BioSpace News Archive

– In the Ongoing Phase 1 Proof-of-Concept Trial Multidose Group, RG6346 1.5, 3.0 and 6.0 mg/kg Dosing Cohorts Reached Mean HBsAg Reduction From Baseline of 1.39, 1.80 and 1.84 Log10 IU/mL, Respectively, at Day 112 End-of-Treatment; Data for Earliest-Dose Cohort of 1.5 mg/kg Showed Durability of Response Through Day 336 – – Self-Resolving ALT Elevations With Preserved Liver Function in Several Participants Treated With RG6346 Suggest ALT Flares Potential

Current independent tests have confirmed that BioSafe Defenses’ patented antimicrobial compounds kill Covid-2 the virus that is the precursor to and causes COVID-19.

Aug. 6, 2020 11:10 UTC Acceleron Announces Second Quarter 2020 REBLOZYL ® Net Sales - Acceleron expects to report approximately $11.1 million in royalty revenue for Q2 2020 from approximately $55.0 million in net U.S. sales of REBLOZYL ® (luspatercept-aamt) as reported by Bristol Myers Squibb - - Acceleron will report its full second quarter 2020 financial and operating results after the close of U.S. financial markets today, August 6, 2020, with its webcast and conference c

− Based on FDA Agreement that RASP is an Objective Sign of Dry Eye Disease, Assessment of Tear RASP Levels in Dry Eye Disease Patients Expected to Begin in the Fourth Quarter of 2020 − New Drug Application (NDA) Submission for Reproxalap in Dry Eye Disease Expected by the End of 2021 − Current Cash Expected to Support Operations Through 2022, Including Potential Approvals for Dry Eye Disease and Allergic Conjunctivitis − Management to H

Closed strategic licensing agreement with Sobi for SEL-212 for $100 million in initial payments and up to $630 million in potential milestones, and tiered double-digit royalties Entered into research license and option agreement with Sarepta for the use of the ImmTOR™ immune tolerance platform in Sarepta’s gene therapy programs in certain neuromuscular diseases Gene therapy program in MMA in collaboration with AskBio on track to enter the clinic in the first half of 2021; preliminary data

Submitted first regulatory application to the U.K.’s MHRA to initiate a Phase 1 study of NTLA-2001 for the treatment of transthyretin amyloidosis; on track to dose first patient by year-end Expanded Regeneron collaboration, receiving $100 million through upfront cash and equity investment and agreeing to co-develop treatments for hemophilia A and B using CRISPR-mediated targeted transgene insertion technology On track to submit an IND or IND-equivalent in 2021 for each of two wholly owne

Enrollment in our Phase 2 clinical trial program for ELX-02 in cystic fibrosis has been resumed in Europe and Israel after being temporarily paused due to the COVID-19 pandemic U.S. FDA has granted orphan drug designation for ELX-02 for the treatment of cystic fibrosis Completing enrollment in our Phase 2 cystic fibrosis clinical trials and reporting top line data remain our highest priorities Preclinical studies continuing to advance in autosomal dominant polycystic kidney disease (ADP

PetVivo Holdings, Inc. an emerging biomedical device company focused on the licensing and commercialization of innovative medical devices and therapeutics for pets is pleased to announce that the United States Patent and Trademark Office has allowed an important patent related to the Company’s proprietary biomaterial, which the company utilizes to produce its proprietary products.

Reports Flat Revenue of $1.5 Billion, and Net Income of $377 Million, or $0.79 per Diluted Share, Increasing 2% and 3%, Respectively, on a Reported Basis for Second Quarter 2020 Reports Adjusted Net Income of $427 Million, or Adjusted Diluted EPS of $0.89 for Second Quarter 2020 Delivers 4% Operational Growth in Revenue and 4% Operational Growth in Adjusted Net Income for Second Quarter 2020 Raises and Narrows Full Year 2020 Reven

Menlo Therapeutics Inc., a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, announced financial results for the second quarter ended June 30, 2020 and provided a corporate update.