Thu, Feb. 26, 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
Nov. 7, 2014, 9:12 AM
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)
Oct. 3, 2014, 10:06 AM
- Titan Pharmaceuticals (OTCQB:TTNP -9.1%) prices its public offering of 21M units at $0.50. Each unit consists of one share of common stock and 0.75 of a warrant. Holders of one full warrant can purchase one share of common stock at $0.60 per share.
- Gross proceeds of $10.5M will fund the ongoing development of Probuphine, the pre-clinical development of other ProNeura technology-based products and general corporate purposes.
Aug. 13, 2014, 8:17 AM
Jun. 9, 2014, 5:30 PM
- The USPTO sends a Notice of Allowance to Titan Pharmaceuticals (TTNP +3.9%) for a patent covering the sustained release of dopamine using the company's proprietary long-term drug delivery technology, ProNeura. "Implantable Polymeric Device for Sustained Release of a Dopamine Agonist" provides IP protection for Titan's ProNeura program for Parkinson's disease and carries a term to at least 2024.
Sep. 27, 2013, 2:20 PM
- Titan Pharmaceuticals (TTNP.OB +16.4%) rallies on huge volume.
- The FDA has granted the company a Type C meeting for November 19 to discuss exactly what went wrong with the Probuphine NDA.
- The company hopes the meeting will provide some "clarity regarding the regulatory path forward" for the buprenorphine implant. (PR)
- The stock collapsed in May when the company received the CRL.
May. 1, 2013, 9:56 AMTitan Pharmaceuticals (TTNP.OB -75.9%) loses more than three quarters of its market value after the FDA rejects its experimental opioid addiction treatment Probuphine. The company says it is "extremely surprised and disappointed" — shareholders likely feel the same. (See SA contributor Brian Wilson's opinion piece for more) | 2 Comments
Mar. 25, 2013, 4:40 PM
Mar. 22, 2013, 12:11 PMShares of Titan Pharmaceuticals (TTNP.OB +35%) rise dramatically after the company says the FDA recommends approval for its opioid addiction treatment drug Probuphine. The terms of a licensing agreement announced last year indicate Titan will receive $50M from its commercialization partner Braeburn Pharmaceuticals upon FDA approval. | 2 Comments
Mar. 19, 2013, 9:34 AMTitan Pharmaceuticals' (TTNP.OB) Probuphine treatment for addiction to heroin and opioid painkillers has shown to be more effective than a placebo, but the data suggests that the dosages given might need to be higher, say FDA staff, who also raise safety concerns. The comments come ahead of a review on Thursday by an advisory panel about whether to recommend of approval for Probuphine. | 7 Comments
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