Phase 3 Trial

Corvus Pharmaceuticals Inc (NASDAQ: CRVS) has shared data from the Phase 3 mupadolimab COVID-19 trial. The data from 40 patients suggested improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to...

The FDA has decided that the Fast Track designation previously granted to Inventiva SA's (NASDAQ: IVA) lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis. The decision follows a Fast Track designation request for lanifibranor in NASH with...

Summit Therapeutics Inc (NASDAQ: SMMT) announced that the FDA disagrees with its proposed change to the primary endpoint in Phase 3 Ri-CoDIFy studies. In a regulatory filing, the Company said that the federal agency does not agree with its proposed change to the primary endpoint...

The Sean M. Healey & AMG Center for ALS at Mass General received approval from the FDA and the Mass General Brigham Institutional Review Board to add SLS-005 (trehalose injection, 90.5 mg/ML for intravenous infusion) as an additional regimen in the HEALEY ALS Platform Trial. ...

India-based Bharat Biotech has completed the Phase 2 and 3 trials of COVID-19 vaccine, Covaxin, for use in 2 to 18 years.  Ocugen Inc (NASDAQ: OCGN) is the U.S. partner for the vaccine. The Company said that data analysis from 1,000 volunteers is ongoing. It will...

AstraZeneca Plc (NASDAQ: AZN) and Daiichi Sankyo's (OTC: DSNKY) Enhertu have shown some striking data in late-stage breast cancer trials and early solid tumor tests.  What Happened: The Phase 3 DESTINY-Breast03 head-to-head study included second-line unresectable or...

The FDA has approved Exelixis Inc's (NASDAQ: EXEL) Cabometyx (cabozantinib) for thyroid cancer in patients aged 12 years and older. The approval covers patients with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular...

BeyondSpring Pharmaceuticals Inc (NASDAQ: BYSI) shared the final intention-to-treat (ITT) dataset from its DUBLIN-3 Phase 3 trial of plinabulin. The trial evaluated plinabulin combined with docetaxel vs. docetaxel alone for 2nd/3rd line non-small cell lung cancer (NSCLC) patients...

Novartis AG (NYSE: NVS) announced results of the final overall survival (OS) analysis of Phase 3 MONALEESA-2 study, which evaluated Kisqali (ribociclib) in combination with letrozole in breast cancer patients. The trial compared the combination therapy to placebo plus letrozole in...

AstraZeneca plc (NASDAQ: AZN) announced updated data from the CASPIAN Phase 3 trial of Imfinzi (durvalumab) combined with a choice of chemotherapies etoposide plus either carboplatin or cisplatin. The Imfinzi-chemotherapy demonstrated a sustained, clinically meaningful overall...

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced results from one cohort from a Phase 2/3 trial evaluating its COVID-19 vaccine on a two-dose schedule (approximately 21 days apart). The data from over 2,200 children aged 5 to 11 years showed a favorable...

Merck & Co Inc (NYSE: MRK) announced the final overall survival (OS) results from the Phase 3 KEYNOTE-355 trial of Keytruda in combination with chemotherapy for the first-line metastatic triple-negative breast cancer (mTNBC).  Keytruda combined with chemotherapy (paclitaxel...

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA (NASDAQ: SNY) hope to expand Libtayo into a broader population with a chemo combo regimen.  According to data released at the European Society for Medical Oncology 2021 (ESMO21), Libtayo, used on top of platinum doublet...

Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) announced four e-poster presentations at the European Society for Medical Oncology (ESMO21) Virtual Conference 2021.  The presentations include updated preliminary results from the ongoing Phase 1b/2 study of rebastinib plus paclitaxel in...

Shanghai Junshi Biosciences Co Ltd and Coherus BioSciences Inc (NASDAQ: CHRS) announced interim results from the Phase 3 JUPITER-06 trial. Related: Coherus, Junshi Toripalimab-Chemo Combo Beat Chemo Alone in Late-Stage Nose & Throat Cancer Trial. The trial is evaluating...