| Wednesday | ||||
Conference call to… Conference call to provide an update on Phase 2 Basket Study and genetic sequencing efforts will be held on January 26 at 8 am. Webcast Link | ||||
| Tuesday | ||||
Rhythm Pharmaceuticals… Rhythm Pharmaceuticals announced that it plans to host a virtual event on Tuesday, January 26, 2021 from 8 to 10 a.m. ET to provide an update on its ongoing exploratory Phase 2 Basket Study and genetic sequencing efforts. At the event, Rhythm management plans to report data for setmelanotide in individuals living with heterozygous obesity due to genetic variants in one of two alleles of the POMC, PCSK1 or LEPR gene, as well as SRC1 and SH2B1 deficiency obesities, and plans to provide an update on data from the Company's sequencing efforts, which now comprises samples from approximately 37,500 individuals with severe obesity. | ||||
| Over a week ago | ||||
Stifel analyst Derek… Stifel analyst Derek Archila raised the firm's price target on Rhythm Pharmaceuticals to $36 from $35 and keeps a Buy rating on the shares while naming it one of his two top picks for 2021 in the small to mid cap biotech space. He thinks results from the ongoing Phase 2 basket trial and an upcoming update on the potential for a Phase 3 registrational basket trial for IMCIVREE could "meaningfully expedite" expanding IMCIVREE's total addressable market "many times over," Archila tells investors. | ||||
Rhythm Pharmaceuticals… Rhythm Pharmaceuticals announced that it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $100M. The PRV was granted to Rhythm by the U.S. Food and Drug Administration with the approval of IMCIVREE for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing. According to the agreement, Rhythm will receive an upfront payment of $100M upon the closing of the transaction, which is subject to customary closing conditions and is expected to occur following expiration of the applicable U.S. antitrust clearance requirements. Jefferies LLC acted as exclusive financial advisor to Rhythm on this transaction. Latham & Watkins LLP acted as legal advisor to Rhythm. The non-dilutive funds expected from this transaction are in addition to the $201.8M in cash, cash equivalents and short-term investments Rhythm reported as of September 30, 2020. | ||||
| Over a month ago | ||||
Rhythm Pharmaceuticals… Rhythm Pharmaceuticals announced positive topline results from a pivotal Phase 3 clinical trial evaluating setmelanotide, the company's melanocortin-4 receptor agonist, for the treatment of insatiable hunger and severe obesity in individuals with Bardet-Biedl syndrome or Alstrom syndrome. The study met its primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in weight and hunger scores. All primary endpoint responders were patients with BBS. There were three evaluable patients with Alstrom syndrome and none of them met the primary endpoint. Rhythm enrolled 32 individuals with BBS and six individuals with Alstrom syndrome in the pivotal cohort for this Phase 3 trial. The primary analysis was conducted on 31 evaluable participants 12 years old and older. Five study participants were younger than 12 years old at enrollment. The analysis of the primary endpoint shows: 11 of 31 or 34.5 percent1 of participants achieved the primary endpoint of at least 10 percent reduction in body weight from baseline at approximately 52 weeks of therapy; 11 of 28 patients with BBS achieved 10 percent reduction in body weight; 0 of 3 patients with Alstrom syndrome achieved 10 percent reduction in body weight. The analysis of the key secondary endpoints shows: Mean reduction from baseline in body weight was -6.2 percent; Mean reduction from baseline in most hunger rating was -30.8 percent; 60.2 percent of participants achieved at least 25 percent reduction in most hunger scores from baseline at approximately 52 weeks of therapy. Consistent with prior clinical experience, setmelanotide was generally well tolerated: Treatment-emergent adverse events included mild injection site reactions and nausea with infrequent vomiting; There were no serious adverse events related to treatment with setmelanotide; Eight patients discontinued from study drug treatment during the trial, five due to AEs, and three for other reasons. Rhythm plans to complete regulatory submissions to both the U.S. Food and Drug Administration and the European Medicines Association for BBS in the second half of 2021. The company expects to finalize a path forward for Alstrom syndrome upon completing a full analysis of the final data from this trial. | ||||
Rhythm Pharmaceuticals… Rhythm Pharmaceuticals (RYTM) announced the appointments of Camille Bedrosian, M.D., and Lynn Tetrault, J.D., to its Board of Directors. Bedrosian serves as EVP and CMO at Ultragenyx Pharmaceutical (RARE). Tetrault spent more than 20 years at AstraZeneca (AZN), including seven years as EVP for Human Resources and Corporate Affairs. | |
Goldman Sachs analyst… Goldman Sachs analyst Graig Suvannavejh keeps a Sell rating and unchanged $18 price target on Rhythm Pharmaceuticals after FDA approval for Imcivree came on time and per his expectations with a "reasonable" label that seems to him to be consistent with prior approvals requiring genetic testing for confirmation of disease and drug eligibility. The label's warnings could potentially limit market uptake, contends Suvannavejh, who maintains his view that consensus 2021/2022 estimates remain too high for Rhythm. | |
Ladenburg Thalmann… Ladenburg Thalmann analyst Michael Higgins reiterates a Buy rating on Rhythm Pharmaceuticals with a $43 price target after Imcivree received FDA approval for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency. Rhythm also received a Pediatric Review Voucher due to the early onset of disease, though the company has not yet indicated whether it will sell or keep the PRV, Higgins tells investors in a research note. The analyst believes the company will sell its PRV for $100M. The PRV and cash should get Rhythm to profitability in 2022, says Higgins. | |
BofA analyst Tazeen Ahmad… BofA analyst Tazeen Ahmad downgraded Rhythm Pharmaceuticals to Neutral from Buy with a price target of $33, up from $27. The analyst cites the FDA approval of IMCIVREE announced on Friday for the treatment of obesities due to POMC/PCSK1 and LepR deficiencies, modeling 300 POMC patients and 1,250 LepR patients in the US, but noting that the upside from bigger markets is largely "baked in" to the stock. Ahmad further states that Rhythm will make Imcivree available to patients starting in Q1 of 2021, with aggregate pricing in the range of $290K-$300K per patient annually. | |
Stock futures saw modest…
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