Month: May 2025

Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026 Attack dataset continues to accumulate in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, strengthening confidence in clinical timelines TQT study waivers received from FDA for both deucrictibant extended-release formulation and deucrictibant immediate-release formulation Pharvaris Management to host R&D call on June 4 at 8:00 a.m. ET (14.00 CET)ZUG, Switzerland, May 13, 2025 (GLOBE NEWSWIRE) — Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired...

– Announced Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 (tambiciclib) in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) Demonstrating 8.9 mOS in AML-MRC and 8.8 mOS in All r/r to Venetoclax-Based Regimens Patients – – SLS009 Shows Promising Efficacy in Pediatric Acute Lymphoblastic Leukemia (ALL) Xenograft Models – – Final Analysis of Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in AML Anticipated in 2025 – – $28.4 million in Cash and Cash Equivalents as of March 31, 2025; Additional $4.0 million Proceeds received in April 2025 through Warrant Exercises – NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range...

SEOUL, South Korea, May 13, 2025 (GLOBE NEWSWIRE) — DoubleDown Interactive Co., Ltd. (NASDAQ: DDI) (“DoubleDown” or the “Company”), a leading developer and publisher of digital games on mobile and web-based platforms, today announced unaudited financial results for the first quarter ended March 31, 2025. Beginning with the fourth quarter of 2024, the Company is reporting its financial results in accordance with International Financial Reporting Standards (“IFRS”). As such, the financial results for the first quarter 2025, as well as the comparable period for 2024, reflect IFRS. The Company previously reported its financial results in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). First Quarter 2025 vs. First Quarter 2024 Summary:         Revenue was $83.5 million in the first...

Early entry of RAS-targeting franchise into clinic enabled by strong execution Initial Phase 1 monotherapy data for pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 expected in 2026 Robust balance sheet with cash, cash equivalents, and marketable securities of $411 million as of March 31, 2025 with cash runway guidance extended to H2 2028 SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) — Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today provided business updates and reported financial results for the fiscal quarter ended March 31, 2025. “We are pleased with the pace and execution of our RAS-targeting franchise and its early entry into the clinic following the recent...

sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. “The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute....

Interim analysis focused on disease-free survival (“DFS”) in randomized Phase 2 AMPLIFY-7P clinical trial expected in Q3 2025 Company has alignment with U.S. Food and Drug Administration (“FDA”) on key design elements of planned Phase 3 study of ELI-002 Current cash position expected to support operations beyond anticipated AMPLIFY-7P Phase 2 interim analysis BOSTON, May 13, 2025 (GLOBE NEWSWIRE) — Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the first quarter ended March 31, 2025, and provided recent corporate and clinical updates. “In the first quarter, we made continued progress toward our upcoming Phase 2 AMPLIFY-7P event-driven interim analysis, expected...

Revenues Increased 12% to $28.3 Million, Including the Renewal of Two Delayed Contracts with the New York City Police Department Company Reaffirms FY 2025 Revenue Guidance Range of $111.0 Million to $113.0 Million, Representing 10% Year-Over-Year Growth at the Midpoint, and Reduces FY 2025 Adjusted EBITDA Margin Guidance Range from 21% to 23% to 20% to 22% Company Reaffirms Expectation for ARR1 to Increase from $95.6 Million at the Beginning of 2025 to Approximately $110.0 Million at the Beginning of 2026 FREMONT, Calif., May 13, 2025 (GLOBE NEWSWIRE) — SoundThinking, Inc. (Nasdaq: SSTI), a leading public safety technology company, today reported financial results for the first quarter ended March 31, 2025. First Quarter 2025 Financial and Operational HighlightsRevenues increased 12% to $28.3 million, compared to $25.4 million...