Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date slated for August 31, 2025Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified; late cycle meeting scheduled for June FDA has indicated intent to convene advisory committee meetingAppointed Dr. Michael Binks as Chief Medical Officer, bringing deep experience ...

Core Insights - Absci Corporation has initiated dosing of participants in the first-in-human study of ABS-101, an anti-TL1A antibody, with interim data expected in the second half of 2025 [1][5] - The company has released non-human primate data for ABS-201, an anti-PRLR antibody, showing extended half-life and high subcutaneous bioavailability, with Phase 1 initiation anticipated in early 2026 [1][5] - Absci's cash, cash equivalents, and short-term investments are sufficient to fund operations into the first half of 2027 [1][6] Internal Pipeline Updates - The first-in-human study of ABS-101 is a randomized, double-blind, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in approximately 40 healthy adult participants [5] - ABS-201 is being developed for androgenetic alopecia, targeting a significant unmet clinical need with a potential patient population of around 80 million in the U.S. [5] - The NHP study for ABS-201 demonstrated a high subcutaneous bioavailability of over 90% and the potential for Q8W-Q12W dosing intervals in humans [5] Financial Results - For Q1 2025, Absci reported revenue of $1.2 million, an increase from $0.9 million in Q1 2024 [7] - Research and development expenses rose to $16.4 million in Q1 2025 from $12.2 million in Q1 2024, driven by advancements in internal programs [8] - The net loss for Q1 2025 was $26.3 million, compared to $22.0 million in Q1 2024 [9] Cash Position - As of March 31, 2025, Absci had cash, cash equivalents, and short-term investments totaling $134.0 million, up from $112.4 million at the end of 2024 [10]

Q1 2025 net revenue of $20.4 million, driven by product net revenue of $17.2 million Completed sale of PRV for gross proceeds of $150 million, positioning balance sheet to drive the Company’s commercial launches and development programs Company to host conference call and webcast today, May 13, 2025, at 4:30 p.m. ET CELEBRATION, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living ...

First quarter 2025 revenue totaled $2.81 million, an increase of 121%, as compared to $1.27 million for the same period the prior year Gross Profit for the quarter was 42.4%, compared to 12.6% in Q1 2024 and 37.2% in Q4 2024 LANGHORNE, Pa., May 13, 2025 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: “NXGL”), a leading provider of ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications, today announced its first quarter 2025 financial results for the ...

Core Insights - Allogene Therapeutics is advancing its allogeneic CAR T product pipeline for cancer and autoimmune diseases, with a focus on pivotal trials and strategic partnerships to enhance patient outcomes [2][3][5] Program Updates - The ALPHA3 trial for cema-cel as a first-line consolidation therapy for large B-cell lymphoma (LBCL) is ongoing, with nearly 50 activated sites across the U.S. and approximately 240 patients being randomized [3][5] - The trial has faced delays in site readiness, shifting the timeline for lymphodepletion regimen selection and futility analysis to the first half of 2026 [4][5] - The RESOLUTION trial for ALLO-329 in autoimmune diseases is set to begin in mid-2025, with proof-of-concept data expected in the first half of 2026 [9] - The TRAVERSE trial for ALLO-316 in renal cell carcinoma (RCC) has completed enrollment, with updated results to be presented at the 2025 ASCO Annual Meeting [10] Financial Results - As of March 31, 2025, the company reported a net loss of $59.7 million, or $0.28 per share, with total operating expenses of $65.2 million [13][20] - Research and development expenses for Q1 2025 were $50.2 million, while general and administrative expenses were $15.0 million [13][20] - The company ended Q1 2025 with $335.5 million in cash, cash equivalents, and investments, extending its cash runway into the second half of 2027 through strategic cost realignment [12][22]

CARLSBAD, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Viasat, Inc. (NASDAQ: VSAT), a global leader in satellite communications, today announced it will release its fourth quarter and fiscal year 2025 financial results on Tuesday, May 20, 2025 after the market closes, via a letter to shareholders posted to the Investor Relations section of its website. The Company will also host a conference call and webcast on Tuesday, May 20, 2025 at 2:30 p.m. Pacific Time / 5:30 p.m. Eastern Time. To participate on the live ...

– Company reports $3.4 million in YCANTH revenue, reflective of increasing demand, following the dispensing of more than 10,000 applicator units in the quarter, the most in company history and a 16.7% growth over Q4’24 – – Late-stage pipeline continues to advance with completion of end-of-Phase 2 meeting with Food and Drug Administration for VP-315, Verrica’s candidate for basal cell carcinoma, and continued advancement towards initiation of global Phase 3 program in common warts (VP-102/YCANTH) with partne ...

REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita’s potential to maintain weight loss after GLP-1 discontinuation in the real world REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN-1 Pivotal Cohort has completed enrollment ahead of schedule; 6-month primary endpoint data anticipated in H2 2026 Rejuva gene therapy platform advancing toward first-in-human studies; first CTA module submis ...

GUILFORD, Conn., May 13, 2025 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced first quarter 2025 financial results and provided a business update. “Our commercial efforts have primarily focused on the hospital business, where we’ve continued to experience longer and more variable sales cycles in the fir ...

Actively screening for the 10,000 participant portion of COVID-19 Phase 2b trial; Dosing expected to begin in second quarter of 2025 Completed enrollment of Phase 1 clinical trial evaluating Company’s second-generation oral norovirus vaccine constructs, with topline data expected in mid-2025 New avian influenza vaccine candidate was 100% protective in a ferret challenge model, compared with 0% survival in placebo-treated animals Jeroen Grasman appointed as Chief Financial Officer effective May 19, 2025 Cash ...