Month: May 2024

–-NDA Resubmitted; FDA Action Expected in Early Q4 24– –-Cash Runway into 2025, including through Potential FDA Approval– –Company to Host Conference Call Today at 8:30 a.m. EDT– DUBLIN, Ireland and CHICAGO, May 13, 2024 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM), (Iterum) a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the first quarter ended March 31, 2024. “We are pleased to have recently resubmitted our new drug application (NDA) for oral sulopenem just three months after reporting positive topline data from our REASSURE trial in January 2024,” said Corey Fishman, Iterum’s Chief Executive...

Initiated a Phase 2 clinical trial of APG777, a subcutaneous half-life extended monoclonal antibody targeting IL-13, in patients with moderate-to-severe atopic dermatitis, with 16-week proof-of-concept data from Part A of the trial expected in 2H 2025 First participant dosed in Phase 1 healthy volunteer clinical trial of APG808, a subcutaneous half-life extended monoclonal antibody targeting IL-4Rα, for the treatment of chronic obstructive pulmonary disease and other inflammatory diseases with interim Phase 1 data expected in 2H 2024 Nominated development candidate for APG990, a subcutaneous half-life extended monoclonal antibody targeting OX40L, with a Phase 1 trial in healthy volunteers expected to initiate in 2H 2024 $816 million cash, cash equivalents and marketable securities with runway into 2028 SAN FRANCISCO and WALTHAM, Mass.,...

– Initiated Phase 2 TRANQUILITY trial in April 2024 following U.S. FDA clearance of Investigational New Drug application (IND) for clinical development program in Atherosclerotic Cardiovascular Disease (ASCVD) – – Expanded Thyroid Eye Disease (TED) clinical development plan, including accelerating the planned initiation of a pivotal Phase 3 trial into 2024 – – Completed underwritten follow-on public offering in January 2024, raising gross proceeds of $172.5 million – – Ended the quarter with $350.3 million of cash, cash equivalents and investments, providing cash runway into 2027 – NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) — Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory...

First patient dosed in Phase 1 clinical trial for the treatment of solid tumors; initial data anticipated in 2024 All treatment-arm patients in the Phase 1 heme program remain relapse-free with no detectable disease, with a median follow-up of >10 months Closed upsized underwritten public offering with gross proceeds of $167.8 million, extending runway into the fourth quarter of 2026 WALTHAM, Mass., May 13, 2024 (GLOBE NEWSWIRE) — TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update. “During the first quarter we advanced our clinical pipeline, most recently marked...

Company’s evaluation of potential strategic alternatives progresses with goal to maximize stockholder value MALVERN, Pa., May 13, 2024 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the first quarter ended March 31, 2024, and provided recent corporate updates. “Our review of strategic options continues, as we strive to maximize value for our stockholders,” said Mel Sorensen, M.D., Galera’s President and CEO. “Potential options may include mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions and may encompass a potential development path for avasopasem. The process...

 Plans to initiate two efficacy studies investigating PRAX-628 in focal onset seizures in the second half of 2024 and first half of 2025, respectively Continued strong recruitment for the pivotal Essential3 trials in Essential Tremor (ET), with over 50,000 pre-screening forms and over 7,000 referrals received to date that meet pre-qualifying eligibility criteria; topline results expected in the second half of 2024 Randomization in PRAX-562 Phase 2 EMBOLD study completed in pediatric patients with developmental and epileptic encephalopathies (DEEs), with topline results expected in the third quarter of 2024 Completed two underwritten public offerings in 2024; Cash and investments of $451.2 million as of April 30, 2024 extends runway into 2027 BOSTON, May 13, 2024 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX),...

― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ― ― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) in the fourth quarter of 2024 ― ― Industry veteran, Patrick Horn M.D., Ph.D., appointed as chief medical officer ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the first quarter of 2024 as well as an update to the business. “It’s a very exciting time for Fulcrum as we remain...

– First Quarter 2024 Total Revenue More Than Doubled Year-over-Year to $21.5 Million – – Driven by 59% Year-over-Year Growth in Direct-to-Consumer Division – ORLANDO, Fla., May 13, 2024 (GLOBE NEWSWIRE) — Abacus Life, Inc. (“Abacus” or the “Company”) (NASDAQ: ABL), a pioneering alternative asset manager specializing in longevity and actuarial technology, today reported results for the first quarter ended March 31, 2024. “We are pleased with our continued momentum, delivering yet another strong quarterly performance due to our relentless execution, and further validating the resiliency and profitability of our business model,” said Jay Jackson, Chief Executive Officer of Abacus. “In addition to our strong growth, we launched our technology subdivision ABL Tech, raised an additional $25 million from the issuance...