Safehold Declares Third Quarter 2021 Common Stock Dividend

PR Newswire

NEW YORK, Sept. 15, 2021 /PRNewswire/ — Safehold Inc. (NYSE: SAFE) announced today that the Company’s Board of Directors has declared common stock dividends of $0.17 per share for the third quarter of 2021. The dividend represents an annualized rate of $0.68 per share and is payable on October 15, 2021 to holders of record on September 30, 2021.  


About Safehold:

Safehold Inc. (NYSE: SAFE) is revolutionizing real estate ownership by providing a new and better way for owners to unlock the value of the land beneath their buildings. Having created the modern ground lease industry in 2017, Safehold continues to help owners of high quality multifamily, office, industrial, hospitality and mixed-use properties generate higher returns with less risk. The Company, which is taxed as a real estate investment trust (REIT) and is managed by its largest shareholder, iStar Inc., seeks to deliver safe, growing income and long-term capital appreciation to its shareholders. Additional information on Safehold is available on its website at www.safeholdinc.com.

Company Contact: 

Jason Fooks
Senior Vice President
Investor Relations & Marketing
T 212.930.9400
E [email protected]

Cision View original content:https://www.prnewswire.com/news-releases/safehold-declares-third-quarter-2021-common-stock-dividend-301370981.html

SOURCE Safehold Inc.

Stock Yards Bancorp to Participate in the Stephens 2021 Bank Forum

LOUISVILLE, Ky., Sept. 15, 2021 (GLOBE NEWSWIRE) — Stock Yards Bancorp, Inc. (NASDAQ: SYBT), parent company of Stock Yards Bank & Trust Company, with offices in the Louisville, central, eastern and northern Kentucky, as well as the Indianapolis, Indiana and Cincinnati, Ohio metropolitan markets, today announced that Phil Poindexter, President, and T. Clay Stinnett, EVP and Chief Financial Officer, will participate in the Stephens 2021 Bank Forum to be held September 22, 2021, and will participate in a series of virtual meetings with institutional investors.

Management’s discussion materials to be used at this conference will be posted to the investor section of the Company’s website, www.syb.com, on or before September 22, 2021.

Louisville, Kentucky-based Stock Yards Bancorp, Inc., with $6.1 billion in assets, was incorporated in 1988 as a bank holding company. It is the parent company of Stock Yards Bank & Trust Company, which was established in 1904. The Company’s common shares trade on The NASDAQ Stock Market under the symbol “SYBT.”

Contact: T. Clay Stinnett
  Executive Vice President,
  Treasurer and Chief Financial Officer
  (502) 625-0890
   
   
   



SL Green Realty Corp. Announces Common and Preferred Stock Dividends

NEW YORK, Sept. 15, 2021 (GLOBE NEWSWIRE) — SL Green Realty Corp. (NYSE:SLG), Manhattan’s largest office landlord, today announced that its board of directors has declared a monthly ordinary dividend of $0.3033 per share of common stock. The dividend is payable in cash on October 15, 2021 to shareholders of record at the close of business on September 30, 2021.

The board of directors also declared the regular quarterly dividend on the company’s Series I Preferred Stock for the period July 15, 2021 through October 14, 2021 of $0.40625 per share, which is the equivalent of an annualized dividend of $1.625 per share. The dividend is payable in cash on October 15, 2021 to shareholders of record at the close of business on September 30, 2021.

About SL Green Realty Corp.

SL Green Realty Corp., Manhattan’s largest office landlord, is a fully integrated real estate investment trust, or REIT, that is focused primarily on acquiring, managing and maximizing value of Manhattan commercial properties. As of June 30, 2021, SL Green held interests in 77 buildings totaling 35.3 million square feet. This included ownership interests in 27.1 million square feet of Manhattan buildings and 7.4 million square feet securing debt and preferred equity investments.

Forward Looking Statement

This press release includes certain statements that may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and are intended to be covered by the safe harbor provisions thereof. All statements, other than statements of historical facts, included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future, are forward-looking statements. Forward-looking statements are not guarantees of future performance and actual results or developments may differ materially, and we caution you not to place undue reliance on such statements. Forward-looking statements are generally identifiable by the use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” “continue,” or the negative of these words, or other similar words or terms.

