Vanda Pharmaceuticals

FDA rejected Vanda Pharmaceuticals' tradipitant for gastroparesis, requesting more studies. Vanda disputes, claiming efficacy, and intends to seek approval.

In 2024, NeurologyLive® highlighted neurology advancements, focusing on sleep disorders. Key updates included FDA approvals for narcolepsy treatments, promising phase 3 trial results for sleep apnea, and a deep learning model predicting cognitive status from sleep EEG data. Light therapy showed benefits for Alzheimer's disease symptoms.

2024 mixed for biotech; sector down 14% due to Q3 results, guidance cuts, pipeline setbacks, and vaccine skeptic nominee. Despite challenges, biotech remains attractive for innovation and M&A activity. Recommended stocks: Allogene Therapeutics (ALLO), Rezolute (RZLT), Vanda Pharmaceuticals (VNDA), all under $10 with strong Zacks Rank and ABR.

U.S. retail investor fund flows into Novo Nordisk surged 32-fold to $15.6 million after weaker-than-expected obesity drug data, offering a dip-buying opportunity. Novo's experimental drug CagriSema helped patients cut 22.7% of their weight, short of the anticipated 25%. Shares dropped 27%, erasing over $100 billion in market value. Retail flows likely provided an exit for institutional investors.

Vanda Pharmaceuticals Inc. received FDA Orphan Drug Designation for VGT-1849A, a JAK2 inhibitor for treating polycythemia vera (PV), a rare blood cancer affecting 1 in 2000 Americans, characterized by abnormal blood cell production and JAK2 mutation in over 95% of patients.

A federal appeals court affirmed the FDA's decision to deny Vanda Pharmaceuticals Inc.'s gastroparesis drug tradipitant fast-track approval, ruling the FDA reasonably rejected the expedited approval request based on available evidence.

The Atopic Dermatitis market, valued at USD 17 billion in 2023 across 7MM, is projected to grow by 2034. Key players include Sanofi/Regeneron, Pfizer, and Eli Lilly, with promising therapies like Baricitinib and Dupilumab. The market is driven by novel treatments and increased awareness, addressing a prevalent population of over 32 million cases in the US alone.

Insomnia market report forecasts growth from 2020 to 2034, driven by increasing prevalence, awareness, and emerging therapies like Seltorexant and TS-142. Challenges include high treatment costs and patient non-compliance, with unmet needs for long-term solutions with minimal side effects.

Vanda Pharmaceuticals reports a 28% sales decline for Hetlioz due to US generic competition. The company seeks FDA approval for Hetlioz to treat jet lag and insomnia, launching Hetlioz LQ for pediatric insomnia. Vanda challenges FDA's jet lag sNDA rejection and defends Hetlioz patent in 2026 trial. EMA decision on Hetlioz for Smith-Magenis Syndrome expected in 2025.

Vanda Pharmaceuticals reports Q3 2024 revenue of $47.7 million, up 23% YoY. Financial guidance for 2024 is revised upwards. Fanapt® launch in bipolar I disorder sees new patient starts increase by over 90% YoY. Fanapt® long-acting injectable program to start in Q4 2024. Milsaperidone NDA for schizophrenia and bipolar I disorder expected in early 2025. PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024. PONVORY® IND applications for psoriasis and ulcerative colitis expected in Q4 2024. Tradipitant NDA for motion sickness to be submitted in Q4 2024.