Goldman Sachs biotech/biopharma analysts hold analyst/industry conference call » 10:2204/1304/13/21
GRTS, TBIO, VIR
SMid Biotech Analyst…
SMid Biotech Analyst Choi, Biopharma Analyst Flynn & Biotech Analyst Richter, along with CEO Allen of Gridstone Oncologym, CEO Scangos of Vir Biotechnology and CTO DeRosa of Translate Bio, discuss what's next on the vaccine and treatment horizon on an Analyst/Industry conference call to be held on April 13 at 11 am.
Piper says IND clearance sets up Axcella Health for potential NASH 'home run' » 09:5604/1304/13/21
After Axcella Health…
After Axcella Health announced IND clearance for AXA1125 for the treatment of NASH in 270 patients with biopsy-confirmed NASH, Piper Sandler analyst Yasmeen Rahimi said she is "pleased" with the details provided on the upcoming Phase 2b trial design and noted that further color on the interim analysis and timelines will be shared during the company's Q1 earnings call. The analyst, who thinks the IND clearance and trial design set up a potential "home run" in NASH, keeps an Overweight rating and $25 price target on Axcella shares.
BridgeBio announces collaboration with Rosewell Park Comprehensive Cancer Center » 07:4604/1304/13/21
BridgeBio Pharma announced a collaboration with Roswell Park Comprehensive Cancer Center to advance the development of investigational therapeutics for patients with genetically driven cancers. Under the partnership, BridgeBio will work with scientists at Roswell Park Comprehensive Cancer Center to evaluate new research and development opportunities in oncology that have promise to advance and potentially provide clinical benefit for patients. Select therapeutic programs may be pursued by BridgeBio, in close collaboration with Roswell Park Comprehensive Cancer Center scientists, who would remain deeply involved in the ongoing development of these investigational therapies. "We are honored to begin collaborating with Roswell Park, which is renowned for its excellence in cancer research and its mission to set the gold standard for treating patients with genetically driven cancers," said BridgeBio CEO and founder Neil Kumar, Ph.D.
BridgeBio announces collaboration agreement with UC San Diego » 07:4504/1304/13/21
BridgeBio Pharma and the…
BridgeBio Pharma and the University of California, San Diego announced a partnership to translate research in genetically driven conditions into potential therapeutic applications for patients, with a focus on oncology and neurology. "UC San Diego is a leading research institution with a top pharmacology department and a strong profile in neurology and oncology. By leveraging their expertise through our collaboration partnership, we hope to advance discoveries into potential treatments as quickly and safely as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D. Under this partnership, BridgeBio and UC San Diego will collaborate on identifying research programs with strong potential for therapeutic applications that address areas of unmet need. BridgeBio will potentially sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.
BridgeBio announces collaboration with UC Davis » 07:4504/1304/13/21
BridgeBio announces collaboration with GlycoNet » 07:4404/1304/13/21
BridgeBio Pharma and the…
BridgeBio Pharma and the Canadian Glycomics Network, or GlycoNet, announced a collaboration to translate scientific research in glycomics into potential treatments for patients with genetic diseases. BridgeBio will work alongside GlycoNet researchers to identify research programs that may have the potential to become treatments for genetic diseases. BridgeBio will potentially sponsor research programs and support clinical investigation through its licensing and affiliate development model. Genetic disease research has benefitted substantially from the study of glycomics, which relates to the functions of glycans, or sugar, in biological systems. "We are thrilled to be partnering with GlycoNet, an institution at the forefront of developing carbohydrate-based drugs to address areas of unmet need," said BridgeBio founder and CEO Neil Kumar, Ph.D. "We understand the clinical benefit research in glycomics could have for certain genetic diseases and by partnering together, we hope to advance potentially life-changing medicines as rapidly as possible."
BridgeBio announces collaboration agreement with OHSU » 07:3804/1304/13/21
BridgeBio announces collaboration agreement with The Lundquist Institute » 07:3604/1304/13/21
BridgeBio Pharma and The…
Axcella announces AXA1125's IND clearance for the treatment of NASH » 07:3404/1304/13/21
Axcella announced that it…
Axcella announced that it has achieved a key milestone with U.S. Food and Drug Administration clearance of an Investigational New Drug application for AXA1125, enabling the company to proceed directly into a Phase 2b clinical trial. AXA1125 is Axcella's multi-targeted oral product candidate for nonalcoholic steatohepatitis, a chronic and progressive liver disease impacting up to 40 million people in the U.S. alone. "This IND follows close on the heels of AXA1665's IND clearance earlier this year, ushering in an exciting new era for Axcella as we seek to tackle a variety of complex diseases and address important unmet needs for patients utilizing multi-targeted EMM compositions," said Bill Hinshaw, President and Chief Executive Officer of Axcella. "I am pleased by our team's strong execution in completing two robust FDA submissions and readying us for the start of our highly efficient, later-stage clinical trials." Axcella expects to initiate its Phase 2b clinical trial in the second quarter of 2021. This randomized, double-blind, placebo-controlled, multi-center trial will evaluate the efficacy, safety and tolerability of AXA1125 in adult patients with biopsy-confirmed F2/F3 NASH. Approximately 270 patients will be enrolled and randomized 1:1:1 to receive either 45.2 or 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 48 weeks, with a four-week safety follow-up period. Patients will be stratified based on the presence or absence of type 2 diabetes.
BridgeBio announces formal collaboration with Brown University » 07:3304/1304/13/21
BridgeBio Pharma and…
BridgeBio Pharma and Brown University announced a formal collaboration to advance research in genetically driven neurological disorders into potential life-changing medicines for patients. "Brown University is a leader in critical neurology research, and we look forward to partnering with their scientists to focus on discovering and advancing new targeted treatment approaches to potentially address challenging and complex diseases of the brain," said BridgeBio founder and CEO Neil Kumar, Ph.D. Under the partnership, BridgeBio will work with scientists at Brown to evaluate new discoveries in neurology research that have promise to advance toward clinical investigation. Select therapeutic programs may be spun out and advanced in BridgeBio affiliate companies, with an opportunity for Brown University scientists to support as company leaders and guide ongoing development, BridgeBio said in a statement.