Biotech Archives - Page 720 of 795

1 minute read

Werewolf Shares Climb As Initial-Stage Solid Tumors Study Kicks-off

September 1, 10:14 AM

Werewolf Therapeutics (NASDAQ: HOWL) has initiated patient dosing in a Phase 1/1b clinical trial evaluating WTX-124, its lead INDUKINET molecule targeting IL-2 for the treatment of solid tumors.

HOWL

1 minute read

BARDA Backs Arcturus’ Influenza Vaccine Program

By Vandana Singh

September 1, 10:06 AM

Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) received an award for up to $63.2 million from the Biomedical Advanced Research and Development Authority…

ARCT

1 minute read

AnaptysBio Faces Another Setback For Imsidolimab, Stalls Work In Skin Scarring Indication

By Vandana Singh

September 1, 9:58 AM

AnaptysBio Inc (NASDAQ: ANAB) announced topline data from its HARP Phase 2 trial of imsidolimab for moderate-to-severe hidradenitis suppurativa (HS).

ANAB

1 minute read

Health Canada Authorizes Moderna’s Bivalent Covid Booster Dose For People Aged 18 And Older

By Benzinga Newsdesk

September 1, 9:56 AM

- Reuters Citing Government Website https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/moderna.html

MRNA

3 minute read

Pfizer And BioNTech Receive Positive CHMP Opinion For Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster In European Union

By Benzinga Newsdesk

September 1, 9:53 AM

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine The Omicron BA.1-adapted bivalent COVID-19 vaccine combines

BNTX

2 minute read

Cue Health Makes De Novo Submission to FDA For Full Clearance Of Its Cue Flu Molecular Test

By Benzinga Newsdesk

September 1, 9:16 AM

SAN DIEGO, Sept. 1, 2022 /PRNewswire/ -- Cue Health ("Cue") (NASDAQ: HLTH) today announced that it has made a de novo submission to the U.S. Food and Drug Administration (FDA) for fullSAN DIEGO, Sept.

HLTH

1 minute read

Vaxart Shares Positive Top-line Data From Mid-Stage Oral Pill COVID-19 Vaccine Study

By Ragothaman Srinivasan

September 1, 9:15 AM

Vaxart (NASDAQ: VXRT) announced positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S. The top-line data readout exhibited that the trial met its primary safety and secondary immunogenicity endpoints.

VXRT

2 minute read

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization For Use Of Moderna’s Omicron-Targeting Bivalent Booster In The European Union

By Bill Haddad

September 1, 9:06 AM

Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273 Positive recommendation follows recent amendment to

MRNA

1 minute read

Axsome Therapeutics Commences Late-Stage Migraine Study

By Ragothaman Srinivasan

September 1, 8:54 AM

Axsome Therapeutics (NASDAQ: AXSM) has enrolled the first patient in the EMERGE trial of its lead candidate AXS-07 for the acute treatment of migraine.

AXSM

7 minute read