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Details:
The Company intends to use the proceeds to fund its clinical development programs, including, IMCIVREE (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, approved by the U.S. Food and Drug Administration for chronic weight management.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Perceptive Advisors LLC
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 01, 2024
Details:
Imcivree (setmelanotide) is a MC4 receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity. It is being evaluated for the treatment of hypothalamic obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2024
Details:
Imcivree (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the FDA for chronic weight management. It is under phase 3 clinical trials for the treatment of hypothalamic obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
Details:
Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist. It is the first and only therapy approved in Canada for weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome (BBS).
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist, which is investigated for the treatment of treatment for acquired hypothalamic obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
Under the agreement, Genpharm will distribute Imcivree (setmelanotide) to patients in GCC countries for the treatment of hyperphagia and obesity due to Bardet-Biedl syndrome or genetically-confirmed biallelic pro-opiomelanocortin, PCSK1, or leptin receptor deficiency.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Genpharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 22, 2023
Details:
Imcivree (setmelanotide acetate), recently Canada approved, is a MC4 receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity and Control of hunger in bardet-biedl syndrome.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2023
Details:
Imcivree (setmelanotide acetate) is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity and Control of hunger in bardet-biedl syndrome.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2023
Details:
Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Rhythm Pharmaceuticals
Deal Size: $211.0 million Upfront Cash: $5.0 million
Deal Type: Acquisition February 27, 2023
Details:
Imcivree (setmelanotide acetate) is an MC4 receptor agonist with 20-fold less activity at the MC3 and MC1 receptors. MC4 receptors in the brain are involved in regulation of hunger, satiety, and energy expenditure. It is approved for POMC, PCSK1, LEPR, BBS disorders.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2023
Details:
The safety profile observed in this study was consistent with that observed with Imcivree (setmelanotide) in previous clinical trials in patients with other rare MC4R pathway diseases. Skin hyperpigmentation (n=23; 60.5%) was the most common adverse event (AE).
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2022
Details:
Imcivree (setmelanotide), has shown significant potential to transform the care of individuals living with the onset of extreme weight gain from hypothalamic obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2022
Details:
Setmelanotide, an MC4R agonist marketed as IMCIVREE®, previously received Breakthrough Designation while being developed for Bardet-Biedl syndrome and proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) and leptin receptor (LEPR) deficiencies.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Details:
Imcivree (setmelanotide) is a MC4R agonist. The MC4R is part of the key biological pathway that regulates hunger, caloric intake and energy expenditure. Variants in genes may impair the function of the MC4R pathway, potentially leading to hyperphagia and obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
Rhythm intends to use the net proceeds from this offering to advance global commercialization of IMCIVREE for obesity due to POMC, PCSK1 or LEPR deficiency and BBS, to advance clinical development of setmelanotide in hypothalamic obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Cowen
Deal Size: $124.8 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 19, 2022
Details:
Setmelanotide (imcivree) is indicated for the treatment of obesity and genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic leptin receptor deficiency in adults and children 6 years of age and above.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
Proceeds will be used to fund the Company’s lead asset, Imcivree (setmelanotide acetate), and support intellectual property development, other commercial activities, and for general working capital purposes.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Cowen
Deal Size: $4.8 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 14, 2022
Details:
Imcivree (setmelanotide) is indicated for treatment of obesity and control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic pro-opiomelanocortin, including PCSK1, deficiency or biallelic leptin receptor deficiency.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: HealthCare Royalty Partners
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
IMCIVREE® (setmelanotide) is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-offunction biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
Imcivree (setmelanotide) also achieved a meaningful reduction in hunger scores. Consistent with prior clinical experience in other rare MC4R pathway diseases, setmelanotide was observed to be generally well tolerated.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Rhythm intends to use the proceeds from the Agreement and its cash on hand to support global commercialization efforts for IMCIVREE® (setmelanotide) and ongoing clinical development.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: HealthCare Royalty Partners
Deal Size: $100.0 million Upfront Cash: $37.5 million
