Executives of TG Therapeutics Inc. have promised a big year in 2021 and the company got off to strong start with accelerated FDA approval of umbralisib in marginal zone lymphoma and follicular lymphoma. Branded Ukoniq, the drug is the first oral, once-daily inhibitor of PI3K delta and CK1 epsilon and TG’s first commercial product. Pricing for Ukoniq has not yet been disclosed.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.
Marking the first time monoclonal antibodies developed by separate companies will be tested in combination against COVID-19, Vir Biotechnology Inc.’s VIR-7831 will be added to Eli Lilly and Co.’s bamlanivimab in the ongoing phase II BLAZE-4 study in low-risk patients with mild to moderate disease. The collaboration comes as early research indicates some antibodies in development appear to lose activity when pitted against emerging SARS-CoV-2 variants. VIR-7831 (also known as GSK-4182136), partnered with Glaxosmithkline plc, is designed to bind to a different epitope of the SARS-CoV-2 spike protein than bamlanivimab. A dual-action antibody, VIR-7831 is designed to both block viral entry into healthy cells and clear infected cells.
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
And just like that, it’s over. Bristol Myers Squibb Co. on Jan. 1 confirmed what many suspected, that FDA approval for lisocabtagene maraleucel (liso-cel) did not happen by the Dec. 31 deadline, thereby automatically terminating the contingent value rights (CVR) agreement issued as part of its acquisition of Celgene Inc.
Macrogenics Inc., which started the year with a pipeline prioritization, ends 2020 with its first FDA approval. The agency cleared its HER2-targeting Fc-engineered monoclonal antibody margetuximab in combination with chemotherapy for use in patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns.
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns.
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
Two weeks after receiving a letter from the FDA citing deficiencies in the NDA seeking approval for VP-102 (cantharidin 0.7% topical solution) in molluscum contagiosum, Verrica Pharmaceuticals Inc. disclosed an unsurprising complete response letter.
