Year: 2025

Face-to-Face Pre-NDA Meeting with the FDA Scheduled for Early December; NDA Submission for D-PLEX₁₀₀ On Track for Early 2026 Advancements in Discussions with Potential U.S. Partners Following Positive Phase 3 Trial Results Company Continues to Advance Towards Commercial Manufacturing Readiness with Successful Completion of IMOH GMP Inspection Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2025. Recent Corporate Highlights:Regulatory Pathway Advancement: The Company continues to make progress in its regulatory...

Transformational Acquisition Sets Stage for Strong Growth Going Forward LOUISVILLE, Ky., Nov. 12, 2025 (GLOBE NEWSWIRE) — Creative Realities, Inc. (“Creative Realities,” “CRI,” or the “Company”) (NASDAQ: CREX), a leading provider of digital signage, media and AdTech solutions, today announced its financial results for the fiscal third quarter ended September 30, 2025. Highlights:Third quarter revenue of $10.5 million versus $14.4 million in the prior-year period Gross profit of $4.8 million for the three months ended September 30, 2025 versus $6.6 million in the third quarter of fiscal 2024 Net loss of $7.8 million for the third quarter of 2025 versus net income of $0.1 million for the prior period Adjusted EBITDA* of $0.8 million for the third quarter of 2025 versus $2.3 million in the prior-year period Annual recurring revenue...

Business development: Secures royalty economic interests in two early stage partnered assets through XOMA Royalty’s announced expected acquisition of LAVA Therapeutics. Company acquisitions: •Completed XOMA Royalty’s acquisitions of Turnstone Biologics and HilleVax; • announced acquisitions of LAVA Therapeutics and Mural Oncology; • acted as structuring agent for XenoTherapeutics’ acquisition of ESSA Pharma. Key Pipeline advancements: • Zevra Therapeutics submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking marketing approval for arimoclomol as a treatment for Niemann-Pick Type C; • Rezolute Bio reconfirmed its expectations to announce topline data in December from its Phase 3 ersodetug trial in patients with congenital hyperinsulinism (HI) and announced alignment with FDA on streamlined...

‒ Q3 2025 Net Revenue of $104.3 million; Pro Forma Net Revenue of $130.8 million ‒ ‒ Q3 2025 Net Income of $108.6 million; Adjusted EBITDA of $71.9 million ‒ ‒ FY 2025 Pro Forma Net Revenue Guidance Raised to a Range of $390 to $410 million ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ BERKELEY HEIGHTS, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the third quarter ended September 30, 2025 and provided an update on its business. Recent Corporate Highlights:CorMedix announces $104.3 million of net revenue and $130.8 million of pro forma net revenue(1) for the third quarter of 2025, largely driven by higher than...

Announces CEO Transition SHOEMAKERSVILLE, Pa., Nov. 12, 2025 (GLOBE NEWSWIRE) — Hydrofarm Holdings Group, Inc. (“Hydrofarm” or the “Company”) (Nasdaq: HYFM), a leading independent manufacturer and distributor of branded hydroponics equipment and supplies for controlled environment agriculture, today announced financial results for its third quarter ended September 30, 2025. Comparison of Third Quarter vs. Prior Year Period:Net sales decreased to $29.4 million compared to $44.0 million. Gross Profit Margin decreased to 11.6% of net sales compared to 19.4%. Adjusted Gross Profit Margin(1) decreased to 18.8% of net sales compared to 24.3%. SG&A expense and Adjusted SG&A(1) expense decreased by 6.8% and 7.4%, respectively. Net loss increased to $16.4 million compared to $13.1 million. Adjusted EBITDA(1) of $(4.4) million...

Meg Alexander appointed Chief Executive Officer effective January 1, 2026; Dr. Jeremy M. Levin to transition to Executive Chair of the Board of Directors Next-generation GABA-aminotransferase (GABA-AT) inhibitor, OV329, demonstrated strong inhibitory activity and a potential best-in-category safety profile in a Phase 1 study, supporting advancement into planned Phase 2 patient studies OV329 Phase 1 results selected for late-breaking poster presentation at the 2025 American Epilepsy Society (AES) annual meeting Ovid’s first-in-class KCC2 direct activator portfolio is progressing on-track with first-in-human data for OV350 intravenous (IV) expected in Q4 2025 and the first-ever oral KCC2 direct activator, OV4071, anticipated to enter the clinic in Q2 2026 Completed private placement of up to $175 million in gross proceeds, including initial...

Over 100 patients treated with AlloNK across autoimmune and oncology indications Refractory rheumatoid arthritis (RA) prioritized as lead indication following FDA Fast Track Designation for AlloNK®, the first known therapy within the emerging deep B-cell depletion category to receive this designation in RA Company to host webcast later this morning to discuss initial safety and translational data from clinical trials evaluating AlloNK in combination with anti-CD20 monoclonal antibodies across autoimmune diseases; presentation to also include outpatient feasibility and tolerability observations Initial clinical response data in refractory RA expected in the first half of 2026, with FDA discussions planned to align on potential pivotal trial design in refractory RA Cash runway into Q2 2027, with cash, cash equivalents, and investments of...

AtaiBeckley solidifies position as a global leader in transformative mental health therapies with a short psychedelic durationBPL-003 (mebufotenin benzoate nasal spray) granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for treatment-resistant depression (TRD) Reported positive topline data from the Phase 2b open-label extension (OLE) study of BPL-003 showing the potential added and sustained antidepressant effects following a second dose in patients with TRD Reported positive open-label Phase 2a data demonstrating improved outcomes with a two-dose induction regimen of BPL-003 in patients with TRD An End-of-Phase 2 meeting is scheduled with the FDA for BPL-003, anticipate providing guidance on the Phase 3 clinical program in the first quarter of 2026 Completed enrollment in the exploratory Phase...

CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $524 million EC and U.S. FDA label updates for CARVYKTI® to include overall survival benefit versus standard of care Over 9,000 patients treated to date Initiated CARVYKTI® commercial production at Tech Lane facility in Belgium Cash and cash equivalents, and time deposits of approximately $1.0 billion, as of September 30, 2025SOMERSET, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its third quarter 2025 unaudited financial results and key corporate highlights. “CARVYKTI continues to deliver strong sequential revenue growth, driven by sustained demand and recognition of its unprecedented survival benefit, now supported by five-year progression free...

Company reports Q3 2025 AUCATZYL® net product revenue of $21.1 million and deferred revenue of $7.6 million; 60 authorized treatment centers achieved ahead of target Clinical execution and data generation to support market growth and expansion continues; data in severe refractory systemic lupus erythematosus (srSLE) show no ICANS or high-grade CRS, demonstrate achievement of definition of remission in SLE (DORIS) in 83% (n=5/6) of patients and complete renal response (CRR) in 50% (n=3/6) of patients Leadership team bolstered to support next phase of growth and optimization of business operations Conference call to be held today at 8:30 am EST / 1:30 pm GMT; conference call participants should pre-register using the link at the bottom of this press releaseLONDON and GAITHERSBURG, Md., Nov. 12, 2025 (GLOBE NEWSWIRE) — Autolus...