BioSpace News Archive

Taysha Gene Therapies, Inc., a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, announced that it has entered into a loan and security agreement with Silicon Valley Bank that provides Taysha with up to $100 million of borrowing capacity.

BeiGene, Ltd. today announced that it will host an investor conference call and webcast on Wednesday, August 25, 2021, at 9:30 a.m. ET to discuss the Company’s early development pipeline and research.

Positive pre-IND/CTA feedback obtained from several key regulatory agencies for TSHA-102 in Rett syndrome, TSHA-101 in GM2 gangliosidosis and TSHA-118 in CLN1 disease, paving the way for multiple anticipated IND/CTA filings in the second half of 2021

Atsena Therapeutics today announced the appointment of Linda B. Couto, PhD, as Chief Scientific Officer (CSO).

Milestone Scientific Inc today provided a business update and announced financial results for the second quarter ended June 30, 2021.

Insulet Announces FDA Clearance of Lyumjev ® Rapid-Acting Insulin for Use with Omnipod ® Products in the United States

Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, announced today the publication of data from its pivotal Phase 3 REST-ON trial of FT218 in SLEEP, the journal of the Sleep Research Society.

Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that the final patient has completed the Phase 3 pivotal Cardigan II study, which is evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.

AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s request to amend its pivotal clinical trial evaluating the safety and effectiveness of the RECELL® System for the repigmentation of stable vitiligo lesions to a streamlined single-arm trial design.

Catalyst Pharmaceuticals, Inc. today announced that Mary Coleman has been appointed to the newly created position of Vice President, Head of Investor Relations.