IMCIVREE ™ (setmelanotide) IMCIVREE indication is indicated for chronic weight management in adult and paediatric patients over 6 years of age who are obese due to proopiomelanocortin (POMC), proprotein convertase subtylazine / kexin type 1 (PCSK1) or leptin receptor (LEPR). The condition should be demonstrated by genetic tests demonstrating variants in the POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, in all likelihood pathogenic or of dubious importance (SUV).
IMCIVREE is not indicated for the treatment of patients with the following situations because IMCIVREE deserves not to be effective:
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WARNINGS AND PRECAUTIONS
Interruption of sexual arousal: The effects of sexual appearance would possibly occur in patients treated with IMCIVREE. Spontaneous erections of the penis in men and effects of sexual appearance in women occurred in clinical studies with IMCIVREE. Ask patients with an erection that lasts more than four hours to see an emergency. Doctor.
Skin pigmentation and darkening of a pre-existing nevo: IMCIVREE can cause a general accumulation of skin pigmentation and a darkening of the pre-existing nevo due to its pharmacological effect; this effect is reversible when the medicine is discontinued. skin before onset and periodically the IMCIVREE remedy to control new and pre-existing skin pigment lesions.
Risk of serious side effects due to benzyl alcohol preservatives in infants and babies with low birth weight: IMCIVREE is approved for use in newborns or infants.
ADVERSE EFFECTS
USE IN SPECIAL POPULATIONS Stop IMCIVREE when pregnancy is recognized, unless the benefits of the remedy outweigh the potential dangers to the fetus.
Refer to the full dose of IMCIVREE.
Forward-Looking Statements This press release comprises forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that do not relate to past facts are worth considering as forward-looking statements. adding, without limitation, statements regarding the prospective, safety, efficacy and regulatory and clinical progress of setmelanotide, adding the expected timing of clinical trial initiation and publication of clinical trial knowledge and our expectations regarding prospective regulatory approvals and the timing of these, our business strategy plans, adding with respect to the commercialization of setmelanotide, leadership adjustments, our participation in future occasions and presentations, and our adequacy of the flow of money, our money equivalents and our investments to cor the term to finance our activities. Statements that use words such as “expect”, “anticipate”, “believe”, “can”, “will” and similar terms are also forward-looking statements. Such statements are subject to many dangers and uncertainties and add to, but are not limited to, the effect on our control transition, our ability to enroll patients in clinical trials, the design and effects of clinical trials. competition, the ability to meet or offload required regulatory approvals, hazards related to research and knowledge reporting, our flow of money and expenses, all have an effect on the COVID-19 pandemic in our business and operations, adding our studies, clinical trials and marketing perspectives, and general economic conditions, and other significant points discussed under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other documents filed with the Stock Market and Securities Commission. Except as required by law, we do not assume any legal responsibility to review the forward-looking statements contained in this press release or to update them to reflect occasions or events that occur after the date of this press release, whether as a result of new information. , in the future. advances or otherwise.
Consolidated condensed income statements (thousands, inventory, and consistent with percentage data)
Investor Contact: Hannah Deresiewicz, Stern Investor Relations, Inc. 212-362-1200hannah. deresiewicz@sternir. com
Media Contact: Adam Daley Berry