- Spark Newswire

2 minute read

Iveric Bio Shares Shoot Higher Following Positive Top-line Data From Late-Stage Geographic Atrophy Study

Today, 11:15 PM

Iveric Bio (NASDAQ: ISEE) announced positive topline results from the second Phase 3 clinical trial of Zimura (avacincaptad pegol) for the treatment of geographic atrophy (GA).

ISEE

1 minute read

IDEAYA Shares Climb As Initial Stage Uveal Melanoma Study Kick-off In Australia

By Ragothaman Srinivasan

Today, 11:15 PM

IDEAYA Biosciences (NASDAQ: IDYA) has initiated Investigator Sponsored Trial to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma (UM) patients.

IDYA

2 minute read

Recap Of Friday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:15 PM

The U.S. Food and Drug Administration (FDA) has approved expanded use of Vertex’s (NASDAQ:VRTX) lead asset ORKAMBI (lumacaftor/ivacaftor) to…

IMRX

1 minute read

Immuneering Shares Climb After Pursuing FDA Nod For RAS Mutant Tumor Study

By Ragothaman Srinivasan

Today, 11:15 PM

Immuneering (NASDAQ: IMRX) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its product candidate IMM-1-104 in development for the treatment of advanced RAS mutant solid tumors.

IMRX

3 minute read

Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:15 PM

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ:NTLA) lead asset NTLA-2002,…

AXSM

1 minute read

FDA Advisory Committee Meeting Scheduled For October 28, 2022 To Review Y-mAbs’ Refiling For Omburtamab

By Ragothaman Srinivasan

Today, 11:15 PM

The Oncologic Drugs Advisory Committee (ODAC) of the U.S.

YMAB

1 minute read

Intellia Gets FDA Orphan Drug Status For Hereditary Angioedema Candidate

By Ragothaman Srinivasan

Today, 11:15 PM

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). NTLA-2002 is currently being evaluated in a Phase 1/2 study in adults with Type I or Type II HAE.

NTLA

1 minute read

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

By Ragothaman Srinivasan

Today, 11:15 PM

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

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

By Ragothaman Srinivasan

Today, 11:15 PM

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

1 minute read

Axsome Therapeutics Commences Late-Stage Migraine Study

By Ragothaman Srinivasan

Today, 11:15 PM

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