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Press releases published on May 9, 2025

Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine

Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine

Results support potential benefit of efruxifermin (EFX) to elicit fibrosis improvement in patients with compensated cirrhosis (F4 fibrosis) due to MASH 96-week data from SYMMETRY trial presented at EASL Congress 2025 SOUTH SAN FRANCISCO, Calif., May 09, …

Anika Reports First Quarter 2025 Financial Results

Anika Reports First Quarter 2025 Financial Results

First Quarter 2025 Commercial Channel revenue up 18% Integrity™ Implant System continues sequential growth and is on pace to more than double procedures in 2025 Key regulatory and clinical milestones achieved for Hyalofast®, Cingal®, and Integrity Updating …

uniQure Announces First Quarter 2025 Financial Results and Highlights of Recent Company Progress

uniQure Announces First Quarter 2025 Financial Results and Highlights of Recent Company Progress

~ AMT-130 granted Breakthrough Therapy designation by FDA ~ ~ Initial safety data from third cohort of Phase I/II study show AMT-130 continues to be generally well-tolerated, with no treatment-related serious adverse events ~ ~ Held Type B FDA meetings in …

Clearside Biomedical Data Featured in Six Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting

Clearside Biomedical Data Featured in Six Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting

ALPHARETTA, Ga., May 09, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS …

Kymera Therapeutics Expands Industry Leading Immunology Pipeline with New First-in-Class, Oral IRF5 Degrader Program with Potential to Address Multiple Immuno-Inflammatory Diseases

Kymera Therapeutics Expands Industry Leading Immunology Pipeline with New First-in-Class, Oral IRF5 Degrader Program with Potential to Address Multiple Immuno-Inflammatory Diseases

IRF5 program strengthens Kymera’s oral immunology pipeline with a complementary mechanism to expand into rheumatic and other autoimmune diseases with a potential best-in-class oral drug IRF5, a historically undrugged transcription factor and master …

Rapid Micro Biosystems Reports First Quarter 2025 Financial Results

Rapid Micro Biosystems Reports First Quarter 2025 Financial Results

Reports first quarter 2025 total revenue of $7.2 million, representing 28% growth compared to the first quarter of 2024. Reports record quarterly service revenue led by strong validation activity. Reports first quarter gross margin of 6%, representing a 33 …

Aclaris Therapeutics to Participate in the HC Wainwright “HCW@Home” Series

Aclaris Therapeutics to Participate in the HC Wainwright “HCW@Home” Series

WAYNE, Pa., May 09, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that Aclaris’ Chief …

OXB to Present at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT)

OXB to Present at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT)

OXB to Present at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) Oxford, UK – 9 May 2025: OXB (LSE: OXB), a global quality and innovation-led cell and gene therapy CDMO, today announces its participation in the 28th Annual …

Agios to Present at the 2025 RBC Capital Markets Global Healthcare Conference on May 21, 2025

Agios to Present at the 2025 RBC Capital Markets Global Healthcare Conference on May 21, 2025

CAMBRIDGE, Mass., May 09, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that its management team is scheduled to present at the …

Kymera Therapeutics Announces First Quarter 2025 Financial Results and Provides a Business Update

Kymera Therapeutics Announces First Quarter 2025 Financial Results and Provides a Business Update

Completed KT-621 (STAT6) SAD/MAD Phase 1 healthy volunteer trial with data to be reported in June 2025 First patient dosed in KT-621 (STAT6) BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) with data expected in 4Q25 KT-579 (IRF5) new …

Boundless Bio Reports First Quarter 2025 Financial Results and Business Highlights

Boundless Bio Reports First Quarter 2025 Financial Results and Business Highlights

Initial proof-of-concept data from the ongoing BBI-355 Phase 1/2 POTENTIATE trial in patients with oncogene-amplified cancers anticipated in the second half of 2025 Novel Kinesin program on track for mid-2025 development candidate nomination and IND filing …

Real-World Study Confirms Long-Term Performance of DecisionDx®-UM for Metastatic Risk Stratification in Uveal Melanoma and Utility of PRAME Biomarker for Refining Risk When Considered with the DecisionDx-UM Class Result

Real-World Study Confirms Long-Term Performance of DecisionDx®-UM for Metastatic Risk Stratification in Uveal Melanoma and Utility of PRAME Biomarker for Refining Risk When Considered with the DecisionDx-UM Class Result

FRIENDSWOOD, Texas, May 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from the first independent validation of the recently …

Vireo Growth Inc. Announces First Quarter 2025 Results

Vireo Growth Inc. Announces First Quarter 2025 Results

– Q1 revenue of $24.5 million increased 1.9% year-over-year, in line with expectations for Vireo’s established markets – – Merger Transactions expected to begin closing in Q2 and further strengthen profitability profile – MINNEAPOLIS, May 09, 2025 (GLOBE …

InspireMD Reports First Quarter 2025 Financial Results

InspireMD Reports First Quarter 2025 Financial Results

MIAMI, May 09, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the first …

Tiziana Life Sciences Announces Significant Reduction in Microglia Activation in PET Scan of Moderate Alzheimer's Patient Treated with Intranasal Foralumab

Tiziana Life Sciences Announces Significant Reduction in Microglia Activation in PET Scan of Moderate Alzheimer's Patient Treated with Intranasal Foralumab

NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a …

ANI Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Raises 2025 Guidance

ANI Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Raises 2025 Guidance

Generated record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4% Total Rare Disease quarterly net revenues of $69.0 million, which includes: Purified Cortrophin® Gel net revenues of $52.9 million, an increase of 43.1% …

Akero Therapeutics Presents Week 96 Results from Phase 2b SYMMETRY Clinical Trial of Efruxifermin in Patients with Compensated Cirrhosis Caused by MASH Showing Fibrosis Improvement without Worsening of MASH at the EASL Congress 2025

Akero Therapeutics Presents Week 96 Results from Phase 2b SYMMETRY Clinical Trial of Efruxifermin in Patients with Compensated Cirrhosis Caused by MASH Showing Fibrosis Improvement without Worsening of MASH at the EASL Congress 2025

SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, presented …

Artax Biopharma presents Phase 2a results for oral Nck modulator AX-158 in late-breaking session at the Society for Investigative Dermatology 2025 Annual Meeting

Artax Biopharma presents Phase 2a results for oral Nck modulator AX-158 in late-breaking session at the Society for Investigative Dermatology 2025 Annual Meeting

First small molecule to modulate the fundamental mechanism of T cell activation underlying autoimmune pathology Statistically significant improvements in T cell and psoriasis-related biomarkers in line with PASI improvements in Phase 2a in patients with …

Rectify Pharma Presents Translational Data for Novel Positive Functional Modulator Demonstrating Improved Biliary and Liver Health at EASL 2025

Rectify Pharma Presents Translational Data for Novel Positive Functional Modulator Demonstrating Improved Biliary and Liver Health at EASL 2025

Oral dual-targeted ABCB4/BSEP positive functional modulator (PFM) improved cholestatic and cholangitis markers in orthogonal models of hepatobiliary disease Data reinforce the potential of this differentiated mechanism of action (MOA) to address the core …

Sanuwave Announces Q1 FY2025 Financial Results

Sanuwave Announces Q1 FY2025 Financial Results

Q1 2025 revenues were $9.3 million, up 61% from $5.8 million in Q1 2024. This represents the highest Q1 quarterly revenues in Company history. Q1 2025 gross margin was 79.0%, versus 72.6% in Q1 2024. GAAP Operating Income was $1.0 million for Q1 2025, an …

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