Phase 3 Trial

Novartis AG (NYSE: NVS) is building the case for its radioligand therapy, 177Lu-PSMA-617. With positive Phase 3 primary endpoint data in the bag, Novartis at the European Society of Medical Oncology Congress 2021 (ESMO21) presented the therapy's effect on the quality of life and pain...

Bristol Myers Squibb Co (NYSE: BMY) announced Opdivo (nivolumab) plus Yervoy (ipilimumab) long-term survival data in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Data were presented at the European Society for Medical Oncology Virtual...

Gilead Sciences Inc (NASDAQ: GILD) announced new data from the Phase 3 ASCENT study of Trodelvy (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies. The results were presented at the...

BeyondSpring Pharmaceuticals (NASDAQ: BYSI) announced new plinabulin data from its chemotherapy-induced neutropenia (CIN) prevention program at the European Society for Medical Oncology (ESMO21) 2021 Congress. Plinabulin combined with G-CSF to prevent CIN is currently under U.S. and...

Exelixis Inc (NASDAQ: EXEL) has announced results demonstrating efficacy benefits of Cabometyx (cabozantinib) in patients with previously untreated advanced renal cell carcinoma (RCC), regardless of prior nephrectomy (surgical removal of a kidney) status. Data were shared at the...

Ampio Pharmaceuticals Inc (NYSE: AMPE) has reported top-line results from the AP-013 Phase 3 trial evaluating the Company's intra-articular (IA) injection of Ampion in adults with pain due to severe osteoarthritis of the knee (OAK).  Related Link: Ampio's Phase 2 Study Of...

RedHill Biopharma Ltd (NASDAQ: RDHL) announced preliminary top-line data from Phase 2/3 study evaluating opaganib in hospitalized patients with severe COVID-19 pneumonia. Read Next: RedHill Biopharma To Test Upamostat In COVID-19 Patients In South Africa. Data from 475 patients...

MiMedx Group Inc (NASDAQ: MDXG) stock dropped after announcing top-line results from two musculoskeletal trials of micronized dehydrated Human Amnion Chorion Membrane (mdHACM). Top-line results from an interim analysis of the six-month efficacy data for the Phase 2B trial for Knee...

The U.K. government has terminated its COVID-19 vaccine contract with Valneva SE (NASDAQ: VALN) over alleged breach of obligations. Related Content: Valneva Initiates Rolling Submission For COVID19 Vaccine Candidate In U.K. "HMG has alleged that the Company is in...

Apellis Pharmaceuticals Inc's (NASDAQ: APLS) pegcetacoplan posted mixed results in two Phase 3 trials in 1,258 geographic atrophy (GA).  Despite the mixed showing, CEO Cedric Francois thinks the candidates' performance was strong enough to warrant an FDA nod. The...

POSEIDON Phase 3 trial results showed AstraZeneca Plc's (NASDAQ: AZN) Imfinzi (durvalumab), tremelimumab, and chemotherapy, extended survival in lung cancer patients. The combo therapy topped overall survival (OS) and progression-free survival (PFS), chemotherapy alone in 1st-...

Sanofi SA's (NASDAQ: SNY) BTK inhibitor, rilzabrutinib, has flunked its first major clinical test. Rilzabrutinib was Principia Biopharma Inc's one of the key candidates that Sanofi acquired last year for $3.68 billion. Investigators randomized 131 newly diagnosed or...

Avillion LLP announces positive topline results from the MANDALA and DENALI Phase 3 trials of PT027 in asthma patients. PT027 is an inhaled, fixed-dose combination of albuterol and budesonide developed by AstraZeneca Plc (NASDAQ: AZN) and Avillion. The trials met all primary...

MacroGenics Inc (NASDAQ: MGNX) scored a big win with its full approval for anti-HER2 drug Margenza in December 2020 based on a head-to-head matchup with breast cancer med Herceptin.  But Margenza's overall survival (OS) data could spell a rough road ahead for the drug....

Travere Therapeutics Inc (NASDAQ: TVTX) has concluded a Type A meeting with the FDA related to sparsentan in focal segmental glomerulosclerosis (FSGS).  See: Travere Therapeutics' Sparsentan Program Submission Pushed to 2022; FDA Requires More Data. Following the...