Stealth BioTherapeutics Enters Going Private Agreement
Stealth BioTherapeutics Corp (NASDAQ:MITO) will be acquired by a consortium of investors led by Morningside Venture (I) Investments Ltd and J.…
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.
Immutep’s Lung Cancer Candidate Shows Encouraging Efficacy As Second-Line Treatment
Immutep Limited (NASDAQ:IMMP) announced new interim data from 2nd line non-small cell lung cancer (NSCLC) patients (Part B) in the Phase…
Avalo Therapeutics, Apollo Therapeutics Ink Pact For Anti-IL-18 Antibody
Avalo Therapeutics Inc (NASDAQ:AVTX) and Apollo Therapeutics Group Limited have entered into a worldwide, exclusive license agreement granting rights to Apollo to research,…
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).
AstraZeneca Cuts Innate-Partnered Phase 3 Trial In Head & Neck Cancer
Innate Pharma SA’s (NASDAQ:IPHA) futility interim analysis of the INTERLINK-1 Phase 3 study sponsored by AstraZeneca Plc (NASDAQ:AZN) did not meet a…
Akari Therapeutics To Reallocate Cash And Resources To Phase 3 Trial On Nomacopan In HSCT-TMA And To Pre-Clinical Program Of PAS-Nomacopan In GA; Will Discontinue Clinical Program Evaluating Nomacopan In Bullous Pemphigoid, Says Is Not Reducing Headcou…
Akari Therapeutics, Plc (NASDAQ:AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that it is prioritizing two pipeline programs. Cash and
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