Important Biotech Catalysts For September 8, 2022 – End Of The Day Summary
The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ (NASDAQ:RVNC) lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for…
Amryt Secures UK Regulatory Nod And Orphan Disease Status For Skin Disorder Candidate
The Medical Healthcare & Products Regulatory Agency (MHRA) has granted Marketing Authorisation Approval (MAA) and Orphan Disease Designation (ODD) for Amryt’s (NASDAQ: AMYT) lead candidate Filsuvez for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in
Important Biotech Catalysts For September 7, 2022 – End Of The Day Summary
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE:PFE) lead drug GBS6…
Pfizer Gets FDA Breakthrough Therapy Designation For GBS Vaccine Candidate
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE: PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.
Rhythm Secures European Commission Marketing Authorization For Genetic Disease Candidate
The European Commission (EC) has expanded the marketing authorization for Rhythm’s (NASDAQ: RYTM) lead drug product IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age an
Vaxcyte Completes Enrolment In Mid-Stage Pneumococcal Disease Study, Sees Top-line Data In H1 2013
Vaxcyte (NASDAQ: PCVX) has completed patient enrollment in the Phase 2 study evaluating VAX-24 in healthy adults 65 years of age and older.
VAX-24 is its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
Eledon Shares Climb After Securing FDA Nod For Mid-Stage Kidney Disease Study
Eledon Pharmaceuticals (NASDAQ: ELDN) received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN).
Ironwood Shares Positive Top-line Data From Late-Stage Functional Constipation Candidate Study In Patients Aged 6-17 Years
Ironwood Pharmaceuticals (NASDAQ: IRWD) announced positive top-line data from its Phase 3 clinical trial evaluating LINZESS (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation (FC).
Emergent Shares Decline Following Commencement Of Initial-Stage Lassa Virus Vaccine Candidate Study
Emergent BioSolutions (NYSE: EBS) has dosed first patient in its Phase 1 study evaluating the safety and immunogenicity of EBS-LASV in healthy subjects.
EBS-LASV is a recombinant VSV-vectored Lassa virus vaccine candidate being evaluated for prevention of disease caused by Lassa virus infection.
MannKind Shares Fall After Completing Initial Stage Lung Disease Study
MannKind Corporation (NASDAQ: MNKD) has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101), an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease.