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I am a professional sell-side equity research analyst. I currently work for Zacks Investment Research. I started my career with Zacks covering the large-cap Pharma sector in 2003. In 2009, I was promoted to Managing Director of Institutional Equity Research. I now focus on small-cap biotech for... More
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  • Auspex Hits Homerun With Phase 3 Data In Huntington's Chorea

    This is a follow up article to my call in November 2014 to 'Buy Auspex Ahead of Phase 3 Data' in December.

    By Jason Napodano, CFA

    On December 16, 2014, Auspex Pharmaceuticals, Inc. (NASDAQ:ASPX) announced positive top-line efficacy and safety results from its Phase 3 registration program evaluating SD-809 for the treatment of chorea associated with Huntington's disease (NYSE:HD). The two Phase 3 trials, First-HD and Arc-HD, studied SD-809, a deuterium-containing analog of tetrabenazine, head-to-head vs. placebo for the treatment of chorea with HD and in transitioning patients on stable doses of tetrabenazine to SD-809, respectively. Results from both trials look outstanding.

    We initiated coverage of Auspex Pharma in November 2014 with a $36 price target. As a result of the positive data, we have adjusted both sales and probability of approval inputs in our financial valuation model. We are raising our price target to $60 per share. Below we provide a brief background on SD-809, review the Phase 3 data, and then conclude with how this impacts our forecasts for sales of the drug and the valuation of Auspex Pharmaceuticals.

    Brief Background On Tetrabenazine & SD-809

    Auspex is developing SD-809, a deuterium substituted version of the established neurological drug tetrabenazine as a treatment for Huntington's disease and other movement disorders. We believe tetrabenazine has a number of important shortcomings that are potentially addressed by Auspex' SD-809.

    Huntington's disease (HD), tardive dyskinesia (NYSE:TD), and Tourette syndrome (NYSE:TS) are all disorders of excessive, uncontrollable movement associated with excess dopaminergic activity in the brain. Tetrabenazine provides symptomatic relief of movement disorders by inhibiting VMAT2, a transporter that packages dopamine and other neurotransmitters into vesicles for release into the synapse. This reduces synaptic dopamine levels, thus relieving overstimulation of dopamine receptors and reducing symptoms of HD, TD, and TS. Tetrabenazine was approved in the United States for the treatment of chorea (uncontrollable movements) associated with Huntington's disease in 2008 and is sold as Xenazine® by Lundbeck.

    Xenazine® has been designated an Orphan Drug in the U.S. given the narrow label for treatment of chorea only associated with HD and the small U.S. HD population of approximately 20,000 to 30,000 individuals (source: The Xenazine® label does not include other movement disorders associated with HD such as dystonia or bradykinesia. U.S. sales in 2013 were $253 million, an increase of 20% over 2012. Orphan Drug exclusivity in the United States expires in August 2015, and there are no unexpired patents. In most Ex-U.S. markets, it is available as a generic, or sold at modest prices due to drug price controls. Outside the U.S., the drug is approved in many foreign markets for HD, TD, or for the broadly defined indication of organic movement disorders.

    The annual cost of Xenazine® treatment in the U.S. can be estimated as $75,000 based on an average daily dose of ~40 mg (note the stable dose for the 36 patients enrolled in Arc-HD was 41 mg). Using $75,000 as the annual cost and Lundbeck's 2013 sales figures of $253 million, we estimate just shy of 4,000 patients in the U.S (about 15% of the U.S. HD population) are currently being treated with the drug - a surprisingly small number. We believe Xenazine® penetration is low due to the significant side effects and poor tolerability of the drug.

    For example, in spite of its demonstrated efficacy in the treatment of movement disorders, tetrabenazine has numerous shortcomings. It has a relatively short half-life, must be administered three or more times daily, and has a poor side effect profile, which includes somnolence, insomnia, parkinsonism, severe depression, fatigue, anxiety, and irritability. The FDA label for tetrabenazine carries a "Black Box" warning for depression and suicide risk. Suicide risk is already greatly elevated in patients with Huntington's disease and schizophrenia, and this is exacerbated by treatment with tetrabenazine. Its pharmacologically active intermediates are metabolically inactivated by CYP2D6, a liver enzyme with activity that varies widely between individuals. Thus, the efficacy and side effects induced by any given dose varies widely across individuals, and dose-titration and pharmacogenomics testing are required to ensure safe use.

