Important Biotech Catalysts For September 8, 2022 - End Of The Day Summary - Silence Therapeutics (NASDAQ:SLN), Alnylam Pharmaceuticals (NASDAQ:ALNY), Eli Lilly (NYSE:LLY)

The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ 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 22.39 percent, in a range of $22.02 to $25.47 on day volume of 8.73 million shares versus three months average volume of 729.3 thousand shares, closed regular trading session at $25.30.

Silence Therapeutics SLN announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead candidate SLN124 for the treatment of polycythemia vera (PV). Silence Therapeutics shares traded as high as 15.55 percent, in a range of $11.23 to $13.3 on day volume of 38.34 thousand shares, closed regular trading session at $11.40.

The Medical Healthcare & Products Regulatory Agency (MHRA) has granted Marketing Authorisation Approval (MAA) and Orphan Disease Designation (ODD) for Amryt’s AMYT lead candidate Filsuvez for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older in Great Britain (GB). Amryt shares traded as high as 3.79 percent, in a range of $7.66 to $7.95 on day volume of 26.2 thousand shares, closed regular trading session at $7.84.

Alnylam ALNY announced positive results from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. The results were presented today in a late-breaker session at the 18^th International Symposium on Amyloidosis (ISA). Alnylam shares traded as high as 8.76 percent, in a range of $203.86 to $227.16 on day volume of 2 million shares versus three months average volume of 1 million shares, closed regular trading session at $226.30.

Axsome Therapeutics AXSM has enrolled the first patient in the ADVANCE-2 trial of AXS-05, an investigational treatment for Alzheimer's disease (AD) agitation. Axsome shares traded in a range of $58.88 to $61.95 on day volume of 751.76 thousand shares, closed regular trading session at $61.21.

Lyra LYRA announced the enrollment of the first patient in the Phase 3 ENLIGHTEN II clinical trial of LYR-210 in adult patients with chronic rhinosinusitis (CRS). Lyra shares traded as high as 3.14 percent, in a range of $6.03 to $6.25 on day volume of 9.91 thousand shares, closed regular trading session at $6.22.

Vistagen Therapeutics VTGN has completed an interim analysis of PALISADE-2, the Company's second Phase 3 clinical trial assessing drug candidate PH94B as an acute treatment of anxiety in adults with Social Anxiety Disorder (SAD), which concluded that PALISADE-2 should continue as planned. VistaGen shares traded as high as 41.18 percent, in a range of $0.17 to $0.24 on day volume of 66.32 million shares versus three months average volume of 12.99 million shares, closed regular trading session at $0.20.

Eli Lilly LLY has announced new detailed results from Phase 3 monotherapy studies in atopic dermatitis (AD) showed investigational lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response* at Week 16 through one year of treatment. Eli Lilly shares traded as high as 1.33 percent, in a range of $307.59 to $315.73 on day volume of 2.04 million shares, closed regular trading session at $315.50.

Ocuphire Pharma OCUP announced that the last patient of the 103 enrolled subjects since April 2021 has completed their 24-week study visit in the Phase 2b ZETA-1 trial of oral APX3330 for the treatment of diabetic retinopathy (DR). Top-line results are expected in the fourth quarter of 2022. Ocuphire shares traded as high as 2.71 percent, in a range of $2.21 to $2.27 on day volume of 47.07 thousand shares, closed regular trading session at $2.26.

SCYNEXIS SCYX announced the presentation of positive interim data in patients with refractory candidiasis treated with oral ibrexafungerp from the ongoing Phase 3 FURI study, as well as data from the ongoing CARES study of patients with Candida auris (C. auris) infections. The new interim analyses are being presented during the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting. SCYNEXIS shares traded as high as 4.94 percent, in a range of $2.43 to $2.55 on day volume of 49.59 thousand shares, closed regular trading session at $2.50. The company shares traded at $2.45, down 2 percent in the after-hours trading session.

Regeneron REGN announced that the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). Regeneron shares traded as high as 20.53 percent, in a range of $668.94 to $718.86 on day volume of 3.73 million shares versus three months average volume of 602.18 thousand shares, closed regular trading session at $708.85.

SINTX Technologies SINT has held a successful 510(k) pre-submission meeting with the United States Food and Drug Administration (FDA) concerning the potential development and commercialization of silicon nitride-PEEK (FleX-SN PEEK) spine implants. SiNtx shares traded as high as 12.82 percent, in a range of $0.39 to $0.44 on day volume of 188.92 thousand shares, closed regular trading session at $0.41. The company shares traded at $0.39, down 4.59 percent in the after-hours trading session.

Important Biotech Catalysts For September 8, 2022 - End Of The Day Summary