Tarsa Therapeutics News

1910, 2015

Tarsa Therapeutics’ NDA for TBRIA(TM), the First Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis, Accepted for Filing

Need for Safe and Effective New Therapies Highlighted by Limited Existing Treatment Options and Large Population of Underserved Osteoporosis Patients
PHILADELPHIA, PA – October 19, 2015 — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon delayed release tablets) submitted to the U.S. Food […]

1408, 2014

Tarsa Therapeutics Secures $10 Million and Adds Industry Veteran Daniel Soland as a Director

PHILADELPHIA, PA – August 13, 2014 — Tarsa Therapeutics, Inc. today announced that it has secured a $10 million senior credit facility from Oxford Finance LLC and Square 1 Bank. The company intends to use the proceeds to support its plans to file a New Drug Application (NDA) with the […]

2905, 2014

Tarsa Therapeutics Raises $7 Million to Prepare for Filing NDA for Ostora, Its Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis

Recently Revised Label for Marketed Calcitonin Products Has Helped Clarify the Regulatory Landscape in the U.S.
Industry Veteran Nicholas LaBella Joins Tarsa as Vice President, Global Regulatory Affairs and Will Oversee the NDA Submission Process
PHILADELPHIA, PA – May 29, 2014 — Tarsa Therapeutics, Inc. today announced that it raised $7 million to prepare […]

710, 2013

Tarsa Therapeutics Presents Meta-analysis at ASBMR 2013 Showing Calcitonin Does Not Appear to be Associated with Increased Risk of Cancer

Study is First to Analyze All Relevant Clinical Trials of Oral and Intranasal Calcitonin in Women
Results are Consistent with Calcitonin’s 30-Year Safety Record and the Lack of Biological Plausibility
BALTIMORE, MD and PHILADELPHIA, PA – October 7, 2013 — Tarsa Therapeutics, Inc. today announced that it presented a new meta-analysis showing that salmon calcitonin […]

1610, 2012

Tarsa Therapeutics Reports Positive Results from Phase II Trial of Its Oral Calcitonin in Prevention of Post-Menopausal Osteoporosis

Oral Presentation at ASBMR 2012 Annual Meeting Shows Tarsa’s Oral Calcitonin Tablet Achieved Efficacy Endpoint with Good Safety Profile
Poster Presentation at ASBMR 2012 Concludes One-Year Use of Tarsa’s Oral Calcitonin Is Not Associated with Increased Risk of Cancers
MINNEAPOLIS, MN and PHILADELPHIA, PA – October 16, 2012 — Tarsa Therapeutics, Inc. today […]

1210, 2012

Tarsa Therapeutics to Assist Therapicon in Its Challenge to CHMP’s Recommendation to Limit Use of Calcitonin

Request of Italian Marketer of Nasal Calcitonin Spray for Reexamination of Recent CHMP Recommendation Has Been Accepted
Study Slated for Presentation at ASBMR 2012 Assesses Whether Tarsa’s Oral Calcitonin Was Associated with Increased Cancer Risk in Two Year-Long Postmenopausal Osteoporosis Trials
Second ASBMR Presentation Discusses Results of Phase II Trial of Tarsa’s […]

2603, 2012

Tarsa Therapeutics Completes $28 Million Series B Financing to Advance Ostora™ Oral Calcitonin

PHILADELPHIA, PA – March 16, 2012 — Tarsa Therapeutics, Inc. today announced completion of a $28 million Series B equity financing led by new investor Foresite Capital.  James Tananbaum, MD, Foresite’s founder and CEO, is joining Tarsa’s Board of Directors.  Tarsa’s existing venture capital investors—Novo A/S, MVM Life Science Partners and […]

2103, 2012

Tarsa Therapeutics Signs Commercial Supply Agreement for Its Ostora™ Oral Calcitonin Product with QS Pharma

PHILADELPHIA, PA – March 21, 2012 —Tarsa Therapeutics today announced it has entered into a commercial supply agreement with QS Pharma for the bulk manufacture of its OSTORA™ oral recombinant salmon calcitonin tablet.  The OSTORA tablets, which will be manufactured in QS Pharma’s state-of-the-art facility in Pennsylvania, will be used for […]

