May 26 Quick Takes: Firsts at FDA for Vir, Myovant; plus Legend’s date with FDA and losses for Larimar
Vir Biotechnology Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) are readying to launch sotrovimab (VIR-7831) to treat mild-to-moderate COVID-19 in high-risk patients ages 12 and older after FDA granted the single dose mAb emergency use authorization. The EUA comes 10 months after the start of clinical testing and gives Vir its first product on the market.
According to the partners, the mAb “maintains activity against all known variants of concern, including the variant from India.” They plan to submit a BLA next half. Vir shares rose 9% to $50 in after-hours trading. They are also testing the therapy in combination with bamlanivimab to treat low-risk outpatients.
A first for Myovant is a boost for women’s health
FDA’s approval of Myfembree relugolix Tuesday comes five months after Myovant Sciences GmbH (NYSE:MYOV) licensed rights to the oral GnRH antagonist to Pfizer Inc. (NYSE:PFE) in a deal that sent a signal that plenty of opportunity still exists in women’s health, despite recent pharma exits. The drug is the first once-daily therapy approved to manage heavy menstrual bleeding associated with uterine fibroids. A launch is slated for next month and approval by EMA is pending after CHMP backed the therapy last week. FDA approved relugolix as Orgovyx on Dec. 18 to treat advanced prostate cancer.
Myovant received an upfront payment of $650 million from Pfizer and is eligible for $200 million in regulatory milestones, and tiered sales milestones for a total deal value of up to $4.2 billion.
Nov. 29 PDUFA date for cilta-cel from Legend, J&J
FDA has set a Nov. 29 action date for a BLA for BCMA-targeted CAR T therapy ciltacabtagene autoleucel (cilta-cel) from Johnson & Johnson (NYSE:JNJ) and Legend Biotech Corp. (NASDAQ:LEGN). The therapy, which is under priority review for relapsed/refractory multiple myeloma, is looking to compete with Abecma idecabtagene vicleucel from Bristol Myers Squibb Co. (NYSE:BMY), which in March became the first CAR T against BCMA to gain FDA approval.
Friedreich’s ataxia setback sinks Larimar shares
Larimar Therapeutics Inc. (NASDAQ:LRMR) is now looking ahead to next year to start its Jive and pediatric MAD trials of CTI-1601 after deaths in a non-human primate tox study of the Friedreich’s ataxia therapy triggered a clinical hold by FDA. The company also announced the termination of its planned $95 million private placement; it said its $81.4 million in cash at March 31 provides runway through 1H22. CTI-1601 is a recombinant fusion protein that aims to deliver human FXN into the mitochondria of patients with Friedreich’s ataxia. The company’s shares dropped 33% to $8.99, leaving it with a market cap of roughly $140 million.
BCMA (TNFRSF17; CD269) – Tumor necrosis factor receptor superfamily member 17
FXN (FRDA) – Frataxin