Inside Financial News
No Result
View All Result
Wednesday, July 9, 2025
  • Home
  • News
    • Precious Metals
    • Battery Metals
    • Energy
    • Special Situation
    • Tech
    • Biotech
    • Crypto
  • Expert Opinions
    • Economy
    • Business
    • Markets
  • Contact Us
×

  • Home
  • News
    • Precious Metals
    • Battery Metals
    • Energy
    • Special Situation
    • Tech
    • Biotech
    • Crypto
  • Expert Opinions
    • Economy
    • Business
    • Markets
  • Contact Us
No Result
View All Result
Inside Financial News
No Result
View All Result
Home News Battery Metals

FDA grants Orphan Drug status to CervoMed’s dementia drug By Investing.com

by Inside Financial
November 27, 2024
in Battery Metals, Biotech, Crypto, Energy, Gadget, Markets, Politics, Precious Metals, Real Estate, Startup, Tech
0
Lifeward director Michael Swinford acquires $30,899 in shares By Investing.com
152
SHARES
1.9k
VIEWS
Share on FacebookShare on Twitter

BOSTON – CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational drug neflamapimod for the treatment of frontotemporal dementia (FTD). This designation is reserved for potential treatments for rare diseases affecting fewer than 200,000 people in the United States.

FTD is a neurodegenerative disease that is one of the leading causes of early onset dementia, impacting an estimated 50,000 to 60,000 people in the U.S. Characterized by significant neuronal loss in the frontal and temporal regions of the brain, FTD leads to symptoms such as behavioral changes and diminished language skills. Currently, there are no FDA- or EMA-approved treatments for FTD.

Neflamapimod, an orally administered drug designed to penetrate the brain, targets the alpha isoform of the p38MAP kinase, which is implicated in synaptic dysfunction. In previous clinical studies, neflamapimod has shown to be generally well tolerated and demonstrated significant improvements in dementia severity and functional mobility in patients with early-stage dementia with Lewy bodies (DLB).

The company is also progressing with a Phase 2b clinical trial for neflamapimod in early-stage DLB, known as the RewinD-LB study. Topline results from the RewinD-LB study are expected in December 2024. If successful, CervoMed plans to initiate a Phase 3 trial in mid-2025.

The Orphan Drug Designation by the FDA provides various development benefits for CervoMed, including tax credits, FDA fee exemptions, and seven years of marketing exclusivity post-approval.

This news is based on a press release statement from CervoMed Inc. and reflects the company’s current expectations regarding the therapeutic potential of neflamapimod and its development timeline.

In other recent news, CervoMed has seen significant developments in its drug candidate, neflamapimod, a treatment for early-stage Dementia with Lewy Body (DLB). Boral (OTC:) Capital Markets initiated coverage of the biopharmaceutical company with a Buy rating, reflecting optimism about CervoMed’s prospects in the DLB treatment market. Meanwhile, Chardan Capital Markets, Jones Trading, and Morgan Stanley (NYSE:) have all initiated coverage on CervoMed with positive ratings, citing the potential of neflamapimod to meet significant unmet medical needs.

The company recently bolstered its leadership team with the appointment of two senior executives, Dr. Claudia Ordonez and Dr. Mark De Rosch, to support the development of neflamapimod. This comes as CervoMed prepares for upcoming milestones, including the anticipated topline data from the RewinD-LB study in December 2024 and the initiation of Phase 3 by mid-2025.

In a shift in capital-raising strategy, CervoMed terminated a sales agreement with BTIG, LLC, which was initially set up for the at-the-market offering of up to $20 million in common stock shares. This termination occurred without any penalties or additional expenses for the company.

Lastly, a reverse-merger between EIP Pharma and Diffusion Pharmaceuticals (NASDAQ:) has taken place, and William Elder has been appointed as Chief Financial Officer. These recent developments further demonstrate CervoMed’s commitment to advancing neflamapimod and addressing the needs of DLB patients.

InvestingPro Insights

CervoMed Inc.’s recent FDA Orphan Drug Designation for neflamapimod comes at a critical time for the company, as reflected in recent financial data and market trends. According to InvestingPro data, CervoMed’s market capitalization stands at $65.86 million, indicating its current position as a small-cap biopharmaceutical player. The company’s revenue for the last twelve months as of Q3 2024 was $10.07 million, with a notable revenue growth of 116.29% over the same period.

