Ragothaman Srinivasan - Spark Newswire

2 minute read

Axsome Shares Shoot Higher As FDA Approves Major Depressive Disorder Candidate

Today, 8:04 AM

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ (NASDAQ: AXSM) lead asset AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.

AXSM

2 minute read

Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 8:04 AM

The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ:KRYS) Biologics License Application (BLA)…

AGLE

1 minute read

FDA Accepts Krystal Biotech’s Filing For Genetic Skin Disorder Candidate Under Priority Review

By Ragothaman Srinivasan

Today, 8:04 AM

The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ: KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB).

KRYS

1 minute read

89bio Shares Climb After Concluding Enrolment In Mid-Stage NASH Study

By Ragothaman Srinivasan

Today, 8:04 AM

89bio (NASDAQ: ETNB) has completed enrollment in ENLIVEN, the Phase 2b trial of pegozafermin for the treatment of non-alcoholic steatohepatitis (NASH).

ETNB

2 minute read

Recap Of Wednesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 8:04 AM

The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ:BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat…

BLUE

1 minute read

RedHill Shares Gain As European Commission Grants Orphan Drug Status To NTM Infections Candidate

By Ragothaman Srinivasan

Today, 8:04 AM

The European Commission has granted Orphan Drug Designation to RedHill Biopharma’s (NASDAQ: RDHL) lead asset RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease.

RDHL

1 minute read

Palisade Bio Shares Drop Following Commencement Of Late-Stage Return Of Bowel Study

By Ragothaman Srinivasan

Today, 8:04 AM

Palisade Bio (NASDAQ: PALI) has dosed first patient in its Phase 3 study evaluating lead asset LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery.

PALI

2 minute read

Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 8:04 AM

The U.S. Food and Drug Administration (FDA) has approved Amphastar’s (NASDAQ:AMPH) New Drug Application (ND”) for Epinephrine injection…

AMPH

4 minute read

Recap Of Monday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 8:04 AM

Gritstone bio (NASDAQ:GRTS) announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy…

ANIX

1 minute read

Gilead Shares Climb On Positive Interim Analysis From Late-Stage Breast Cancer Study

By Ragothaman Srinivasan

Today, 8:04 AM

Gilead Sciences, Inc. (NASDAQ: GILD) announced positive results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer.

GILD