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Phase 3 Study to Assess PF614 Efficacy in Treating Post-Surgical Pain
SAN DIEGO, CA / ACCESSWIRE / September 19, 2024 /Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced it has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA.
The study, once finalized with the FDA, will be conducted through four to six clinical sites in the United States, and is designed to assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate-to-severe pain following abdominoplasty. Additionally, Ensysce will evaluate PF614 versus an active comparator, the use of rescue medication and the safety and tolerability of PF614.
Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "The review of this study protocol represents another key milestone that brings us one step closer to executing the last clinical phase of evaluation for PF614. We anticipate the results of this Phase 3 trial will continue to prove the positive qualities of PF614 over existing oxycodone products. We remain dedicated to bringing PF614, a ‘next-generation opioid', to market."
Dr. Lynn Kirkpatrick, CEO of Ensysce, offered, "We believe that the features of PF614 will be a game changer for the treatment of short-term severe pain. The fact that PF614 delivers the pain-relieving qualities of OxyContin but lasts twice as long, should alleviate the common problem of recurring breakthrough pain between dosing. In parallel with its reduced abuse potential, PF614 is anticipated to offer this market a superior pain product. We look forward to conducting this trial and expect results in late 2025."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
Forward-Looking Statements
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.
Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196
Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811ENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
View the original press release on accesswire.com~ PF614 and PF614-MPAR Highlighted at Symposium on Severe Pain ~
SAN DIEGO, CA / ACCESSWIRE / September 13, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, has made available two video segments from its August 8th symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam, Netherlands. The Company's symposium emphasized opioid use worldwide, the current landscape for treating severe pain, including post-surgical and cancer pain treatment, and discussed Ensysce's innovative new class of opioid drug products.
The discussion allowed for feedback and questions from experts in attendance facilitating proper introduction and explanation of the differentiated Ensysce approach and the possible needs from countries outside the United States for these unique opioids.
Two short videos from the session have been posted to Media / Science Center page on the Company's website. Dr. William Schmidt, Chief Medical Officer of Ensysce explains the government support the Company has received from both the National Institutes of Health and the FDA, as well as described how the profile of Ensysce's lead agent, PF614, checks all the categories of what could be perceived as an ideal pain product.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, who moderated the symposium, commented, "Developing a novel opioid is not easy and we have been interested in sharing and discussing our technology with experts in the field who treat patients with pain on a daily basis. Our aim is to provide a new approach to treat severe pain with our novel class of opioid products that use our TAAP and MPAR platforms. These we believe will result in less abuse and overdose that have plagued traditional opioid products. We announced our plans to begin a Phase 3 pivotal trial shortly, as well as our intent to explore the use of PF614 in other indications such as cancer. Both trials are moving us one step closer to offering prescribers a new option to treat their patients more effectively."
The IASP has a mission to deliver pain relief throughout the world. Please find more information at the IASP website: https://www.iasp-pain.org.
About Ensysce Biosciences Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.
Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196
Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811ENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
View the original press release on accesswire.comU.S. stocks traded higher toward the end of trading, with the Dow Jones index gaining 1% on Thursday.
The Dow traded up 1.02% to 41,508.88 while the NASDAQ rose 0.34% to 17,616.32. The S&P 500 also rose, gaining, 0.50% to 5,620.08.
Check This Out: Top 3 Tech Stocks You’ll Regret Missing This Month
Leading and Lagging Sectors
Energy shares climbed by 1.5% on Thursday.
In trading on Thursday, real estate shares fell by 0.5%.
Top Headline
Dollar General Corporation reported worse-than-expected second-quarter results and lowered its 2024 guidance.
The retail behemoth reported second-quarter earnings per share of $1.70, missing the analyst consensus of $1.78. Quarterly sales of $10.21 billion (+4.2% year over year) missed the street view of $10.368 billion.
Dollar General has revised its fiscal year 2024 outlook, lowering its EPS forecast from a range of $6.80 to $7.55 to a new range of $5.50 to $6.20, compared to the $7.12 estimate. The company also reduced its revenue forecast from $41.01 billion to $41.28 billion to a revised range of $40.51 billion to $40.74 billion, against the $41.02 billion estimate.
Equities Trading UP
Equities Trading DOWN
Commodities
In commodity news, oil traded up 1.8% to $75.88 while gold traded up 0.9% at $2,559.70.
Silver traded up 2.5% to $29.925 on Thursday, while copper rose 0.1% to $4.2225.
Euro zone
European shares closed higher today. The eurozone's STOXX 600 gained 0.76%, Germany's DAX rose 0.69% and France's CAC 40 rose 0.84%. Spain's IBEX 35 Index rose 0.23%, while London's FTSE 100 rose 0.43%.
Annual inflation rate in Germany eased to 1.9% in August from 2.3% in July. The consumer confidence indicator in the Eurozone declined to -13.5 in August, versus earlier expectations of -13.4. The economic sentiment indicator in the Eurozone climbed to 96.6 in August from the revised 96 in the prior month
Asia Pacific Markets
Asian markets closed mixed on Thursday, with Japan's Nikkei 225 falling 0.02%, Hong Kong's Hang Seng Index gaining 0.53%, China's Shanghai Composite Index falling 0.50% and India's BSE Sensex rising 0.43%.
The consumer confidence index in Japan came in unchanged at 36.7 in August.
Economics
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© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
U.S. stocks traded higher midway through trading, with the Nasdaq Composite gaining over 200 points on Thursday.
The Dow traded up 1.03% to 41,513.10 while the NASDAQ rose 1.15% to 17,758.29. The S&P 500 also rose, gaining, 0.88% to 5,641.47.
Check This Out: Top 3 Tech Stocks You’ll Regret Missing This Month
Leading and Lagging Sectors
Industrials shares climbed by 1.4% on Thursday.
