Month: March 2025

First clinical data demonstrating robust confirmed responses and CNS anti-tumor activity for firmonertinib in first-line NSCLC EGFR PACC mutations Global pivotal Phase 3 monotherapy study for firmonertinib in first-line NSCLC harboring EGFR exon 20 insertion mutations achieved target enrollment Selected next-generation ADC candidate ARR-002 for IND enabling studies Cash and cash equivalents of $266.5 million as of December 31, 2024NEWTOWN SQUARE, Pa., March 03, 2025 (GLOBE NEWSWIRE) — ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the year ended December 31, 2024, and highlighted recent Company progress. “This has been a productive year for ArriVent that...

— LUMRYZ™ generated $50.4 million in sales in the fourth quarter, up 158% year-over-year, taking the full-year total to $169.1 million, in line with preliminary results published January 8 — Reiterates 2025 guidance, with the number of patients on LUMRYZ expected to increase to 3,300-3,500 by year-end, generating $240-$260 million in net product revenue and cash flow of $20-40 million — Executing multiple initiatives to accelerate patient demand for LUMRYZ — Patient enrollment is on track in the Phase 3 REVITALYZ™ study to evaluate efficacy and safety of LUMRYZ in Idiopathic Hypersomnia (IH) — Avadel management to host a conference call today at 8:30 a.m. ET DUBLIN, March 03, 2025 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming...

KOASTAL-2 and -3 studies optimized based on learnings from KOASTAL-1; topline data expected from KOASTAL-3 in the first quarter of 2026 and -2 in the second quarter of 2026 Topline data from NMRA-511 in Alzheimer’s disease agitation expected by the end of 2025 Expect to progress next M4 positive allosteric modulator (PAM) program into the clinic by mid-2025 Strong financial position with $307.6 million in cash, cash equivalents and marketable securities expected to support operations into mid-2026 WATERTOWN, Mass., March 03, 2025 (GLOBE NEWSWIRE) — Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including two clinical-stage programs, today announced financial results for the fourth quarter and full year ended December 31,...

Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to showcase expected best-in-class durability FDA approves Amendment to SOL-1 Special Protocol Agreement (SPA) to include AXPAXLI re-dosing at Weeks 52 and 76 SOL-1 trial Week 36 primary endpoint data now expected in 1Q 2026 due to requirement for masking until Week 52 to allow for re-dosing Inclusion of re-dosing in SOL-1, along with exceptional retention seen to date in the study, paves way for reduction of SOL-R trial size to 555 subjects (previously 825), potentially accelerating registration timelines Additional updates provided on SOL-R non-inferiority margin and rescue criteria Cash balance of $392.1M as of December 31, 2024, expected to fund operations into 2028 and the Company currently...

Fourth quarter and full year 2024 BRIUMVI U.S. net revenue of $103.6 million and $310 million, respectively Target guidance of approximately $540 million in total global revenue for 2025 Conference call to be held today, March 3, 2025, at 8:30 AM ET NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and full year ended December 31, 2024, along with recent company developments. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “2024 was a year of significant outperformance and growth for TG, highlighted by the strong adoption of BRIUMVI for adult patients with relapsing forms of multiple sclerosis, which surpassed our initial expectations. Additionally, we made meaningful progress...

– Completed first quarter as a public company and raised $10.6 mil CAD concurrent with listing – Next-generation Novasight design freeze completed on schedule, usability testing and system validation expected to complete next quarter – U.S. FDA submission on track for Q3 calendar 2025 TORONTO, March 03, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (“Conavi Medical” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, today reported financial results for the fiscal quarter ended December 31, 2024. These unaudited interim results are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. “We made significant...