Cynapsus Therapeutics Inc. (CYNAF) - OTCQX
  • Mon, Apr. 4, 6:57 AM
    • Cynapsus Therapeutics (OTCQX:CYNAF) inks a global licensing agreement for certain intellectual property (IP) covering all oral films containing apomorphine for the treatment of OFF episodes in Parkinson's disease (PD) patients. The deal further strengthens the company's IP covering APL-130277, its investigational sublingual (under the tongue) formulation of apomorphine for the treatment of OFF episodes.
    • Under the terms of the agreement, Monosol Rx will receive an upfront payment, milestones and single-digit royalties on net sales of APL-130277.
    • APL-130277 is currently in Phase 3 development. The company plans to submit its New Drug Application (NDA) in the U.S. by the end of the year or early 2017.
    • An OFF episode, a time during which PD patients are unable to perform routine activities like eating, bathing or dressing, is thought to occur when dopamine levels in the brain fall below a certain threshold. It is considered one of the greatest unmet medical needs of PD sufferers.
    • Read now Cynapsus' Oral Parkinson's Candidate Is Undervalued 
    | Mon, Apr. 4, 6:57 AM | 1 Comment
  • Jun. 29, 2015, 7:41 AM
    • Cynapsus Therapeutics (OTCQX:CYNAF) announces that the first patient has been enrolled in a Phase 3 trial, called CTH-300, evaluating APL-130277 for the treatment of OFF episodes in patients with Parkinson's disease (PD). The double-blind, placebo-controlled, parallel-design study will enroll 126 PD patients who have at least one OFF episode every 24 hours with at least two hours of OFF time per day. The primary endpoint, measured at week 12, is the mean change in MDS-UPDRS Part III score versus placebo 30 minutes after dosing.
    • An OFF episode, a time during which PD patients are unable to perform routine activities like eating, bathing or dressing, is thought to occur when dopamine levels in the brain fall below a certain threshold. It is considered one of the greatest unmet medical needs of PD sufferers.
    • APL-130277 is a sublingual (under the tongue) formulation of apomorphine.
    | Jun. 29, 2015, 7:41 AM | 1 Comment
  • Mar. 11, 2015, 5:08 PM
    • Based on the feedback from the FDA during an end-of-Phase 2 meeting regarding its drug candidate for the acute rescue of OFF episodes associated with Parkinson's disease (PD), APL-130277, Cynapsus Therapeutics (OTCQX:CYNAF) plans to initiate a Phase 3 program in Q2. During the meeting, the parties agreed on the design, duration and size of the Phase 3.
    • The company intends to submit its New Drug Application for APL-130277 in 2016 under the 505(b)(2) pathway, which allows the sponsor (company) to include some data from studies completed by third parties.
    • The Phase 3 program involves three studies: CTH-200 Bridging Study - a single-dose crossover comparative bioavailability and pharmacokinetic study in healthy volunteers that should start in Q2; CTH-300 Efficacy Study - a double-blind, placebo-controlled, parallel-designed study in 126 PD patients who have at least one OFF episode every 24 hours, with a total OFF time of at least two hours per day that should also start in Q2 and CTH-301 Safety Study - a long-term, single arm safety study in 226 PD patients with the same profile as CTH-300, expected to start in Q3.
    • APL-130277 is fast-acting formulation of apomorphine, administered via a sublingual (under the tongue) thin film strip.
    | Mar. 11, 2015, 5:08 PM | 5 Comments
  • 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%)
    | Feb. 26, 2015, 10:23 AM | 3 Comments
  • 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)
    | Dec. 10, 2014, 8:06 AM
  • Nov. 19, 2014, 1:16 PM
    • Thinly-traded nano cap Cynapsus Therapeutics (OTCQX:CYNAF +23.4%) jumps on turnover of 1.6M shares in response to its announcement of positive top-line results from a Phase 2 clinical trial evaluating APL-130277 for the management of OFF motor symptoms in patients with Parkinson's disease (PD).
    • APL-130277 is a fast-acting sublingual thin filmstrip of apomorphine. An OFF episode is a complication of PD that leaves the patient rigid and unable to move and communicate. An estimated 25 - 50% of PD sufferers experience an OFF episode at least once per day and up to six times per day, with each episode lasting between 30 minutes and two hours.
    • Of the 16 patients treated with APL-130277, 14 converted from OFF to ON with all available doses (10, 15, 20, 25 and 30 mg). Clinically meaningful improvement in motor control occurred as quickly as 10 minutes after administration of APL-130277 and lasted as long as 90 minutes. The maximum mean change from baseline UPDRS III was 18.4, a large clinically important difference. Treatment with APL-130277 was safe and well-tolerated.
    • The company plans to advance APL-130277 to Phase 3 development.
    | Nov. 19, 2014, 1:16 PM | 1 Comment
  • 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. 20, 2014, 8:27 AM | 36 Comments
  • Aug. 13, 2014, 11:04 AM
    • Cynapsus Therapeutics (OTCQX:CYNAF) Q2 results: Revenues: $0; Net Loss: ($2.8M) (-189.4%); Quick Assets: $20.6M (+801.5%).
    • Awarded $500K from Michael J. Fox Foundation for Parkinson's Research on July 8, 2014.
    • No financial guidance given.
    | Aug. 13, 2014, 11:04 AM
Company Description
Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual thin filmstrip for the acute rescue of "OFF" motor symptoms of Parkinson's disease.
Sector: Healthcare
Industry: Drug Related Products
Country: Canada