Month: September 2023

If approved, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL – the two most common subtypes of non-Hodgkin lymphoma European Medicines Agency also reviewing odronextamab Marketing Authorization Application TARRYTOWN, N.Y., Sept. 29, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The target action date for the FDA decision is March 31, 2024. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge...

Dovre Group Plc                            Press release                 September 29, 2023, at 3.30 pm Dovre Group´s Norwegian operations, i.e. Dovre Group Energy and Dovre Group Consulting, have been attacked by ransom virus at one of our servers in Stavanger We are working closely together with our IT-partner on our contingency plan and are already up and running on safe email and basic office systems. The server involved contains part of our financial systems and operational directories. The impact for our consultants and clients is limited as the majority of our consultants in Norway are working within our clients´ organization, using their IT-systems. Our main challenge is that our internal administration will have an extra burden in the coming period.   It is too early to estimate further economic consequences, focus now is to secure...

SAN FRANCISCO,, Sept. 29, 2023 (GLOBE NEWSWIRE) — The RealReal (the “Company” or “The RealReal”) (Nasdaq: REAL)—the world’s largest online marketplace for authenticated, resale luxury goods—today announced that Robert Julian will step down from his role as Chief Financial Officer (“CFO”) of the Company effective on the earlier of January 31, 2024 or the date a new CFO assumes the position. If a new CFO assumes the position prior to January 31, 2024, Mr. Julian will continue as an employee and serve as an executive advisor to the Company through January 31, 2024. To assist with the transition of his role, Mr. Julian has agreed to provide limited consulting services to the Company following his termination of employment from February 1, 2024 until June 30, 2024. The Board of Directors of the Company will retain an executive search...

Manila-based Animation Studio Profiled in 60-minute Program Detailing Creative Industry’s Role in Serving Global Audiences and Contributions to National Economy BOCA RATON, Fla., Sept. 29, 2023 (GLOBE NEWSWIRE) — Top Draw Animation (TDA), a leading source of premium animation production services for programming shown around the world, and a division of Grom Social Enterprises Inc. (NASDAQ: GROM), is featured in the recently-premiered Creative PH, a sixty-minute special examining the impact of creative industries on the Filipino economy and global audiences. The special, which premiered locally on CNN Philippines yesterday, was shared today by Top Draw Animation’s Executive Vice President, Jared Wolfson. The special’s segment on Top Draw Animation appears from (time codes) 14:47 through 28:23 here on CNN Philippines. For more information...

DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD). The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population. This is only the ninth Breakthrough...

Financial HighlightsGross Profit for the fourth fiscal quarter and fiscal 2023 increased $9.6 million, or 5%, and $79.2 million, or 9%, respectively, compared to the prior year periods. Margin per gallon for the fourth fiscal quarter and fiscal 2023 increased 10% and 12%, respectively, compared to the prior year periods. Net loss attributable to Ferrellgas Partners, L.P. was $29.1 million for the fourth fiscal quarter compared to a net loss of $19.4 million in the prior year period. Net earnings attributable to Ferrellgas Partners, L.P. was $136.9 million and $148.0 million for fiscal 2023 and 2022, respectively. Adjusted EBITDA for the fourth fiscal quarter decreased by $5.2 million, or 15%, compared to the prior year period. For fiscal 2023, Adjusted EBITDA increased by $20.1 million, or 6%, compared to fiscal 2022.Company HighlightsOn...

FREDERICK, Md., Sept. 29, 2023 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, is rolling out two new products, the SteraMist Hybrid and SteraMist Transport, to support its ongoing commitment to providing superior disinfection decontamination solutions for its growing customer base. SteraMist Hybrid An integral component of the SteraMist Environment System, SteraMist Hybrid is designed with capabilities to communicate with a facility.  The system is strategically positioned in a centralized location of the facility through a docking station and features our newly designed permanently mounted stainless steel applicators.  Recently, TOMI successfully installed the first SteraMist Hybrid at Indigo Pharmaceutical, Inc.’s existing...

Highlights include the company’s strong foundation for growth, focus on innovation and attractive long-term outlook SAN DIEGO, Sept. 29, 2023 (GLOBE NEWSWIRE) — Maravai LifeSciences Holdings, Inc. (“Maravai” or the “Company”) (NASDAQ: MRVI), a global provider of life science reagents and services to researchers and biotech innovators, hosted its 2023 Investor R&D Day featuring presentations by Trey Martin, Chief Executive Officer, and other members of the Maravai leadership team that showcased the company’s strong foundation for growth, key differentiators, innovations, and attractive long-term growth outlook. “Maravai has established an exceptionally strong foundation and we are building momentum toward our long-term goal of achieving high teens revenue growth with expanding EBITDA margins,” said Trey Martin, CEO of Maravai...

JACKSONVILLE, Fla., Sept. 29, 2023 (GLOBE NEWSWIRE) — Regency Centers Corporation (The “Company”) (NASDAQ: REG) will announce its Third Quarter 2023 earnings results on Thursday, November 2, 2023, after the market closes. The Company’s earnings release and supplemental information package will be posted on the Investor Relations section of the Company’s website – investors.regencycenters.com. The Company will host an earnings conference call on Friday, November 3, 2023, at 11:00 a.m. ET.Third Quarter 2023 Earnings Conference CallDate: Friday, November 3, 2023Time: 11:00 a.m. ETDial#: 877-407-0789 or 201-689-8562Webcast: 3rd Quarter 2023 Webcast Link   Replay Webcast Archive: Investor Relations page under Webcasts & Presentations About Regency Centers Corporation (NASDAQ: REG) Regency Centers is a preeminent...

ISELIN, N.J., Sept. 29, 2023 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated August 29, 2023 regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval...