The FDA issues a complete response letter to Vanda's new drug application for tradipitant for treating symptoms in gastroparesis.
NEW YORK, NY / ACCESSWIRE / September 20, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Vanda Pharmaceuticals Inc. ("Vanda Pharmaceuticals Inc.") (NASDAQ:VNDA) concerning possible violations of federal securities laws. Vanda issued a press release disclosing that "[o]n September 18, 2024, the U.S. Food and Drug Administration (FDA) declined to approve Vanda's New Drug Application (NDA) of tradipitant for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).
The biotech had discouraging news to report about one of its pipeline drugs. The FDA declined to approve its application.
NEW YORK, NY / ACCESSWIRE / September 19, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.
Thursday, the FDA declined to approve Vanda Pharmaceuticals Inc.'s VNDA New Drug Application (NDA) of tradipitant for symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms, the company said on Thursday.
Vanda Pharmaceuticals Inc. received and then refused two takeover bids that were well above current market prices. Vanda currently trades below net cash despite having significant revenue and operations. Vanda has disgruntled shareholders who may find creative ways to maximize shareholder value, despite a recent AGM failing to oust the unpopular Board of Directors and an existing poison pill.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q2 2024 Earnings Conference Call July 31, 2024 4:30 PM ET Company Participants Kevin Moran - Chief Financial Officer Mihael Polymeropoulos - President, Chief Executive Officer & Chairman of the Board Conference Call Participants Charles Duncan - Cantor Fitzgerald Andrew Tsai - Jefferies Operator Thank you for standing by. My name is Meg, and I will be your conference operator today.
Contract manufacturer Future Pak said on Wednesday it has withdrawn its offer to acquire Vanda Pharmaceuticals , citing non-engagement from the U.S. drugmaker.
U.S. stock futures were higher this morning, with the Nasdaq futures gaining around 100 points on Thursday.
Vanda Pharmaceuticals said on Wednesday that it has rejected takeover offers from UK-based Cycle Pharmaceutical and a revised bid from contract manufacturer Future Pak, adding that both offers undervalue the U.S. drugmaker.
Vanda Pharmaceuticals' portfolio includes FDA-approved Hetlioz for sleep disorders, Fanapt for schizophrenia and bipolar I disorder, and Ponvory for multiple sclerosis. VNDA's upcoming pipeline features milsaperidone and tradipitant, with promising Phase III trials for new indications and long-acting injectables. Acquisition offers from Future Pak and Cycle Pharmaceuticals highlight VNDA's undervaluation and strategic value.