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03:09:31 AM

ALPMY Stock News

01/20/23 1:00 AM
OTC : ALPMY
clinical trial
Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration has lifted the clinical hold on January 19 th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease. "With that same spirit and focus on patient safety, we look forward to resuming the...
RHEA-AI
neutral
01/19/23 10:00 AM
OTC : ALPMY
conferencesclinical trial
Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium
Astellas Pharma Inc. today will present detailed results from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 targeted monoclonal antibody, plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or...
RHEA-AI
neutral
12/20/22 6:45 AM
OTC, Nasdaq, NYSE : ALPMY, SGEN, MRK
Astellas, Seagen and Merck Announce FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
– This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting –– FDA granted the applications Priority Review with a PDUFA date of April 21, 2023 –TOKYO, BOTHELL, Wash. and RAHWAY, N.J. , Dec. 20, 2022
RHEA-AI
neutral
12/20/22 6:45 AM
Nasdaq, NYSE, OTC : SGEN, MRK, ALPMY
Seagen, Astellas and Merck Announce FDA Acceptance of sBLAs for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
. Seagen Inc., Astellas Pharma Inc. and Merck, known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration has accepted for Priority Review supplemental Biologics License Applications for PADCEV ® and...
RHEA-AI
neutral
12/15/22 6:30 PM
OTC : ALPMY
clinical trial
Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Astellas' GLOW trial, the second Phase 3 trial in CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ cancers, meets primary endpoint for progression-free survival (PFS) and key secondary endpoint for overall survival (OS)GLOW results, along with SPOTLIGHT
RHEA-AI
neutral