    Below is a graph from the U.S. FDA showing the side effect profile of Xenazine®.

    Auspex's platform technology uses deuterium, a stable, non-radioactive, non-toxic, and naturally occurring isotope of hydrogen to design improved variations of existing drugs. Deuterium has a natural abundance of about 1%, and is present in about one in every 50 water molecules on Earth. It has the same size and shape as a hydrogen atom, and differs only in forming very slightly stronger chemical bonds. The removal of a hydrogen atom attached to a carbon atom is the first and rate-limiting step in the metabolism of many drugs. If the hydrogen that is removed in the first step of the metabolic process is replaced by deuterium, the metabolic process is slowed by a factor of up to 8-fold because the C-D bond, which is stronger than a C-H bond, is harder to break (source: Auspex Pharma). Below is a cartoon showing the differences between tetrabenazine and SD-809.

    Auspex Phase 3 Data - Outstanding Results!

    Auspex examined SD-809 in a 90 subject Phase 3 clinical trial called First-HD comparing the drug to placebo (1:1 randomization) for the treatment of chorea symptoms of Huntington's disease, a condition for which the FDA has grantedSD-809 Orphan Drug designation. The primary efficacy endpoint for the study was the change from baseline to maintenance therapy in the Total Maximal Chorea (TMC) score of the Unified Huntington's Disease Rating Scale (UHDRS). SD-809 met the pre-specified primary efficacy endpoint. Patients taking SD-809 achieved a meaningful improvement of 2.5 points on the TMC score from baseline to maintenance therapy compared to placebo (p < 0.0001). Additional results from First-HD are as follows (source: Auspex Pharma):

    (click to enlarge)

    The results look very similar on an efficacy standpoint to the Lundbeck Phase 3 trial with Xenazine®, which showed around a 3 point decline in TMC at week 12 compared to placebo (source: FDA). However, Auspex noted on their conference call that endpoints in Total Motor Score, which includes other movement disorders such as dystonia and bradykinesia, also met statistical significance. We note these added benefits are not listed on the Xenazine® label. At this point, we are unsure on just how much this increases the market opportunity for SD-809 beyond the current Xenazine® population. Additionally, there were four pre-specified key secondary endpoints that were tested on a hierarchical basis: treatment success based on patient global impression of change (PGIC) and clinical global impression of change (CGIC), quality of life and balance. Other pre-specified motor endpoints were also analyzed.

    (click to enlarge)

    A total of 90 patients (45 in each group) were enrolled for evaluation over 13 weeks: patients were titrated weekly to an optimal dose up to week eight; were on maintenance therapy for four weeks, and; were taken off study medication in the final week of the study. Dose of SD-809 at week 12 was approximately 40 mg. A total of 87 patients completed the study; one patient in the SD-809 group and two in the placebo group discontinued.

    As important as the efficacy data for SD-809 are the safety and tolerability data. In fact, we believe the data below are what will separate SD-809 from Xenazine® / generic tetrabenazine once approved. In general, SD-809 was well tolerated; there was no difference in the rate of dose reduction between SD-809 and placebo (6.7% in each group). Results from First-HD show a favorable safety and tolerability profile of SD-809; following are the number of patients reporting adverse events by system organ class:

    (click to enlarge)

    We believe these safety and tolerability results are outstanding. Below we highlight some of the key differentiators seen between SD-809 in Auspex Phase 3 trial vs. Xenazine® (tetrabenazine) in the Lundbeck Phase 3 trial. Note the meaningful reduction in things like somnolence, sedation, fatigue, insomnia, anxiety, depression, and akathisia.

