Spotlight Growth
No Result
View All Result
Saturday, March 25, 2023
  • Home
  • News
    • Bio/Med/Pharma
    • Cannabis
    • Commodities
    • Consumer Goods
    • Crowdfunding
    • Cryptocurrency
    • Crypto Cheat Sheets
    • Earnings
    • Entertainment
    • Financials
    • Market News
    • Opinion
    • Politics
    • Technology
    • Venture Capital/Private Equity (VC/PE)
  • Video
  • Stock and Crypto Screener
  • Home
  • News
    • Bio/Med/Pharma
    • Cannabis
    • Commodities
    • Consumer Goods
    • Crowdfunding
    • Cryptocurrency
    • Crypto Cheat Sheets
    • Earnings
    • Entertainment
    • Financials
    • Market News
    • Opinion
    • Politics
    • Technology
    • Venture Capital/Private Equity (VC/PE)
  • Video
  • Stock and Crypto Screener
No Result
View All Result
No Result
View All Result
Home Bio/Med/Pharma

Y-mAbs Therapeutics (NASDAQ: YMAB) Completes FDA Pre-BLA Meeting for Omburtamab

by admin
February 11, 2022
in Bio/Med/Pharma
0
Y-mAbs Therapeutics Pre BLA Meeting FDA Spotlight Growth

Y-mAbs Therapeutics Pre BLA Meeting FDA Spotlight Growth

Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) is engaged as a commercial-stage biopharmaceutical company, which is focused on the research, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Shares of the biopharma company are rallying 27% through early trading on Friday, February 11, 2022. Over the past three months, YMAB has seen average daily volume of around 414,300 shares. However, volume of 6.14 million shares or dollar volume of around $52.19 million, has already exchanged hands through early trading.

Shares of Y-mAbs Therapeutics are gaining after the company announced it has completed a Pre-Biologics License Application (Pre-BLA) meeting with the U.S. Food and Drug Administration (FDA) regarding its omburtamab candidate. The meeting discussed potential pathways for the health regulator to approve omburtamab as a treatment for patients with CNS/leptomeningeal metastases from neuroblastoma. Y-mAbs Therapeutics says they estimate resubmitting the BLA by the end of the first quarter 2022.

Omburtamab had undergone a single-center clinical study at Memorial Sloan Kettering, which evaluated 107 patients suffering from CNS/leptomeningeal metastases from neuroblastoma. Each patient received up to two doses of radiolabeled omburtamab and showed a median survival of 50 months. A final median has not yet been determined. Y-mAbs Therapeutics says they will send the completed clinical data package in the BLA and will release the full data later this year.

“We are pleased with the outcome of the pre-BLA meeting for omburtamab providing a clear regulatory path forward for the resubmission of the BLA. We believe omburtamab has the potential to make a meaningful impact in addressing a substantial unmet medical need for children suffering from high-risk neuroblastoma brain tumors and may potentially add an important treatment option to doctors and families facing this diagnosis,” said Thomas Gad, founder, Chairman and President.

Disclosure: No position. Spotlight Growth has no relationships with any of the companies mentioned in this article and did not receive payment in any form for its creation. This is an opinion article and is not meant to be financial advise. We are not broker-dealers or investment professionals. Please conduct your own due diligence. For more information on our disclosures, please visit: https://spotlightgrowth.com/disclosures/

Tags: biopharmaceuticalsbiotechBLABLA meetingcommon stockemerging growthFDAhealth stockshealthcare stocksinvestinginvesting newsinvestmentmedicalmicrocap stocksNASDAQnewspharmaceuticalspublic companyRobinhoodrobinhood stockssalessmall cap companiessmall cap stockssmall capsSpotlight GrowthSpotlight Growth Stocksstock marketstock market investingstock market newsstocksstocks to watchtechtradingtreatmentY-mAbs TherapeuticsYMABYMAB stock
  • Trending
  • Comments
  • Latest
Asure Software NASDAQ ASUR Human Capital Management HCM Industry Spotlight Growth

Asure Software (NASDAQ: ASUR) is Expanding to Meet the Rising Demand for Human Capital Management Software

September 27, 2022
OLB Group NASDAQ OLB Cuentas NASDAQ CUEN Partnership Fintech Spotlight Growth

