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Press releases published on April 28, 2025

Krystal Biotech Announces European Commission Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa

Krystal Biotech Announces European Commission Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa

VYJUVEK approved for the treatment of DEB from birth in Europe Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional PITTSBURGH, April 28, 2025 ( …

ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process

ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process

Approval Supports Revenue Growth and Margin Expansion Opportunity, and Substantially Increases Peak Production Output Capacity First U.S. Regulatory Approval of Innovative IG Yield Enhancement Process Highlights ADMA’s Uniquely Efficient Internal R…

Senti Bio’s SENTI-202, a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, Demonstrates Positive Preliminary Clinical Results in the Treatment of Patients with Relapsed/Refractory AML

Senti Bio’s SENTI-202, a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, Demonstrates Positive Preliminary Clinical Results in the Treatment of Patients with Relapsed/Refractory AML

Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Dose Finding completed with no dose limiting toxicities and preliminary recommended Phase 2 dose (RP2D) identified 5 of 7 best overall response evaluable patients …

Auron Presents Preclinical Data Highlighting the Activity of AUTX-703 in Prostate Cancer at 2025 AACR Annual Meeting

Auron Presents Preclinical Data Highlighting the Activity of AUTX-703 in Prostate Cancer at 2025 AACR Annual Meeting

NEWTON, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Auron Therapeutics, a clinical-stage biotechnology company targeting cell-state plasticity to improve patient outcomes in oncology and inflammatory disease, today announced preclinical data in prostate …

Ascentage Pharma Presents Results from Five Preclinical Studies at 2025 American Association of Cancer Research (AACR) Annual Meeting, Highlighting Strong Synergistic Effects of Olverembatinib Combined with Lisaftoclax

Ascentage Pharma Presents Results from Five Preclinical Studies at 2025 American Association of Cancer Research (AACR) Annual Meeting, Highlighting Strong Synergistic Effects of Olverembatinib Combined with Lisaftoclax

ROCKVILLE, Md. and SUZHOU, China, April 28, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs …

Ampersand Biomedicines Presents Preclinical Data on AMP-410, a Novel Anti-VEGF/4-1BB Bifunctional AND-Body™ Therapeutic, at AACR 2025

Ampersand Biomedicines Presents Preclinical Data on AMP-410, a Novel Anti-VEGF/4-1BB Bifunctional AND-Body™ Therapeutic, at AACR 2025

Lead development candidate, AMP-410, leverages proprietary Ampersand technology to block VEGF and allosterically activate 4-1BB signaling – unlike traditional bispecific molecules – driving both adaptive and innate anti-tumor activity In multiple …

Ocular Therapeutix™ to Report First Quarter 2025 Financial Results on May 5, 2025

Ocular Therapeutix™ to Report First Quarter 2025 Financial Results on May 5, 2025

BEDFORD, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced that it plans to issue a press release regarding first quarter …

DecisionDx®-Melanoma Test Ordered More Than 200,000 Times for Patients Diagnosed with Cutaneous Melanoma

DecisionDx®-Melanoma Test Ordered More Than 200,000 Times for Patients Diagnosed with Cutaneous Melanoma

FRIENDSWOOD, Texas, April 28, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its achievement of surpassing a significant milestone of 200,000 …

XORTX Announces Grant of European Patent

XORTX Announces Grant of European Patent

CALGARY, Alberta, April 28, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and …

Eton Pharmaceuticals Announces Submission of NDA for ET-600 (Desmopressin Oral Solution)

Eton Pharmaceuticals Announces Submission of NDA for ET-600 (Desmopressin Oral Solution)

- NDA submitted for the treatment of central diabetes insipidus - - Expected 10-month review; commercial preparations underway for a potential Q1 2026 launch – DEER PARK, Ill., April 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “ …

Arvinas Shares New Preclinical Combination Data for the PROTAC BCL6 Degrader, ARV-393, at the 2025 American Association for Cancer Research Annual Meeting

Arvinas Shares New Preclinical Combination Data for the PROTAC BCL6 Degrader, ARV-393, at the 2025 American Association for Cancer Research Annual Meeting

