Phase 3 Trial

After reviewing the FDA's information requests and considering all other options, DBV Technologies (NASDAQ: DBVT) has decided not to pursue the sequential approach to develop Viaskin Peanut (allergen uptake/transport study before STAMP).  DBV estimates that heeding to...

Aldeyra Therapeutics Inc (NASDAQ: ALDX) reported topline data from Phase 3 TRANQUILITY Trial of reproxalap ophthalmic solution for dry eye disease. The trial failed to meet the primary endpoint of ocular redness, but it did achieve statistical significance for the dry eye disease...

Summit Therapeutics Inc (NASDAQ: SMMT) shares are trading lower after disappointing results from the Phase 3 Ri-CoDIFy study of ridinilazole for C. difficile infection (CDI).  The study showed that ridinilazole resulted in a higher observed Sustained Clinical Response (SCR)...

Novartis AG (NYSE: NVS) said that its ligelizumab antibody treatment against recurring hives did not meet the goal of superiority to standard treatment Xolair (omalizumab) in a late-stage study. Novartis' PEARL 1 and PEARL 2 Phase 3 studies met the goal for ligelizumab to show...

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) seek complete FDA approval for their COVID-19 vaccine for adolescents ages 12 to 15. The agency had fully approved the vaccine in August for people 16 years and older. The Pfizer-BioNTech vaccine is currently...

Ipsen SA (OTC: IPSEY) has entered into a long-term strategic partnership to develop, manufacture, and commercialize and Genfit SA's (NASDAQ: GNFT) elafibranor for Primary Biliary Cholangitis (PBC).  Under the agreement, Ipsen will pay Genfit up to €480...

Mesoblast Limited (NASDAQ: MESO) received feedback from the FDA's Office of Tissues and Advanced Therapies (OTAT) on the Phase 3 program of rexlemestrocel-L in patients. The trial is assessing rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative...

Valneva SE (NASDAQ: VALN) said its COVID-19 vaccine candidate was efficient as a booster for people who had received the same shot as an initial vaccination. The news comes almost two weeks after a British study showed VLA2001 was the only shot out of seven that offered no immunity boost...

Sanofi SA (NASDAQ: SNY) and GlaxoSmithKline Plc (NYSE: GSK) expect data from late-stage trials of its COVID-19 booster dose in Q1 2022, instead of this year. The news came as the companies shared preliminary data from trials that showed the single-dose booster provided strong...

Atea Pharmaceuticals Inc (NASDAQ: AVIR) said it would close the global Phase 3 MORNINGSKY trial. The decision comes after considering the changing COVID-19 landscape with the anticipated availability of new antiviral treatment regimens. In addition to MORNINGSKY, the follow-on...

Roche Holdings AG (OTC: RHHBY) announced results from the Phase 3 POLARIX study of Polivy (polatuzumab vedotin) with MabThera/Rituxan (rituximab) and the chemotherapy regimen R-CHOP. Data were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition. Polivy...

Cidara Therapeutics Inc (NASDAQ: CDTX) and Mundipharma posted topline data from the ReSTORE Phase 3 trial of rezafungin for candidemia and invasive candidiasis. Rezafungin met the FDA primary endpoint of all-cause mortality at Day 30 and the primary endpoint for the European...

Sanofi SA (NASDAQ: SNY) presented data from two Phase 3 studies of fitusiran for the prophylactic treatment with hemophilia A or B, with or without inhibitors. Data were shared at the American Society of Hematology (ASH) Annual Meeting.  Fitusiran, an RNAi drug designed to...

Galera Therapeutics Inc (NASDAQ: GRTX) has announced corrected results from its Phase 3 ROMAN trial of avasopasem for RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC). The corrected data showed that avasopasem achieved statistical...

Pfizer Inc (NYSE: PFE) announced final results from an analysis of all 2,246 adults enrolled in its Phase 2/3 EPIC-HR trial of Paxlovid.  These results were consistent with the interim analysis, showing Paxlovid reduced the risk of hospitalization or death for any cause by...