    In parallel to the First-HD study, Auspex completed the four-week "switch" study called Arc-HD in which maintenance of chorea control was assessed after switching patients overnight from tetrabenazine to SD-809 (at approximately half the dose of tetrabenazine). All available data through eight weeks following the switch were included in the analysis. Dose adjustments were permitted after week one. The mean total chorea score decreased by approximately one point from baseline on the TMC score (week one = -0.8 ± 0.4 / week four = -0.8 ± 0.5). In addition, there were 21 patients for whom data were available at week eight; these data demonstrated an improvement of 1.9 (± 0.8) points on the TMC score. Data for the remaining 15 patients will be available at a future date. The Arc-HD study has an ongoing long-term safety component as well. Results from Arc-HD, presented below in graphical form, are outstanding.

    (click to enlarge)

    The results from First-HD and Arc-HD show SD-809 to be a superior drug to Xenazine®. We believe the efficacy is comparable in reducing chorea associated with HD and that SD-809 offers additional benefits of reducing other motor function disorders associated with the disease such as dystonia and bradykinesia. Safety and tolerability data show a marked reduction in key adverse events that currently limit Xenazine® uptake like sedation and depression, and results from Arc-HD prove that patients can be switched from Xenazine® to SD-809 with no loss of chorea control. Week eight data from Arc-HD suggests additive control with SD-809 over Xenazine®, likely due to the ability to increase the dose to higher levels thanks to the added tolerability.

    Implications For Auspex

    These are obviously fantastic results (note the stock is up 101% as of writing this report). We had previously believed that Auspex would be able to capture 15% of the HD market once SD-809 was approved. This assumed taking 50% of the Xenazine® market share (7.5% of the market) and bringing in another 7.5% new patients. However, based on the results of First-HD and Arc-HD, we now believe that Auspex will take nearly all the market away from Lundbeck's Xenazine®, as well as bring in a new 25% of the population. As a result, we are increasing our sales assumptions from SD-809 in HD from our previous estimate of $250 million (similar to the current Xenazine® market) to $550 million.

    We also see increased likelihood of success in the ongoing Phase 3 Arm-TD and Aim-TD clinical trials studying SD-809 in Tardive Dyskinesia (TD); and the potential to expand SD-809 use in Tourette syndrome, currently in a Phase 1b study. The graphs below show the efficacy response rates to tetrabenazine in HD, TD, and tics (representative of Tourette syndrome) as found in a retrospective analysis of patients with movement disorders followed over an average of 2.3 years (Kenney et al, 2007). A total of 98 patients had HD, 149 had TD, and 93 had tics (including TS). Approximately 80% of patients with each type of movement disorder achieved a moderate-to- marked reduction in symptoms when evaluated on a 5 point rating scale.

    Data from the Phase 3 Arm-TD and Aim-TD studies are expected to report around the middle of 2015 and in 2016. Phase 1b data in Tourette syndrome are also expected around the middle of 2015. Auspex management anticipates filing the U.S. FDA for SD-809 in HD by the middle of 2015. We remind investors that Auspex will seek approval for SD-809 via the 505(2) pathway.

    Valuation & Recommendation

    As noted above, we are dramatically increased our sales assumptions for SD-809. We previously believed the drug would do sales in HD around $250 million. We now believe eclipsing $500 million is achievable. We have also increased our sales assumptions in both TD and Tourette syndrome. At peak, we believe SD-809 could be a $2 billion drug, albeit we place a slightly higher discount rate on the sales in TD and Tourette syndrome based simply on stage of development.

    We assume a limited impact from generic tetrabenazine, believing that the SD-809 data is superior enough to the clinical profile of tetrabenazine that the majority of patients will switch to the new drug. Our only concern at this standpoint is pending competition from Neurocrine Bio's (NASDAQ:NBIX) Phase 3 drug, valbenazine. Neurocrine is pursuing indications in TD and Tourette with valbenazine, a purified active metabolite prodrug of the (+)-alpha isomer of tetrabenazine. Nevertheless, we believe the market is large enough, particularly in TD with an estimated 500,000 patients in the U.S., where both Auspex and Neurocrine can see meaningful success with their respective drugs.