Forward-looking statements contained in this press release are subject to a number of risks and uncertainties, many of which are beyond our control, that may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements made by us. Factors and risks to our business that could cause actual results to differ from those contained in the forward-looking statements include risks and uncertainties related to the on-going COVID-19 pandemic and the duration and impact it will have on our business and the industry as a whole and the other risks and uncertainties described in our filings with the Securities and Exchange Commission. Except to the extent required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information or otherwise.

SLG – DIV

Matt DiLiberto
Chief Financial Officer
212.594.2700



Pacira BioSciences Reports Preliminary Net Product Sales of $42.3 Million for August 2021

— Expanding EXPAREL utilization continues to drive growth with average daily sales at 109% of August 2020 —

— More than nine million patients treated with EXPAREL as of August 2021 —

PARSIPPANY, N.J., Sept. 15, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales. EXPAREL® (bupivacaine liposome injectable suspension) net product sales increased 15 percent to $41.4 million for the month of August 2021, compared with $36.1 million for the prior year. Net product sales of iovera° increased 13 percent to $0.9 million for the month of August 2021, compared with $0.8 million for the prior year. EXPAREL average daily sales for the month of August 2021 were 109 percent of August 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 22 in August 2021 and 21 in August 2020.

“We continue to solidify our leadership position in opioid-sparing pain management with EXPAREL now having treated more than nine million patients since launch with penetration increasing across all target market segments,” said Dave Stack, chairman and chief executive officer of Pacira BioSciences. “EXPAREL utilization continues to significantly outpace the recovery of the elective surgery market, which is facing additional pandemic-related challenges this summer with regional surges in delta variant cases, staffing shortages, and surgical fatigue from care teams addressing significant procedure backlogs. We expect these variables to subside and the fourth quarter to reflect improving market dynamics.”

“From a competitive standpoint, we have not experienced impact from new market entrants and EXPAREL remains extremely well positioned given its broad efficacy label that spans infiltration, field blocks and brachial plexus nerve block. In addition, a pristine safety profile and proven ability to reliably facilitate surgical migration to outpatient sites of care continue to be hallmarks of EXPAREL adoption across pediatric and adult settings. Looking ahead, we remain confident in our ability to achieve our five-year objectives and deliver topline annual growth in the high teens with operating margins that exceed 50 percent by the end of our planning period,” continued Mr. Stack.

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2021.

About Pacira BioSciences

Pacira BioSciences, Inc. (Nasdaq: PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients’ journeys along the neural pain pathway. The company’s long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

About EXPAREL

®

EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. Since its launch, EXPAREL has been used in over nine million patients.   The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information for Patients

EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

About iovera°®

The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system’s “1×90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

1 Radnovich, R. et al. “Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.” Osteoarthritis and Cartilage (2017) p1-10.

Important Safety Information

The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud’s disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

Forward-Looking Statements

Any statements in this press release about the company’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the success of the company’s sales and manufacturing efforts in support of the commercialization of EXPAREL and iovera°; the rate and degree of market acceptance of EXPAREL and iovera°; the size and growth of the potential markets for EXPAREL and iovera° and the company’s ability to serve those markets; the company’s plans to expand the use of EXPAREL and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL and iovera°; the ability to successfully integrate any future acquisitions into the company’s existing business and the recoverability of our deferred tax assets and other factors discussed in the “Risk Factors” of the company’s most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it 
specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.



Investor Contact:
Susan Mesco, (973) 451-4030
[email protected]

Media Contact:
Coyne Public Relations
Kristin Capone, (973) 588-2108
[email protected]

Biogen Plans to Initiate Phase 3b Study Evaluating Potential Benefit of a Higher Dose of Nusinersen in Patients Previously Treated with Evrysdi® (risdiplam)

  • Clinical data available to date suggest there are remaining unmet needs in some spinal muscular atrophy (SMA) patients treated with Evrysdi1-3
  • The ASCEND study aims to evaluate whether treatment with a higher dose of nusinersen has the potential to improve clinical outcomes in these patients
  • Building on the proven efficacy and well-established safety of the currently approved 12-milligram dose, patients in this study will receive an investigational higher dose of nusinersen, which is also being evaluated in the DEVOTE study

CAMBRIDGE, Mass., Sept. 15, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced plans to initiate a global Phase 3b clinical study, ASCEND. The ASCEND study is designed to evaluate the clinical outcomes and assess the safety of a higher dose of nusinersen* in children, teens and adults with later-onset spinal muscular atrophy (SMA) following treatment with Evrysdi® (risdiplam).

