Recap Of Monday’s Biotech Catalysts – End Of the Day Summary
The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ:ELDN) Investigational New Drug (IND) application…
SCYNEXIS Shares Climb As FDA Accepts Filing For Vaginal Yeast Infection Candidate Under Priority Review
SCYNEXIS (NASDAQ: SCYX) announced that the U.S. Food and Drug Administration (FDA) has accepted its submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC).
FDA Accepts Gamida’s Filing For Stem Cell Transplant Candidate Under Priority Review
The U.S. Food and Drug Administration (FDA) has accepted for filing the Gamida Cell’s (NASDAQ: GMDA) Biologics License Application (BLA) for omidubicel in the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.
Scisparc Signs Clinical Trial Agreement With Yale University To Conduct Its Phase IIB Trial In Tourette Syndrome
SciSparc Ltd. (NASDAQ:SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system,
Krystal Biotech Gets FDA Nod For Initial-Stage Lung Infection Study
The United States Food and Drug Administration (FDA) has accepted Krystal Biotech’ (NASDAQ: KRYS) Investigational New Drug (IND) application to evaluate KB407 in a clinical trial for cystic fibrosis (CF).
Evofem Announces Completion of Last Subject Last Visit (LSLV) In Registrational Phase 3 “EVOGUARD” Trial Evaluating Phexxi For Prevention Of Chlamydia And Gonorrhea In Women
-- Top-line readout of data expected in October 2022 --
-- U.S. regulatory submission planned for the first half of 2023 --
Armata Pharmaceuticals Announces Clearance Of IND For Prosthetic Joint Infections
Second indication for AP-SA02 which targets Staphylococcus aureus including MRSA
Potential to significantly improve PJI patient outcomes
Expands Armata's pursuit of phage therapy as a solution for
Aileron Therapeutics Outlines Strategy To Strengthen Phase 1b Clinical Trial Of ALRN-6924 In Patients With p53-Mutated Breast Cancer
Enhancements to protocol, informed by recent ALRN-6924 data, are designed to improve the opportunity to demonstrate protection against chemotherapy-induced severe neutropenia, alopecia (hair loss) and potentially other toxicities in patients with p53-mutated breast cancer
Eledon Secures FDA Clearance For Kidney Transplant Rejection Study
The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ: ELDN) Investigational New Drug (IND) application to evaluate Tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.
Beam Therapeutics Announces FDA Clinical Hold On BEAM-201 IND Application
Beam Therapeutics Inc. (NASDAQ:BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that on Friday, July 29, 2022, the company was informed via e-mail communication