Despite the positive news on the regulatory front, CervoMed faces financial challenges. An InvestingPro Tip highlights that the company is not profitable over the last twelve months, with a negative gross profit of $4.5 million and an operating income margin of -125.83%. This financial situation underscores the importance of the Orphan Drug Designation, which could provide crucial development benefits and potential future revenue streams.

The stock’s recent performance has been volatile, with InvestingPro data showing a 52.13% price decline over the last three months. This downturn is reflected in another InvestingPro Tip, which notes that the stock’s Relative Strength Index (RSI) suggests it is in oversold territory. This could indicate a potential buying opportunity for investors who believe in the company’s long-term prospects, especially given the recent regulatory milestone.

For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for CervoMed, providing a deeper understanding of the company’s financial health and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Source link

Previous Post

Noah’s 3Q2024 Earnings Showcase Robust Overseas Growth By Investing.com

Next Post

CTA stock exposure is long US, short Europe, UBS analysts say By Investing.com

Next Post
CTA stock exposure is long US, short Europe, UBS analysts say By Investing.com

CTA stock exposure is long US, short Europe, UBS analysts say By Investing.com

Please login to join discussion

Twitter Feeds

  • Trending
  • Comments
  • Latest

Mining’s “Tom Brady” – Bob Dickinson Fuels Copper & Gold Discovery

January 31, 2025
Lithium M&A Continues with Rio Tinto’s $6.7 Billion Arcadium Lithium Acquisition – Lithium Explorers and Developers begin rallying

Lithium M&A Continues with Rio Tinto’s $6.7 Billion Arcadium Acquisition and Piedment Sayona $623 Million Merger – Lithium Explorers and Developers begin rallying

November 21, 2024

Billions are being committed to Hydrogen development in Canada and the USA with Hydrogen explorers and developers starting to rally – 4 Stocks that could benefit significantly

January 12, 2025

THE M&A BOOM THAT NEVER STOPS BOOMING

February 21, 2025

High Street Retailers Pin Hopes On Discount Splurge In Black Friday Fever

0

UK Faces Two Decades of No Earnings Growth and More Austerity

0

High-Speed Traders In Search of New Markets Jump Into Bitcoin

0

Brexit Has Created A Political Climate No Budget Can Fix

0

Institutional Bitcoin Adoption Accelerates: Hyper Bit Technologies Steps Into the Spotlight

June 23, 2025

Uranium Powers Up: Meta’s Nuclear Deal Sparks New Era for AI and Energy Security

June 23, 2025
Crypto’s Wild Ride and the Crypto Miners that are the backbone of an industry

Crypto’s Wild Ride and the Crypto Miners that are the backbone of an industry

May 22, 2025
4 Copper Stocks to Watch as Copper Hits $4.80 per Pound.

4 Copper Stocks to Watch as Copper Hits $4.80 per Pound.

March 11, 2025

Recent News

Institutional Bitcoin Adoption Accelerates: Hyper Bit Technologies Steps Into the Spotlight

June 23, 2025

Uranium Powers Up: Meta’s Nuclear Deal Sparks New Era for AI and Energy Security

June 23, 2025

Categories

  • Acquisition
  • Aviator
  • Battery Metals
  • Biotech
  • Business
  • Copper
  • Crypto
  • Economy
  • Energy
  • Expert Opinions
  • Finance News
  • Gadget
  • Gold
  • Lithium
  • Markets
  • Mining
  • News
  • Politics
  • Precious Metals
  • Real Estate
  • Special Situation
  • Startup
  • Stocks News
  • Tech
  • Tech
  • Uncategorized

Site Navigation

  • Home
  • Advertisement
  • Contact Us
  • Privacy & Policy
  • Other Links
Inside Financial News

We bring you the best website that perfect for news, magazine, personal blog, etc. Check our landing page for details.

© 2025 Inside Financial News

No Result
View All Result
  • Home
  • News
    • Precious Metals
    • Battery Metals
    • Energy
    • Special Situation
    • Tech
    • Biotech
    • Crypto
  • Expert Opinions
    • Economy
    • Business
    • Markets
  • Contact Us

© 2025 Inside Financial News

Subscribe Now For A Chance To Win Big!