|Over a week ago|
Seres Therapeutics price target raised to $38 from $34 at Oppenheimer » 16:5611/0911/09/20
Oppenheimer analyst Mark…
Oppenheimer analyst Mark Breidenbach raised the firm's price target on Seres Therapeutics to $38 from $34 and keeps an Outperform rating on the shares after its Q3 results earlier this morning. The analyst notes that following the positive ECOSPOR-III data in recurrent Clostridium difficile infection, the top priority for Seres is enrolling patients into the open-label ECOSPOR-IV extension study to satisfy safety database requirements ahead of a potential registrational filing. Breidenbach adds that the long-term safety/efficacy results from ECOSPOR-III could help drive investigator enthusiasm and accelerate ECOSPOR-IV enrollment.
Seres Therapeutics price target raised to $49 from $40 at Piper Sandler » 12:3011/0911/09/20
Piper Sandler analyst…
Piper Sandler analyst Edward Tenthoff raised the firm's price target on Seres Therapeutics to $49 from $40 and keeps an Overweight rating on the shares. The FDA confirmed that positive Phase III ECOSPOR-III trial would meet efficacy requirements and that a total of 300 rCDI patients are necessary for the safety database, Tenthoff tells investors in a research note, adding that Seres is enrolling the SER-109 OLE study to generate for BLA filing, which is anticipated in 2021. Additionally, the analyst notes that Seres dosed the first UC patient in the Phase Ib study of fermented SER-301 and expects to file an IND for SER-155 in HSCT patients in early 2021.
Seres Therapeutics reports Q3 EPS ,(36c) consensus (25c) » 07:0811/0911/09/20
Reports Q3 revenue…
Reports Q3 revenue $1.42M, consensus $7.28M."Supported by our positive, highly significant SER-109 Phase 3 results, we expect SER-109 to be the first-ever microbiome therapy approved by the U.S. FDA. Following those remarkable SER-109 study data and a significant capital infusion, Seres is in the midst of transformational growth toward becoming a commercial-stage microbiome company, with a broad portfolio of promising therapeutic candidates. We are expanding our field-leading capabilities across R&D, manufacturing, and commercial operations to maximize the multitude of opportunities we see for our approach," said Eric Shaff, President and Chief Executive Officer of Seres. "Our immediate priorities are to drive enrollment in our SER-109 open-label study to fulfill our safety database requirements and prepare to file a Biologics License Application (BLA), while also preparing the Company for the potential commercialization of SER-109." "In tandem, we continue to advance our deep microbiome pipeline, including SER-287, SER-301, SER-401, and SER-155. These therapeutic candidates span infectious diseases, inflammatory disease, and cancer, and we believe all have the potential to fundamentally improve upon the current standard of care. Most recently, we were pleased to dose the first subject in our SER-301 Phase 1b study in patients with ulcerative colitis. Moving forward, we expect to reach a number of value-creating milestones across multiple therapeutic areas," concluded Mr. Shaff.
Seres Therapeutics doses first patient in SER-301 trial » 07:3011/0611/06/20
Seres Therapeutics announced that it has dosed the first patient in its Phase 1b trial evaluating SER-301 for the treatment of active mild-to-moderate ulcerative colitis, or UC. SER-301 is an oral, rationally-designed microbiome therapeutic designed to dampen the aberrant gastrointestinal inflammation central to ulcerative colitis and induce clinical remission in patients suffering from active UC. SER-301 is designed to modify the gastrointestinal microbiome and microbe-associated metabolites to modulate multiple pathways associated with ulcerative colitis. SER-301 is a consortium of bacteria designed using Seres' reverse translational discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments using human cell-based assays and in vitro and in vivo disease models. SER-301 is designed to reduce induction of pro-inflammatory activity, improve epithelial barrier integrity and TNF driven inflammation in intestinal epithelial cells, and modulate UC-relevant anti-inflammatory, innate and adaptive immune pathways. The design of SER-301 incorporated learnings obtained through the Company's prior SER-287 Phase 1b clinical study conducted in patients with ulcerative colitis. SER-287 Phase 1b study results demonstrated favorable pharmacodynamic changes, signals of clinical activity, and a favorable safety profile. SER-301 was developed with innovative and novel manufacturing methods that do not require human donor material. It includes strains delivered in spore form and strains fermented in non-spore form. The product candidate is delivered using enterically-protected technology designed to release in the colon. GMP manufacturing technologies developed through the SER-301 program broaden the breadth of biology that can be incorporated into Seres' microbiome therapeutics.