1312, 2011

Tarsa Therapeutics Targets 2012 NDA Submission for Its Ostora™ Oral Calcitonin

PHILADELPHIA, PA – December 13, 2011 —Tarsa Therapeutics today confirmed that it is planning to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2012 for OSTORA™, the company’s oral recombinant salmon calcitonin tablet for the treatment of postmenopausal osteoporosis.  This follows […]

1809, 2011

Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial

Data Presented at ASBMR 2011 Annual Meeting Show Tarsa’s Oral Calcitonin Tablet OSTORA™ Achieved Positive Results on Efficacy Endpoints
SAN DIEGO, CA and PHILADELPHIA, PA – September 18, 2011 —Tarsa Therapeutics today presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA™, the company’s oral recombinant salmon calcitonin […]

1207, 2011

Tarsa Therapeutics Advances Its Oral Calcitonin for the Treatment and Prevention of Postmenopausal Osteoporosis

Completes Patient Enrollment in Phase II Osteoporosis Prevention Trial
Will Present Full Data Set on Phase III ORACAL Treatment Trial at ASBMR
Closes Additional Tranche of a Financing That Has Raised a Total of $24.5 Million
PHILADELPHIA, PA – July 12, 2011 —Tarsa Therapeutics today reported progress in its two ongoing  clinical development programs […]

2403, 2011

Tarsa Therapeutics Reports Positive Top-Line Results from Pivotal Phase III Oracal Trial of Its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis

Positive, Statistically Significant Top-Line Results Support Proceeding to NDA Submission in 2011
Trial Conducted in Accordance with Special Protocol Assessment with FDA
Full Results to Be Presented in Peer-Reviewed Forum Later this Year
PHILADELPHIA, PA – March 24, 2011 —Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon […]

1402, 2011

Tarsa Therapeutics Completes Phase III Trial of Its Oral Calcitonin for Treatment of Postmenopausal Osteoporosis and Initiates Phase II Trial in Osteoporosis Prevention

Completes Patient Dosing in ORACAL Trial; Results Expected in Early Spring
Enrollment Opened in New Phase II Postmenopausal Osteoporosis Prevention Trial
PHILADELPHIA, PA – February 14, 2011 — Tarsa Therapeutics, Inc. today announced completion of its global Phase III ORACAL trial testing the company’s once-daily oral recombinant calcitonin for the treatment of postmenopausal […]

2409, 2010

Tarsa Therapeutics and Unigene Present Preclinical Data Suggesting Calcitonin May Have Utility in Combination Therapy for the Treatment Of Osteoarthritis

Philadelphia, PA, Boonton, NJ and Brussels, Belgium – September 24, 2010—Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. (OTCBB: UGNE) today reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis.  The data are being presented at the […]

2207, 2010

Tarsa Therapeutics Advances Phase III Oracal Trial of Its Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis

—Completes Patient Enrollment in Global, Randomized, Double-Blind Phase III Trial—
—Receives Positive Safety Reports from Two Separate Reviews by Independent Data Monitoring Committee—
PHILADELPHIA, PA – July 22, 2010 — Tarsa Therapeutics, Inc. today announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis.  The company […]

2910, 2009

Unigene Licenses Phase III Oral Calcitonin Program to Tarsa Therapeutics

New Company Established by Unigene and Three Leading Venture Capital Firms Launched with $24 Million Series A Financing
BOONTON, NJ and PHILADELPHIA, PA – October 20, 2009 — Unigene Laboratories, Inc. (OTCBB: UGNE) and Tarsa Therapeutics, Inc. today announced that Unigene has licensed its Phase III oral calcitonin program to Tarsa, […]

2010, 2009

Unigene to Host Conference Call to Discuss Phase III Oral Calcitonin Licensing Agreement with Tarsa Therapeutics

Conference Call Wednesday, October 21st, 9:00 AM EDT

BOONTON, N.J.–(BUSINESS WIRE)–Oct. 20, 2009– Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) will host a conference call on Wednesday, October 21, 2009, at 9:00 AM EDT to update investors on the Company’s recently announced agreement to license Unigene’s Phase III oral calcitonin program to […]