    We have conducted a discounted cash flow analysis inputting our sales assumptions for SD-809 along with the following additional assumptions: 12% CoGS, R&D and G&A expenses that bottom out at 7% and 10% of gross revenues, respectively, 32% effective tax rate beginning in 2017, 22% discount rate. Based on our assumptions, we calculate a fair value for Auspex Pharmaceuticals of approximately $1.9 billion, or $60 per share. We continue to rate the shares 'Buy'.

    Tags: ASPX, NBIX
    Dec 17 12:36 PM | Link | 2 Comments
  • Cynapsus Shares Set For Major Move Higher On Backs Of Positive Phase 2 Data

    APL-130277 Shows Clear Proof-of-Concept In Phase 2 Trial

    On November 19, 2014, Cynapsus Therapeutics Inc. (OTCQX:CYNAF) (CTH.V) announced what looks to be a clear demonstration of proof-of-concept via positive top-line results from the CTH-105 Phase 2 clinical trial. The CTH-105 study was the first to test Cynapsus APL-130277, a fast-acting, sublingual, thin filmstrip formulation of apomorphine in Parkinson's patient for the management of "off" motor symptoms. We believe these data set the stage for a significant re-valuation of the shares to meaningfully higher levels. Our target is $2.75 per share, offering 250% upside.

    …Quick Highlight Of The Data…

    The primary objective of CTH-105 (NCT02228590) was to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD). The primary endpoint was the efficacy based on "time to on" using the percent change in UPDRS. Safety and tolerability, as well as frequency of adverse events, were also primary and secondary outcome measures in the study. In the trial, patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until "on" was achieved. UPDRS III score was measured at 15, 30, 45, 60 and 90 minutes. Pooled data from 16 patients was released this morning, with management noting that three additional patients are continuing dosing.

    According to management, all five doses of APL-130277 used in the study (10, 15, 20, 25, 30 mg) resulted in patients moving from "off" to "on". We are encouraged by the fact that even the lowest dose showed efficacy, with 3 of the 16 patients (~19%) moving to "on". Out of 16 patients treated with APL-130277, 14 converted from "off" to "on" time. Study investigators hypothesized that the two patients (~13%) that did not convert to "on" probably need more drug, as their baseline UPDRS scores were significantly higher than the mean for the other 14 patients. This is consistent with prescribing label for subcutaneous apomorphine were approximately 20% of PD patients require the highest dose. We suspect that management can dose 35 or 40 mg in the upcoming Phase 3 trial.

    Mean baseline UPDRS III scores for the pool group was 41.4. The maximum mean change from baseline was 18.4. This data compares well with published literature for subcutaneous apomorphine. Cynapsus reported that onset to clinically meaningful improvement was seen in as early as 10 minutes and last up to 90 minutes (the last measured time point). Mean "time to on" was 22 minutes. Below is a graph showing the mean change in UPDRS Part III from baseline over the study period for patients converting from "off" to "on" time. Take note, even at 90 minutes patients were still "on", suggesting that APL-130277 could act as a bridge between regular oral levodopa dosing (typically 4x daily).

    Cynapsus reported that treatment with APL-130277 was safe and well tolerated. Nausea, reported by three subjects at doses of 10, 15 and 20 mg, looked to be the most common side effect. One of these patients also experienced a mild episode of vomiting. There were no reports of nausea at higher doses of 25 and 30 mg. There were no reports of local irritation or hypotension in any subject treated. A total of 60 doses of APL-130277 were administered to the 16 patients who completed dosing in the CTH-105 study. Additional safety data will be presented with all 19 patients complete dosing. We expect to see individual patient data at an upcoming medical meeting or when the results are published by study investigators.