People with SMA do not produce enough survival motor neuron (SMN) protein, which is critical for the ongoing maintenance of motor neurons that support sitting, standing and movement. Over time, people with SMA may lose their ability to perform everyday activities, including brushing their teeth, turning on a light switch or drinking from a cup.4,5 The goal of treatment in SMA is to sufficiently protect motor neurons and help preserve function.

“We believe that lower drug exposure may be contributing to less-than-optimal treatment outcomes for some patients treated with Evrysdi. The ASCEND study seeks to understand if nusinersen may address that unmet medical need and will help inform the future of SMA treatment, with the hope of improving patients’ outcomes for the long term,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen.

Available data suggest that exposure to Evrysdi diminishes with increased age and weight, with an approximately 40 percent reduction in drug concentration in adults compared to infants.6,7 Evrysdi’s dosing is capped at 5 milligrams (mg) once patients reach 20 kilograms (kg).8

At the approved 12-mg dose, motor neuron exposure to nusinersen remains similar as patients age and grow.9 Further, nusinersen has demonstrated proven, sustained efficacy and a well-characterized safety profile, with long-term data in patients treated for more than 7 years across ages and SMA types. Taken together, these data support further exploration of whether a higher dose can deliver even greater efficacy to patients. The ASCEND study will assess if nusinersen at a higher dose may address outstanding clinical needs among later-onset SMA patients treated with Evrysdi who want to make a change in their treatment regimen. The same investigational higher dose of nusinersen is also being evaluated in the ongoing DEVOTE study.

“There have been significant advances in SMA treatment; however, there is still no cure and unmet medical needs remain,” said Professor Tim Hagenacker, Head of Neuromuscular Diseases Unit, Essen University in Germany, and a member of the ASCEND study steering committee. “As part of my clinical practice, we’ve observed an opportunity to potentially further improve patient outcomes. With a higher dose of nusinersen, we are positioned to explore what may be possible.”

The ASCEND protocol has been submitted to the U.S. Food and Drug Administration and is planned to be an approximately 2.5-year study projected to enroll up to 135 later-onset, non-ambulatory individuals with SMA (aged 5 to 39). All participants must have been previously treated with Evrysdi at the maximum recommended dose of 5 mg and be willing and able to change their treatment regimen to a higher dose of nusinersen. Participants must also fall within a particular Revised Upper Limb Module (RULM) measurement range to enter the study. Individuals enrolled in ASCEND will receive two loading doses of nusinersen 50 mg two weeks apart, followed by a maintenance dose of 28 mg every four months during the study period. Efficacy is planned to be assessed by RULM. Additional clinical outcomes include safety, Hammersmith Functional Motor Scale Expanded (HFMSE) and caregiver burden. The study will also evaluate upper limb fine motor function in participants aged 13 and older using the mobile application Konectom™, and neurofilament levels as a marker of biological disease activity, both exploratory endpoints.

The study aims to include children, teens and adults naïve to treatment with nusinersen, as well as adults who were previously treated with nusinersen prior to Evrysdi. The company aims for the first eligible patients to be enrolled in 2021.

In addition to ASCEND, as a leader in SMA Biogen supports over 15 SMA disease registries with more than 4,000 patients across the globe, which will help support treatment decisions within the context of currently approved therapies, including the 12-mg dose of nusinersen.

*Nusinersen is currently commercialized under the brand name SPINRAZA

®

, and the U.S. Food and Drug Administration-approved dose is 12 mg.

About SPINRAZA

®

 (nusinersen)

The SPINRAZA clinical development program encompasses 10 clinical studies, which have included more than 300 individuals across a broad spectrum of patient populations,10 including two randomized controlled studies (ENDEAR and CHERISH). The ongoing SHINE and NURTURE open-label extension studies are evaluating the long-term impact of SPINRAZA. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in antisense therapeutics. Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country’s product website.