Seres Therapeutics price target raised to $34 from $29 at Oppenheimer » 07:3910/2710/27/20
Oppenheimer analyst Mark…
Oppenheimer analyst Mark Breidenbach raised the firm's price target on Seres Therapeutics to $34 from $29 and keeps an Outperform rating on the shares. The analyst notes that Seres has presented updated results from its Phase 3 ECOSPOR III trial of SER-109 in multiply recurrent Clostridium difficile infection. Breidenbach believes SER-109's durable efficacy, coupled with clean safety, could help SER-109 secure a dominant share of the recurrent CDI market. As such, he has increased his worldwide peak sales estimates for SER-109 to $850M from $600M.
Seres Therapeutics price target raised to $34 from $29 at Oppenheimer » 16:0510/2610/26/20
Oppenheimer analyst Mark…
Oppenheimer analyst Mark Breidenbach raised the firm's price target on Seres Therapeutics to $34 from $29 and reiterates an Outperform rating on the shares after the company presented updated results from its Phase 3 ECOSPOR III trial of SER-109 in multiply recurrent clostridium difficile infection. At 12 weeks, the trial showed evidence of durable protection against CDI recurrence, with a 31.1% treatment delta between active and placebo arms of the trial, Breidenbach tells investors in a research note. The analyst believes SER-109's "durable" efficacy and "clean" safety could help it secure a "dominant shar" of the recurrent CDI market.
|Over a month ago|
Seres Therapeutics appoints David Ege as CTO, Jayne Gansler as CPO » 07:1410/2210/22/20
Seres Therapeutics (MCRB)…
Seres Therapeutics (MCRB) announced the expansion of its leadership team with the appointments of David Ege as executive VP, CTO and Jayne Gansler as executive VP, CPO. Ege brings to the role of CTO more than 15 years of experience in the pharmaceutical industry with a focus on manufacturing and developing vaccines and biologics. He joins Seres after an extensive career at Merck (MRK), where he worked on a number of breakthrough, novel products with complex manufacturing. Gansler brings to the newly created role of CPO more than 25 years of experience leading global human resources organizations in the biotechnology, pharmaceutical and medical device industries. Prior to joining Seres, Gansler was senior VP, head of human resources at Ariad Pharmaceuticals and served as a leader during a time of significant change that included the sale and integration of Ariad.
Seres Therapeutics price target raised to $42 from $38 at Canaccord » 07:2009/2109/21/20
Canaccord analyst John…
Canaccord analyst John Newman raised the firm's price target on Seres Therapeutics to $42 from $38 and keeps a Buy rating on the shares. The analyst raised his target based on interesting evidence for SER-287 success in ulcerative colitis based on four prior randomized studies for fecal microbiota transplant.
Seres Therapeutics downgraded to Neutral from Buy at Chardan » 07:2809/1809/18/20
MCRB, EVLO, FBRX, KLDO, SYBX
Chardan analyst Gbola…
Chardan analyst Gbola Amusa downgraded Seres Therapeutics (MCRB) to Neutral from Buy with a price target of $27.50, down from $32.50. The stock is up about 479% from the close prior to the announcement on August 10 of positive pivotal phase 3 data for microbiome medicine SER-109 in recurrent C. difficile, noted Amusa. However, the analyst believes privately-held Finch Therapeutics may have the advantage in the recurrent C. difficile market while also seeing Seres' stock trading at the "unjustifiable 2.2x multiple to the aggregate valuation of 5 public comps," namely Evelo Biosciences (EVLO), Forte Biosciences (FBRX), Kaleido Biosciences (KLDO), Synlogic (SYBX) and the U.K.'s 4D Pharma.
Seres Therapeutics announces FDA correspondence regarding SER-109 BLA » 07:0509/1109/11/20
Seres Therapeutics announced that it has obtained correspondence from the Office of Vaccines Research and Review of the FDA regarding the company's plans to submit a biologics license application, or BLA, to support product approval of SER-109 for recurrent C. difficile infection, or CDI. After obtaining highly statistically significant topline Phase 3 ECOSPOR III SER-109 study results in recurrent CDI, Seres requested a Breakthrough Therapy Designation meeting with the FDA. In response to the meeting request, the FDA reaffirmed its prior guidance regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the recent positive SER-109 Phase 3 study results, reaffirmed its prior guidance that at least 300 patients will be required for the safety database, and indicated there was not a reason for a meeting at this time. Seres is using its SER-109 open-label study, which also admits patients with a single recurrence of CDI as previously discussed with the FDA, to expand the SER-109 safety database. Seres is taking various measures to expedite open-label study enrollment, including increasing the number of SER-109 clinical study sites across the U.S. and Canada. Seres also anticipates that the quarantine of material used for unapproved Fecal Microbiota Transplantation, or FMT, by a national provider will accelerate SER-109 open-label study enrollment.