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Titan Pharmaceuticals THIRD Quarter 2015 Financial Results

MONDAY, NOVEMBER 16, 2015 - 1:05 PM PT | 4:05 PM ET

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Titan Pharmaceuticals Latest Press Releases

SOUTH SAN FRANCISCO, CA and PRINCETON, NJ – January 12, 2016 Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and partner Braeburn Pharmaceuticals today announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.

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SOUTH SAN FRANCISCO, CA – January 12, 2016 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that Nasdaq has halted trading in its common stock. The U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) is meeting today to discuss the New Drug Application (NDA) for Probuphine® for the maintenance treatment of opioid addiction.

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SOUTH SAN FRANCISCO, CA – December 9, 2015Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) and partner Braeburn Pharmaceuticals today announced that the U.S. Food and Drug Administration has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) on Jan. 12, 2016 to review the New Drug Application (NDA) for Probuphine® for the maintenance treatment of opioid addiction. The meeting notice appears in today’s Federal Register and can be found at http://federalregister.gov/a/2015-30970. The NDA was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. An agency action date has been set for Feb. 27, 2016.

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SOUTH SAN FRANCISCO, CA – Nov. 16, 2015 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery technology, announced today that it has added an implantable triiodothyronine (T3) product for the treatment of hypothyroidism to its product development pipeline. ProNeura-T3 could potentially offer significant advantages over once-daily oral delivery for patients who need T3 in their treatment regimen.

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Probuphine®

Probuphine is Titan’s novel subdermal implant formulation designed using its ProNeura technology to deliver six months of buprenorphine hydrochloride (“buprenorphine”) following a single treatment. Probuphine is being developed for the treatment of opioid dependence...

 

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Probuphine® Program Update

 

April. 15, 2015
Phase 3 Study Completion on Schedule for Late Q2, 2015

Titan announced completion of patient enrollment in the Phase 3 study of Probuphine®, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence, on Nov. 30. The study is expected to be completed on schedule by the end of the second quarter ...

 

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Titan Pharmaceuticals, Inc. is a biopharmaceutical Company developing proprietary therapeutics primarily for the treatment of central nervous system (“CNS”) disorders.

Titan’s principal asset is Probuphine®, the first slow-release implant formulation of buprenorphine hydrochloride (“buprenorphine”), designed to maintain a stable, round-the-clock blood level of the medicine in patients for up to six months following a single treatment. The outpatient treatment of opioid dependence with daily dosed sublingual buprenorphine formulations represents a $1.5 billion market in the U.S., and a seven day transdermal patch formulation of buprenorphine for the treatment of chronic pain was launched in the U.S. in 2011.  This novel implant formulation is inserted subdermally in a patient’s upper arm providing continuous medication...

 

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