About Spinal Muscular Atrophy (SMA)

SMA is a rare, genetic, neuromuscular disease that affects individuals of all ages. It is characterized by a loss of motor neurons in the spinal cord and lower brain stem, resulting in progressive muscle atrophy and weakness.11 SMA is caused by a deficiency in the production of survival motor neuron (SMN) protein due to a damaged or missing SMN1 gene, with a spectrum of disease severity.11 Some individuals with SMA may never sit; some sit but never walk; and some walk but may lose that ability over time.12 In the absence of treatment, children with the most severe form of SMA would not be expected to reach their second birthday.11

SMA impacts approximately 1 in 11,000 live births,13 is a leading cause of genetic death among infants13 and causes a range of disability in teenagers and adults.12

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor 

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential benefits, safety and efficacy of nusinersen; the results of certain real-world data; the identification and treatment of SMA; our research and development program for the identification and treatment of SMA; the clinical development program for nusinersen, including the study protocol and enrollment of the ASCEND study and the timing thereof; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis, including from the planned ASCEND study; the risk that we may not fully enroll our clinical trials, including the planned ASCEND study, or enrollment will take longer than expected; failure to obtain regulatory approvals in other jurisdictions; risks of unexpected costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

References:

  1. Mercuri E. et al. SUNFISH Part 2: Efficacy and safety of risdiplam (RG7916) in patients with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). SMA Europe Feb 5-7, 2020 presentation.
  2. Evrysdi US FDA Summary Basis of Approval (SBA) documents. Clinical Review(s): Page 67, table 15. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213535Orig1s000TOC.cfm. Accessed: September 2021.
  3. European Medicines Agency: EMA/216061/2021 – Evrysdi EPAR. Page 195, table 41. Available at: https://www.ema.europa.eu/en/documents/assessment-report/evrysdi-epar-public-assessment-report_en.pdf. Accessed September 2021.
  4. Rouault F, et al. Disease impact on general well-being and therapeutic expectations of European Type II and Type III spinal muscular atrophy patients. Neuromuscul Disord. 2017 May;27(5):428-438. doi: 10.1016/j.nmd.2017.01.018. Epub 2017 Feb 3.
  5. Mazzone ES, et al. Revised upper limb module for spinal muscular atrophy: Development of a new module. Muscle Nerve. 2017 Jun;55(6):869-874. doi: 10.1002/mus.25430. Epub 2017 Feb 6.
  6. Evrysdi US FDA SBA documents. Clinical Pharmacology Review(s): Page 41, table 18. The approximately 40% reduction is the percentage difference between risdiplam observed exposures in the youngest infants and adults. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213535Orig1s000TOC.cfm. Accessed: September 2021.
  7. European Medicines Agency: EMA/216061/2021 – Evrysdi EPAR. Page 71, figure 13. The approximately 40% reduction is the percentage difference between risdiplam observed exposures in the youngest infants and adults. Available at: https://www.ema.europa.eu/en/documents/assessment-report/evrysdi-epar-public-assessment-report_en.pdf. Accessed September 2021.
  8. Evrysdi U.S. Prescribing Information. Available at: https://www.gene.com/download/pdf/evrysdi_prescribing.pdf. Accessed: September 2021.
  9. Finkel RS, et al. Scientific Rationale for a Higher Dose of Nusinersen. Cure SMA Virtual Research and Clinical Care Meeting June 9–11, 2021 poster presentation.
  10. Core Data Sheet, Version 9, January 2019. SPINRAZA. Biogen Inc, Cambridge, MA.
  11. National Institute of Neurological Disorders and Stroke, NIH. Spinal Muscular Atrophy Fact Sheet. Available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Spinal-Muscular-Atrophy-Fact-Sheet. Accessed: September 2021.
  12. Wadman RI, Wijngaarde CA, Stam M, et al. Muscle strength and motor function throughout life in a cross-sectional cohort of 180 patients with spinal muscular atrophy types 1c–4. Eur J Neurol. 2018;25(3):512-518.
  13. Cure SMA. About SMA. Available at https://www.curesma.org/about-sma/. Accessed: September 2021.
MEDIA CONTACT:
Allison Parks
+1 781 464 3260
[email protected]
INVESTOR CONTACT:
Mike Hencke
+1 781 464 2442
[email protected]

 



MICT Subsidiary Magpie Securities Launches First Product, Magpie Invest – a Mobile-Based Stock Trading App – in Hong Kong


Magpie Invest is a


Proprietary Platform and Technology


that Offers Stocks from


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lobal


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MONTVALE, N.J., Sept. 15, 2021 (GLOBE NEWSWIRE) — MICT, Inc. (Nasdaq: MICT), (the “Company”) wholly-owned subsidiary Magpie Securities today announces the launch of Magpie Invest, its mobile stock trading app. The Magpie Invest trading app will be available to investors in Hong Kong, and is licensed under Hong Kong SFC, the most highly regarded financial market in China.

