Vanda Pharmaceuticals Inc. (VNDA) faced a setback in its pursuit of FDA approval for its pipeline candidate, tradipitant, intended for treating gastroparesis symptoms. The company announced on Sept. 19 that the FDA had issued a Complete Response Letter (CRL) to its new drug application (NDA) for tradipitant. Following the news, Vanda’s shares dropped 6.1%.
Gastroparesis, a serious condition characterized by delayed gastric emptying, significantly slows down the stomach’s ability to empty its contents. The FDA hasn’t approved any effective treatment for gastroparesis in over 40 years, making the potential approval of tradipitant highly anticipated. Vanda’s stock had been performing well year-to-date, rising 10.2% compared to the industry’s 0.4% increase.
The FDA’s CRL highlighted a demand for additional studies on tradipitant. The agency requested a study design that deviated from the advice of leading experts in the field and didn’t align with the current scientific understanding of the disease. Furthermore, Vanda’s management expressed disappointment over the FDA’s delayed decision, exceeding the 180-day timeframe stipulated by the Food Drug and Cosmetic Act (FDCA). The FDA’s failure to provide an approval or schedule a hearing within the specified timeframe raised concerns. Vanda repeatedly requested an advisory committee meeting to discuss the tradipitant NDA, but the FDA declined.
Adding to the complexity, several patients treated with tradipitant have submitted a Citizen Petition urging the FDA to approve the drug for gastroparesis treatment. This petition highlights the desperate need for effective treatment options for this debilitating condition.
Despite the FDA’s decision to withhold approval for gastroparesis, Vanda remains committed to pursuing marketing approval for tradipitant in this indication. The company is also actively developing tradipitant to prevent vomiting induced by motion sickness. In May 2024, Vanda reported positive results from a second Phase III study investigating the effectiveness of tradipitant in preventing motion sickness-induced vomiting. The company intends to submit an NDA to the FDA for tradipitant as a motion sickness treatment later in 2024.
Vanda currently holds a Zacks Rank #4 (Sell). However, other biotech companies are showing strong potential, including Illumina, Inc. (ILMN), Krystal Biotech, Inc. (KRYS), and Fulcrum Therapeutics, Inc. (FULC). All three companies boast a Zacks Rank #1 (Strong Buy). These companies have experienced positive earnings revisions and share price performance, showcasing promising growth prospects within the biotech sector.