– ARV-393 demonstrated strong synergistic antitumor activity, including complete regressions, in combination with standard-of-care chemotherapy, biologics, and select investigational oral small molecule inhibitors – – Findings support continued evaluation …

Portage Biotech Reports Confirmatory Preclinical Results in Mesothelioma Supporting First-In-Human Trial of PORT-7

Portage Biotech Reports Confirmatory Preclinical Results in Mesothelioma Supporting First-In-Human Trial of PORT-7

DOVER, Del., April 28, 2025 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company today reports confirmatory preclinical efficacy data for PORT-7 (TT-4), a selective adenosine A2B receptor inhibitor. Dr. Luciano …

BEYONTTRA® (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved by the UK Medicines and Healthcare Products Regulatory Agency to Treat ATTR-CM

BEYONTTRA® (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved by the UK Medicines and Healthcare Products Regulatory Agency to Treat ATTR-CM

- The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date - In as few as 3 months, the time to first event (all-cause mortality ( …

BlackfinBio Announces FDA Clearance to Initiate Phase 1/2 Clinical Trial for Novel AAV Gene Therapy BFB-101 to Treat the Rare Neurological Disease Hereditary Spastic Paraplegia, Type 47 (SPG47)

BlackfinBio Announces FDA Clearance to Initiate Phase 1/2 Clinical Trial for Novel AAV Gene Therapy BFB-101 to Treat the Rare Neurological Disease Hereditary Spastic Paraplegia, Type 47 (SPG47)

CHESHIRE, United Kingdom, April 28, 2025 (GLOBE NEWSWIRE) -- BlackfinBio Ltd, a clinical stage gene therapy company focused on the development of treatments for rare neurological diseases, announces today that the U.S. Food and Drug Administration (FDA) …

EnteroBiotix Announces Oral Presentation of Phase 2a IBS-C Results at Digestive Disease Week® 2025

EnteroBiotix Announces Oral Presentation of Phase 2a IBS-C Results at Digestive Disease Week® 2025

EnteroBiotix Announces Oral Presentation of Phase 2a IBS-C Results at Digestive Disease Week® 2025 Glasgow, Scotland – 28 April 2025. EnteroBiotix Limited (‘EnteroBiotix’), a biopharmaceutical company developing best-in-class therapies for gut health, …

ONWARD Medical Announces Release of 2024 Annual Report

ONWARD Medical Announces Release of 2024 Annual Report

EINDHOVEN, the Netherlands, April 28, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal …

Merck KGaA, Darmstadt, Germany to Acquire SpringWorks Therapeutics to Accelerate Sustainable Growth of Healthcare Business

Merck KGaA, Darmstadt, Germany to Acquire SpringWorks Therapeutics to Accelerate Sustainable Growth of Healthcare Business

– Purchase price of $47 per share in cash represents an equity value of approximately $3.9 billion, or an enterprise value of $3.4 billion (€3.0 billion) – – Planned acquisition will immediately add revenue and accelerate mid- to long-term growth for Merck …

Purespring Therapeutics granted European Medicines Agency (EMA) orphan drug designation for PS-002 for the treatment of patients with primary IgA nephropathy (IgAN)

Purespring Therapeutics granted European Medicines Agency (EMA) orphan drug designation for PS-002 for the treatment of patients with primary IgA nephropathy (IgAN)

EMA designation provides orphan status to medicines being developed for rare conditions that are intended for the diagnosis, prevention or treatment of diseases affecting fewer than 5 in 10,000 people in the European Union Purespring has previously …

LIfT BioSciences announces partnership with University of Galway for clinical trial in Ireland

LIfT BioSciences announces partnership with University of Galway for clinical trial in Ireland

LIfT BioSciences announces partnership with University of Galway for clinical trial in Ireland London, 28 April 2025– LIfT BioSciences, (‘LIfT’ or ‘the Company’), a rapidly emerging biotech and the global leader in neutrophil immunotherapies, today …

argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDP First novel mechanism of action for CIDP treatment in more than 30 years CHMP positive opinion based on ADHERE data, the largest ever CIDP clinical trial European Commission (EC) …

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