The Magpie Invest Trading App is a proprietary platform and technology built by MICT that offers customers access to more financial markets, a wider range of stocks, more market data, enhanced analytics, market information, and an engaging user experience.

“From the moment we merged with Global Fintech Holdings we have been promising our stockholders that we will deliver state-of-the-art fintech solutions to the Asian market, today we have momentously achieved this promise. We have injected nearly half a billion Hong Kong dollars into launching Magpie Securities, a leading SFC-regulated securities business, which is introducing its first product, the mobile trading app, Magpie Invest. We have chosen the Hong Kong market to launch as it is the number-one financial center in Asia, with very sophisticated retail investors,” stated MICT Chief Executive Officer Darren Mercer. “Magpie Invest enables investors in Hong Kong with free real time data and market information and allows its users to trade on exchanges from around the globe. The Magpie Invest launch in Hong Kong is only the beginning of the realization of the Company’s business plan, as we now aim to gain regulatory approval in numerous jurisdictions for investors throughout the world to be able to utilize the trading app.”

About MICT, Inc.

MICT is a Nasdaq-listed, global fintech company founded in 2002. It has three trading platforms operating in several high growth markets: an insurance brokerage, a commodities platform, and now a stock trading platform, Magpie Securities, with the launch of the Magpie Invest Trading App. Subsequently, the launch of Magpie Securities will be announced later in the month of September.

MICT, Inc. (Nasdaq: MICT) operates through its wholly owned subsidiary, GFH Intermediate Holdings Ltd (“GFHI”), GFHI’s various fully owned subsidiaries or VIE structures. GFHI’s versatile proprietary trading technology platform is designed to serve a large number of high growth sectors in the global fintech space. Primary areas of focus include online brokerage for equities trading and sales of insurance products in several high-growth foreign markets including Asia.

Forward-looking Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. All statements other than statements of historical fact contained in this press release are forward-looking statements. The words “believe,” “may” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, business prospectus, growth strategy and liquidity. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. The forward-looking statements contained in this press release are subject to other risks and uncertainties, including those discussed in the “Risk Factors” section and elsewhere in the Company’s annual report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission. Except as otherwise required by law, the Company is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events or otherwise.

Contact information:
Tel: (201) 225-0190
[email protected]



David Claus Arrives Early This Year: DAVIDsTEA Launches 2021 Holiday Countdown Collection

Discover DAVIDsTEA’s three merry calendars this holiday season, because counting down the days to Christmas can be done at any age!

MONTRÉAL, Sept. 15, 2021 (GLOBE NEWSWIRE) — DAVIDsTEA Inc. (Nasdaq:DTEA), a leading tea merchant in North America, is pleased to announce the launch of its biggest Holiday Countdown Collection yet. 24 Days of Tea, the company’s highly anticipated tea calendars, are now available at all 18 DAVIDsTEA flagship stores across Canada, and online at davidstea.com.

While it might seem early to start counting the days to Christmas, there is no better time than now to purchase one of DAVIDsTEA’s three exclusive 24 Days of Tea calendars. With limited quantities available, it’s best to order ahead to make sure the countdown is ready to go on December 1st.

DAVIDsTEA is excited to invite tea lovers from across North America to unwrap a selection of curated teas designed to please all palates. Featuring the all-new 24 Days of Tea – Caffeine-Free, which showcases DAVIDsTEA’s favourite herbal tea selection, the 2021 Holiday Countdown Collection will also include the return of 2020 top seller 24 Days of Matcha, in addition to the tried-and-true classic 24 Days of Tea, highlighting the best of DAVIDsTEA blends. Convinced that the countdown is just as good as the main event, all three items of the Holiday Countdown Collection are the perfect way to sample the brand’s top teas and to discover a new favourite.