    Acorda Acquires Civitas And Validates The Market

    We have been saying that the market opportunity for an effective rescue medication to treat off episodes in Parkinson's patients in a potential multi-hundred million-dollar opportunity. In fact, in our most recent Zacks report on Cynapsus Therapeutics, we estimated the peak U.S. sales for APL-130277 were $387 million. And we believe this estimate includes conservative forecasts on both pricing and market penetration (see below). It also does not include forecasts for sales in Europe or Asia.

    On September 24, 2014, Acorda Therapeutics (NASDAQ:ACOR) announced it had made an offer to acquire privately-held Civitas Therapeutics for $525 million in cash. The impetus of the acquisition by Acorda was to get CVT-301, a Phase 3 inhaled formulation of levodopa for the treatment of off episodes in Parkinson's patients. With CVT-301, Acorda believes it has an attractive late-stage asset to add to the company's CNS-focused pipeline. The CVT-301 Phase 3 study is expected to begin enrollment in early 2015, with a new drug application (NDA) planned for 2016. Acorda estimates the market opportunity for CVT-301 is in excess of $500 million. Civitas had been previously planning an initial public offering, but the $525 million all-cash offer from Acorda was simply too attractive to pass up.

    Civitas' CVT-301 looks only a few months ahead of Cynapsus' APL-130277. Cynapsus just recently completed the CTH-105 study discussed above. The next step is a bridging study, dubbed CTH-200, designed to be a single dose, crossover comparative bioavailability and pharmacokinetic study in healthy volunteers. This study is designed to provide the clinical "bridge" to the FDA's finding of safety and efficacy for the reference-listed drug (Apokyn®) - a necessary step to file an application via the 505(b)(2) pathway. The CTH-200 Bridging Study is expected to begin shortly. Meanwhile, Cynapsus has already schedule an "End of Phase 2" meeting with the U.S. FDA to discuss the Phase 3 program. This meeting is expected to take place in early February 2015. As such, we expect the Phase 3 program for APL-130277 to begin during the second quarter of 2015. Again, based on the recent positive data from CTH-105, we estimated CVT-301 is only a few months ahead of APL-130277.

    …And We Think Cynapsus Drug Is Clearly The Better Design…

    Ever since the announced acquisition of Civitas, investors have been asking, "Why Civitas and not Cynapsus?" and "What does the added competition do to our forecasts?" The answer is simple - We think Acorda bought the wrong drug and that APL-130277 clearly has better attributes than CVT-301.

    Specifically, CVT-301 is an inhaled formulation of levodopa. Levodopa is the most common form of dopamine replacement therapy, a backbone regimen and standard of care for the treatment of Parkinson's disease. Parkinson's disease is a slowly progressing neurological disorder characterized by tremor, stiffness and decreased movement. The decreased movement is a direct result of the lack of dopamine in the brain. Levodopa, when taken orally, is converted into dopamine in the substantia nigra by dopa decarboxylase. The administration of levodopa temporarily diminishes the motor symptoms associated with the lack dopamine in the substantia nigra. Carbidopa, a dopa decarboxylase inhibitor, is commonly dosed with levodopa to prevent L-DOPA metabolism before it reaches the blood-brain barrier. In fact, co-formulations of levodopa/carbidopa (Sinemet-CR) are available. Civitas' formulation of levodopa bypasses the gut metabolism through inhalation, a pathway known to for rapid uptake and onset of action.

    There are, however, major limitations to the use of levodopa as a treatment for Parkinson's disease. Mainly, the patient must have substantial remaining dopaminergic neurons in the substantia nigra to metabolize the drug. However, according to research published in the Journal of Neural Transmission by P. Riederer et al in 1976, pathological studies of Parkinson's disease show at least 70-80% of the dopaminergic neurons are lost before the onset of symptoms. This work was confirmed by K. Yoshikawa et al, 2004. This explains why levodopa is very effective for a period of time, then wanes with disease progression. A newly diagnosed Parkinson's patient has the capacity to process levodopa. As the patient loses this capacity, the therapeutic window for levodopa therapy begins to narrow. Levodopa also has a relatively short half-life of only 60-90 minutes. The drugs effect, even in the mild Parkinson's patient, only lasts for 1.5 to 2.0 hours post dose (Brooks, D, 2008).

