Needham initiated coverage on Monday for GH Research PLC (NASDAQ:GHRS), citing the company’s lead drug candidate, GH-001, which had demonstrated impressive efficacy in Phase 2 versus competition.
• GHRS is showing upward movement. See the full breakdown here.
Recently, the company submitted a complete response to the previously announced clinical hold on the Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration.
GH Research received a response from the FDA with only one hold topic remaining. The FDA requested that the company provide additional data or further justification related to the previously announced respiratory tract histology findings in rats.
There are no additional requests related to dog toxicology. No device-related issues are remaining.
Also Read: Why Is GH Research Stock Trading Higher On Monday?
Previously, the company reported on the initial results from the phase 2b clinical trial of GH001 in treatment-resistant depression.
The full analysis of the OLE confirms a 73% remission rate at six months with infrequent treatment visits and no mandated psychotherapeutic intervention.
GH001 delivered consistent MADRS reduction with re-treatments as needed. 57.5% of patients achieved remission at day eight, and 90% were in remission at month six.
Needham initiated with a Buy rating and a price forecast of $19.
Regarding the FDA’s clinical hold, Needham analyst Ami Fadia says that while the management believes it can address the one outstanding FDA issue and could lift an important overhang on GH Research in the near term, although it is hard to perform due diligence.
The analyst estimates GH001 could be a significant opportunity with sales of $1.9 billion in the U.S. by 2035, but uses a 35% probability of success to reflect the risks.
At an enterprise value of $500 million, Needham sees potential upside to GH Research in the longer term.
GHRS Price Action: GH Research stock is up 3.93% at $13.09 at publication on Monday.
Read Next:
Photo: Shutterstock
