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Grocery Outlet CMO: The eat-at-home trend 'isn't going to change'

Grocery Outlet CMO Layla Kasha joins Yahoo Finance's Melody Hahm to discuss how the company is faring amid the COVID-19 pandemic, and what they're expecting in 2021.

Latest Stories

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  • KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD

    Conference Call and Live Audio Webcast Scheduled for Tomorrow, Wednesday, March 3, at 8:30 a.m. ET CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS™ (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement (the “License Agreement”) between KemPharm and an affiliate of GPC. Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021. “The FDA approval of the AZSTARYS NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “Today’s approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT® platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug. We look forward to continuing our support of Corium as they forge ahead with the commercial launch of AZSTARYS.” “Today’s approval by the FDA is met with great excitement for this innovative new ADHD therapy and the potential it holds to meet the unmet needs of children, adolescents and adults,” said Perry Sternberg, CEO of Corium. “Our team is mobilized to put our commercial plans into action as the approval of the AZSTARYS NDA now enables us to finalize our preparations for commercial launch as early as the second half of this year.” Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine and an investigator in the AZSTARYS clinical trial, commented: “The ADHD industry, and specifically the MPH space, has seen little innovation in recent years, leaving prescribers and patients desiring new treatment options. In my research and practice, three properties are repeatedly cited by patients and their caregivers as being underserved by current ADHD medications: onset of action, duration of effect and consistency of therapy. Having investigated AZSTARYS and directly observed its clinical impact on patients, I believe this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.” As a result of the FDA’s approval of the AZSTARYS NDA, KemPharm has earned a regulatory milestone payment following FDA approval as provided under the License Agreement, and KemPharm is working with GPC to evaluate the related provisions and amounts. Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S. The complete label for AZSTARYS, including prescribing information and important safety information, may be found at www.kempharm.com/pipeline-products/#kp415. The complete label may also be downloaded in PDF format here: http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315. Conference Call Information: KemPharm will host a conference call and live audio webcast with slide presentation tomorrow, Wednesday, March 3, 2021, at 8:30 a.m. ET, to discuss FDA approval of the AZSTARYS NDA. Interested participants and investors may access the conference call by dialing either: (866) 395-2480 (U.S.)(678) 509-7538 (international)Conference ID: 4272912 An audio webcast with slide presentation will be accessible via the Investor Relations section of the Company’s website, http://investors.kempharm.com/. An archive of the webcast and presentation will be available for 90 days beginning tomorrow, March 3, 2021, at approximately 9:30 a.m. ET. About Attention Deficit Hyperactivity Disorder (ADHD): Attention-deficit/hyperactivity disorder (ADHD) is one of the most common mental disorders affecting children. ADHD also affects many adults. Symptoms of ADHD include inattention (not being able to keep focus), hyperactivity (excess movement that is not fitting to the setting) and impulsivity (hasty acts that occur in the moment without thought).1 An estimated 8.4% of children and 2.5% of adults have ADHD.23 The ADHD market accounted for approximately $17.9 billion of revenue in 2019 with a year-over-year prescription growth rate greater than four percent (4%). Within this, the branded portion of the ADHD market was approximately $7.4 billion in 2019, with extended-release products representing more than 97% of the branded prescriptions. In 2019, the methylphenidate segment of the ADHD market accounted for approximately 20 million prescriptions and $4.9 billion in sales. About AZSTARYSTM: AZSTARYSTM is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH. The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here: http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315. About KemPharm: KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s product portfolio is highlighted by AZSTARYS™, an FDA-approved, once-daily treatment for attention deficit hyperactivity disorder (ADHD) which is based on serdexmethylphenidate, (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). KemPharm is also advancing several clinical development candidates, including KP484 for the treatment of ADHD and KP879 for the treatment of Stimulant Use Disorder (SUD). AZSTARYS, KP484, and KP879 are all based on SDX. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube. Caution Concerning Forward Looking Statements: This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation KemPharm’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements about the commercial launch of AZSTARYS, including the timing of launch, the regulatory milestone payment, and the potential clinical benefits of AZSTARYS. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in the “Risk Factors” sections of KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and KemPharm’s other filings with the Securities and Exchange Commission. KemPharm 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. KemPharm Contacts: Jason Rando/Maureen McEnroe, CFATiberend Strategic Advisors, Inc.(212) 375-2665 / 2664jrando@tiberend.commmcenroe@tiberend.com ________________________1 American Psychiatric Association (https://www.psychiatry.org/patients-families/adhd/what-is-adhd) 2 Danielson, ML, et al. Prevalence of Parent-Reported ADHD Diagnosis and Associated Treatment Among U.S. Children and Adolescents, 2016. Journal of Clinical Child & Adolescent Psychology, Volume 47, 2018 - Issue 23 Simon V , Czobor P, Bálint S , et al: :Prevalence and correlates of adult attention-deficit hyperactivity disorder: a meta-analysis. Br J Psychiatry194(3):204–211, 2009

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  • SpiceJet and WheelTug conclude agreement for 400 slots of the state-of-the-art electric taxi system

