Atossa Therapeutics Inc. moved a step closer in its efforts to develop a preventative approach to breast cancer, with top-line data from a phase II study showing (Z)-endoxifen significantly reduced mammographic breast density, while demonstrating a good tolerability profile.
Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).
Shares of Essa Pharma Inc. tanked Nov. 1 after the company said it is terminating all trials of masofaniten, its N-terminal domain androgen receptor inhibitor and sole clinical-stage program, following a disappointing readout from a phase II study in metastatic castration-resistant prostate cancer. The stock (NASDAQ:EPIX) hit a 52-week low, closing at $1.40, down $3.80, or 73%.
The second time around wasn’t lovelier for Lexicon Pharmaceuticals Inc. as it once again made its case before the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin to improve glycemic control in people with type 1 diabetes and mild to moderate chronic kidney disease.
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis.
Two days after Monte Rosa Therapeutics Inc. signed a molecular glue degrader deal with Novartis AG, two other companies, Biogen Inc. and Neomorph Inc., are moving forward in the same space in a partnership worth up to $1.45 billion. Cambridge, Mass.-based Biogen and San Diego-based Neomorph will develop molecular glue degraders (MGDs) for priority targets in Alzheimer’s, rare neurological and immunological diseases, using Neomorph’s MGD platform to identify and validate novel small-molecule protein degraders.
Lexicon Pharmaceuticals Inc. is counting on the Oct. 31 meeting of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to help it break through the type 1 diabetes (T1D) door with Zynquista (sotagliflozin), proposed as an adjunct to insulin to improve glycemic control in people with T1D and mild to moderate chronic kidney disease.
With another failure of E-selectin antagonist uproleselan on the books, Glycomimetics Inc. signed an acquisition agreement with privately held, solid tumor-focused Crescent Biopharma Inc., and a syndicate of investors has put up $200 million to make the merger possible. The combined firm will operate under Crescent’s name after the deal closes in the second quarter of 2025, subject to shareholders’ go-ahead.
An old target that found new life at Monte Rosa Therapeutics Inc. has become the subject of a sizeable deal between the company and Novartis AG, as the pair set about developing molecular glue degraders (MGDs). Shares of Monte Rosa (NASDAQ:GLUE) closed Oct. 28 at $9.48, up $4.59, or 93.9%, on word of the Boston-based firm’s deal with Novartis to advance VAV1 MGDs, including MRT-6160, a prospect undergoing a phase I single ascending dose/multiple ascending dose study in healthy volunteers for immune-mediated conditions.
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