OLB Group (NASDAQ: OLB) and Cuentas (NASDAQ: CUEN) Team Up to Bring Fintech Solutions to Over 32,000 Bodegas Across the United States

October 6, 2022
Siyata Mobile NASDAQ SYTA SYTAW SD7 VK7 Purchase Orders Spotlight Growth

New Purchase Orders for SD7 Rugged Device, VK7, and Other Accessories Boost Siyata Mobile’s Outlook (NASDAQ: SYTA)

December 14, 2021
Telcoin TEL Crypto Spotlight Growth

Telcoin (TEL) Quietly Leads a Crypto Remittance Revolution

June 15, 2021
Cybersecurity Stocks Coming Into Focus Amid High-Profile Attacks

Cybersecurity Stocks Coming Into Focus Amid High-Profile Attacks

0
Safe-T SFET NASDAQ UN Presentation

Safe-T (NASDAQ: SFET) Has Been Selected to Present at the United Nations’ Office of Information and Communications Technology Event

0
Safe-T Group SFET Q4 FY 2020 Financial Results

Safe-T Group (NASDAQ: SFET) Reports Fourth Quarter and Full Year 2020 Financial Results

0
Safe-T Group NASDAQ SFET FY 2020 Prelim

Safe-T Group Ltd. (NASDAQ: SFET) Estimates Record-High Annual Revenues of Approximately $4.9 Million Representing ~50% Growth YoY 2020

0
Is U.S. Government Trying to Ban Crypto Spotlight Growth

Is The U.S. Government Trying to Ban Crypto?

March 23, 2023
Bioadaptives OTC Pink BDPT LOI World Wellness Health and Wellness Spotlight Growth

Bioadaptives (OTC Pink: BDPT) Signs LOI with World Wellness, LLC to Develop New Health and Wellness Products

March 23, 2023
JanOne NASDAQ JAN Sells ARCA Recycling Business Focus on Biopharma Spotlight Growth

JanOne (NASDAQ: JAN) Sells ARCA Recycling Business to VM7, Will Focus on Budding Biopharmaceuticals Business

March 22, 2023
89bio NASDAQ ETNB Phase 2b ENLIVEN Trial Pegozafermin NASH Spotlight Growth

89bio (NASDAQ: ETNB) Reports Phase 2b ENLIVEN Trial of Pegozafermin Achieved Primary Endpoints For Treatment of Nonalcoholic Steatohepatitis (NASH)

March 22, 2023

Recent News

Is U.S. Government Trying to Ban Crypto Spotlight Growth

Is The U.S. Government Trying to Ban Crypto?

March 23, 2023
Bioadaptives OTC Pink BDPT LOI World Wellness Health and Wellness Spotlight Growth

Bioadaptives (OTC Pink: BDPT) Signs LOI with World Wellness, LLC to Develop New Health and Wellness Products

March 23, 2023

Categories

  • Bio/Med/Pharma
  • Cannabis
  • Commodities
  • Consumer Goods
  • Crowdfunding
  • Crypto Cheat Sheets
  • Cryptocurrency
  • Earnings
  • Education
  • Entertainment
  • Financials
  • Market News
  • Opinion
  • Politics
  • Real Estate
  • Split Watch
  • Sponsored
  • Store
  • Technology
  • Uncategorized
  • Venture Capital/Private Equity (VC/PE)

Site Navigation

  • Disclosures
  • Terms Of Service
  • Privacy Policy
  • Contact Us

Copyright © 2017-2022 Spotlight Growth. All Right Reserved. Designed by Cool Cat Interactive.

No Result
View All Result
  • Home
  • News
    • Bio/Med/Pharma
    • Cannabis
    • Commodities
    • Consumer Goods
    • Crowdfunding
    • Cryptocurrency
    • Crypto Cheat Sheets
    • Earnings
    • Entertainment
    • Financials
    • Market News
    • Opinion
    • Politics
    • Technology
    • Venture Capital/Private Equity (VC/PE)
  • Video
  • Stock and Crypto Screener

Copyright © 2017-2022 Spotlight Growth. All Right Reserved. Designed by Cool Cat Interactive.

Newsletter Signup

Subscribe to our weekly newsletter below and never miss the latest small/micro-cap analysis and investment news from Spotlight Growth.

Enter your email address

Thanks, I’m not interested