Day: February 27, 2025

Targeting NDA submission for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025 through accelerated approval pathway; on track to initiate APOLLO post-marketing confirmatory trial by mid-2025 Positive update from Phase 1b trial of DISC-0974 in patients with anemia of myelofibrosis (MF) presented at ASH 2024; initial data from ongoing Phase 2 expected in H2 2025 Positive data from initial cohorts of ongoing Phase 1b study of DISC-0974 in patients with anemia of non-dialysis-dependent chronic kidney disease (NDD-CKD) presented at ASN Kidney Week 2024; initial data from multiple dose portion of this study expected in H2 2025 Presented first-in-human SAD/MAD data from Phase 1 trial of DISC-3405 demonstrating proof-of-mechanism; a Phase 2 study in polycythemia vera (PV) expected to initiate in H1 2025 Strong financial position ending...

Full-Year Total Revenue Growth of 20% to $237.2 Million, with MACI Revenue Growth of 20% and Burn Care Revenue Growth of 22% Full-Year Adjusted EBITDA Growth of 58% to $53.4 Million Record Fourth Quarter Gross Margin of 78%, Adjusted EBITDA Margin of 40%, and Net Income of $19.8 Million Mid-Term Profitability Targets Increased to Gross Margin in the High-70% Range and Adjusted EBITDA Margin in the High-30% Range Strong MACI Arthro Key Launch Indicators, with Approximately 250 MACI Arthro Surgeons Trained to Date 2025 Financial Guidance with Total Revenue Growth of 20% to 23% Reaffirmed Conference Call Today at 8:30am Eastern Time CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today reported financial results...

2024 net revenues increased 4.9% to $1.10 billion, compared to 2023; or 5.4% on a constant currency basis 2024 net income of $44 million or $0.16 per diluted share, compared to 2023 2024 Adjusted EBITDA(1) increased 3.9% to $549 million, compared to 2023; or 4.6% on a constant currency basis 2024 Adjusted EPS(1) of $0.70, a decrease of $0.02 per diluted share, compared to 2023 Full-year 2025 outlook of 4.0% – 6.0% net revenues growth and 4.5% – 6.5% Adjusted EBITDA growth, both on a constant currency basisCLEVELAND, Feb. 27, 2025 (GLOBE NEWSWIRE) — Sotera Health Company (“Sotera Health” or the “Company”) (Nasdaq: SHC), a leading global provider of mission-critical end-to-end sterilization solutions, lab testing and advisory services for the healthcare industry, today announced financial results for the fourth-quarter...

CHICAGO, Feb. 27, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three and twelve months ended December 31, 2024. Fourth Quarter HighlightsAchieved net revenues of $389.1 million, a substantial 41% increase compared to the prior year period.Submissions grew to 481,445, representing a 67% increase compared to the prior year period.Net income of $58.0 million, a substantial improvement of $60.3 million compared to the prior year period.Adjusted EBITDA1 surged to $117.8 million, a significant 107% increase compared to the prior year period.Compared to the prior year period, Direct Operating Cost per Submission2 improved 27%, to an industry leading $501.The...

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:...