Clarus Therapeutics Inc

Type: Company
Name: Clarus Therapeutics Inc
First reported Sep 09 2014 - Updated Sep 09 2014 - 1 reports

Preview: FDA September 17 Adcom On Testosterone Replacement Therapy

Summary The FDA is set to hold a joint meeting of the Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committees on Sep. 17. The purpose of the meeting is to discuss the appropriate population for testosterone ... [Published Seeking Alpha - Sep 09 2014]
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Lipocine Is A Compelling Investment Opportunity With Impending Phase 3 Data

Summary Lipocine is a specialty pharmaceutical company with a novel drug delivery technology for application in men’s and women’s health. The company’s lead product, LPCN 1021, is an oral testosterone replacement therapy (TRT) in a Phase 3 pivotal trial ... [Published Seeking Alpha - Aug 19 2014]
First reported Aug 13 2014 - Updated Aug 13 2014 - 1 reports

Lipocine: An Undervalued Biotech With An Approaching Catalyst

Summary Lipocine's Phase III results for its lead compound LPCN-1021 are expected to be announced in the third quarter of 2014. LPCN-1021 could be the first and only oral testosterone replacement therapy indicated for low testosterone in the U.S. LPCN-1021 ... [Published Seeking Alpha - Aug 13 2014]
First reported Aug 11 2014 - Updated Aug 11 2014 - 1 reports

Urology Product Preview: Testosterone agent meets efficacy endpoint in phase III studies

Testosterone agent meets efficacy endpoint in phase III studiesClarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral testosterone undecanoate (REXTORO) for testosterone ... [Published Urology Times - Aug 11 2014]
First reported Aug 11 2014 - Updated Aug 11 2014 - 1 reports

Testosterone, clomiphene yield similar satisfaction

No difference in qADAM scores among clomiphene, T injection, and T gel groupsOrlando, FL— Symptomatic hypogonadal men treated with clomiphene citrate (Clomid) or testosterone gels report similar satisfaction levels as age-matched men treated with testosterone ... [Published Urology Times - Aug 11 2014]
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

Upcoming AdComms By Subject Matter

In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so often.  It is just a different way of ... [Published Eye on FDA - Jul 28 2014]
First reported May 27 2014 - Updated May 27 2014 - 1 reports

The Daily Startup: VCs Feeling Confident About Gene Therapy Again

Gene therapy investments soared in the middle of the last decade before falling off a cliff. Now the sector is rebounding. Global venture investment in gene therapies peaked in 2006 with $507.7 million, according to data from Dow Jones VentureSource, ... [Published WSJ.com: Venture Capital Dispatch - May 27 2014]
First reported May 21 2014 - Updated May 21 2014 - 1 reports

Clarus Therapeutics Appoints Patrick Shea Chief Commercial Officer

(GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a men's health specialty pharmaceutical company focused on the development and commercialization of REXTORO, an oral testosterone (T) replacement product, today announced that Patrick Shea has joined the ... [Published GlobeNewswire - May 21 2014]

Quotes

"These studies do not provide conclusive evidence of increased cardiovascular risk associated with testosterone therapy."
...The FDA is requiring that "co-primary efficacy endpoint should show statically significant and clinically relevant differences" . The company plans on filing an NDA by the end of 2014...
Mr. Shea commented, "This is a great opportunity to join a talented management team that has unique expertise in T-replacement therapy and is poised to commercialize a product that addresses an unmet need in the treatment of hypogonadal men. If approved, there is significant opportunity for REXTORO to capture market share given the severity of potential side effects from transference and the inconvenience of administration associated with the currently approved treatment options. I look forward to working with the team as Clarus enters this exciting and important phase of its development." Clarus is an emerging men's specialty pharmaceutical company preparing for the commercial launch of REXTORO, an oral testosterone, or T, replacement...

More Content

All (12) | News (6) | Reports (0) | Blogs (2) | Audio/Video (0) | Fact Sheets (0) | Press Releases (4)
sort by: Date | Relevance
Preview: FDA September 17 Adcom On Testosterone... [Published Seeking Alpha - Sep 09 2014]
Lipocine Is A Compelling Investment Opportunity... [Published Seeking Alpha - Aug 19 2014]
Lipocine: An Undervalued Biotech With An Approa... [Published Seeking Alpha - Aug 13 2014]
Testosterone, clomiphene yield similar satisfac... [Published Urology Times - Aug 11 2014]
Urology Product Preview: Testosterone agent mee... [Published Urology Times - Aug 11 2014]
Upcoming AdComms By Subject Matter [Published Eye on FDA - Jul 28 2014]
Clarus Therapeutics Expands Board of Directors ... [Published GlobeNewswire: Acquisitions News - Jul 21 2014]
Clarus Therapeutics Presents Phase 3 Data for R... [Published GlobeNewswire: Acquisitions News - Jun 22 2014]
Clarus Therapeutics Secures $31.5 Million in Fi... [Published GlobeNewswire: Advertising News - Jun 12 2014]
Clarus Therapeutics to Present Phase 3 Data for... [Published GlobeNewswire: Advertising News - May 28 2014]
The Daily Startup: VCs Feeling Confident About ... [Published WSJ.com: Venture Capital Dispatch - May 27 2014]
Clarus Therapeutics Appoints Patrick Shea Chief... [Published GlobeNewswire - May 21 2014]
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Upcoming AdComms By Subject Matter [Published Eye on FDA - Jul 28 2014]
In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so often.  It is just a different way of ...
The Daily Startup: VCs Feeling Confident About ... [Published WSJ.com: Venture Capital Dispatch - May 27 2014]
Gene therapy investments soared in the middle of the last decade before falling off a cliff. Now the sector is rebounding. Global venture investment in gene therapies peaked in 2006 with $507.7 million, according to data from Dow Jones VentureSource, ...
1

Press Releases

sort by: Date | Relevance
Clarus Therapeutics Expands Board of Directors ... [Published GlobeNewswire: Acquisitions News - Jul 21 2014]
Clarus Therapeutics Presents Phase 3 Data for R... [Published GlobeNewswire: Acquisitions News - Jun 22 2014]
Clarus Therapeutics Secures $31.5 Million in Fi... [Published GlobeNewswire: Advertising News - Jun 12 2014]
Clarus Therapeutics to Present Phase 3 Data for... [Published GlobeNewswire: Advertising News - May 28 2014]
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