Day: March 19, 2025

New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 Upon FDA approval, commercial launch activities to commence immediately with LNZ100 product availability anticipated in the fourth quarter of 2025 Cash, cash equivalents and marketable securities of $209.1 million as of December 31, 2024; cash runway anticipated to extend to post-launch positive operating cash flow Company to host a conference call today at 4:30 p.m. EST SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) — LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today reported financial results for...

– Presented Phase 2 STRIDE OLE 52-week psoriasis data at AAD 2025 demonstrating next-generation oral TYK2 inhibitor ESK-001 treatment led to robust long-term clinical responses and was well tolerated; Phase 3 ONWARD program data readout now expected 1Q 2026 – – Presented Phase 1 clinical data at ACTRIMS 2025 demonstrating first-in-class oral TYK2 inhibitor A-005 has ability to cross blood-brain barrier and was well tolerated; Phase 2 in MS to begin 2H 2025 – – Announced merger agreement with ACELYRIN to create combined company with differentiated late-stage portfolio of therapies and strong balance sheet; expected to close 2Q 2025 – SOUTH SAN FRANCISCO, Calif., March 19, 2025 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize...

Announced the U.S. FDA has accepted our Biologics License Application (BLA) seeking full approval of deramiocel for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy BLA granted priority review with a Prescription Drug User Fee Act (PDUFA) target action date set for August 31, 2025 Reported positive data from HOPE-2 open label extension (OLE) trial at 2025 MDA Conference showing preservation of skeletal muscle function over 3 years resulting in 52% slowing of disease Received $10 million milestone payment from Nippon Shinyaku; cash balance of approximately $152 million at year-end 2024 expected to support current planned operations into 2027 Capricor to host conference call and webcast today at 4:30 p.m. ETSAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company...

PHOENIX, March 19, 2025 (GLOBE NEWSWIRE) — TILT Holdings Inc. (“TILT” or the “Company”) (Cboe CA: TILT) (OTCQB: TLLTF), a global provider of cannabis business solutions including inhalation technologies, cultivation, manufacturing, processing, brand development and retail, is reporting its financial and operating results for the three and twelve months ended December 31, 2024. All financial information is reported in U.S. dollars and prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) unless otherwise indicated. “2024 was a transformative year for TILT, as we took deliberate steps to streamline our business and sharpen our focus on Jupiter,” said TILT’s Chief Executive Officer, Tim Conder. “With the divestiture of our Massachusetts retail assets now underway, and a path toward exiting our remaining...

Preclinical pipeline re-prioritization to focus on four potentially transformative programs to advance toward clinic, led by CNTY-308 in B-cell mediated autoimmune diseases and malignanciesNew concentrated clinical focus for CNTY-101 based on unique profile with transformational potential in autoimmune disease; data anticipated in 2025Cash runway estimate extended into fourth quarter of 2026PHILADELPHIA, March 19, 2025 (GLOBE NEWSWIRE) — Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in autoimmune disease and cancer, today reported financial results and business highlights for the full year 2024. “Today we announced a pipeline re-prioritization to streamline resources on advancing candidates that are potentially...

scPharmaceuticals generated fourth quarter 2024 net FUROSCIX® revenue of $12.2 million, and full year 2024 revenue of $36.3 million Cash and cash equivalents of $75.7 million as of December 31, 2024 U.S. Food and Drug Administration (FDA) approved the FUROSCIX expanded label indication to include the treatment of edema due to fluid overload in patients with chronic kidney disease scPharmaceuticals to host investor conference call and webcast today, Wednesday, March 19th, at 4:30pm ET BURLINGTON, Mass., March 19, 2025 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. Business...

NASHUA, N.H., March 19, 2025 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered breast health solutions, today reported its financial and operating results for the fourth quarter and full year ended December 31, 2024.  Fourth Quarter 2024 Highlights (Year-over-Year Performance):Total ARR (Annual Recurring Revenue) was $9.8 million, up 11% year over year Total revenues increased 14% to $5.4 million Gross Profit Margin of 86% 382 Total deals closed in 2024, 42 of which were ProFound Cloud ProFound Detection V4.0 granted FDA clearance Expanded global reach with new distribution agreements in South Africa, Portugal, and the UKDana Brown, President and CEO of iCAD commented,...

– Total Revenues increased 30.8% for the quarter over the prior year period to $51.7 million –– Total Written Premium increased 20.0% for the quarter over the prior year period to $361.4 million –– Organic Revenue Growth Rate* of 20.5% for the quarter –– Diluted Earnings Per Share and Adjusted Diluted Earnings Per Share* of $0.11 and $0.19 for the quarter, respectively –– Adjusted EBITDA* increased 91.7% for the quarter over the prior year period to $13.8 million – THE WOODLANDS, Texas, March 19, 2025 (GLOBE NEWSWIRE) — TWFG, Inc. (“TWFG”, the “Company” or “we”) (NASDAQ: TWFG), a high-growth insurance distribution company, today announced results for the fourth quarter and the full year ended December 31, 2024. Fourth Quarter 2024 HighlightsTotal revenues for the quarter increased 30.8% to $51.7 million, compared to $39.6 million...

Net Sales Increase of 7.8% for Q4 and 10.4% for Fiscal 2024 ex the 53rd week GAAP Diluted EPS of $3.39 for Q4 and $4.60 for Fiscal 2024 Adjusted Diluted EPS of $3.48 for Q4 and $5.04 for Fiscal 2024 PHILADELPHIA, PA, March 19, 2025 (GLOBE NEWSWIRE) — Five Below, Inc. (NASDAQ: FIVE) today announced financial results for the fourth quarter and full year of fiscal 2024 ended February 1, 2025. The fourth quarter and full year of fiscal 2023 ended February 3, 2024 contained one additional week (“53rd week”), which represented $48.1 million in net sales and approximately $0.15 in diluted earnings per share. For the fourth quarter ended February 1, 2025:Net sales increased by 4.0% to $1.39 billion from $1.34 billion in the fourth quarter of fiscal 2023 or an increase of 7.8% when excluding the impact of the 53rd week in...