Zynerba Pharmaceuticals, Inc. (ZYNE)
Chart Events
Performance Outlook
| Previous Close | 3.7200 |
| Open | 3.6300 |
| Bid | 3.5500 x 1000 |
| Ask | 3.7400 x 900 |
| Day's Range | 3.6100 - 3.6300 |
| 52 Week Range | 2.5500 - 8.2500 |
| Volume | 7,715 |
| Avg. Volume | 567,365 |
| Market Cap | 105.611M |
| Beta (5Y Monthly) | 2.83 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -1.8900 |
| Earnings Date | Aug 10, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 10.00 |
- TipRanks
Canaccord Predicts Over 100% Rally for These 3 “Strong Buy” Stocks
After passing one speed bump, is the market heading towards more bumps in the road? Following the September sell-off, there has been a surge in COVID-19 cases and limited progress on the next stimulus package. In addition, the likelihood of a Biden victory in the November elections increased.At the same time, however, the broader market has been ramping up, with the NYSE Cumulative Advance/Decline line reaching a record high and the percentage of SPX components trading above their 10-day moving averages landing at 93% for the first time since early April.Weighing in for Canaccord, strategist Tony Dwyer commented, “The strength of the broad market driven by the economy recovery beneficiaries has been dramatic, and while we believe the market should remain volatile (in both directions) into year end, our positive fundamental core thesis driven by excess liquidity and a synchronized global recovery suggests inevitable periods of weakness following these type ramps should be used as an opportunity to add equity exposure.”Turning Dwyer’s outlook into concrete recommendations, Canaccord’s analysts have pinpointed three stocks that could soar in the year ahead, with over 100% upside potential forecasted for each. What’s more, after using TipRanks’ database, we found out that all three have scored enough positive reviews from the broader analyst community to earn a “Strong Buy” consensus rating.Zynerba Pharmaceuticals (ZYNE)Developing next-generation transdermally-delivered cannabinoid therapeutics, Zynerba Pharmaceuticals wants to help improve the lives of patients with rare and near-rare neuropsychiatric conditions. With shares changing hands for $3.65, Canaccord believes that the share price presents an attractive entry point.This summer, ZYNE revealed that in the CONNECT-FX pivotal trial evaluating Zygel, its transdermal cannabidiol gel, in Fragile X syndrome (FXS), the therapy did not achieve statistical significance on its primary or secondary endpoints in the full analysis set, or 210 patients. That being said, it did demonstrate significance on the primary endpoint in patients with full methylation of the FMR1 gene, which was an ad-hoc pre-planned analysis, and secondary endpoints were promising.Of the patients in the trial, 80% had full methylation, and the company estimates 60% of the 71,000 U.S. FXS patients fall into this category. To this end, ZYNE will meet with the FDA to discuss the next steps for potential approval in this indication, likely in 2H20.Writing for Canaccord, 5-star analyst Sumant Kulkarni believes that “the key to ZYNE stock lies in the outcome of the company's interactions with the FDA on its clinical programs for Zygel... It is always difficult to second-guess what the agency might do, but a ‘good’ outcome would involve ZYNE being potentially able to file Zygel for approval in fully-methylated FXS patients. Given there are no products approved for FXS, such an outcome, with perhaps a confirmatory trial to be run, cannot be ruled out.”Given this result, Kulkarni argues ZYNE will now target the fully-methylated FXS patients. With the analyst seeing the targeting of this subgroup as “the best way forward for its FXS program,” he continues to model a 50% probability of approval for Zygel in FXS.Additionally, ZYNE is expected to report results from its discussions with the FDA on the path forward for Zygel in developmental and epileptic encephalopathies (DEE) in Q3 2020, and meet with the FDA on its program in autism spectrum disorder (ASD) in 2H20. Therefore, “there could be opportunity for risk-tolerant investors ahead of news on the outcome of FDA interactions,” in Kulkarni’s opinion.With new posters released yesterday, supporting Zygel in Fragile X and Autism, Kulkarni stays with the bulls. To this end, the top analyst rates ZYNE a Buy along with a $12 price target. Investors could be pocketing a gain of 215%, should this target be met. (To watch Kulkarni’s track record, click here)Turning to the rest of the Street, the bulls have it on this one. With 3 Buys and a lone Hold, the word on the Street is that ZYNE is a Strong Buy. At $13, the average price target implies 245% upside potential. (See ZYNE stock analysis on TipRanks)Atreca (BCEL)Bringing a deep understanding of the human immune response to the table, Atreca develops