Phase 3 Trial

Optinose Inc (NASDAQ: OPTN) has announced positive data from the ReOpen1 Phase 3 trial of Xhance (fluticasone propionate) Exhalation Delivery System in chronic sinusitis. The trial met both of its co-primary endpoints - First, a composite symptom score (comprising nasal congestion,...

Merck & Co Inc (NYSE: MRK) announced data from Phase 3 KEYNOTE-716 trial of Keytruda (pembrolizumab) as adjuvant treatment for patients with resected stage IIB and IIC melanoma. The trial has met its key secondary endpoint of distant metastasis-free survival (DMFS) at a...

SAB Biotherapeutics Inc (NASDAQ: SABS) said that due to low hospitalization and death rates in the trial, the National Institutes of Health's (NIH) ACTIV-2 Program is discontinuing enrollment in its Phase 3 COVID-19 trial. SAB-185 was being assessed as part of Phase 3 ACTIV-2 master...

The FDA has issued a clinical hold letter to Finch Therapeutics Group Inc's (NASDAQ: FNCH) PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI). The Company has paused enrollment in the trial as the FDA has asked for additional information about Finch...

Pfizer Inc (NYSE: PFE) announced data from the CLOVER Phase 3 trial evaluating Clostridioides difficile vaccine candidate to prevent C. difficile infection (CDI). Initial analyses of two secondary endpoints indicated a highly favorable benefit in reducing CDI severity and 100% vaccine...

InflaRx N.V. (NASDAQ: IFRX) has received an advice letter from the FDA about the vilobelimab Phase 3 program for hidradenitis suppurativa (HS), a condition that causes small, painful lumps to form under the skin.  The feedback recommends using the Hidradenitis Suppurativa Clinical...

According to an SEC filing, Karuna Therapeutics Inc (NASDAQ: KRTX) is withdrawing its prior guidance for the timing of topline data for its Phase 3 EMERGENT-3 trial evaluating KarXT in schizophrenia.  The Company had expected topline data from the EMERGENT-3 trial in 2H of 2022. At...

Marinus Pharmaceuticals Inc (NASDAQ: MRNS) expects data from the RAISE Phase 3 trial of ganaxolone in refractory status epilepticus in 2H of 2023. Earlier data from the trial was expected in 2H of 2022. The delay is due to the impact of the COVID-19 omicron variant and an interruption of...

AstraZeneca plc (NASDAQ: AZN) said that Enhertu prolonged survival and slowed the progression of metastatic breast cancer with low levels of a protein known as HER2. Data from the pivotal DESTINY-Breast04 Phase 3 trial showed Enhertu (trastuzumab deruxtecan) demonstrated a...

Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) have reported disappointing results from the Phase 3 trial of Dupixent (dupilumab) in chronic spontaneous urticaria (CSU). The trial included CSU patients who don't respond to biologic treatment,...

Sage Therapeutics Inc (NASDAQ: SAGE) and Biogen Inc (NASDAQ: BIIB) said zuranolone combined with a standard of care antidepressant met the primary goal of showing rapid and significant reduction in depressive symptoms in a late-stage study. The drug, zuranolone, also met the...

ImmunityBio Inc (NASDAQ: IBRX) announced data from its bladder cancer trial (QUILT-3.032) Phase 2/3 study of intravesical BCG plus Anktiva (N-803). The data showed sustained complete response rates in patients with BCG-unresponsive non-muscle-invasive carcinoma in situ (NMIBC CIS)...

Bristol Myers Squibb Co (NYSE: BMY) and Exelixis Inc (NASDAQ: EXEL) announced two-year follow-up results from the Phase 3 CheckMate -9ER trial of Opdivo (nivolumab) and Cabometyx (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma....

Aveo Pharmaceuticals Inc (NASDAQ: AVEO) will present new long-term progression-free survival (PFS) data from the Phase 3 TIVO-3 study in kidney cancer at the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium. The trial is evaluating Fotivda (...

The Independent Data Monitoring Committee (IDMC) has conducted a planned conditional power analysis of the first 75 randomized patients in Veru Inc's (NASDAQ: VERU) Phase 3 trial of sabizabulin. The trial included hospitalized patients with moderate to severe COVID-19 infection at...