Tags : Sarepta

Sarepta Receives the US FDA’s Approval for VYONDYS 53 (golodirsen)

Sarepta’s VYONDYS 53 is an antisense oligonucleotide derived using phosphorodiamidate morpholino oligomer (PMO) platform targeting DMD patients in patients with a confirmed mutation amenable to exon 53 skipping In Aug 2019, the company received a CRL for VYONDYS 53 from Drug Evaluation 1 following the New Drug Application (NDA) submission to and review by the […]Read More

PharmaShots Weekly Snapshot (November 11-15, 2019)

Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as an Adjuvant Treatment for Patients with HER2+ eBC with Residual Invasive Disease After Neoadjuvant Treatment Published: Nov 15, 2019 | Tags: Roche, Kadcyla, trastuzumab emtansine, Receives, CHMP, Recommendation, Approval, Adjuvant, Treatment, HER2+ Early Breast Cancer 2. Stanford Medicine Reports Results of Apple Heart Study for Detecting […]Read More

Sarepta Signs a License Agreement with Stride Bio to Develop

Shots: The companies collaborated to develop in vivo AAV-based therapies for up to eight central nervous system and neuromuscular targets. StrideBio will be responsible for research, development and manufacturing of the first four CNS targets which include MECP2 (Rett syndrome), SCN1A (Dravet syndrome), UBE3A (Angelman syndrome), and NPC1 (Niemann-Pick) Stride Bio to receive $48M upfront […]Read More

Sarepta Exercises its Exclusive Option to Acquire Myngonexus Therapeutics for

Shots: Sarepta exercises its option to acquire Myonexus Therapeutics, in all stock transaction for $165M with its five Limb-girdle muscular dystrophy (LGMDs) gene therapies programs i.e LGMD2E, LGMD2D, LGMD2B, LGMD2L & LGMD2C In May,2018 Sarepta and Myonexus collaborated to develop and advance multiple gene therapy programs for LGMD, paying $60M upfront & milestones, gaining excsluive […]Read More

Sarepta Signs an Exclusive Global (Except EU) License Agreement with

Shots: Lysogene to get $26M (€22M) upfront cash with equity investment of $2.5M (€2.2M) at a 30% premium, receive development, regulatory, and commercial milestone payments ~$125 M (€108M) with royalties on sales of product Sarepta will get hold of exclusive commercial rights to LYS-SAF302 in the US and and has an option to license CNS […]Read More