Month: October 2023

Today at 2 PM, Akero Therapeutics Presented at the H.C. Wainwright 7th Annual NASH Virtual Investor Conference

Akero Therapeutics Presented at the H.C. Wainwright 7th Annual NASH Conference Indeed, today, Akero Therapeutics (AKRO) presented virtually at the H.C. Wainwright 7th Annual NASH Conference on Tuesday, October 24, 2023, at 12:00 p.m. E.T. A live webcast of the fireside chat will be available through the investor relations section of the Company’s website at www.akerotx.com In case you missed the live webcast, an archived …

Intellia Therapeutics: FDA Clearance of its Systemically Administered NDA of NTLA-2001 in Global Phase 3 Trial

Intellia Therapeutics' NTLA-2001 Intellia Therapeutics' NTLA-2001 is the first-ever investigational in vivo CRISPR-based gene editing therapy cleared to enter late-stage clinical development.   Today, October 18, 2023, Intellia Therapeutics (NTLA) announced that the U.S. Food and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Intellia Therapeutics Receives PRIME Designation from the EMA for NTLA-2002 – Investigational In Vivo CRISPR Genome Editing Treatment for Hereditary Angioedema

Intellia Therapeutics Receives PRIME Designation from EMA Intellia Therapeutics (NTLA) announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to its product NTLA-2002.  As we already know, NTLA-2002 is an in vivo CRISPR-based investigational therapy designed to prevent potentially life-threatening swelling attacks in people with Hereditary Angioedema  (HAE). From Intellia Therapeutics . . . This content is for paid subscribers. Please …

INOVIO Receives FDA Feedback that Data from Completed Phase 1/2 Trial of INO-3107 Can be Used to Submit a BLA

Inovio Receives FDA Feedback for INO-3107 INOVIO (INO) - a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, announced that it received feedback from the U.S. FDA that data from its completed Phase 1/2 trial of INO-3107 for the treatment of Recurrent . . . This content is for paid subscribers. …

Akero Therapeutics’ October 10, 2023 Press Release

Akero Therapeutics Press Release Akero Therapeutics Reports Encouraging 36-Week Analysis of 96-Week Phase 2b SYMMETRY Study, with a Trend on Fibrosis Improvement and Statistically Significant Results for NASH Resolution, Markers of Liver Injury and Fibrosis, Insulin Sensitization and Lip Akero Therapeutics (AKRO)
Please Don’t Miss Akero Therapeutics Investor Conference Tomorrow, October 10th at 8 AM

Please Don’t Miss Akero Therapeutics Investor Conference Tomorrow, October 10th at 8 AM

Akero Therapeutics to Present Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis Due to NASH Investor webcast on Tuesday, October 10th at 8:00 a.m. ET to present clinical data.   Akero Therapeutics (AKRO) will hold an investor conference . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Apellis Pharmaceuticals Announces Preliminary U.S. Net Revenues of Approximately $74 M for SYFOVRE® in the Q3 2023

Apellis Pharmaceuticals Launch Update of SYFOVRE® On October 5, 2023, Apellis Pharmaceuticals (APLS) provided an update on the launch of its product SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). About Geographic Atrophy GA is an advanced form of age-related macular degeneration and a leading cause of blindness, impacting more than one million Americans . . . This content is for …

Neurocrine Biosciences Announced Positive Results from Phase 3 CAHtalyst™ Study

Neurocrine Biosciences Announcement Today, Neurocrine Biosciences (NBIX) announced positive top-line data from the Phase 3 CAHtalyst™ Pediatric Study evaluating the safety, efficacy and tolerability of the firm’s product crinecerfont treating children and adolescents with classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency. The Disease Congenital adrenal hyperplasia refers to a group of genetic conditions that result in an enzyme deficiency that alters . . . …

Akero Therapeutics Announced Publication in the Lancet Gastroenterology & Hepatology of HARMONY Phase 2b Trial Results for NASH

Akero Therapeutics Akero Therapeutics (AKRO) announced publication in The Lancet Gastroenterology & Hepatology of results from the HARMONY Phase 2b trial in nonalcoholic steatohepatitis (NASH). The paper, which is available online, provides data on the safety, tolerability, and efficacy of once-weekly subcutaneous injections . . . This content is for paid subscribers. Please click here to subscribe or here to log in.