Vanda Pharmaceuticals’ (NASDAQ:VNDA) stock fell by as much as 9 percent today, after the FDA denied the experimental treatment tradipitant.
This therapy aims to treat gastroparesis – a medical condition that is related to stomach paralysis.
Vanda Pharmaceuticals has been asked by the FDA to complete additional studies prior to resubmitting their application.
VNDA has not held back in its criticism of the regulator, as they feel hard done by.
According to the company, the FDA’s ruling is not in compliance with the Food Drug and Cosmetic Act. According to the company:
According to the FDCA, the FDA must review a drug application within 180 days and either approve it or provide an opportunity for an hearing. The FDA did not do anything in this instance.
It also claims that FDA has refused to meet with it in an AdCom, even though it had repeatedly requested it.
AdCom meetings are where FDA receives external advice on drugs and then uses it to make a final decision.
Vanda’s product pipeline is already very weak.
Vanda has only a handful of products to its name. Fanapt is a drug that treats bipolar disorder and has five competitors.
Abilify is one of them, and it costs just $5 per month. It has been preferred by doctors for many years over the other options.
The product is still struggling to recover its costs despite the fact that it has successfully entered the market.
Ponvory is also struggling.
Ponvory was acquired by Johnson & Johnson at a cost of $100 million.
The company will be left with a costly acquisition, which is not likely to increase its profit.
Vanda’s Hetlioz, a generic drug that is rapidly becoming the victim of competition from other brands. Revenues have nearly doubled YoY.
The company has suffered a severe blow as a result of the refusal to accept tradipitant.
Analysts believe the FDA will approve the drug, but it won’t be effective on the market.
Vanda maintains a strong financial position in spite of struggles
Vanda has $103 Million in Cash as of 30 June 2024. The total assets of Vanda are $439 millions.
The business also had a cash flow of $641,000 for the first six months, indicating that it is self-sustaining without external funding.
Market capitalization of the company is $270 Million.
The stock will skyrocket if there is any indication that an activist shareholder may be nearing the company.
Vanda also received buyouts this year.
Both offers were rejected by the company, despite their being well over its current stock price.
Other companies’ interest in the assets of the company shows that there are benefits to acquiring them.
Shareholders are unlikely to benefit from these assets if the management cannot utilize them to their maximum potential.
The post Vanda Pharmaceuticals denounces FDA’s rejection as unfair of stomach paralysis medication may be updated as new developments unfold.
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