Month: February 2025

Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025; CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S. Zipalertinib pivotal Phase 2b study met primary endpoint; full results mid-year 2025 and NDA submission planned H2 2025, pending regulatory discussions Cash and investments of $606.9 million as of December 31, 2024, continues to provide runway into 2028 CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31,...

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for completion of last patient visit in the open-label extension in Q1 2025 Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UK Full response to the IND hold on track for submission in mid-2025 Cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024 Net cash proceeds of an additional $139.8 million from public offering received in February 2025DUBLIN, Feb. 27, 2025 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the year ended December...

31 ALLY Robotic Cataract Laser Systems™ placed in Q4 2024, representing an 86% increase in ALLY placements in full year 2024 over 2023; Company’s total installed systems increased to approximately 385 as of December 31, 2024, representing a 26% increase over 2023 Fourth quarter 2024 revenue increased 38% over fourth quarter 2023; Full-year revenue increased 27% over 2023 Recurring revenue exceeds $40 million for the full year; increased 23% over 2023 ORLANDO, Fla., Feb. 27, 2025 (GLOBE NEWSWIRE) — LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or the “Company), a global medical technology company focused on advanced robotic laser solutions for the treatment of cataracts, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided an update on key operational initiatives. “The fourth...

Achieves fourth quarter key guidance metrics and full-year 2024 capital return commitment Reaffirms 2024/2025 two-year Adjusted Free Cash Flow guidance TYSONS, Va., Feb. 27, 2025 (GLOBE NEWSWIRE) — TEGNA Inc. (NYSE: TGNA) today announced financial results for the fourth quarter and full-year 2024 ended December 31, 2024. “As TEGNA enters its next chapter, we are reinventing how we create and monetize content to capture the full opportunity in both linear TV and digital,” said Mike Steib, CEO. “With rapid advancements in technology and a shifting regulatory landscape, we see tremendous potential in broadcasting. Backed by industry-leading brands, top talent, and a strong balance sheet, we are well-positioned to seize transformative moments in media and build a sustainable future for local news.” FOURTH QUARTER FINANCIAL HIGHLIGHTS:...

– Received FDA Fast Track Designation for DYNE-101 in DM1 – – Full enrollment of Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 Planned for Mid-2025 to Support Submission for U.S. Accelerated Approval – – Full Enrollment of Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD Planned for Q1 2025 to Support Submission for U.S. Accelerated Approval – WALTHAM, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the fourth quarter and full year 2024 and recent business highlights. “Our most recent clinical data for DYNE-101 from the ACHIEVE trial in...

Dosed first patient in global Phase 3 HAELO study evaluating NTLA-2002 for hereditary angioedema (HAE) Expect to complete enrollment of the HAELO study in the second half of 2025 and submit a Biologics License Application in the second half of 2026 to support plans for U.S. launch in 2027 Enrollment in the pivotal Phase 3 MAGNITUDE trial of nexiguran ziclumeran (nex-z) in patients with transthyretin amyloidosis (ATTR) with cardiomyopathy continues to track ahead of projections; more than 550 total patients expected to be enrolled by year end Actively screening for the Phase 3 MAGNITUDE-2 trial for nex-z in hereditary ATTR amyloidosis with polyneuropathy; on track to dose first patient in 1Q25 Ended 2024 with approximately $862 million in cash, cash equivalents and marketable securitiesCAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE)...

Net revenue in Q4 2024 increased by 27% year-over-year to $30.3 million; Net revenue in FY 2024 increased by 35% year-over-year to $117.6 million Spinach® Ends 2024 as the Number One Cannabis Brand in Canada1 PEACE NATURALS® Ends 2024 as the Number One Cannabis Brand in Israel 2 Industry leading balance sheet with $859 million in cash and cash equivalents TORONTO, Feb. 27, 2025 (GLOBE NEWSWIRE) — Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos” or the “Company”), today announced its 2024 fourth quarter and full-year business results. “We set ambitious goals to deliver robust growth, improve margins, and achieve operational excellence. Today, I am proud to say that Cronos has not only met but exceeded these objectives, as evidenced by our strong 2024 results. Our unwavering commitment to innovation, quality, and disciplined...

Fiscal Year 2024 Net Revenue of $606.3 million, up 28.5% versus Fiscal Year 2023FY 2025 Outlook of $740 million in Net Revenue and $100 million in Adjusted EBITDAOn Track to Reach $1 Billion Net Revenue Target in 2027 AUSTIN, Texas, Feb. 27, 2025 (GLOBE NEWSWIRE) — Vital Farms (Nasdaq: VITL), a Certified B Corporation that offers a range of ethically produced foods nationwide, today reported financial results for its fourth quarter and fiscal year ended December 29, 2024. Financial highlights for the fourth quarter ended December 29, 2024 (13 weeks), compared to the fourth quarter ended December 31, 2023 (14 weeks), include:Net Revenue increased 22.2% to $166.0 million on a reported basis, compared to $135.8 million, and increased 30% on a like-for-like basis when accounting for one fewer week in the fourth quarter of 2024 (13...