NBI-1117568 is an oral, muscarinic M4 selective receptor agonist discovered by Nxera advancing through clinical development under a multi-program collaboration with Neurocrine Biosciences The once-daily 20 mg dose efficacy, safety and tolerability Phase 2 results support advancement to Phase 3 in schizophrenia in early 2025 The once-daily 20 mg dose met the primary endpoint, demonstrating a statistically significant 7.5-point improvement (p=0.011, 0.61 effect size) in the PANSS total score compa

Aug. 26, 2024 -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. (“Roche”) for treatment of unresponsive (MSI Low) metastatic colorectal cancer. As part of the clinical trial (NCT06012734, clinicaltrials.gov), LIXTE is providing its lead compound, LB-100, and Roche is providing ate

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the European Commission (EC) has extended the indications of the antifungal Cresemba® (isavuconazole) to pediatric patients and also granted an extension of market exclusivity by two additional years, which triggered a CHF 10 million milestone payment from Basilea’s license partner Pfizer Inc.

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older The KP.2 adaptation is based on FDA guidance, which stated that KP.2 is the preferred strain for COVID-19 vaccines for the US 2024-2025 fall and winter season, if feasible Shipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country August 22, 20

Aug. 20, 2024 -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced that interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung ca

Payment of special dividend conditioned upon ARCA stockholder approval of the Proposed Merger with Oruka Aug. 16, 2024 -- ARCA biopharma, Inc. (NASDAQ: ABIO) (“ARCA”) today announced that its Board of Directors has declared a special cash dividend (the “Special Dividend”) in connection with the previously announced merger (the “Merger”) with Oruka Therapeutics, Inc. (“Oruka”) pursuant to the Agreement and Plan of Merger and Reorganization, dated April 3, 2024 (the “Merger Agreement”). The Spec

Aug. 07, 2024 -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that it has signed a non-binding agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) whereby the companies will co-develop a formulation of clobetasol propionate ophthalmic suspension 0.05% (“clobetasol propionate”) in combination with the Optejet device for the short-term relief of dry eye disease

BioMarin’s gene therapy is getting a shot at the FDA as the agency accepted the BLA, the biotech said Wednesday night. With a de­ci­sion date of March 31, 2023, an ap­proval would come two and a half years af­ter the reg­u­la­tor orig­i­nal­ly re­ject­ed the AAV gene ther­a­py, which the biotech net­ted con­di­tion­al ap­proval for in the EU in late Au­gust. BioMarin is attempting to become the first gene therapy maker in the US to secure an approval for severe hemophilia A, which is charac

EUROBIO SCIENTIFIC COMPLETES ACQUISITION OF ENDOPREDICT® GENOMIC TEST FROM MYRIAD GENETICS Eurobio Scientific (FR0013240934, ALERS), a leading French group in in vitro specialty medical diagnostics and life sciences, announces the finalisation of its agreement with Myriad Genetics to acquire the EndoPredict® genomic test. As part of the agreement announced on 7 May 2024 (see press release below), on 1 August 2024 the Group has completed the acquisition of the second-generation genomic test Endo

July 30, 2024 -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced the achievement of $100 million in milestones from Incyte Corporation related to development progress of ZYNYZ® (retifanlimab-dlwr), following an agreement on July 24, 2024, pursuant to which certain milestones were deemed to have been met. ZYNYZ is an intravenous