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Find Drugs in Development News & Deals for Daxibotulinumtoxin A

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Details:

The Company intends to use the net proceeds from the offering to advance the commercial growth of its aesthetics portfolio, including DAXXIFY (daxibotulinumtoxinA-Lanm), which is being used for the treatment of moderate to severe glabellar lines.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Daxxify

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Barclays

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 04, 2024

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Daxiffy (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent. It is being evaluated in Phase 3 clinical trials for the treatment of cervical dystonia in adults.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Neurology Product Name: Daxxify

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 02, 2024

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Revance will use the proceeds for developing and commercializing innovative aesthetic and therapeutic offerings, including DAXXIFY™ (daxibotulinumtoxinA-lanm) for injection, the RHA® collection of dermal fillers.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Daxxify

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Goldman Sachs & Co.

Deal Size: $230.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering September 15, 2022

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DaxibotulinumtoxinA for Injection, is next-generation product aiming to establish a new, premium, long-lasting neuromodulator category. DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Daxi

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2022

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DaxibotulinumtoxinA for Injection, including Revance’s first oral presentation of the ASPEN-1 Phase 3 clinical trial data, the positive topline results from the ASPEN Open Label Study, which demonstrated long-term safety and efficacy of repeat treatments.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Neurology Product Name: Daxxify

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Syneos Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2022

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Partnering with Athyrium on a non-dilutive financing that substantially strengthens the financial position ahead of the potential FDA approval of the lead drug product, DaxibotulinumtoxinA for Injection for glabellar lines.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Daxi

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Athyrium Capital Management

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Agreement March 21, 2022

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Details:

DaxibotulinumtoxinA for Injection, an investigational agent not approved by FDA and is currently under regulatory review, combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: DAXI

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 10, 2022

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DaxibotulinumtoxinA combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components for the treatment of moderate to severe glabellar (frown) lines aesthetic.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Daxi

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 15, 2021

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Details:

Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Daxi

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 12, 2021

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FDA plans to initiate its pre-approval inspection of the company’s manufacturing facility for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines by the end of June 2021.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2021

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Details:

The video presentation will include data from a subgroup analysis from the Phase 3 SAKURA clinical trial show the efficacy, duration, and safety of DaxibotulinumtoxinA for Injection in adult females across multiple age cohorts following the treatment of glabellar lines.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2021

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Details:

The company will showcase results on the elimination of glabellar lines following treatment with DaxibotulinumtoxinA for Injection, made evident through a novel approach visualizing the entire distribution of glabellar line severity ratings in the depiction of efficacy.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2021

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Revance will present results from its ASPEN-1 Phase 3 clinical trial evaluating the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Neurology Product Name: Daxxify

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Syneos Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 01, 2021

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The presentations will showcase findings from the open-label Phase 2 study evaluating DaxibotulinumtoxinA for Injection for the simultaneous treatment of moderate to severe upper facial lines.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2021

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Details:

Aji Bio-Pharma will operate as a dual source of supply and provide drug product manufacturing services to Revance for the supply of DaxibotulinumtoxinA for Injection at the company's aseptic manufacturing facility in San Diego, California.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: DaxibotulinumtoxinA

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Revance Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership December 22, 2020

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Details:

Revance’s Phase 2, multicenter, open-label study to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for the combined treatment of upper facial lines was conducted at eight sites in the United States and Canada.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 17, 2020

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Details:

The decision on Revance's BLA for DaxibotulinumtoxinA Injection for mild to severe glabellar lines was deferred by the FDA as the agency was unable to perform the necessary inspection of the company's Northern California manufacturing facility due to travel restrictions.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 25, 2020

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Details:

This Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluated the safety and efficacy of two doses of DaxibotulinumtoxinA for Injection in reducing the signs and symptoms of plantar fasciitis.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 09, 2020

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Details:

DaxibotulinumtoxinA for Injection was effective and generally well-tolerated in reducing the signs and symptoms for cervical dystonia, delivering up to a median duration of 24 weeks.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Neurology Product Name: Daxxify

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 14, 2020

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Details:

Two oral presentations highlighting new data on DaxibotulinumtoxinA for Injection from the SAKURA Phase 3 program, the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar lines.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 06, 2020

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Details:

The two publications reported efficacy data as well as detailed safety results from the SAKURA 3 Phase 3 open-label, long-term safety study. The SAKURA 3 study is part of the largest Phase 3 clinical development program for a neuromodulator in the treatment of glabellar lines.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2020

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The company has announced a decision to complete enrollment in its JUNIPER Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury.


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

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Details:

Biologics License Application for DAXI in the treatment of moderate to severe glabellar lines has been accepted for review by the U.S. Food and Drug Administration (FDA).


Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 06, 2020

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