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GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule
GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule

Yahoo

time09-07-2025

  • Business
  • Yahoo

GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule

GH Research (NASDAQ:GHRS) is one of the best-performing NASDAQ stocks according to analysts. On June 20, GH Research announced that it had submitted a complete response to the US FDA regarding the clinical hold on its Investigational New Drug/IND Application for GH001. The submission was made ahead of schedule, which showed the company's commitment to advancing its lead product candidate. The CEO of GH Research, Dr. Velichka Valcheva, pointed out that the response addressed the FDA's requests with comprehensive data and completed toxicology studies. GH001 is GH Research's lead product candidate, which was formulated for mebufotenin (5-methoxy-N,N-dimethyltryptamine or 5-MeO-DMT) administration via a proprietary inhalation approach. The company believes that GH001 has the potential to transform the treatment of treatment-resistant depression/TRD. This belief is supported by the observed clinical activity in their Phase 2b GH001-TRD-201 trial. In this trial, the primary endpoint was met, showing a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline of -15.5 points compared with placebo on Day 8. A biochemist in a laboratory conducting research on a new psychiatric therapy. GH Research (NASDAQ:GHRS) is a clinical-stage biopharmaceutical company that develops treatments for depression in the US. While we acknowledge the potential of GHRS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.

Analysts Offer Insights on Healthcare Companies: COMPASS Pathways (CMPS) and GH Research (GHRS)
Analysts Offer Insights on Healthcare Companies: COMPASS Pathways (CMPS) and GH Research (GHRS)

Business Insider

time13-05-2025

  • Business
  • Business Insider

Analysts Offer Insights on Healthcare Companies: COMPASS Pathways (CMPS) and GH Research (GHRS)

There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on COMPASS Pathways (CMPS – Research Report) and GH Research (GHRS – Research Report) with bullish sentiments. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. COMPASS Pathways (CMPS) In a report issued on May 8, Leonid Timashev from RBC Capital maintained a Buy rating on COMPASS Pathways, with a price target of $15.00. The company's shares closed last Monday at $3.91, close to its 52-week low of $2.88. According to Timashev is a 2-star analyst with an average return of -0.5% and a 31.6% success rate. Timashev covers the Healthcare sector, focusing on stocks such as NewAmsterdam Pharma Company, Edgewise Therapeutics, and Axsome Therapeutics. COMPASS Pathways has an analyst consensus of Strong Buy, with a price target consensus of $18.75, representing a 368.8% upside. In a report issued on May 8, TD Cowen also maintained a Buy rating on the stock with a $23.00 price target. GH Research (GHRS) RBC Capital analyst Brian Abrahams maintained a Buy rating on GH Research on May 8 and set a price target of $32.00. The company's shares closed last Monday at $10.16. According to Abrahams ' ranking currently consits of 0 on a 0-5 ranking scale, with an average return of -3.0% and a 40.0% success rate. Abrahams covers the Healthcare sector, focusing on stocks such as Aardvark Therapeutics, Inc., MoonLake Immunotherapeutics, and Neumora Therapeutics, Inc. Currently, the analyst consensus on GH Research is a Strong Buy with an average price target of $31.43, representing a 199.9% upside. In a report issued on May 9, Guggenheim also maintained a Buy rating on the stock with a $29.00 price target.

GH Research PLC's (NASDAQ:GHRS) Top Key Executive Florian Schonharting is the most upbeat insider, and their holdings increased by 31% last week
GH Research PLC's (NASDAQ:GHRS) Top Key Executive Florian Schonharting is the most upbeat insider, and their holdings increased by 31% last week

Yahoo

time09-02-2025

  • Business
  • Yahoo

GH Research PLC's (NASDAQ:GHRS) Top Key Executive Florian Schonharting is the most upbeat insider, and their holdings increased by 31% last week

GH Research's significant insider ownership suggests inherent interests in company's expansion A total of 3 investors have a majority stake in the company with 51% ownership Institutional ownership in GH Research is 17% To get a sense of who is truly in control of GH Research PLC (NASDAQ:GHRS), it is important to understand the ownership structure of the business. With 34% stake, individual insiders possess the maximum shares in the company. Put another way, the group faces the maximum upside potential (or downside risk). As a result, insiders were the biggest beneficiaries of last week's 31% gain. Let's take a closer look to see what the different types of shareholders can tell us about GH Research. Check out our latest analysis for GH Research Many institutions measure their performance against an index that approximates the local market. So they usually pay more attention to companies that are included in major indices. As you can see, institutional investors have a fair amount of stake in GH Research. This implies the analysts working for those institutions have looked at the stock and they like it. But just like anyone else, they could be wrong. It is not uncommon to see a big share price drop if two large institutional investors try to sell out of a stock at the same time. So it is worth checking the past earnings trajectory of GH Research, (below). Of course, keep in mind that there are other factors to consider, too. It would appear that 22% of GH Research shares are controlled by hedge funds. That catches my attention because hedge funds sometimes try to influence management, or bring about changes that will create near term value for shareholders. From our data, we infer that the largest shareholder is Florian Schonharting (who also holds the title of Top Key Executive) with 24% of shares outstanding. Its usually considered a good sign when insiders own a significant number of shares in the company, and in this case, we're glad to see a company insider play the role of a key stakeholder. For context, the second largest shareholder holds about 17% of the shares outstanding, followed by an ownership of 11% by the third-largest shareholder. A more detailed study of the shareholder registry showed us that 3 of the top shareholders have a considerable amount of ownership in the company, via their 51% stake. While studying institutional ownership for a company can add value to your research, it is also a good practice to research analyst recommendations to get a deeper understand of a stock's expected performance. There are plenty of analysts covering the stock, so it might be worth seeing what they are forecasting, too. The definition of company insiders can be subjective and does vary between jurisdictions. Our data reflects individual insiders, capturing board members at the very least. Company management run the business, but the CEO will answer to the board, even if he or she is a member of it. Most consider insider ownership a positive because it can indicate the board is well aligned with other shareholders. However, on some occasions too much power is concentrated within this group. Our most recent data indicates that insiders own a reasonable proportion of GH Research PLC. Insiders have a US$292m stake in this US$861m business. This may suggest that the founders still own a lot of shares. You can click here to see if they have been buying or selling. With a 17% ownership, the general public, mostly comprising of individual investors, have some degree of sway over GH Research. While this group can't necessarily call the shots, it can certainly have a real influence on how the company is run. With an ownership of 11%, private equity firms are in a position to play a role in shaping corporate strategy with a focus on value creation. Some might like this, because private equity are sometimes activists who hold management accountable. But other times, private equity is selling out, having taking the company public. It's always worth thinking about the different groups who own shares in a company. But to understand GH Research better, we need to consider many other factors. To that end, you should learn about the 5 warning signs we've spotted with GH Research (including 3 which are concerning) . If you would prefer discover what analysts are predicting in terms of future growth, do not miss this free report on analyst forecasts. NB: Figures in this article are calculated using data from the last twelve months, which refer to the 12-month period ending on the last date of the month the financial statement is dated. This may not be consistent with full year annual report figures. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio

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