    Work done by Olanow et al, 2006 shows that a therapeutic window for Parkinson's disease patients rapidly closes (narrows) as patients gain experience with Levodopa use. This is due to a combination of disease progression, loss of dopaminergic neurons in the substantial nigra, and the short half-life of the drug.

    As such, dosing dynamics for levodopa are challenging (Schapira et al, 2009). Too much drug (or too frequent dosing) leads to leads to dyskinesia, a direct result of excess dopamine in the brain. Too little drug leads to increase "off" time (bradykinesia / akinesia), the specific condition that both Civitas and Cynapsus are aiming to treat.

    We question the concept of treating "off" episodes in Parkinson's patients with more levodopa. Many neurologists and movement disorder doctors will delay the use of levodopa in newly diagnosed Parkinson's patients specifically to avoid the narrowing of the therapeutic window and the risks of complications such as dyskinesia (see this YouTube video from the MJFF talking about Levodopa and Off/On time). We believe CVT-301 complicates the dosing regimen for the Parkinson's patient taking a drug like Sinemet-CR. We suspect substantial acceleration of the narrowing of the therapeutic window and dyskinesia with the drugs use. And as the Parkinson's patient progresses from mild to moderate or severe disease, we suspect that CVT-301 will become a less effective drug. We also strongly question the approvability of an inhaled drug, with chronic use, in an elderly population for a non-pulmonary disease. The pathway to approval for CVT-301 seems arduous.

    Apomorphine, the active drug in the only currently approved rescue medication for the treatment of off episodes in the U.S. in Apokyn®, is not a dopamine replacement therapy. Apomorphine is a dopamine agonist, and acts directly at the post-synaptic dopamine receptor, thus bypassing the need for dopamine and dopaminergic neurons in the substantial nigra. Instead, apomorphine can act directly on the gabaergic neurons that are not impacted by Parkinson's disease, and provide an effective treatment option as a rescue medication to patients at all stages of disease progression.

    The knock on apomorphine is that because the drug is rapidly metabolized by the liver, it must be administered by a route that bypasses the gut. As such, the currently approved formulation of apomorphine in the U.S. is a subcutaneous injection. Subcutaneous injectable apomorphine, sold in the U.S. as Apokyn®, is a horrible impractical and inefficient drug, flawed by its delivery system and quick peak-to-trough pharmacokinetic profile. Apomorphine is highly lipid soluble and quickly crosses the blood-brain barrier. Onset of action is as little as five minutes, but only lasts for 60-90 minutes. Under QID dosing for levodopa, patients with advanced disease may still experience off episodes.

    Self-administration of subcutaneous Apokyn is next to impossible for the akinetic (or dyskinetic) Parkinson's patient. For example, the Instructions For Use for Apokyn® is 27 pages long, and consists of steps that logically seem impossible for the frozen or rigid Parkinson's patient to complete. Because self-administration of Apokyn® is nearly impossible, the treatment of off episodes requires direct caregiver support, likely from a skilled nurse. This places undue burden on the healthcare system.

    The above inhibiting attributes greatly limit sales of Apokyn in the U.S. Cynapsus' APL-130277 is a sublingual formulation of apomorphine, with each thin film strip found inside an easy to open non-superimposable die cut peelable foil laminate pouch. The product can be self-administered, under the tongue, and is designed to be used anywhere, anytime, with little or no assistance required. The comparable dose strength of Apokyn® sells for $13-15 per injection. We believe Cynapsus APL-130277, with a far more convenient administration and lack of skilled caregiver requirement, will see sizable market shares gains and expansion over the current Apokyn market.

    For example, Cynapsus sponsored neurologist surgery (n=500) with data conclusions suggesting a 7.5-fold increase in penetration across the board for mild, moderate, and severe Parkinson's patients. It is for these reasons that we believe APL-130277 has peak U.S. sales far in excess of Apokyn, or Acorda's newly acquired CVT-301.