In trading on Thursday, real estate shares fell by 0.6%.
Top Headline
Best Buy Co., Inc reported better-than-expected second-quarter financial results raised its FY25 earnings guidance on Thursday.
Best Buy reported fiscal second-quarter adjusted EPS of $1.34, beating the street view of $1.16. Quarterly sales of $9.29 billion beat the analyst consensus of $9.24 billion. The stock gained after the print.
Equities Trading UP
Equities Trading DOWN
Commodities
In commodity news, oil traded up 1.8% to $75.88 while gold traded up 0.7% at $2,556.10.
Silver traded up 2.4% to $29.905 on Thursday, while copper fell 0.1% to $4.2130.
Euro zone
European shares were higher today. The eurozone's STOXX 600 gained 0.76%, Germany's DAX rose 0.69% and France's CAC 40 rose 0.84%. Spain's IBEX 35 Index rose 0.23%, while London's FTSE 100 rose 0.43%.
Annual inflation rate in Germany eased to 1.9% in August from 2.3% in July. The consumer confidence indicator in the Eurozone declined to -13.5 in August, versus earlier expectations of -13.4. The economic sentiment indicator in the Eurozone climbed to 96.6 in August from the revised 96 in the prior month
Asia Pacific Markets
Asian markets closed mixed on Thursday, with Japan's Nikkei 225 falling 0.02%, Hong Kong's Hang Seng Index gaining 0.53%, China's Shanghai Composite Index falling 0.50% and India's BSE Sensex rising 0.43%.
The consumer confidence index in Japan came in unchanged at 36.7 in August.
Economics
Now Read This:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Ensysce Biosciences Inc shares are trading lower by 30% to 44 cents during Thursday’s session after the company announced a $5 million registered direct offering and concurrent private placement.
What Investors Need To Know: Ensysce issued 3.55 million shares of common stock at a price of 47 cents per share. Additionally, Ensysce entered into agreements to exercise existing warrants, originally issued in February 2024, at a reduced exercise price of 47 cents per share, down from $1.06.
The company also conducted a concurrent private placement, issuing unregistered Series A-3 and A-4 warrants for the purchase of up to 14.36 million shares each, with the same 47 cent exercise price.
The Series A-3 warrants are valid for 18 months, and the Series A-4 warrants are valid for five years, both starting from the date of stockholder approval.
What Else: The proceeds will be used to further develop Ensysce’s TAAPTM and MPAR® programs and to provide working capital.
This fundraising effort also complements a recent $14 million NIH grant aimed at supporting the clinical development of PF614-MPAR, an abuse-deterrent opioid with overdose protection.
Read Also: Why BioCardia (BCDA) Stock Is Up 95% Today
Should I Sell My ENSC Stock?
Whether to sell or hold a stock largely depends on an investor's strategy and risk tolerance. Swing traders may sell an outperforming stock to lock in a capital gain, while long-term investors might ride out the turbulence in anticipation of further share price growth.
Similarly, traders willing to minimize losses may sell a stock that falls a certain percentage, while long-term investors may see this as an opportunity to buy more shares at a discounted price.
Shares of Ensysce Biosciences have lost 76.75% year to date. This compares to the average annual return of -90.53%, meaning the stock has outperformed its historical averages. Investors can compare a stock's movement to its historical performance to gauge whether this is a normal movement or a potential trading opportunity.
Investors may also consider market dynamics. The Relative Strength Index can be used to indicate whether a stock is overbought or oversold. Ensysce Biosciences stock currently has an RSI of 90.15, indicating overbought conditions.
For analysis tools, charting data and access to exclusive stock news, check out Benzinga PRO. Try it for free.
According to data from Benzinga Pro, ENSC has a 52-week high of $2.06 and a 52-week low of $0.36.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
U.S. stocks traded higher this morning, with the Dow Jones index gaining over 100 points on Thursday.
Following the market opening Thursday, the Dow traded up 0.28% to 41,206.85 while the NASDAQ rose 0.73% to 17,683.80. The S&P 500 also rose, gaining, 0.44% to 5,616.60.
Check This Out: Top 3 Tech Stocks You’ll Regret Missing This Month
Leading and Lagging Sectors
Consumer discretionary shares climbed by 0.8% on Thursday.
In trading on Thursday, real estate shares fell by 0.5%.
Top Headline
Nvidia Corp. reported better-than-expected earnings and sales results for its second quarter on Wednesday.
The company issued above-consensus third-quarter revenue guidance and announced a $50-billion additional stock repurchase authorization. However, the gross margin contracted from the first quarter.
Equities Trading UP
Equities Trading DOWN
Commodities
In commodity news, oil traded up 2.5% to $76.39 while gold traded up 0.3% at $2,545.60.
Silver traded up 1.4% to $29.635 on Thursday, while copper fell 0.5% to $4.1955.
Euro zone
European shares were higher today. The eurozone's STOXX 600 gained 0.7%, Germany's DAX rose 0.7% and France's CAC 40 rose 0.8%. Spain's IBEX 35 Index rose 0.4%, while London's FTSE 100 rose 0.4%.
Annual inflation rate in Germany eased to 1.9% in August from 2.3% in July. The consumer confidence indicator in the Eurozone declined to -13.5 in August, versus earlier expectations of -13.4. The economic sentiment indicator in the Eurozone climbed to 96.6 in August from the revised 96 in the prior month
Asia Pacific Markets
Asian markets closed mixed on Thursday, with Japan's Nikkei 225 falling 0.02%, Hong Kong's Hang Seng Index gaining 0.53%, China's Shanghai Composite Index falling 0.50% and India's BSE Sensex rising 0.43%.
The consumer confidence index in Japan came in unchanged at 36.7 in August.
Economics
Now Read This:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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