![Renejix CDMO Partner for Small Molecule Oral Dosage Forms](https://www.pharmacompass.com/image/flap/renejix-w35-desktop-header-01gif-33629.gif)
![Renejix CDMO Partner for Small Molecule Oral Dosage Forms](https://www.pharmacompass.com/image/flap/renejix-w35-mob-header-01gif-17728.gif)
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2024
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
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
Details:
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
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
Details:
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
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
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
Details:
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
Details:
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
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
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
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
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
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
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
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
Details:
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
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