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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Rhythm Pharmaceuticals Inc | NASDAQ:RYTM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
2.42 | 5.53% | 46.18 | 43.42 | 46.00 | 44.37 | 42.71 | 43.78 | 982,464 | 01:00:00 |
“We enter 2021 with tremendous momentum on our journey to transform the care of people with rare genetic diseases of obesity,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “In recent months, we secured our first approval of IMCIVREE, validating the melanoticortin-4 receptor (MC4R) pathway as an important therapeutic target and bringing the first-ever therapy to people suffering from obesity due to POMC, PCSK1 or LEPR deficiency. The patients with defects in the MC4R pathway we have studied to date, including those with our approved indications and patients who participated in our Phase 2 Basket Study, have severe obesity and have largely failed other treatment modalities.”
Dr. Meeker continued, “We also announced positive topline data from our pivotal, Phase 3 trial in Bardet-Biedl syndrome (BBS), and we achieved proof-of-concept in multiple additional genetic diseases of obesity, paving the way for a potentially registration-enabling trial this year. On the heels of these recent achievements, we are entering our next phase as we begin to commercialize IMCIVREE and work to expand setmelanotide’s reach to address the unmet needs of many more people with a range of genetic variants in the MC4R pathway. We look forward to completing regulatory submissions to both the FDA and the EMA seeking marketing authorization for setmelanotide for the treatment of obesity in patient with BBS in the second half of 2021 and, in parallel, initiating new trials in a broad clinical program. Following the sale of our priority review voucher (PRV) and recent public offering, we are well-funded, with sufficient resources to advance the development of setmelanotide while supporting the patient community and driving awareness of genetic testing to identify and properly diagnose people with these rare conditions.”
Fourth Quarter and Recent Business Highlights:
Pipeline and Recent Developments:
Corporate:
Key Upcoming Milestones:
Rhythm expects to achieve the following milestones in 2021:
Commercial and Regulatory Milestones:
Clinical Milestones:
Fourth Quarter and Full Year 2020 Financial Results:
Financial Guidance: Based on its current operating plans, Rhythm expects that its existing cash, cash equivalents and short-term investments as of December 31, 2020, together with an aggregate of approximately $260.1 million in net proceeds from the February 2021 sale of its Rare Disease PRV and the February 2021 follow-on public offering, will be sufficient to fund its operating expenses and capital expenditure requirements through at least the second half of 2023.
About Rhythm PharmaceuticalsRhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity. The Company’s precision medicine, IMCIVREE™ (setmelanotide), has been approved by the FDA for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing. IMCIVREE is the first-ever FDA approved therapy for these rare genetic diseases of obesity. Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity. The Company is leveraging the Rhythm Engine and the largest known obesity DNA database - now with approximately 37,500 sequencing samples - to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.
IMCIVREE™ (setmelanotide) Indication IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The condition must be confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
Limitations of Use
IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE. Instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.
Skin Pigmentation and Darkening of Pre-Existing Nevi: IMCIVREE may cause generalized increased skin pigmentation and darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants.
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONSDiscontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
Treatment with IMCIVREE is not recommended for use while breastfeeding. To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See Full Prescribing Information for IMCIVREE.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including the anticipated timing for initiation of clinical trials and release of clinical trial data and our expectations surrounding potential regulatory submissions, approvals and timing thereof, our business strategy and plans, including regarding commercialization of setmelanotide, management changes, our participation in upcoming events and presentations, and the sufficiency of our cash, cash equivalents and short-term investments to fund our operations. Statements using word such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, the impact of our management transition, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
Condensed Consolidated Statements of Operations(in thousands, except share and per share data)
Three months ended December 31, | Year ended December 31, | ||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 21,954 | $ | 24,810 | $ | 90,450 | $ | 109,450 | |||||||||
Selling, general, and administrative | 13,119 | 9,414 | 46,125 | 36,550 | |||||||||||||
Total operating expenses | 35,073 | 34,224 | 136,575 | 146,000 | |||||||||||||
Loss from operations | (35,073 | ) | (34,224 | ) | (136,575 | ) | (146,000 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Interest income, net | 176 | 1,268 | 2,579 | 5,271 | |||||||||||||
Total other income: | 176 | 1,268 | 2,579 | 5,271 | |||||||||||||
Net loss | $ | (34,897 | ) | $ | (32,956 | ) | $ | (133,996 | ) | $ | (140,729 | ) | |||||
Net loss per common share, basic and diluted | $ | (0.79 | ) | $ | (0.78 | ) | $ | (3.04 | ) | $ | (3.86 | ) | |||||
Weighted average common shares outstanding,basic and diluted | 44,216,694 | 42,213,180 | 44,127,220 | 36,422,450 |
RHYTHM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31, | December 31, | |||||||
2020 | 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 100,854 | $ | 62,294 | ||||
Short-term investments | 71,938 | 230,165 | ||||||
Prepaid expenses and other current assets | 8,876 | 9,945 | ||||||
Total current assets | 181,668 | 302,404 | ||||||
Property and equipment, net | 3,195 | 3,671 | ||||||
Right-of-use asset | 1,807 | 2,045 | ||||||
Restricted cash | 403 | 403 | ||||||
Total assets | $ | 187,073 | $ | 308,523 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 4,900 | $ | 10,415 | ||||
Accrued expenses and other current liabilities | 12,559 | 13,530 | ||||||
Lease liability | 535 | 472 | ||||||
Total current liabilities | 17,994 | 24,417 | ||||||
Long-term liabilities: | ||||||||
Lease liability | 2,551 | 3,086 | ||||||
Total liabilities | 20,545 | 27,503 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2020 and December 31, 2019 | — | — | ||||||
Common stock | 44 | 44 | ||||||
Additional paid-in capital | 625,762 | 606,307 | ||||||
Accumulated other comprehensive income | 49 | — | ||||||
Accumulated deficit | (459,327 | ) | (325,331 | ) | ||||
Total stockholders’ equity | 166,528 | 281,020 | ||||||
Total liabilities and stockholders’ equity | $ | 187,073 | $ | 308,523 |
Corporate Contact:David ConnollyHead of Investor Relations and Corporate CommunicationsRhythm Pharmaceuticals, Inc.857-264-4280dconnolly@rhythmtx.com
Investor Contact:Hannah DeresiewiczStern Investor Relations, Inc.212-362-1200hannah.deresiewicz@sternir.com
Media Contact:Adam Daley Berry & Company Public Relations212-253-8881adaley@berrypr.com
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