Biotech Catalysts - EOD Summary

Pfizer (NYSE: PFE) announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and...

The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s (NASDAQ: TCON) lead asset envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS)...

Akero Therapeutics (NASDAQ: AKRO) revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), the study met its primary endpoint for both the...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mersana Therapeutics’ (NASDAQ: MRSN) lead candidate XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer (TNBC). Mersana shares traded as high as 1.79 percent,...

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ: SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. Spectrum Pharmaceuticals shares traded as high as 3.17 percent,...

The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ (NASDAQ: RVNC) lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severecfrown lines (glabellar lines) in adults. Revance shares traded as high as 22....

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE: PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during...

The U.S. Food and Drug Administration (FDA) has approved expanded use of Vertex’s (NASDAQ: VRTX) lead asset ORKAMBI (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) ages 12 to <24 months. Vertex shares traded in a range of $279.5 to $292 on day volume of 1.12...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ: NTLA) lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in a range of $56.52 to $60.06 on day volume of 901.43 thousand shares...

Amgen (NASDAQ: AMGN) announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib) in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), the study met primary endpoint. Amgen shares traded in a range of $238....

The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ: INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement....

Pfizer (NYSE: PFE) announced positive top-line data from the Phase 3 clinical trial RENOIR investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. Pfizer, Inc. shares traded in a range of $47.27 to $47.95 on day volume of 14...

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ: BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients....

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE: MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). Merck shares traded in a range of $89.72 to $90.97 on...

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ: PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D). Insulet shares traded in a range of $260.13 to $266.73 on day volume of...