innovative immunotherapies. Ahead of a key data readout, Canaccord is pounding the table on this healthcare play.Representing the firm, 5-star analyst John Newman has high hopes for ATRC-101, its product that targets a differentiated intracellular protein, PolyAdenylate Binding Protein (PABP-1) which is restricted to tumor tissues.According to the analyst, this suggests ATRC-101 “will have a favorable safety profile and will not affect healthy tissues.” He added, “Importantly, ATRC-101 can be clinically impactful in a number of tumor types including: lung, breast, ovarian, colon, skin, and liver cancers, which comprise a large market opportunity.”Further speaking to the candidate’s potential, ATRC-101's cutting-edge mechanism of action (MOA) involves both innate response through binding of tumor tissues, and adaptive response via delivering tumor associated antigens to macrophages and dendritic cells. The dendritic cells are then stimulated, releasing chemokines, cytokines and promoting a CD8+ T-cell response, which kills tumor cells. The company has already published data to support the MOA, which is helpful to better “understand the underpinnings of the drug's efficacy,” in Newman’s opinion.As screening is underway in the ATRC-101 monotherapy study, and patients are currently being enrolled in the second cohort dose, Newman expects initial safety data to come by YE20 and early 2021, respectively. “With the second cohort dose starting and first cohort dose showing promising preclinical results, we look forward to progression of the cohort doses and eventually initiating the third cohort dose,” he noted.On top of this, Newman is optimistic about the trial evaluating ATRC-101 in combination with PD-1 inhibitor and chemotherapeutic agents, which is slated to kick off in 2021. “Chemotherapy has shown to induce the target of ATRC-101, which could lead to positive outcomes. Chemotherapy can also increase ATRC-101's target expression, promote antigen release, and can allow earlier use of ATRC-101 in treatment paradigms,” he explained.Everything that BCEL has going for it convinced Newman to reiterate his Buy rating. In addition to the call, he left the price target at $33, suggesting 120% upside potential. (To watch Newman’s track record, click here)All in all, other analysts are on the same page. 3 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $28.67, the upside potential comes in at 91%. (See BCEL stock analysis on TipRanks)Cara Therapeutics (CARA)Hoping to provide solutions for those suffering from chronic pruritus, Cara Therapeutics develops peripherally acting kappa opioid agonist therapeutics. Following an update on the company’s development candidates, Canaccord sees a compelling opportunity.Firm analyst Arlinda Lee tells clients that she recently spoke with CARA President and CEO Dr. Derek Chalmers, and he provided upbeat commentary on lead candidate Korsuva, a kappa opioid receptor agonist designed for moderate to severe pruritus.One of the analyst’s key takeaways was that oral Korsuva has the potential for a broad label in chronic atopic dermatitis (AD - eczema or itchy skin). AD affects roughly 20 million people in the U.S., and it is a complex disease, with the mechanisms of pruritus still being studied. Dr. Chalmers argues that Korsuva's MOA is agnostic to the type and level of cytokine release in the skin as kappa opioid receptor agonists work downstream of cytokine interaction, and cytokine release is also inhibited.It should be noted that regardless of pathology, the incidence of pruritus in AD is 100%, with approximately 20% classified as moderate to severe. For the 80% of patients with mild to moderate itch, biologics and immunosuppressants are not appropriate. “With its benign safety profile, oral Korsuva may be well-positioned to serve this patient segment with a frontline systemic treatment,” Lee commented. Therefore, she believes the release of Phase 2 oral Korsuva AD data in 2021 could drive serious upside.In the Phase 2 trial evaluating oral Korsuva for chronic kidney disease associated pruritus (CKD-aP) in non-hemodialysis patients, there was a 50% placebo response, but two factors could have caused this. Earlier stage CKD patients have intermittent pruritus, so they are more susceptible to placebo response. Additionally, CARA used sites and investigators that had experience with IV Korsuva and expectation bias may have been transferred to non-hemodialysis patients, according to Dr. Chalmers. “CARA can mitigate these by utilizing a longer run-in period for more consistent patients; using de novo sites to eliminate expectation bias; and employing 1:1 randomization,” Lee mentioned.If that wasn’t enough, the IV Korsuva NDA filing for CKD-aP is expected in Q4 2020. Lee thinks the chances of an FDA AdCom are low, based on its robust safety profile and number of New Chemical