The stock rally by Tango Therapeutics Inc. over the past month or so has further revved the long-percolating interest in protein arginine methyl transferase 5 (PRMT5) and in synthetic lethality, where a number of parties have programs ongoing.
Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D.
As Wall Street waits to find out later this year whether Stoke Therapeutics Inc.’s positive results with a low, single dose of STK-001 for Dravet syndrome pans out in more extensive research, a number of players large and small are investigating candidates for the rare but dismal form of epilepsy.
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).