    GURUGRAM, India, March 02, 2021 (GLOBE NEWSWIRE) -- SpiceJet, the country’s favourite airline, has tied-up with WheelTug Plc for reserving 400 production slots for the state-of-the-art electric taxi system that will enable the airline in saving fuel, reducing CO2 emissions as well as noise levels, improve its fleet utilization thereby directly improving the company’s bottom line. The innovative WheelTug system places high-torque motors in the nose wheels of the aircraft. Pilots control the aircraft themselves, performing ground operations without requiring tugs for maneuvers. By keeping jet engines off in tight areas, the airline will lower its emissions. Additionally, SpiceJet gate and stand operations will be faster and more dependable helping the airline eliminate unexpected long delays affecting the schedule on any given day. “SpiceJet is a strong advocate for reducing carbon emissions. By inducting WheelTug into its B737 operations, the company aims to reduce the fuel burn during Taxi out and in,” said a SpiceJet spokesperson. SpiceJet is the largest Boeing 737 operator in India. Isaiah Cox, Chief Executive Officer, WheelTug said, "Signing SpiceJet at this time shows both companies are looking forward to a strong recovery for the industry as the world responds to the Covid-19 crisis.” “To that end, we also wish to recognize SpiceJet’s leading role in transporting vaccines to India.” About SpiceJet Ltd SpiceJet is India’s favourite airline that has made flying affordable for more Indians than ever before. The airline operates a fleet of Boeing 737s, Bombardier Q-400s & freighters and is the country’s largest regional player operating 63 daily flights under UDAN or the Regional Connectivity Scheme. The majority of the airline’s fleet offers SpiceMax, the most spacious economy class seating in India. The airline also operates a dedicated air cargo service under the brand name SpiceXpress offering safe, on-time, efficient and seamless cargo connectivity across India and on international routes. About WheelTug plc Based in the Isle of Man, WheelTug plc is developing the WheelTug aircraft electric drive system. More than 25 airlines representing 2000+ aircraft have reserved slots for WheelTug systems. www.wheeltug.com. Forward-looking statement: http://www.wheeltug.com/fls.shtml For more information: SpiceJet media contact: Tushar SrivastavaHead, Corporate Affairs & CSRtushar.srivastava@spicejet.com Anand DeoraSr. Manager –Corporate Communications+91 -98103 44335 anand.deora@spicejet.com

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  • Vasilevskiy 3rd shutout in row as Lightning top Stars 2-0

    DALLAS — Andrei Vasilevskiy stopped 28 shots for his third consecutive shutout, extending his scoreless streak to 200 minutes, and the Stanley Cup champion Tampa Bay Lightning beat the Dallas Stars 2-0 on Tuesday night. Vasilevskiy also held the struggling Stars without a goal four days earlier at home, a 5-0 win in the first meeting this season between the teams that played in the Stanley Cup Final in the NHL bubble last September. The three straight shutouts are a career best for Vasilevskiy, the 26-year-old goalie who has played all seven of his NHL seasons for Tampa Bay. Vasilevskiy surpassed his previous record scoreless streak of 184 minutes, 49 seconds, set three seasons ago, and is the 70th NHL goalie to surpass 200 minutes (200:45). His streak of 10-plus scoreless periods is the longest in the NHL this season. Just as they did against Dallas on Saturday, the Lightning went ahead to stay on a power-play goal in the first period by Ondrej Palat. Their other goal was an empty-netter by Yanni Gourde with five seconds left. Tampa Bay (15-4-1) has the NHL's longest active winning streak at five games and leads the Central Division with 31 points, one more than the Florida Panthers, who have played one more game than the Lightning. Dallas has won only once in its last 10 games. The Stars played at home for the first time since Feb. 13, before having four consecutive home games postponed because of extreme winter weather that led to extended power problems in North Texas and made the American Airlines Center unavailable. Anton Khudobin stopped 17 shots for Dallas. Palat scored 7 1/2 minutes into the game, and only 10 seconds after the Lightning went on the power play. After Palat's initial shot from the right side was blocked by Esa Lindell, the puck ricocheted across to captain Steven Stamkos on the other side. He passed to Victor Hedman in the middle and the puck went back to Palat for a one-timer between Khudobin and the right post. Andrew Cogliano had a point-blank shot for Dallas late in the first period, but it was pushed aside by Vasilevskiy. The Lightning goalie had also secured the puck after Joe Pavelski's shot was followed by captain Jamie Benn's two shots in quick succession. Benn had a shot midway through the second period that hit under Vasilevskiy's right arm, then ricocheted off the post. Vasilevskiy has stopped 92 consecutive shots, including 20 in his previous shutout of the Stars. POWER PALAT Palat's tally in the first period was his sixth power-play goal of the season, already a career high after only 20 games. His previous career best had been five over 56 games in 2016-17. It was also his NHL-best sixth time this season scoring the first goal of a game. STARS SCHEDULE The Stars played the first of 40 games over 70 days to finish out the reduced 56-game regular season. They came into the game off their last two-day break of the season, and started a seven-week stretch when they have games scheduled every Tuesday, Thursday, Saturday and Sunday through mid-April. Even after that, they aren't scheduled to have more than one day off between games, and will finish the regular season with seven consecutive road games over 12 days. WHAT’S NEXT Tampa Bay plays three games in four days at the Chicago Blackhawks, starting Thursday. Dallas stays at home for five more games, hosting Columbus on Thursday and Saturday. ___ More AP NHL coverage: https://apnews.com/hub/NHL and https://twitter.com/AP_Sports Stephen Hawkins, The Associated Press

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