Entities recently approved without an AdCom. IV Korsuva might not be classified as a scheduled controlled substance, given that it lacks traditional opioid side effects and acts in the periphery, not the central nervous system (CNS).Taking the above into consideration, Lee maintains a Buy rating and $30 price target. This target conveys her confidence in CARA’s ability to climb 124% higher in the next year. (To watch Lee’s track record, click here)Are other analysts in agreement? They are. Only Buy ratings have been issued in the last three months. Therefore, the consensus is unanimous: CARA is a Strong Buy. Given the $32.67 average price target, shares could climb 118.5% in the next year. (See Cara stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
- SmarterAnalyst
Zynerba Up 6% As Zygel Shows Promise In Autism Trial
Shares in Zynerba Pharma (ZYNE) jumped 6.4% in Thursday’s trading, and continued to climb 1.6% after-hours, after new data from the Phase 2 Bright trial showed the potential for Zygel (ZYN002) to improve behavioral symptoms of autism alongside stable standard of care in children and adolescents with moderate-to-severe autism spectrum disorder (ASD).“The Phase 2 BRIGHT trial provides the first clinical evidence of the potential for Zygel to improve behavioral symptomology in a group of highly symptomatic pediatric and adolescent patients with ASD,” said Helen Heussler, principal investigator in the trial.“In these children receiving Zygel, the observed changes from baseline are promising. In particular, the improvements seen in core symptoms of autism, as specifically assessed by the Autism Impact Measure, are of special interest” she added.The BRIGHT Phase 2 trial is an exploratory, single-center, open-label Phase 2 study evaluating the safety and tolerability and efficacy of Zygel in children and adolescents with ASD who are 3 to <18 years old.New data presented revealed that patients receiving Zygel achieved statistically significant caregiver-reported improvements compared to baseline across the core ASD symptoms, namely: Atypical behavior, Communication, Peer Interaction, Repetitive Behavior, and Social Reciprocity.In addition, statistically significant improvements compared to baseline were observed at week 14 of treatment with Zygel in the Autism Parenting Stress Index.Zynerba also measured notable improvements in behaviors utilizing the Qualitative Caregiver Behavioral Problems Survey after 14 weeks of study drug. Clinically meaningful improvements were observed by a majority of surveyed caregivers in behavioral, social and emotional behavioral problems.Zygel was also very well tolerated and the safety profile was consistent with previously released data from other Zygel clinical trials. No serious or severe adverse events were reported.Zynerba focuses on pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders including Fragile X syndrome and developmental and epileptic encephalopathies. (See ZYNE stock analysis on TipRanks)Shares in the company have plunged 37% year-to-date, but the stock scores a bullish Strong Buy Street consensus with 3 recent buy ratings vs 1 hold rating. Meanwhile the average analyst price target stands at $13 (242% upside potential).“We continue to believe ZYNE is offering investors a compelling entry point this fall when paired against its peers: including Zogenix and Stoke” comments Ladenburg Thalmann analyst Michael Higgins. He has a buy rating on the stock and $15 price target.Related News: Vertex Sinks 12% On Halt of VX-814 Development; Merrill Lynch Says Buy J&J Halts Covid-19 Vaccine Trial Due To ‘Unexplained Illness’ Amarin Pops 4% After-Hours On Positive PCI Data For Vascepa More recent articles from Smarter Analyst: * Intuitive Surgical Plunges 4% Despite 3Q Earnings Beat * Cars.com Soars 26% On Strong 3Q Sales Outlook, Analyst Upgrade * Zogenix Rallies 7% On New Fintepla Data For Dravet Syndrome * Marten Transport Sinks 8% After-Hours On 3Q Revenue Miss
- GlobeNewswire
Zynerba Pharmaceuticals Presents Data Supporting FMR1 Methylation Status as a Correlate to Fragile X Syndrome Severity at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting
