Cynapsus Therapeutics(CYNA)- NASDAQ
  • Thu, Sep. 1, 12:47 PM
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  • Thu, Sep. 1, 9:24 AM
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  • Wed, Aug. 31, 5:56 PM
    • Cynapsus Therapeutics (NASDAQ:CYNA) +117.9% AH after agreeing to be acquired by privately-held Sunovion Pharmaceuticals for $40.50/share in cash, or ~$624M.
    • Sunovion would acquire CYNA's APL-130277 product candidate, which is designed to be an easy-to-use, on-demand treatment option for Parkinson’s disease.
    • Sunovion says the deal expands its leadership in treatments for central nervous system disorders.
    | Wed, Aug. 31, 5:56 PM | 17 Comments
  • Mon, Aug. 29, 11:10 AM
    • The FDA designates Cynapsus Therapeutics' (CYNA +0.5%) Phase 3-stage AL-130277 for Fast Track review for the treatment of OFF episodes in patients with Parkinson's disease (PD).
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    • 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.
    | Mon, Aug. 29, 11:10 AM
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  • Mon, Jul. 18, 5:18 PM
    • Thinly traded micro cap Cynapsus Therapeutics (NASDAQ:CYNA) is up 1% after hours on light volume in response to its announcement of positive results from its Phase 3 dose titration study, CTH-300, assessing APL-130277 for the treatment of OFF episodes in Parkinson's disease (PD) patients.
    • Data from the first 92 subjects showed a 22-point improvement from baseline to 30 minutes in a PD rating scale called MDS-UPDRS Part III. In addition, 60% of patients showed improvement in motor function between five and 12 minutes after dosing, improvement in motor function was maintained beyond 90 minutes and 83% of patients transitioned from OFF to fully ON. The median dose of APL-130277 that turned patients to fully ON was 20 mg.
    • The primary endpoint of CTH-300 is the mean change in motor function from baseline to 30 minutes at week 12 as measured by MDS-UPDRS MOTOR. According to ClinicalTrials.gov, the estimated study completion date is October. A long-term safety study, CTH-301, is currently recruiting patients (participants in CTH-300 are eligible). It should be completed by November.
    • The company plans to file its New Drug Application in the U.S. under the abbreviated 505(b)(2) pathway in H1 2017. A pivotal study in Europe should start next quarter.
    • 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.
    | Mon, Jul. 18, 5:18 PM
  • Fri, Jun. 17, 6:53 AM
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    • Cepheid (NASDAQ:CPHD) initiated with Equal Weight rating and $30 (1% upside) price target by Morgan Stanley.
    • Amsurg (NASDAQ:AMSG) initiated with Market Perform rating by Wells Fargo.
    • Cynapsus Therapeutics (NASDAQ:CYNA) initiated with Buy rating and $24 (41% upside) price target by Janney Capital.
    • Entellus Medical (NASDAQ:ENTL) initiated with Buy rating and $22 (20% upside) price target by BTIG Research.
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    | Fri, Jun. 17, 6:53 AM | 1 Comment
  • Fri, May 27, 11:00 AM
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  • 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
  • Wed, Mar. 9, 4:27 PM
    • Cynapsus Therapeutics (NASDAQ:CYNA): Q4 EPS of -$0.70.
    | Wed, Mar. 9, 4:27 PM
  • Nov. 12, 2015, 6:30 AM
    • Cynapsus Therapeutics (NASDAQ:CYNA): Q3 Net Loss of $2.9M.
    | Nov. 12, 2015, 6:30 AM
  • 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.
    • Update: On June 30, the company announced that the last patient has been enrolled. Top-line data are expected in Q3.
    | Jun. 29, 2015, 7:41 AM | 1 Comment
  • Jun. 18, 2015, 6:58 AM
    • Cynapsus Therapeutics (OTCQX:CYNAD) prices its public offering of 4.5M shares of common stock at $14 per share. Underwriters over-allotment is an additional 675K shares. Closing date is June 23.
    • Net proceeds will fund its Phase 3 studies, pre-approval commercialization efforts in the U.S., initial clinical and regulatory activities in Europe, working capital and general corporate purposes.
    • The company's stock will trade under the symbol "CYNA" effective today.
    | Jun. 18, 2015, 6:58 AM
  • Jun. 9, 2015, 4:25 PM
    • Toronto-based Cynapsus Therapeutics (OTCQX:CYNAD) commences a public offering of 4.5M shares of common stock. Underwriters over-allotment is an additional 675K shares. Price has yet to be announced.
    • The company has applied for a listing on the Nasdaq Capital Market under the symbol "CYNA."
    | Jun. 9, 2015, 4:25 PM