BioSpace News Archive

- Completed commercial-scale drug substance PPQ campaign ahead of schedule, enabling the expected on-time completion of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 - - Expect to submit clinical module of rolling BLA for teplizumab in Q3 2020 - - Extended follow-up results from the pivotal “At-Risk” TN-10 Study presented at ADA demonstrated that teplizumab significantly delays the onset of insulin-dependent T1D by a median of

Encouraging STRO-002 Interim Phase 1 Clinical Data Presented at the AACR Virtual Meeting in April STRO-002 Preclinical Data Presented at 2020 AACR Virtual Annual Meeting II in June Suggests Synergy between STRO-002 and Immune Checkpoint Inhibitors STRO-001 Dose Escalation Ongoing in Phase 1 Clinical Trial for Multiple Myeloma and Lymphoma Sutro’s Partner Merck KGaA, Unveiled Preclinical Data from the Collaboration’s potential First-in-Class Bispecific Antibody-Drug

BiomX Inc. (NYSE: PHGE), a clinical-stage company developing both natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will host a conference call and live audio webcast on Thursday, Aug. 13, 2020, at 8:00 a.m. EDT, to report second quarter 2020 financial results and provide a corporate update. The conference call dial-in numbers are 1-877-407-0724 (U.S.), 1-

– 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