With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
Veru Pharmaceuticals Inc.’s COVID-19 therapy VERU-111 (sabizabulin) failed to win full support from the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee, which was asked to decide about endorsing the firm’s request for an emergency use authorization to market the drug.
Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19.
Shares of Oyster Point Pharma Inc. (NASDAQ:OYST) soared to $11.57, or 38.6% on word of the buyout by Viatris Inc., which is also taking over privately held, development-stage Famy Life Sciences Ltd. to create an ophthalmology franchise that Viatris estimates could mean at least $1 billion in sales by 2028 as well as at least $500 million more in adjusted EBITDA.
Shares of Oyster Point Pharma Inc. (NASDAQ:OYST) soared to $11.57, or 38.6% on word of the buyout by Viatris Inc., which is also taking over privately held, development-stage Famy Life Sciences Ltd. to create an ophthalmology franchise that Viatris estimates could mean at least $1 billion in sales by 2028 as well as at least $500 million more in adjusted EBITDA.
Given Bioatla Inc.’s positive update from the study testing mecbotamab vedotin (BA-3011) in metastatic non-small-cell lung cancer sharpened investor thirst for more data by the end of this year, and Wall Street wanted to know how good the findings need to be in order to advance further.
At the end of September, C4 Therapeutics Inc. disclosed the U.S. FDA’s green light for the phase I/II trial with CFT-1946 in solid tumors, but the firm has piqued Wall Street’s interest more with another program due to face off with Bristol Myers Squibb Co. (BMS) in multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
Alkermes plc’s decision to explore separating its commercial-stage neuroscience business from earlier-stage oncology efforts – forming a distinct, publicly traded company to investigate cancer therapies – drove speculation about the launch of the firm’s Lybalvi (olanzapine and samidorphan), approved by the U.S. FDA in the middle of 2021 for schizophrenia and bipolar I disorder.
In relapsed/refractory acute myeloid leukemia (AML), an indication that still needs adequate standard-of-care therapy, Actinium Pharmaceuticals Inc.’s topline pivotal phase III data shone brightly with radiotherapy lead candidate Iomab-B.
Skeptical briefing documents pertaining to the U.S. FDA’s adcom meeting on Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) turned out predictive of the less-than-happy outcome, as the regulator’s Oncologic Drugs Advisory Committee (ODAC) turned thumbs down on the prospective drug for pediatric central nervous system/leptomeningeal metastasis from neuroblastoma.