Figure 1: Greater Percentages of Participants Achieved Meaningful Change in ABC-CFXS Social Avoidance and Irritability with ZYN002 vs Placebo Figure 1: Greater Percentages of Participants Achieved Meaningful Change in ABC-CFXS Social Avoidance and Irritability with ZYN002 vs PlaceboDEVON, Pa., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting a poster describing data from the CONNECT-FX (Clinical study Of CaNNabidiol (CBD) in ChildrEn and AdolesCenTs with Fragile X) trial describing the role of FMR1 methylation status in children and adolescents with Fragile X syndrome (FXS) as a correlate to disease severity and as a prognostic biomarker. These data are being presented at the virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting. These data will also be presented as an oral presentation during the “Research Pipeline: New Findings on Diagnostic and Therapeutics” session of the virtual American Academy of Child and Adolescent Psychiatry (AACAP) 2020 Annual Meeting on Friday, October 23rd, 2020. A copy of the poster entitled, “ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome: Role of Methylation Status as a Correlate to Disease Severity and as a Prognostic Biomarker” is available on the Zynerba corporate website at http://zynerba.com/publications/.“We are excited to provide an update on the potential role of methylation status of the FMR1 gene as a predictive biomarker of preferential response to Zygel™ (ZYN002) in the treatment of the behavioral symptoms of FXS,” said Zynerba’s Chief Medical Officer, Joseph M. Palumbo, MD, FAPA, MACPsych. “These new data demonstrate that in patients diagnosed with FXS with a fully methylated FMR1 gene significantly more patients who received Zygel achieved a clinically meaningful improvement in their behavioral symptoms compared to patients who received placebo.”CONNECT-FX is a randomized, double-blind, multinational, 14-week pivotal study to evaluate the efficacy and safety of Zygel in children/adolescents aged 3 to 17 years. Although the CONNECT-FX full analysis set did not achieve statistical significance in its endpoints, building on current scientific evidence, a pre-planned ad hoc analysis of patients having at least 90% methylation (“full methylation” or FMet) of the impacted FMR1 gene, representing 80% of the overall study population, was performed. The results, including the achievement of statistical significance (p=0.020) in the primary endpoint of improvement at 12 weeks of treatment in the Social Avoidance subscale of the ABC-CFXS compared to placebo, suggest that Zygel may have benefit in patients with full methylation of the FMR1 gene.Zynerba utilized psychometric analyses to determine what constitutes a clinically meaningful change from baseline as measured by subscales of the ABC-CFXS. New results described today include the results of these analyses which support the definition of a clinically meaningful treatment response over 12 weeks of treatment as an improvement of three points or greater for the Social Avoidance subscale, nine points or greater for the Irritability subscale, and five points or greater for the Socially Unresponsive / Lethargic subscale. The Company determined that 58.2% of FMet patients receiving Zygel achieved a clinically meaningful change in their socially avoidant behavior compared to 40.6% of patients receiving placebo (statistically significant; p=0.031), and 40.3% of patients receiving Zygel achieved a clinically meaningful change in Irritability compared to 23.8% of patients receiving placebo (statistically significant; p=0.036).Figure 1: Greater Percentages of Participants Achieved Meaningful Change in ABC-CFXS Social Avoidance and Irritability with ZYN002 vs Placebohttps://www.globenewswire.com/NewsRoom/AttachmentNg/d8cf2270-883e-4618-9515-82b29393a6dcThe authors of the poster concluded that: * To our knowledge, CONNECT-FX is the largest controlled study ever performed in FXS. * These results may represent an important step forward in biomarker-driven prediction of response in FXS and neuroscience. * Zygel was well tolerated, and the safety profile was consistent with previously reported clinical trials. * In the FMet group, Zygel was superior to placebo in multiple analyses, including: * Statistically significant mean change in Social Avoidance vs placebo; * Proportion of patients attaining threshold of clinically meaningful change in Social Avoidance and Irritability; * Caregiver reported improvements, including statistically significant improvements in Social Avoidance and Isolation, Social Interaction, and Irritable and Disruptive Behaviors. * Zynerba will be meeting with the FDA in the fourth quarter of 2020 to discuss these data.About Zynerba Pharmaceuticals, Inc. Zynerba Pharmaceuticals is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome, autism spectrum disorder, 22q11.2 deletion syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration and foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Company’s reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates; the timing and outcome of current and future legal proceedings; and the extent to which health epidemics and other outbreaks of communicable diseases, including COVID-19, could disrupt our operations or adversely affect our business and financial conditions. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.Zynerba Contact Will Roberts, VP Investor Relations and Corporate Communications 484.581.7489 robertsw@zynerba.comMedia contact Molly Devlin Evoke KYNE 215.928.2199 Molly.Devlin@evokegroup.com
