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Details:
Haduvio (oral nalbuphine ER) is a centrally and peripherally acting investigational therapy which is under phase 2 clinical development for the treatment of refractory chronic cough (RCC).
Lead Product(s): Nalbuphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Haduvio
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
The company will use the net proceeds from the offering for the development of clinical pipeline including its lead product Haduvio (nalbuphine) and for other general and corporate purpose.
Lead Product(s): Nalbuphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Haduvio
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $55.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 23, 2022
Details:
Primary efficacy endpoint demonstrated 77.3% reduction in daytime cough frequency from baseline with use of Haduvio (nalbuphine ER) compared to 25.7% reduction with placebo, 52% placebo-adjusted reduction in geometric mean percent change in daytime cough frequency (p<0.0001).
Lead Product(s): Nalbuphine
Therapeutic Area: Dermatology Product Name: Haduvio
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2022
Details:
Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint as measured by a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) (p=0.0157).
Lead Product(s): Nalbuphine
Therapeutic Area: Dermatology Product Name: Haduvio
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2022
Details:
Company intends to use net proceeds from the private placement for the clinical development of Haduvio (Nalbuphine ER), a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist for chronic cough in IPF and working capital and other general corporate purposes.
Lead Product(s): Nalbuphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Haduvio
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Frazier Life Sciences
Deal Size: $55.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 07, 2022
Details:
The primary efficacy endpoint demonstrated a 77.3% reduction in daytime cough frequency from baseline with use of Haduvio compared to a 25.7% reduction with placebo, demonstrating a 52% placebo-adjusted reduction in geometric mean percent change in daytime cough frequency.
Lead Product(s): Nalbuphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Haduvio
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
Interim analysis showed primary efficacy endpoint of cough reduction was highly statistically significant (p<0.0001) for Haduvio (nalbuphine ER) in idiopathic pulmonary fibrosis patients (IPF) suffering from chronic cough, establishing proof of concept.
Lead Product(s): Nalbuphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Haduvio
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2022
Details:
Phase 2b/3 PRISM trial enrollment completed for Haduvio (nalbuphine ER), mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist for the treatment of pruritus associated with prurigo nodularis.
Lead Product(s): Nalbuphine
Therapeutic Area: Dermatology Product Name: Haduvio
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
The Company will use the net proceeds from the private placement for the development of an investigational therapy Haduvio™, an oral extended-release (ER) formulation of nalbuphine to treat serious neurologically mediated conditions.
Lead Product(s): Nalbuphine
Therapeutic Area: Dermatology Product Name: Haduvio
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Stifel
Deal Size: $11.8 million Upfront Cash: Undisclosed
Deal Type: Private Placement September 30, 2021
Details:
LT1001 is the world's first week-long extended-release analgesic injection. The approval from Singapore has significance in accelerating the introduction of LT1001 in Southeast Asia.
Lead Product(s): Nalbuphine
Therapeutic Area: Neurology Product Name: LT1001
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
Details:
Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a trial that was paused due to IPF patients being an at-risk population for COVID-19.
Lead Product(s): Nalbuphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Haduvio
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
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