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FDA Grants Extra Access to Vanda's Tradipitant to a Patient

Vanda Pharmaceuticals Inc. VNDA announced that the Division of Gastroenterology has authorized expanded accessto its pipeline candidate, tradipitant, for a patient in an Individual Patient Expanded Access protocol (VP-VLY-686-3303). 

We note that the patient had previously participated in a 12-week phase III study of tradipitant to treat gastroparesis, a disease of the muscles of the stomach. The company’s press release mentioned that the patient and his doctor requested for expanded access to the candidate to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient's gastroparesis symptoms. The phase III study is ongoing. 

The patient has been granted expanded access to tradipitant for six more months. The request was authorized with the condition that the access will be further renewed when the patient gives a written request containing additional safety information collected during those six months.

Shares of Vanda have plunged 30.8% so far this year against the industry’s growth of 6.4%.

We note that Vanda in-licensed tradipitant, a neurokinin-1 receptor antagonist, from pharma giant Eli Lilly LLY in 2012.The candidate is currently not approved for any indication and other than gastroparesis, the candidate is being developed for motion sickness and atopic dermatitis.

In April this year, Vanda along with The Feinstein Institutes for Medical Research (a research arm of Northwell Health) initiated a late-stage clinical study, ODYSSEY VLY-686-3501, on tradipitant for the treatment of neurogenic inflammation of the lung, secondary to COVID-19 infection.

Meanwhile, several companies are testing their marketed drugs in studies to check the inflammatory response in patients with severe corona virus infection.

 

Vanda Pharmaceuticals Inc. Price

 

Vanda Pharmaceuticals Inc. Price

Vanda Pharmaceuticals Inc. price | Vanda Pharmaceuticals Inc. Quote

Stocks to Consider

Some top-ranked stocks in the biotech sector are Emergent Biosolutions Inc. EBS, and BioMarin Pharmaceuttical Inc. BMRN, both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings per share estimates have increased from $3.18 to $4.03 for 2020 and from $3.32 to $4.31 for 2021 in the past 60 days.

BioMarin’s earnings per share estimates have increased from $1.51 to $1.56 for 2020 and from $2.46 to $2.79 for 2021 in the past 60 days.

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