Vanda

Vanda Pharmaceuticals to Announce First Quarter 2024 Financial Results on May 8, 2024

Retrieved on: 
Tuesday, April 30, 2024
Vanda

WASHINGTON, April 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2024 on Wednesday, May 8, 2024, after the market closes.

Key Points: 
  • WASHINGTON, April 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2024 on Wednesday, May 8, 2024, after the market closes.
  • Vanda will host a conference call at 4:30 PM ET on Wednesday, May 8, 2024, during which management will discuss the first quarter 2024 financial results and other corporate activities.
  • To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 2594340.
  • Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

Future Pak Confirms Proposal to Acquire Vanda Pharmaceuticals for $7.25 to $7.75 Per Share in Cash

Retrieved on: 
Wednesday, April 17, 2024
Packaging, Health, Manufacturing, Other Health, Pharmaceutical, Biotechnology, Vanda, Pak, Honigman LLP, Contingent value rights

Future Pak LLC (“Future Pak”) today announced that it has submitted three proposals since February to acquire all of the outstanding shares of common stock of Vanda Pharmaceuticals, Inc. (“Vanda”) (NASDAQ: VNDA), and confirms that its most recent proposal to acquire Vanda for cash consideration of $7.25 to $7.75 per share remains open for Vanda and its Board of Directors to consider.

Key Points: 
  • Future Pak LLC (“Future Pak”) today announced that it has submitted three proposals since February to acquire all of the outstanding shares of common stock of Vanda Pharmaceuticals, Inc. (“Vanda”) (NASDAQ: VNDA), and confirms that its most recent proposal to acquire Vanda for cash consideration of $7.25 to $7.75 per share remains open for Vanda and its Board of Directors to consider.
  • The current proposal implies a premium of 79.0% to 91.4% to Vanda's closing price of $4.05 as of April 16, 2024.
  • In its letters to Vanda, Future Pak has also expressed a willingness to explore various ways to further improve its proposal that could provide Vanda shareholders additional upside beyond the stated cash consideration.
  • Building on this proposal, whether through structural enhancements, such as Contingent Value Rights, or a potential increase in cash consideration, would require engagement with and information from Vanda.

Vanda Pharmaceuticals Reacts to U.S. Supreme Court's Denial of its Petition in HETLIOZ® ANDA Litigation

Retrieved on: 
Tuesday, April 23, 2024
Vanda, Public, Patient, Apotex, Supreme court

WASHINGTON, April 22, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Supreme Court denied Vanda's petition for a writ of certiorari in its HETLIOZ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp.

Key Points: 
  • WASHINGTON, April 22, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Supreme Court denied Vanda's petition for a writ of certiorari in its HETLIOZ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp.
    "We are disappointed that the Supreme Court has decided not to hear our case and clarify the lower court standard for obviousness in patent law.
  • However, we are pleased that our case has drawn attention to an area of law that has broad and significant implications in life sciences innovation," said Dr. Mihael H. Polymeropoulos, President, CEO and Chairman of the Board.
  • "We look forward to future cases that may resolve these issues for the benefit of innovators, patients and public health."

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Retrieved on: 
Wednesday, March 6, 2024
Symantec Endpoint Protection, FDA, Food, Shanda, CRL, New Drug Application, Insomnia, Vanda, Pharmaceutical industry

In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Key Points: 
  • In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.
  • As previously reported, on February 4, 2024, the FDA provided a notification stating that it identified deficiencies that precluded discussion of labeling and postmarketing requirements/commitments.
  • Consistent with that notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form.
  • Vanda is reviewing the CRL and evaluating its next steps.

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Retrieved on: 
Monday, February 5, 2024
Hearing, Sleep, Patient, Shanda, New Drug Application, FDCA, FDA, Food, Insomnia, Communication, Vanda, Pharmaceutical industry

No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review.

Key Points: 
  • No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review.
  • Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation.
  • Vanda is also challenging the FDA's approvals of several generic versions of HETLIOZ®, which have been marketed since 2023.
  • Vanda remains committed to its efforts to hold the FDA accountable to the law, ensuring predictable regulatory conduct.

Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2023 Financial Results on February 7, 2024

Retrieved on: 
Wednesday, January 31, 2024
Vanda

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2023 on Wednesday, February 7, 2024, after the market closes.  

Key Points: 
  • WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2023 on Wednesday, February 7, 2024, after the market closes.
  • Vanda will host a conference call at 4:30 PM ET on Wednesday, February 7, 2024, during which management will discuss the fourth quarter and full year 2023 financial results and other corporate activities.
  • To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 8053170.
  • Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

Retrieved on: 
Wednesday, January 31, 2024
Streptomyces, Fungal infection, Investigational New Drug, Venous stasis, Nail disease, Prevalence, IND, HDAC, Dermatophytosis, FDA, Ciclopirox, Onycholysis, Food, Vanda, Onychomycosis, Fungus, Antibiotics

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis.

Key Points: 
  • WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis.
  • Onychomycosis, or tinea unguium, is a fungal infection of the nail.
  • Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the nail bed), and nail plate thickening.
  • There have not been any new onychomycosis treatments approved by the FDA since 2014.4
    Centers for Disease Control and Prevention.

Court Orders FDA to Resolve Vanda Pharmaceuticals' Jet Lag Hearing Request by March 5, 2024

Retrieved on: 
Tuesday, January 30, 2024
Policy, Hearing, Congress, Therapy, Patient, Shanda, FDCA, FDA, District court, Vanda, Court, Pharmaceutical industry

The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.

Key Points: 
  • The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.
  • Following multiple attempts to informally resolve the complete response letter, Vanda requested an opportunity for a hearing in July 2022, and the FDA provided Vanda a private notice of an opportunity for a hearing.
  • As the Court explained, "the statute requires that a hearing shall commence within 300 days after an application is filed.
  • Vanda's application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for hearing."

Court Orders FDA to Resolve Vanda Pharmaceuticals' Jet Lag Hearing Request by March 5, 2024

Retrieved on: 
Tuesday, January 30, 2024
Patient, Shanda, Policy, District court, Court, Congress, FDA, Therapy, Vanda, FDCA, Hearing, Pharmaceutical industry

The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.

Key Points: 
  • The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.
  • Following multiple attempts to informally resolve the complete response letter, Vanda requested an opportunity for a hearing in July 2022, and the FDA provided Vanda a private notice of an opportunity for a hearing.
  • As the Court explained, "the statute requires that a hearing shall commence within 300 days after an application is filed.
  • Vanda's application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for hearing."

Vanda Pharmaceuticals Announces a U.S. Patent Allowance for PONVORY® (ponesimod) in the U.S.

Retrieved on: 
Friday, January 26, 2024
Multiple sclerosis, Janssen, Actelion, Orange Book, Food, Ponesimod, Vanda, The Orange Book, Patent, Pharmaceutical industry

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.

Key Points: 
  • WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.
  • When issued, this patent is anticipated to expire on October 10, 2042.
  • Upon issuance, Vanda intends to list this patent in the U.S. Food and Drug Administration publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
  • Vanda acquired rights to U.S. and Canadian rights to PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.