    Conclusion, Valuation & Recommendation

    Off time is a significant problem for patients with advanced Parkinson's disease. In the U.S., there are an estimated one million PD patients (4-6 million globally). According to a recent survey by the Michael J. Fox Foundation, more than 90% of PD patients report having "off" episodes each day. Roughly two-thirds have "off" time greater than two hours, with 20% experiencing "off" time of greater than four hours. This is a significant problem for PD patients and an enormous unmet medical need.

    Data from the recently completed CTH-105 study clearly validates the proof-of-concept for APL-130277. The drug demonstrated substantial signs of efficacy for all doses (10, 15, 20, 25, and 30 mg). Onset of action was as soon as ten minutes for some patients, with mean "time to on" of 22 minutes - admittedly not as rapid as CVT-301 but still well within the reasonable range for a rescue medication. More importantly, duration of effect was still evident at 90 minutes, exceeding what has been demonstrated with Apokyn or what we suspect will be shown in the CVT-301 Phase 3 trial given the half-life of levodopa has been documented to be less than 90 minutes.

    In conclusion, we see APl-130277 as an easier-to-use and more effective drug than CVT-301, along with a better mechanism of action and pathway to approval. Data from CTH-105 de-risks the story and Cynapsus has enough cash to fund all necessary clinical trials prior to the U.S. NDA filing (see our quick review of the Q3 financial results). A recent paper published by researchers out of the UK on behalf of EUROPAR and EPDA confirms our belief that this is a potential enormous market. The paper concludes that early-morning "off" episodes are a significantly larger problem than believed even five years ago, with nearly two-thirds of all PD patients suffering across all stages of the disease (Rizos et al, 2012).

    We do not know whether or not Acorda approached Cynapsus with a potential buy-out to acquire APL-130277 prior to its decision to scoop-up Civitas for $525 million. What we do know is that Cynapsus, on a fully-diluted basis, is currently worth only $75 million. If Civitas was worth $525 million, Cynapsus is worth more. As such, we could be looking at a ten-fold increase in valuation for Cynapsus over the next 2 years.

    Tags: CYNAF
    Nov 19 10:32 AM | Link | 7 Comments
  • You're Invited - Zacks Healthcare Meet-Up

    On September 8, 2014, Zacks Small-Cap Research will host its First Annual Healthcare Meet-Up at the Whiskey Blue Bar in New York City. Investors are invited to attend an informal and social gathering where there will be an opportunity to speak with an interact with Senior Management teams from some exciting small-cap healthcare companies. Also in attendance will be Zacks Senior Biotechnology Analysts Jason Napodano, CFA and Grant Zeng, CFA.

    Companies that have been confirmed to attend the event include:

    - Tonix Pharmaceuticals (NASDAQ:TNXP)

    - Amarantus BioScience Holdings (OTCQB:AMBS)

    - Sorrento Therapeutics (NASDAQ:SRNE)

    - Cytomedix, Inc. (CMXI)

    - InVivo Therapeutics (OTCQB:NVIV)

    - AmpliPhi Biosciences Corp (OTCQB:APHB)

    - Immune Pharmaceuticals (OTCQX:IMNP)

    - Nuvo Research (NRI.T)

    - DARA BioSciences (NASDAQ:DARA)

    - NanoViricides Inc. (NYSEMKT:NNVC)

    - BrainStorm Cell Therapeutics (OTCQB:BCLI)

    - ULURU, Inc. (OTCQB:ULUR)

    - Neuralstem Inc. (NYSEMKT:CUR)

    - NeoStem (NASDAQ:NBS)

    - Replicel Life Science (RP.V)

    Additional attendees will be announced shortly.

    Registration is free for investors. To RSVP for the event, please visit the Zacks Small-Cap Research website (name and email address required). Open bar and appetizers will be served. Whiskey Blue is located on 541 Lexington Ave, New York, NY 10022. The reception will begin at 7PM.

    For additional information, please contact Zacks Small-Cap Research at

    Sep 06 8:34 PM | Link | 2 Comments
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