Year: 2022

PEMBROKE, Bermuda, Oct. 10, 2022 (GLOBE NEWSWIRE) — James River Group Holdings, Ltd. (the “Company”) (NASDAQ: JRVR) today announced it will release its earnings for the quarter ended September 30, 2022 after the market closes on Tuesday, November 1, 2022. The Company will also host a conference call to discuss its results with analysts and investors on Wednesday, November 2, 2022 beginning at 8:00 a.m. (Eastern Time). Investors may access the conference call by dialing (800) 715-9871, conference ID 2262462, or via the internet by visiting www.jrvrgroup.com and clicking on the “Investor Relations” link. A webcast replay of the call will be available by visiting the company website. About James River Group Holdings, Ltd. James River Group Holdings, Ltd. is a Bermuda-based insurance holding company which owns and operates a group...

SZN-043 preclinical data shows rapid, transient increases in hepatocyte proliferation and was well tolerated in non-clinical toxicology studies SZN-1326 preclinical data shows improved intestinal epithelial healing, restored epithelial barrier, and reduced colitis-associated collagen deposition and was well tolerated in non-clinical toxicology studiesSOUTH SAN FRANCISCO, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) — Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today announced the presentation of data supporting the continued development of its lead therapeutic programs at United European Gastroenterology Week (UEGW), being held Oct. 8-11 in Vienna. “These data reinforce the compelling mechanism-based...

REDWOOD CITY, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) — PROCEPT® BioRobotics Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, announced today that it has entered into a new five-year $52 million loan arrangement with CIBC Innovation Banking. Proceeds from the new term loan were used to retire a $50 million debt facility with the Company’s existing lender. The Company’s new term loan includes a final maturity date of five years from the closing date. The new term loan has an interest-only period of 36 months, which may be extended to 48 months. “In order to further strengthen our balance sheet, we have successfully extinguished our $50 million term loan and entered into a new facility with favorable terms,” said Kevin Waters,...

NEW YORK, NY, Oct. 10, 2022 (GLOBE NEWSWIRE) — Elys Game Technology, Corp. (“Elys” or the Company”) (Nasdaq: ELYS), an interactive gaming and sports betting technology company, today announced a partnership with Bookmakers, LLC to provide land-based sportsbook services within the Top Hat Sports Bar & Grill, located in Parkville, Maryland. Under the agreement, Elys will receive a percentage of all sports betting revenue generated pending final regulatory approval of the Maryland Lottery and Gaming Control Commission. Karen Senac, owner of Bookmakers, LLC commented, “We are delighted to partner with Elys to provide sportsbook services within the Top Hat Sports Bar & Grill located in Parkville, Maryland. Elys’ experience in the market, ease of use for players and reporting for regulatory compliance is what drove Bookmakers...

Ovaprene has the Potential to be the First FDA-Approved Monthly, Self-Administered, Hormone-Free Contraceptive Product SAN DIEGO, Oct. 10, 2022 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food & Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene®, an investigational hormone-free monthly intravaginal contraceptive. The IDE approval reflects that the FDA determined the Company provided sufficient data to support the initiation and conduct of the study. The IDE submission included the results of the postcoital test (PCT) clinical study of Ovaprene, in which Ovaprene prevented essentially all sperm from entering...

Announces Preliminary Financial Results for Third Quarter 2022 WINTER SPRINGS, Fla., Oct. 10, 2022 (GLOBE NEWSWIRE) — IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump. Roger Susi, President and Chief Executive Officer of the Company, commented, “We have been engaged in several productive and positive discussions with the FDA. The FDA requested additional information that was not feasible to provide within FDA’s review deadline; therefore, we decided to withdraw our application to provide us more time to understand and resolve the FDA’s concerns. We are confident that after working with the FDA, we will be able to submit a 510(k) application that leads to a timely clearance for the MRidium 3870 Infusion...

200 mg BID dose demonstrates receptor saturation and statistically significant increases in key circulating T lymphocyte populations Lymphocyte changes consistent with approved α4β7 inhibitor WALTHAM, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) — Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the presentation of new phase 1 data from MORF-057 phase 1 studies at the United European Gastroenterology (UEG) Week 2022. These new data describe a 200 mg BID (bis in diem) MORF-057 dose cohort and build upon the previously reported safety and pharmacodynamic data from the MORF-057-101 study. MORF-057 is being developed as an oral α4β7 inhibitor candidate for the treatment of inflammatory bowel disease (IBD) with...