Day: November 10, 2023

Phase 2b SYMMETRY 36-week data, including new subgroup analysis, showed that EFX is active in patients with advanced cirrhosis and support continued development of EFX for treatment of cirrhosis due to NASH/MASH 22% and 10% of patients with more advanced cirrhosis in the 50mg and 28mg dose groups, respectively, had at least a one-stage improvement in fibrosis without worsening of NASH, over 7 and 3 times, respectively, the placebo rate of 3% Additional analyses from the HARMONY and SYMMETRY studies indicate that histological improvements associated with EFX do not appear to be attributable to concomitant use of GLP-1 SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked...

HOUSTON, Nov. 10, 2023 (GLOBE NEWSWIRE) — Koil Energy Solutions, Inc. (OTCQB: KLNG) has rescheduled its investor conference call to discuss its third quarter 2023 results to Monday, November 13, 2023 at 10:00 am Eastern Time (call details below).Call Dial-in:     Toll Free: 1-833-630-1956      Toll/International: 1-412-317-1837      Please ask to join the Koil Energy Solutions call.Webcast URL: https://edge.media-server.com/mmc/p/24vftbx6 A replay will be available through November 27, 2023 on our website, www.koilenergy.com, under the “Investors” section. About Koil Energy, Inc. (www.koilenergy.com) Koil Energy Solutions is a leading energy services company offering subsea equipment and support services to the world’s energy and offshore industries. We provide innovative solutions to complex customer challenges presented...

Leiden, The Netherlands, November 10, 2023: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has received a Day 180 Second List of Outstanding Issues (LoOI) from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) regarding its Marketing Authorisation Application (MAA) for leniolisib for adult and pediatric patients 12 years of age and older with APDS, a rare primary immunodeficiency. Based on the timetable included in the CHMP Day 180 Second LoOI, and considering the CHMP’s decision to reschedule the Ad-Hoc Expert Group (AEG) meeting to the end of November, Pharming now expects the CHMP to issue its opinion on the leniolisib MAA in the first quarter of 2024. Pharming now intends to file an MAA with the U.K. Medicines and Healthcare products Regulatory...

Data release to follow late-breaker poster presentation at AASLD The Liver Meeting® 2023 EDISON, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it expects to release additional efficacy data from the Phase 2 ALTITUDE-NASH clinical trial of its lead drug, rencofilstat, after market close on Monday, November 13, 2023. The data release will follow a late-breaker poster presentation by Hepion’s Senior Vice President, Clinical Pharmacology, Patrick Mayo, PhD, at the Liver Meeting® 2023, to be hosted by the American Association...

WARREN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced that two posters recapping the positive data from pharmacokinetic (PK) and pharmacodynamic (PD) pre-clinical and clinical studies of Anaphylm™ (epinephrine) Sublingual Film will be presented at the American College of Allergy Asthma and Immunology (ACAAI) annual meeting, which will be held from November 9-13 in Anaheim, California. “We are thrilled to have a significant presence at ACAAI this year and are excited to share the positive results from our completed Anaphylm pharmacokinetic and pharmacodynamic studies with leaders in the...

VANCOUVER, British Columbia, Nov. 10, 2023 (GLOBE NEWSWIRE) — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”) is pleased to announce the successful resolution of a dispute that arose in connection with a termination notice related to a supply agreement (“the Supply Agreement”) signed with a private entity on May 4, 2023. Optimi is pleased to confirm that the dispute has been amicably resolved and the Supply Agreement has been terminated through a negotiated settlement. This resolution underscores Optimi’s commitment to maintaining positive relationships with its partners while upholding its business integrity. The Company remains dedicated to delivering on its mission of providing high-quality drug candidates and services in the psychedelics sector. For...

MONTRÉAL, Nov. 10, 2023 (GLOBE NEWSWIRE) — Saputo Inc. (TSX:SAP) – Saputo will release its fiscal 2024 second quarter financial results on Thursday, November 9, 2023. A press release will be issued after markets close, and a conference call is scheduled on Friday, November 10, 2023, at 8:30 a.m. (Eastern Time) to discuss the Company’s results. The speakers will be Mr. Lino A. Saputo, Chair of the Board, President and CEO and Mr. Maxime Therrien, Chief Financial Officer and Secretary. To participate:Webcast: https://www.gowebcasting.com/12926Presentation slides will be included in the webcast and can also be accessed in the “Investors” section of Saputo’s website (www.saputo.com), under “Calendar of Events”.Conference line: 1-800-940-2599Please dial-in five minutes prior to the start time.Replay of the conference call and...