Day: February 25, 2021

– U.S. FDA Accepts NDA Filing for KORSUVA™ Injection in CKD-aP –– Conference call today at 4:30 p.m. ET –STAMFORD, Conn., Feb. 25, 2021 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced financial results and operational highlights for the fourth quarter and full year ended December 31, 2020.“During 2020, we made significant advances in our late-stage clinical pruritus programs, culminating in the acceptance by the U.S. Food and Drug Administration (FDA) of our first New Drug Application (NDA) filing for our lead product candidate, KORSUVA™ (CR845/difelikefalin) Injection for the treatment of moderate-to-severe pruritus...

PLEASANTON, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) — Natus Medical Incorporated (NASDAQ:NTUS) (the “Company” or “Natus”), a leading provider of medical device solutions focused on the diagnosis and treatment of central nervous and sensory system disorders for patients of all ages, today announced financial results for the three months and full year ended December 31, 2020.For the fourth quarter ended December 31, 2020, the Company reported revenue of $118.7 million, a decline of 9.7% compared to $131.4 million reported for the fourth quarter 2019. GAAP gross margin was 55.3% during the fourth quarter of 2020 compared to 61.2% in the fourth quarter 2019. GAAP net income was $5.2 million, or $0.15 earnings per diluted share, compared with GAAP net income of $3.0 million, or $0.09 earnings per diluted share in the fourth quarter 2019.Non-GAAP...

Fiscal Fourth Quarter Total Revenues of $1.13 Billion, Up 15.9% Year Over YearSubscription Revenue of $1.01 Billion, Up 19.8% Year Over Year24-Month Subscription Revenue Backlog of $6.53 Billion, Up 19.2% Year Over YearTotal Subscription Revenue Backlog of $10.09 Billion, Up 21.6% Year Over YearFiscal Year 2021 Total Revenues of $4.32 Billion, Up 19.0% Year Over YearSubscription Revenue of $3.79 Billion, Up 22.4% Year Over YearOperating Cash Flows of $1.27 Billion, Up 46.7% Year Over YearPLEASANTON, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) — Workday, Inc. (NASDAQ: WDAY), a leader in enterprise cloud applications for finance and human resources, today announced results for the fiscal fourth quarter and full year ended January 31, 2021.Fiscal Fourth Quarter 2021 ResultsTotal revenues were $1.13 billion, an increase of 15.9% from the...

Expects to Provide Complete Response to FDA Requests on IND Application for VY-HTT01 for Huntington’s Disease in the First Half of 2021Continues to Progress Pipeline and Platform Activities with Expected Presentations of Data in the First Half of 2021CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) — Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe neurological diseases, today reported its fourth quarter and full year 2020 financial results and provided corporate updates.“We have made significant progress readying our lead wholly owned program, VY-HTT01 for Huntington’s disease, for clinical trials,” said Andre Turenne, President and CEO of Voyager. “We have also continued to advance our preclinical portfolio, including...

SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the full year ended December 31, 2020 and provided business highlights.“We kicked off 2021 with more encouraging data from our ETV:IDS (DNL310) Phase 1/2 study in Hunter syndrome, further suggesting that we may be able to treat a wide array of diseases with CNS and bodily manifestations via intravenous infusion by leveraging our blood-brain barrier Transport Vehicle technology,” said Ryan Watts, Ph.D., Denali’s Chief Executive Officer. “In 2021 we plan to advance our lead LRRK2 inhibitor, DNL151 (BIIB122), with Biogen into late-stage...

– 2020 First Full-Year of Profitability, Driven by Xtampza®ER Revenue Growth and the Nucynta®Acquisition –– Collegium Reiterates Previously Issued 2021 Guidance –– Conference Call Scheduled for Today at 4:30 p.m. ET –STOUGHTON, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update. “Our differentiated pain portfolio performed well during the fourth quarter, laying the groundwork for a strong start in the new year,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “As we turn to 2021, we are encouraged by underlying trends in our business and remain focused...

Recent Highlights:Net revenues of $22.4 million in the fourth quarter and $69.2 million for the full year of 2020, representing 110.8% and 110.9% increases, respectively, over the corresponding periods of 2019Gross systems shipped of 12,096 in the fourth quarter and 38,243 for the full year of 2020, representing 67.7% and 67.8% increases, respectively, over the corresponding periods of 2019Return accrual rate of 24.4% in the fourth quarter and 25.9% for the full year of 2020, representing a 9.6 and 9.0 percentage point improvement, respectively, over the corresponding periods of 2019Gross margin of 70.6% in the fourth quarter and 68.4% for the full year of 2020, representing a 15.4 and 16.6 percentage point improvement, respectively, over the corresponding periods of 2019; non-GAAP gross margin of 70.8% in the fourth quarter and 68.5%...

PHOENIX, Feb. 25, 2021 (GLOBE NEWSWIRE) — WillScot Mobile Mini Holdings Corp. (“WillScot Mobile Mini Holdings” or the “Company”) (Nasdaq: WSC), the North American leader in turnkey modular space and portable storage solutions, today announced fourth quarter and full year 2020 financial results and provided an update on merger integration activities, the current market environment and its 2021 outlook.On July 1, 2020, Williams Scotsman, Inc. closed the merger with Mobile Mini, Inc. (the “Merger”) and assumed the name WillScot Mobile Mini Holdings Corp. (Nasdaq: WSC). Our reported results only include Mobile Mini for the periods subsequent to the Merger. Our Pro Forma Results include Mobile Mini’s results as if the Merger and financing transactions had occurred on January 1, 2019, which we believe is a better representation...

Recent Highlights:Completed V1.25L Aqualyzer program; achieved a 100% improvement in lead production throughput, in addition to improved equipment and operating costsContinued progress with potential licensing partners; ongoing discussions with several parties on three continents, inclusive of ClariosSubmitted provisional patent to protect process enabling ultra-pure AquaRefined material to be utilized directly in the production of oxide for new batteriesEstablished partnership with BASF, including a commitment to supply AquaRefining electrolyte to licensees and commercial cooperation to offer Aqua Metals servicesSecured investment in LINICO Corporation (“LiNiCo”), a cleantech lithium-ion battery recycling innovatorEstablished plans to form an eco-network with other innovative companies to advance recycling technologies for lithium-ion...