“24 Days of Tea is undeniably our most anticipated launch of the year,” said Sarah Segal, Chief Executive Officer and Chief Brand Officer, DAVIDsTEA. “We are excited to offer our loyal customers not one, but three iconic DAVIDsTEA holiday calendars this year. Whether you prefer the classic seasonal offering, are looking for caffeine-free options or seeking an all-matcha experience, we have taken customer feedback to heart, and created a 24 Days of Tea calendar for absolutely everyone this holiday season.”

Follow DAVIDsTEA on Instagram (@davidstea), Facebook (@davidstea), and on TikTok (@davidstea_official) to put the jingle in your bells.

2021 Holiday Countdown Collection


  • 24 Days of Tea:
    It’s the most wonderful teatime of the year! Back for its 11th season, unwrap 24 days of pure holiday spirit with our top festive loose-leaf blends. We’ve even thrown in some throwback faves, unique online exclusives and sneak peeks to make every day until the big event feel special.


  • 24 Days of Tea – Caffeine-Free
    : Make every night a silent night. Well, 24 of them. These caffeine-free blends were specifically chosen to help you wind down after a day of celebration, wrapping presents and kitchen crises.


  • 24 Days of Matcha
    : The ghost of holiday past is here: it’s a merry matcha extravaganza! Returning by popular demand, our favourite festive and classic blends are hiding behind every door. The largest matcha collection in North America conveniently packed into 24 days? Yes please.

With limited quantities available, there is no better time than now to purchase one or all three items from DAVIDsTEA’s 2021 Holiday Countdown Collection, available online at davidstea.com for Canadian and U.S. customers, or in-store at one of DAVIDsTEA’s 18 flagship locations across Canada.

About DAVIDsTEA

DAVIDsTEA offers a specialty branded selection of high-quality loose-leaf teas, pre-packaged teas, tea sachets, tea-related accessories and gifts through its e-commerce platform at www.davidstea.com, the Amazon Marketplace, its wholesale customers which include over 3,300 grocery stores and pharmacies, and 18 company-owned stores across Canada. It offers primarily proprietary tea blends that are exclusive to the Company, as well as traditional single-origin teas and herbs. The team’s passion for and knowledge of tea permeates the Company’s culture and is rooted in an excitement to explore the taste, health and lifestyle elements of tea. With a focus on innovative flavours, wellness-driven ingredients and organic tea, the Company launches seasonally driven “collections” with a mission of making tea fun and accessible to all. The Company is headquartered in Montréal, Canada.

For more information or media requests, please contact:

Sarah Vincent, Public Relations and Partnerships Specialist, DAVIDsTEA
[email protected]

Lyla Radmanovich, PELICAN PR
514-845-8763
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ffca1438-2aef-48a9-a97f-4f38799a1e25



Heat Biologics CEO to Present at the Cantor Fitzgerald Global Healthcare Conference on September 29th

DURHAM, N.C., Sept. 15, 2021 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting at the Cantor Fitzgerald Global Healthcare Conference being held virtually between September 27-30, 2021.

Presentation Details:

Date: Wednesday, September 29, 2021
Time: 9:20 AM ET / 6:20 AM PT
Webcast: Cantor Global Healthcare Conference

About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.

For more information, please visit: www.heatbio.com, and also follow us on Twitter.

Media and Investor Relations Contact

David Waldman
+1 919 289 4017
[email protected]



Revolution Medicines to Participate in 3rd Annual RAS-Targeted Drug Development Summit

Company’s Scientific Leadership to Highlight Key Findings from Ongoing RAS(ON) Inhibitor Programs

REDWOOD CITY, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, today announced that the company will participate in the upcoming 3rd Annual RAS-Targeted Drug Development Summit being held September 21-23, 2021. Steve Kelsey, M.D., president, research and development, will serve as chairperson for one of the conference’s scientific tracks and moderate a panel discussion during the virtual event. In addition, Jan Smith, Ph.D., senior vice president, biology and Bob Nichols, Ph.D., project lead for RMC-6291, the company’s development-stage KRASG12C(ON) inhibitor, will each deliver a scientific presentation as part of the conference.

