Potential First Novel Treatment in 40+ Years Awaits FDA Verdict

  • FDA decision on Vanda Pharma’s gastroparesis drug expected this week
  • Tradipitant could be first novel drug approved in over four decades for gastroparesis treatment
  • Eli Lilly to receive $10 million milestone for U.S. approval of tradipitant
  • Positive results from second Phase 3 study of tradipitant for motion sickness

The Food and Drug Administration (FDA) is set to make a decision on Vanda Pharmaceuticals’ proposed drug, tradipitant, for gastroparesis treatment. The FDA accepted the application in December 2023 and set a target action date of September 18th. If approved, tradipitant would be the first novel drug for gastroparesis in over four decades. Vanda has a license agreement with Eli Lilly to develop and commercialize tradipitant for all human indications. A positive FDA decision would trigger a $10 million milestone for Eli Lilly. Vanda also reported positive Phase 3 study results for tradipitant in motion sickness treatment.

Factuality Level: 8
Factuality Justification: The article provides accurate information about Vanda Pharmaceuticals’ proposed drug for gastroparesis, the FDA’s decision timeline, and the collaboration with Eli Lilly. It also mentions positive results from a Phase 3 study of tradipitant for motion sickness. However, it lacks personal opinions or sensationalism.
Noise Level: 2
Noise Justification: The article provides relevant information about the FDA’s decision on a drug application for gastroparesis treatment and mentions the involvement of Eli Lilly in the development process. It also includes details about the timeline and potential milestones. However, it lacks analysis or exploration of long-term trends or consequences.
Public Companies: Vanda Pharmaceuticals (VNDA), Eli Lilly (LLY)
Key People: Colin Kellaher (Author)

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Financial Relevance: Yes
Financial Markets Impacted: Vanda Pharmaceuticals, Eli Lilly
Financial Rating Justification: The article discusses a potential FDA decision on a drug application from Vanda Pharmaceuticals and its impact on the company’s financial situation, as well as a license agreement with Eli Lilly. This directly pertains to financial topics and impacts both companies involved.
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Extreme Rating Justification: There is no mention of an extreme event in the text and it does not meet the criteria for being within the last 48 hours.
Move Size: No market move size mentioned.
Sector: Healthcare
Direction: Up
Magnitude: Small
Affected Instruments: Stocks

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