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Wed, Jan. 13, 9:17 AM
Wed, Jan. 13, 7:11 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee voted 12 to 5 in favor of approval of Titan Pharmaceuticals' (NASDAQ:TTNP) Probuphine subdermal implant for the maintenance treatment of opioid addiction. The PDUFA date is February 27.
- Shares are up 35% premarket on robust volume.
- Privately held Braeburn Pharmaceuticals will commercialize if approved.
- Previously: Ad Comm review set for Braeburn Pharma and Titan Pharma's Probuphine (Dec. 9, 2015)
- Previously: Ad Com approaches for Titan Pharma's Probuphine implant for opioid addiction; shares down 27% premarket (Jan. 8)
Fri, Jan. 8, 9:14 AM
- Thinly traded micro cap Titan Pharmaceuticals (NASDAQ:TTNP) is getting some rude treatment premarket. Shares are down 27% on light volume as investors show of an apparent lack of confidence in Probuphine's prospects in Tuesday's meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, which will discuss the New Drug Application (NDA) submitted by licensee Braeburn Pharmaceuticals. The PDUFA date is February 27.
- The company received a Complete Response Letter (CRL) in April 2013 in response to its first NDA submission.
- Draft questions
- FDA briefing doc
- Braeburn briefing doc
- Errata to Braeburn doc
- Previously: Ad Comm review set for Braeburn Pharma and Titan Pharma's Probuphine (Dec. 9, 2015)
- Previously: Titan Pharma's Probuphine subdermal implant successful in Phase 3 study (June 8, 2015)
Dec. 9, 2015, 7:17 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on January 12, 2016 to discuss Braeburn Pharmaceuticals and Titan Pharmaceuticals' (NASDAQ:TTNP) New Drug Application (NDA) for Probuphine subdermal implant for the maintenance treatment of opioid addiction.
- The PDUFA date is February 27, 2016.
Nov. 16, 2015, 7:27 AM
- Titan Pharmaceuticals (TTNP -0.6%) Q3 results: Revenues: $0; R&D Expense: $1M (+25.0%); SG&A: $0.8M (-11.1%); Net Loss: ($1.8M) (-357.1%); Loss Per Share: ($0.09) (-80.0%); Quick Assets: $9.7M (-37.4%).
- No guidance given.
Nov. 16, 2015, 7:03 AM
- Titan Pharmaceuticals (NASDAQ:TTNP): Q3 EPS of -$0.09 beats by $0.02.
Sep. 28, 2015, 9:36 AM
- Titan Pharmaceuticals (OTCQB:TTNP) executes a 1:5.5 reverse split of its common shares effective tomorrow. Trading in split-adjusted shares will commence at the opening bell. The action satisfies one of the criteria for uplisting to the Nasdaq Capital Market.
Aug. 31, 2015, 11:15 AM
- Titan Pharmaceuticals (OTCQB:TTNP +2%) announces that licensee Braeburn Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA seeking approval for Probuphine (buprenorphine hydrochloride) for the maintenance treatment of opioid addiction. Probuphine, a subdermal implant based on the company's ProNeura technology, is designed to deliver continuous non-fluctuating levels of buprenorphine for six months.
- Braeburn Pharma has commercialization rights to Probuphine in the U.S. and Canada. If approved, it will be the only treatment for opioid addiction that provides continuous therapy for six months following a single procedure.
- Previously: Titan Pharma's Probuphine subdermal implant successful in Phase 3 study (June 8)
Jun. 8, 2015, 7:53 AM
- A Phase 3 study evaluating Titan Pharmaceuticals' (OTCQB:TTNP) Probuphine, a subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction, met its primary endpoint of non-inferiority (no worse than) compared to sublingual buprenorphine/naloxone.
- The study enrolled 177 subjects who were randomized to receive either Probuphine implants or sublingual tablets for six months. One group received four Probuphine implants plus daily placebo sublingual tablets while the other group received four placebo implants plus daily sublingual buprenorphine/naloxone tablets.
- The primary endpoint was a non-inferiority comparison of the proportions of treatment responders in each group. A responder was defined as one who had at least four of six months free of illicit opioids based on urine testing and self-reporting. The response rate for the Probuphine arm was 96.4% compared to 87.6% for the sublingual buprenorphine/naloxone arm.
- The number of subjects testing negative for illicit opioids all six months was 88% in the Probuphine arm versus 72% in the sublingual tablet arm (p=0.008).
