SA News • Wed, Dec. 10
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- Cynapsus has sufficient cash on hand to fund completion of its trials for APL-130277, an oral medication for "off" Parkinson's patients.
- If successful, an oral product versus a subcutaneous injection (which is the only available product currently approved for treatment) has tremendous market potential.
- Cynapsus appears considerably undervalued, based on the probability of success and the market potential, if successful.
- Investor misconceptions about Cynapsus have led to an incredible buying opportunity.
- We believe the company's APL-130277 is a potential $700 million product.
- Cynapsus recently raised $25 million in cash, enough to fund operations through the NDA filing.
- Our DCF valuation pegs the shares at $2.25-2.50 right now, with upside to $4.50 on a take-out in 2016.
Analyst Interview: Cynapsus Therapeutics Still A Top Pick
- The following is a transcript of an interview with Zacks' Sr. Biotech analyst Jason Napodano.
- The recent financing pulled in $23+ million in cash and looks to be enough to fund operations and development of APL-130277 through the NDA filing.
- Jason continues to believe Cynapsus shares represent a compelling value for investors.
- Target price is $2.15 per share, or 250% upside from today.
Cynapsus Therapeutics Shares Will Soar - Here's Why
There are no Transcripts on CYNAF.
Wed, Dec. 10, 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 with 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)
Wed, Nov. 19, 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.
Mon, Oct. 20, 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)
Wed, Aug. 13, 11:04 AM
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