Details of Revolution Medicines’ participation in the 3rd Annual RAS-Targeted Drug Development Summit are as follows:


Presentations:

   
Title: Targeting KRASG12C(ON) & Potential Application to Overcoming Drug Resistance in RAS-Addicted Tumors
Presenter: Bob Nichols, Ph.D., project lead for RMC-6291
Date: Wednesday, September 22, 2021
Time: 11:55 a.m. Eastern
   
Title: Combination Strategies to Defeat RAS-Addicted Cancers
Presenter: Jan Smith, Ph.D., senior vice president, biology
Date: Wednesday, September 22, 2021
Time: 2:00 p.m. Eastern
   

Panel Discussion:
   
Title: On the Horizon – Discussing the Post-Approval Landscape for Successful RAS Drugs Beyond AMG510
Moderator: Steve Kelsey, M.D., president, research and development
Date: Thursday, September 23, 2021
Time: 4:15 p.m. Eastern
   

Scientific Track:
   
Title: Validating Robust Combination Strategies
Chairperson: Steve Kelsey, M.D., president, research and development
Date/Time: Wednesday, September 22, 2021; 11:30 a.m. – 5:00 p.m. Eastern
Thursday, September 23, 2021; 11:00 a.m. – 12:30 p.m. Eastern
   

Additional information on the Digital RAS-Targeted Drug Discovery Summit is available through the conference website at https://ras-drugdevelopment.com/

About Revolution Medicines, Inc.

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.

The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291, RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.

Contacts:

For Investors:
Vida Strategic Partners
Stephanie Diaz
415-675-7401
[email protected]

For Media:
Vida Strategic Partners
Tim Brons
415-675-7402
[email protected]



Qualigen to Present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

CARLSBAD, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today that CEO and Chairman Michael Poirier will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit September 20-23, 2021.

The presentation will provide an overview of the Company’s strategy focusing primarily on its oncology drug pipeline which includes QN-247 and RAS-F assets for which Qualigen has already seen encouraging preclinical data.


Qualigen


Therapeutics, Inc


. Presentation


Details are as follows:

Format: Virtual

Presentation Webcast: www.qualigeninc.com/opco21

Presentation Time: Wednesday, September 22, 2021, 4:35 pm EDT. The webcast link will broadcast the presentation live, and can be viewed for 90 days thereafter.

Virtual Meetings: One-on-one meetings will be held virtually and will be available to registered attendees. Qualigen Management will be available throughout each day September 20-22, 2021. Contact your Oppenheimer representative to register. You may also email [email protected] to register.

About
Qualigen
Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation. Qualigen’s aptamer platform, of which QN-247 is the lead candidate, inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells, thus influencing their proliferation, survival and metastasis. QN-247 has shown promise in pre-clinical studies for the treatment of acute myeloid leukemia (AML). Qualigen’s RAS-F platform is a family of RAS oncogene protein-protein interaction inhibitor small molecules that is believed to disrupt pathways for cancer genes that cause tumor formation. Such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. The RAS pathway has generated considerable interest due to recent breakthrough developments in the field and the first clinical approval earlier this year for a K-RAS directed drug. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems for the management of prostate cancer and other diseases and health conditions. Qualigen’s management has significant experience in drug and medical device development, manufacturing, marketing and distribution.

For more information about Qualigen Therapeutics, Inc. please visit www.qualigeninc.com.

Forward-Looking Statements

This news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. These statements include those related to the Company’s prospects and strategy for the development of therapeutic drug candidates. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance that the Company will develop any drugs (including QN-247 and RAS-F); that preclinical or clinical development of the Company’s drugs (including QN-247 and RAS-F, and deprioritized infectious-disease programs such as QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (including Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company’s owned and in-licensed patent applications; that such patents, if any, and the Company’s currently owned and inlicensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company’s prospective therapeutic products (including QN-247 and RAS-F, and any repositioning of QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company’s diagnostic products. The Company’s stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company’s business can be found in the Company’s prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at www.sec.gov.

The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

For further information: David Kugelman
Atlanta Capital Partners, LLC
(404) 856-9157 or (866) 692-6847 Toll Free – U.S. & Canada
[email protected]

Tony Schor
Investor Awareness, Inc.
(847) 971-0922
[email protected]