The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.
Versant Ventures-backed Firefly Bio is part of a growing group of companies developing degrader antibody conjugates, or DACs. These targeted cancer therapies combine properties of antibody drug conjugates and protein degraders in order to overcome limitations of both types of therapies.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller.
Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies. The data are from a small study and a short time frame, but Structure was able to leverage the encouraging preliminary results into a private placement of securities.
By revealing how tumors interact with immune cells, Noetik aims to identify new targets for new cancer drugs. The startup and its artificial intelligence-driven platform are supported by $14 million in seed financing.
Startup Star Therapeutics will use the Series B funding to support clinical development of a drug candidate for von Willebrand disease, a bleeding disorder. The capital will also support the formation of new biotech subsidiaries developing antibodies with therapeutic applications in hematology and immunology.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Vistagen Therapeutics’ fast-acting nasal spray drug, fasedienol, hit primary and secondary goals of an abbreviated late-stage study in social anxiety disorder. Vistagen’s stock price rocketed skyward on the results, which support progression to another Phase 3 study.
Eli Lilly’s acquisition of Dice Therapeutics comes eight months after the biotech reported positive data from a Phase 1 study in psoriasis. Dice develops oral small molecule drugs intended to offer alternatives to biologic drugs that are injected or infused.
Sanofi is acquiring rights to a Maze Therapeutics drug candidate for Pompe disease that could give the pharmaceutical giant another option to offer patients who have the rare metabolic disorder. In February, the drug posted positive data from a Phase 1 study.
Merck, Sanofi, and Eli Lilly joined the Series A financing of Therini Bio, a startup developing a drug that selectively targets fibrin as a way of reducing disease-driving inflammation in neurodegeneration and eye disorders such as diabetic macular edema. Therini is preparing to advance its lead program to clinical testing.
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Cytokinetics drug reldesemtiv has failed a pivotal clinical trial in amyotrophic lateral sclerosis. The small molecule had previously failed in Phase 2, but the biotech believed adjustments could lead to better results in Phase 3.
Regeneron is paying Sonoma Biotherapeutics $75 million to begin a partnership focused on developing cell therapies based on regulatory T cells, or Tregs. Each company brings technological capabilities to the alliance, which is initially focused on ulcerative colitis and Crohn’s disease.
Vaxart says its pill vaccines for Covid-19 still have advantages over injectable ones, but norovirus offers a faster path to validating its technology. The company is shelving its Covid-19 clinical trial in a corporate restructuring that will shave headcount by 27%.
The Aligos Therapeutics pipeline reprioritization comes after clinical trial setbacks to two hepatitis B drug candidates led the biotech to end both programs. Still intact is a Merck research collaboration focused on developing NASH therapies.
Despite challenging financial market conditions, clinical-stage Structure Therapeutics was able to upsize its IPO. Much of the new cash will support its lead program, an oral small molecule that could weigh in on the diabetes and obesity indications currently dominated by blockbuster injectable medicines.