Year: 2023

– Interim data from 20 mg/kg cohort in IGNITE Phase 2 clinical trial of VGL101 in ALSP on track for this quarter – – First participant dosed in Phase 1 study of VG-3927, the first and only small molecule TREM2 agonist in clinical development for potential treatment of Alzheimer’s disease – – Announced VGL101 complete Phase 1 data analysis and Phase 2 IGNITE trial design at 2023 ANA Annual Meeting – WATERTOWN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) — Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2023, and provided an update on recent progress. “We continue to make significant progress in advancing our novel TREM2 agonist candidates...

3Q 2023 ZYNLONTA®1 net sales of $14.3 million reflect disruption following restructuring of commercial organization, increased competition and higher gross-to-net deductions Operating expenses decreased 23%2 year-over-year due to portfolio prioritization and operational efficiencies; Expected cash runway into mid-2025 Prioritized pipeline progressing with initial data readouts from LOTIS-7 and studies of ADCT-601 targeting AXL and ADCT-901 targeting KAAG1 expected in 1H 2024 Company to host conference call today at 8:30 a.m. EST LAUSANNE, Switzerland, Nov. 07, 2023 (GLOBE NEWSWIRE) — ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the third quarter 2023 and provided business updates. “During the third quarter, we fully rolled out the new commercial strategy, advanced our prioritized pipeline programs and continued...

Immunocore Reports Third Quarter 2023 Financial Results and Provides Business Update KIMMTRAK net revenues of £49.7 million ($60.7 million) in Q3 2023, maintaining strong momentum in major markets with continued reimbursement expansion globally New Phase 3 clinical trial of KIMMTRAK adjuvant therapy for uveal (or ocular) melanoma (ATOM) in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) Long-term survival for KIMMTRAK in metastatic uveal melanoma demonstrated – published in the New England Journal of Medicine and presented as a mini oral at ESMO Congress 2023 IMC-F106C (PRAME-A02) progressing; data in multiple tumors expected in 1H 2024 and first patient randomized in Phase 3 cutaneous melanoma trial (PRISM-MEL301) in 1Q 2024 Cash and cash equivalents increased to £364 million ($445 million) as...

Arimoclomol NDA resubmission remains on track for end of year filing Proposed acquisition of Acer Therapeutics on track to close Q4 2023 and will diversify Zevra’s revenue with FDA-approved OLPRUVA® for urea cycle disorders (UCDs) Net revenue of $2.9M for Q3 2023 Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026 Conference call and live audio webcast scheduled for today, Nov 7, 2023, 8:00 a.m. ET  CELEBRATION, Fla., Nov. 07, 2023 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended September 30, 2023.  “This is a pivotal time for Zevra as we advance our pipeline programs toward multiple potential value inflection...

Company Delivers First Quarter Expectations, Reaffirms Fiscal 2024 Outlook HOBOKEN, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) — Hain Celestial Group (Nasdaq: HAIN) (“Hain”, “Hain Celestial” or the “Company”), a leading manufacturer of better-for-you brands to inspire healthier living, today reported financial results for the fiscal first quarter ended September 30, 2023. “During the quarter, we unveiled Hain Reimagined, our bold strategy to transform the business and deliver sustainable profitable growth,” said Wendy Davidson, President and Chief Executive Officer. “Several initiatives underlying Hain Reimagined showed signs of progress in the fiscal first quarter, contributing to net sales that were in line with our expectations and adjusted EBITDA that beat our guidance. Davidson continued, “We are realizing early progress in Garden...

Record profitability driven by continued growth in infrastructure-related businessesSales of $949 million, up 13% 17% organic sales growth in infrastructure-related businesses EBITDA(1) of $193 million, or a margin(1) of 20.3%, up from 14.1% in Q3 2022 Net income of $110 million, or $1.91 per share, up 79% from EPS in Q3 2022 Acquired utility pole manufacturing business of Baldwin Pole and Piling (“Baldwin”) Normal Course Issuer Bid announced for 2023-2024MONTREAL, Nov. 07, 2023 (GLOBE NEWSWIRE) — Stella-Jones Inc. (TSX: SJ) (“Stella-Jones” or the “Company”) today announced financial results for its third quarter ended September 30, 2023. “In Q3, Stella-Jones made notable progress in its growth trajectory, delivering not only another quarter of strong sales growth, but record increase in profitability,” said Eric...

ALACHUA, Fla. and TAMPA, Fla., Nov. 07, 2023 (GLOBE NEWSWIRE) — Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today reported financial results and business highlights for the third quarter ended September 30, 2023. Third Quarter Financial ResultsRevenue was $41.3 million during the third quarter, an increase of approximately 12% over the third quarter of 2022. The Company estimates that revenues from emergent trauma procedures represented approximately half of total revenues during the third quarter and grew in the mid-single digit range versus the third quarter of 2022. The Company estimates that revenues from scheduled non-trauma procedures represented approximately half of total revenues during the third quarter and grew approximately 20%...

― Completed enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); expect to report topline data in the fourth quarter of 2024 ― ― U.S. Food and Drug Administration (FDA) lifted clinical hold for pociredir (formerly FTX-6058) in sickle cell disease (SCD); trial reinitiation underway ― ― Cash runway extended into 2026 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2023 and provided a business update. “In the third quarter of 2023, we completed enrollment...