to the conference call, please dial: – 866-271-6130 from the United S... 
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04/27/09First Ever Prospective Fracture Study in Prostate Cancer Patients on ADT Reveals These Men Are at High Risk for Skeletal Fractures
CHICAGO--(BUSINESS WIRE)--Apr. 27, 2009-- GTx, Inc. (Nasdaq: GTXI) announced today that in a recent Phase III clinical trial of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT), nearly one in four placebo group subjects developed bone fractures or critical bone loss (>7% loss) within two years. This analysis of placebo group data from the Phase III clinical trial evaluating toremifene 80 mg for the prevention... 
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04/23/09GTx, Inc. Appoints Michael K. Brawer, MD as Executive Director, Medical Affairs and Clinical Development
MEMPHIS, Tenn.--(BUSINESS WIRE)--Apr. 23, 2009-- GTx, Inc. (NASDAQ: GTXI) announced today the appointment of Michael K. Brawer, MD as Executive Director of Medical Affairs and Clinical Development. Dr. Brawer will assist GTx Chief Medical Officer Ronald A. Morton, Jr. and Vice President of Medical Affairs Shontelle Dodson in educating the medical community about disease states of interest to GTx and will also participate in the development and execut... 
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04/22/09GTx Announces Toremifene 80 mg Phase III ADT Clinical Trial Data to be Presented at the Annual Meeting of the American Urological Association
MEMPHIS, Tenn.--(BUSINESS WIRE)--Apr. 22, 2009-- GTx, Inc. (NASDAQ: GTXI) today announced that data from the Phase III clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy will be the subject of an oral podium presentation at the 2009 Annual Meeting of the American Urological Association being held in Chicago April 25 - 30. Abstract #639 – “Posi... 
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03/25/09GTx Announces Upcoming Investor Conference Presentations
MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar. 25, 2009-- GTx, Inc. (NASDAQ: GTXI) announced today upcoming presentations at two investor conferences. On April 1, GTx management will present a company overview at the 4th Annual Citi Biotech Day in New York. The GTx presentation will begin at 2:40 p.m. Eastern Time. On April 2, GTx management will present a company overview at the 2009 Future Leaders in the Biotech Industry Conference in New Y... 
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03/10/09GTx Announces Corporate Presentation at the Cowen and Company 29th Annual Health Care Conference
MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar. 10, 2009-- GTx, Inc. (NASDAQ: GTXI) announced today that management will present a company overview on March 17th at the Cowen and Company 29th Annual Health Care Conference in Boston. The GTx presentation will begin at 8:00 a.m. Eastern Time. A simultaneous webcast of the presentation will be accessible from the GTx website at www.gtxinc.com. An archived replay of the presentation will be available on the compan... 
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03/05/09FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA
MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar. 5, 2009-- GTx, Inc. (Nasdaq: GTXI), today announced that the United States Food and Drug Administration will target a Prescription Drug User Fee Act agency action date of October 30, 2009 for the toremifene 80 mg New Drug Application (NDA), which is within 10 months of the submission of the NDA. Toremifene 80 mg is an oral selective estrogen receptor modulator which GTx seeks to market for the pr... 
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02/26/09GTx Announces Phase III Clinical Development of Toremifene 20 mg on Course Following Planned Safety Review
MEMPHIS, Tenn.--(BUSINESS WIRE)--Feb. 26, 2009-- GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate. ... 
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02/23/09GTx Initiates Phase I Clinical Trial for GTx-758, an Oral Luteinizing Hormone Inhibitor for Advanced Prostate Cancer
MEMPHIS, Tenn.--(BUSINESS WIRE)--Feb. 23, 2009-- GTx, Inc. (NASDAQ: GTXI) announced today that it has initiated a Phase I clinical trial for GTx-758, an oral luteinizing hormone (LH) inhibitor to treat men with advanced prostate cancer. The Phase I study will evaluate the safety, tolerability and pharmacokinetic profile of GTx-758 using a single ascending dose, double blind, placebo controlled design in healthy male volunteers. "We are... 
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02/18/09GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA
MEMPHIS, Tenn.--(BUSINESS WIRE)--Feb. 18, 2009-- GTx, Inc. (Nasdaq: GTXI) announced today that the United States Food and Drug Administration has accepted for filing and review the New Drug Application (NDA) for toremifene 80 mg, an oral selective estrogen receptor modulator, which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT). The NDA is supported by results ... 
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02/17/09GTX Reports Fourth Quarter and Year End 2008 Results
MEMPHIS, Tenn.--(BUSINESS WIRE)--Feb. 17, 2009-- GTx, Inc. (Nasdaq: GTXI), today reported financial results for the fourth quarter and year ended December 31, 2008. The net loss for the quarter and year ended December 31, 2008 was $13.9 million and $51.8 million, respectively, compared with a net loss of $12.8 million and $40.4 million for the same periods in 2007. At December 31, 2008, GTx had cash, cash equivalents and short-term investments of $97... 
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02/05/09GTx, Inc. Announces Fourth Quarter and Year End 2008 Corporate Results Conference Call and Webcast
MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx, Inc. (Nasdaq: GTXI) today announced that it will host a conference call and webcast to discuss the Company's fourth quarter and year end 2008 corporate results on Tuesday, February 17 at 9:00 a.m. Eastern. The call and webcast will follow the release of fourth quarter and year end 2008 corporate results earlier that day. To listen to the conference call, please dial: -- 800-299-0433 fr... 
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02/03/09GTx Announces Webcast of Corporate Presentation at the 11th Annual BIO CEO & Investor Conference
MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx, Inc. (NASDAQ: GTXI) announced today that management will present a company overview on February 10th at the 11th Annual BIO CEO & Investor Conference in New York. The GTx presentation will begin at 10:30 a.m. Eastern Time. A simultaneous webcast of the presentation will be accessible from the GTx website at www.gtxinc.com. An archived replay of the presentation will be available on the company website... 
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01/30/09GTx Congratulates Dr. Duane D. Miller on His Induction into the American Chemical Society Medicinal Chemistry Hall of Fame
MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx, Inc. (NASDAQ: GTXI) congratulates Dr. Duane D. Miller on his induction into the American Chemical Society’s Medicinal Chemistry Hall of Fame, the highest honor bestowed by ACS. The Memphis Local ACS Section will honor Dr. Miller at a dinner at GTx tonight. Duane D. Miller, PhD, GTx Director of Medicinal Chemistry since 2003, is the Harriet S. Van Vleet Professor of Medicinal Chemistry and Associate ... 
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01/23/09GTx Announces Conference Call to Discuss EMEA Label Changes to Fareston(R)
MEMPHIS, Tenn.--(BUSINESS WIRE)--Jan. 23, 2009--GTx, Inc. (NASDAQ: GTXI) announced that it will hold a conference call at noon Eastern time today to discuss the label change for Fareston(R) (toremifene citrate) 60 mg announced on January 22nd by the European Medicines Agency (EMEA) recommending that Fareston not be used in patients at risk of prolonged QT interval, as well as the results of a Thorough QT/QTc study of toremifene conducted by GTx, and GTx's v... 
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01/08/09GTx Announces Webcast of Corporate Presentation at the 27th Annual JP Morgan Healthcare Conference
MEMPHIS, Tenn.--(BUSINESS WIRE)--Jan. 8, 2009--GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on January 15th at the 27th Annual JP Morgan Healthcare Conference in San Francisco. The GTx presentation will begin at 8:30 a.m. Pacific Time. A simultaneous webcast of the presentation will be accessible from the GTx website at www.gtxinc.com. An archived replay of the presentation will be available on the company ... 
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