Rhythm Pharmaceuticals Inc. (RYTM) shares plummeted 8.08% in after-hours on Friday, January 14, 2022, and closed the daily trading at $8.30. However, in the regular trading session on Friday, RYTM’s stock gained 4.88%. RYTM shares have fallen 73.64% over the last 12 months, and they have moved down 3.01% in the past week. Over the past three months, the stock has lost 20.16%, while over the past six months, it has plunged 51.94%.
Let’s see what are the latest news about the company?
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RYTM dosed the first patient with setmelanotide
On January 13, 2022, Rhythm Pharmaceuticals, Inc. (RYTM) dosed the first patient with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, in the Phase 2 DAYBREAK clinical trial to treat the severe obesity and hyperphagia potentially caused by a genetic variant that impairs the function of the MC4R pathway. The company also announced the dosing of the first patient in the Phase 3 trial evaluating a switch from the daily to a novel weekly formulation of setmelanotide.
The DAYBREAK trial is evaluating setmelanotide in patients who carry a confirmed variant in one or more of 31 genes with strong or very strong relevance to the MC4R pathway, which regulates the body’s energy balance, including appetite, energy expenditure, and body weight. The result will identify future patient populations and inform the design of future registrational studies to support setmelanotide label expansion.
RYTM agreement with RareStone Ltd
On December 06, 2021, Rhythm Pharmaceuticals, Inc. (RYTM) and RareStone LTD, formerly Citrine Medicine, announced an exclusive licensing agreement for the development and commercialization of IMCIVREE® (setmelanotide) in China.
This is the first licensing agreement by the company to expand its footprints into Asia and is designed to accelerate patient access to IMCIVREE.
FDA accepted RYTM sNDA for IMCIVREE
On November 15, 2021, the U.S. Food and Drug Administration (FDA) accepted Rhythm Pharmaceuticals, Inc. (RYTM) New Drug Application (sNDA) for IMCIVREE® (setmelanotide), for patients with Bardet-Biedl syndrome (BBS) or Alström syndrome. The FDA granted a Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2022.
RYTM latest financial results
On November 02, 2021, Rhythm Pharmaceuticals, Inc. (RYTM) reported financial results for the third quarter that ended September 30, 2021.
Q3 2021 financial highlights
- After approval of IMCIVREE, RYTM reported revenue of $1.0 million for the third quarter of 2021 compared to zero revenue in Q3 2020.
- Total cost and expenses were $45.3 million in Q3 2021 compared to $34.3 million in Q3 2020.
- It suffered a net loss of $35.1 million, or a net loss per basic and diluted share of $0.70 for the third quarter of 2021, as compared to a net loss of $33.8 million, or a net loss per basic and diluted share of $0.77 for the third quarter of 2020.
- The company ended the third quarter with cash, cash equivalents, and short-term investments of approximately $328.4 million compared to $172.8 million as of December 31, 2020.
The stock went up in the regular trading after the company announced the previous day that it dosed the first patient with setmelanotide but there was no reason for its decline in the after-hours session on Friday.