| Thursday | ||||
US Large Cap Biotech… US Large Cap Biotech Analyst Kasimov holds a conference call with CEO Greene and CFO Iguchi and CRO Doherty on December 2 at 2 pm hosted by JPMorgan. | ||||
US Large Cap Biotech… US Large Cap Biotech Analyst Kasimov holds a conference call with CEO Greene and CFO Iguchi and CRO Doherty on December 2 at 2 pm hosted by JPMorgan. | ||||
| Wednesday | ||||
Sage Therapeutics (SAGE)… Sage Therapeutics (SAGE) and Biogen (BIIB) announced 12-month data for the cohort of patients who received zuranolone 50 mg once nightly for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study and had the opportunity to be followed for 12-months. The SHORELINE Study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with major depressive disorder - MDD - and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year. For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received. Zuranolone has demonstrated improvements in depressive symptoms and a well-tolerated safety profile throughout the LANDSCAPE clinical program. Secondary endpoints included the percentage of patients who received repeat dosing with zuranolone as well as response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression. In the zuranolone 50 mg cohort, nearly 75% of patients responded to the initial 2-week treatment course. Of those who responded to the initial course and continued in the study, approximately 80% of those patients received at most one additional zuranolone treatment during their time in the study. Enrollment of an anticipated 300 additional patients in the 50 mg cohort is ongoing. The companies plan to present additional data from the ongoing SHORELINE Study in future scientific forums. | ||||
| Monday | ||||
Sage Therapeutics… Sage Therapeutics announced that it will host Sage FutureCast: An R&D and Portfolio Review on Tuesday, December 14 from 8:00 a.m. to 10:00 a.m. ET. Sage FutureCast will discuss the Company's research and development strategy, and clinical progress in programs throughout the depression, neurology, and neuropsychiatry franchises including zuranolone, SAGE-324 and SAGE-718, respectively. | ||||
| Over a week ago | ||||
Mizuho analyst Vamil… Mizuho analyst Vamil Divan lowered the firm's price target on Sage Therapeutics to $44 from $52 and keeps a Neutral rating on the shares. | ||||
| Over a month ago | ||||
H.C. Wainwright analyst… H.C. Wainwright analyst Douglas Tsao lowered the firm's price target on Sage Therapeutics to $55 from $80 and keeps a Neutral rating on the shares. The analyst says the primary endpoint modification for CORAL "could complicate the regulatory review as Sage focuses on totality of the data." The move likely to adds confusion to an already complex regulatory dossier and signals the company's lack of confidence in the original 15-day endpoint, Tsao tells investors in a research note. The analyst sees continued uncertainty around zuranolone. | ||||
RBC Capital analyst Brian… RBC Capital analyst Brian Abrahams lowered the firm's price target on Sage Therapeutics to $48 from $52 and keeps a Sector Perform rating on the shares after the company reported Q3 results and made changes to the design of its CORAL trial of zuranolone that "should not be a huge surprise to many." While the changes should improve the trial's likelihood of success, which would potentially make the zuranolone MDD regulatory filing more straightforward, they are unlikely to improve investor or physician confidence in the drug's durability of effect, which is still "the key commercial question," said Abrahams. His lowered target reflects adjustments accounting for operating expenses, CORAL changes, and revised timelines for the company's programs, Abrahams noted. | ||||
Piper Sandler analyst… Piper Sandler analyst Yasmeen Rahimi said that although she was "a little surprised" by Sage Therapeutics' decision to shift its primary endpoint for the CORAL adjunctive study from change in HAM-D17 at Day 15 to change in HAM-D17 at Day 3, she believes that that the decision to shorten the primary readout increases the probability of hitting statistical significance based on evidence from previous studies. This could provide a boost to the zuranolone NDA package with an additional positive study, said Rahimi. She was also surprised with the announcement of the CMO departure, but called it "a personal decision and not associated with any red flags." Rahimi reiterates an Overweight rating on Sage with a $100 price target for the shares. | ||||
Guggenheim analyst Yatin… Guggenheim analyst Yatin Suneja upgraded Sage Therapeutics to Buy from Neutral with a $55 price target following the company's Q3 results. On the conference call, Sage announced that the primary endpoint for the ongoing CORAL study, evaluating zuranolone when co-administered with a new antidepressant therapy has been changed to Day 3 vs. Day 15 like previous studies, and Suneja tells investors in a research note that the study is now powered to be statistically significant at this new endpoint. Suneja thinks not having another "failed study" is important, and showing such a rapid relief on a primary endpoint can be effectively marketed, which could make the positioning of the drug even better, if successful. | ||||
Guggenheim analyst Yatin… Guggenheim analyst Yatin Suneja upgraded Sage Therapeutics to Buy from Neutral with a $55 price target. | ||||