Deal Type: Agreement June 16, 2022
Details:
IMCIVREE (setmelanotide acetate) indicated for chronic weight management in adult and pediatric patients 6 years old and older with monogenic or syndromic obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency, or BBS.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2022
Details:
New data showed Imcivree (setmelanotide) treatment led to clinically meaningful improvements in lipid parameters, without affecting blood pressure or heart rate in patients with BBS.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
Imcivree (setmelanotide) is a melanocortin-4 receptor (MC4R) agonist designed to address the underlying cause of obesities driven by genetic variants that impair function of the MC4R pathway.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Nutrition and Weight Loss Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
This licensing agreement marks the first expansion of Rhythm’s pipeline into Asia and is designed to accelerate patient access to IMCIVREE where there remains significant unmet need to address the severe, early-onset obesity and hyperphagia.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: RareStone
Deal Size: $75.5 million Upfront Cash: $12.0 million
Deal Type: Licensing Agreement December 06, 2021
Details:
Phase 2 Basket trial demonstrated setmelanotide’s ability to reduce hunger in people living with rare genetic diseases of obesity in the trial, further reinforcing confidence in the DAYBREAK and EMANATE trials.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
Setmelanotide resulted in clinically meaningful improvement in HRQOL in eight of 13 (73%) of patients after 52 weeks of treatment, with improvements in HRQOL that were 2 to 3 times larger than the relevant meaningful threshold.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
Details:
Setmelanotide, an MC4R agonist used in patients with five distinct rare genetic diseases of obesity, including patients whose obesity is linked to certain variants of the SRC1 or SH2B1 genes and Bardet-Biedl syndrome.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2021
Details:
IMCIVREE® (setmelanotide) is a melanocortin 4 (MC4) receptor agonist used for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with Bardet-Biedl syndrome (BBS) or Alström syndrome.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2021
Details:
IMCIVREE was approved on November 2020 by the U.S.FDA for chronic weight management in adults and pediatric patients 6 years of age and older with obesity due to POMC, proprotein convertase subtilisin/kexin type 1 (PCSK1) or LEPR deficiency confirmed by genetic testing.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Medison Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 22, 2021
Details:
As an MC4 receptor agonist, setmelanotide is designed to restore impaired MC4 receptor pathway activity arising due to genetic deficits upstream of the MC4 receptor.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Imcivree
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2021
Details:
Additional poster presentations include Phase 3 data in Bardet-Biedl and Alström syndromes and analyses of adverse events in Phase 2 and Phase 3 studies in POMC, PCSK1, or LEPR deficiency showing consistent safety results for setmelanotide.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2021
Details:
Phase 2 Basket Study responder rates and updated sequencing results suggest 100,000-200,000 potentially setmelanotide-responsive HET POMC, PCSK1 or LEPR deficiencies and SRC1 or SH2B1 deficiency obesity patients in U.S.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
Setmelanotide is Rhythm Pharma's melanocortin-4 receptor (MC4R) agonist, for the treatment of insatiable hunger and severe obesity in individuals with Alström syndrome. The data showed that setmelanotide reduced weight and alleviated hunger in BBS patients.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-439
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 December 22, 2020
Details:
Interim data from Phase 2 study showed that once-weekly formulation of setmelanotide achieved safety and efficacy results comparable to daily-dosing formulation.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Data from the studies demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, led to statistically significant and clinically meaningful reductions of weight and hunger.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2020
Details:
Data from the study demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, reduced body weight and hunger in individuals with BBS.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Company has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency for setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
U.S. FDA has granted rare pediatric disease designations for setmelanotide, an investigational melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
Healthy obese people treated with the weekly formulation of setmelanotide achieved comparable weight loss to those treated with the daily formulation, and both weekly and daily formulations of setmelanotide were observed to be safe and well-tolerated.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: RM-493
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
Details:
FDA has accepted the company's New Drug Application (NDA) for setmelanotide, an investigational, melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease 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 May 13, 2020
Details:
Rhythm is currently evaluating setmelanotide’s ability to reduce hunger and affect weight loss in an ongoing pivotal Phase 3 trial in patients living with Alström and Bardet-Biedl syndromes.
Lead Product(s): Setmelanotide Acetate
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
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