- Titan and commercialization partner Braeburn Pharmaceuticals intend to resubmit the New Drug Application (NDA) to the FDA in H2. If approved, Probuphine will be the first maintenance treatment of opioid addiction lasting six months following a single procedure. The FDA issued a Complete Response Letter (CRL) in April 2013 after reviewing the first NDA citing the need for additional data in three areas.
- The company will host a conference call this morning at 9:00 am ET to discuss the results.
- TTNP has not traded premarket.
Jun. 5, 2015, 5:58 PM
- Titan Pharmaceuticals (OTCQB:TTNP) will host a conference call Monday morning at 9:00 am ET to discuss the results from the Phase 3 trial of Probuphine (buprenorphine HCl), its subdermal implant for the long term maintenance of opioid addiction. The primary endpoint was non-inferiority to sublingual buprenorphine.
- Previously: Enrollment complete in Probuphine Phase 3 (Nov. 20, 2014)
Feb. 26, 2015, 10:23 AM
- The European Commission approves Xadago (safinamide) for the treatment of idiopathic Parkinson's disease (PD). The drug was developed by Newron Pharmaceuticals S.p.A. and will be commercialized by privately-held Zambon S.p.A., both based in Italy.
- Xadago's specific indication is for the treatment of mid-to-late stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicines.
- Safinamide is a new chemical entity, the first approved in Europe in 10 years for PD, with a unique mode of action including selective and reversible MAO-B (monoamine oxidase) inhibition, use-dependent Na (sodium) channels blockade and Ca (calcium) channels modulation which enables it to modulate abnormal glutamate release. Glutamate is an important neurotransmitter that plays a key role in neural activation.
- PD-related tickers: (SNY -2.9%)(ABBV -0.2%)(IPXL -0.5%)(NDRM +1.2%)(XNPT)(OTCPK:BIOZF)(ACOR -1.6%)(OTCQX:RHHBY -0.4%)(PRTA -3.4%)(ADMS -2.5%)(TEVA)(OTCQX:CYNAF -0.9%)(OTCQB:TTNP +2.9%)
Dec. 10, 2014, 8:06 AM
- The Phase 3 study of Acorda Therapeutics' (NASDAQ:ACOR) CVT-301 for the treatment of OFF episodes in patients with Parkinson's disease (PD) is underway with the enrollment of the first patient. An OFF episode is a period of time during which PD symptoms such as tremor, muscle stiffness and slow movement reemerge despite taking PD medications.
- CVT-301 is a self-administered inhaled therapy that delivers a precise dose of levodopa through the lungs to return PD patients to an ON state.
- The multi-center, double-blind, randomized Phase 3 trial will enroll ~345 subjects across three treatment arms: 50 mg, 35 mg or placebo. The primary endpoint is improvement on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
- Acorda obtained the rights to CVT-301 via its acquisition of Civitas Therapeutics.
- Previously: Acorda to buy biopharma firm (Sept. 24, 2014)
- PD-OFF-related tickers: (OTCQX:CYNAF) (NASDAQ:NDRM) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRTA) (OTCQX:RHHBY)
Nov. 20, 2014, 10:03 AM
- Titan Pharmaceuticals (OTCQB:TTNP -1.3%) announces the completion of enrollment in the ongoing Phase 3 clinical trial of Probuphine, the company's investigational subdermal implant for the maintenance treatment of opioid dependence.
- The trial, sponsored and managed by Braeburn Pharmaceuticals, is now fully enrolled with 178 patients across 21 centers.
- The study population is clinically stable patients who are receiving maintenance treatment with an FDA-approved sublingual formulation containing buprenorphine at a daily dose of 8 mg or less. Patients have been randomized either to receive four Probuphine implants or to continue the daily sublingual buprenorphine therapy. The treatment period is six months. The primary endpoint is non-inferiority.
Nov. 13, 2014, 10:38 AM
- Titan Pharmaceuticals (OTCQB:TTNP): Q3 EPS of -$0.01 in-line.
- Revenue of $0.9M (-59.1% Y/Y) in-line.
Nov. 7, 2014, 9:12 AM
- Titan Pharmaceuticals (OTCQB:TTNP) will report Q3 results on the morning of November 14. The conference call will begin at 8:00 am PT/11:00 am ET.
- Consensus view is a loss of ($0.01) per share on revenues of $910K.
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
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