Positive top-line phase II results caused Mymd Pharmaceuticals Inc.’s stock (NASDQ:MYMD) to surge 31.8% on July 31 to close at $1.45 per share. The data behind the push were for MYMD-1 (isomyosmine) for treating chronic inflammation associated with sarcopenia.
Clinical data in the first half of 2023 is up 1.51% compared to the same time period last year. So far in 2023 BioWorld reported on 1,810 drugs in phase I-III, compared to 1,783 in the first half of 2022. The number of trial updates is down 13.6% from the 2,095 in 2021, but more than 2020’s 1,799 and 2019’s 1,477.
Investors will have to wait for durability of response (DoR) data from Urogen Pharma Ltd.’s phase III Envision study with UGN-102 (mitomycin intravesical solution) in low-grade, intermediate-risk, non-muscle invasive bladder cancer, but urologists already characterize what’s available so far from that study, as well as Atlas – another late-stage experiment – as practice-changing.
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
Mersana Therapeutics Inc. followed grim June news with an even worse headline as the phase Ib/II study called Uplift with upifitamab rilsodotin (upri) did not meet its primary endpoint in platinum-resistant ovarian cancer (prOC). The antibody-drug conjugate (ADC) targets the sodium-dependent phosphate transport protein NaPi2b and was developed via the company’s platform called Dolaflexin. Shares of Mersana (NASDAQ:MRSN) tumbled 73%, or $2.84, to close July 27 at $1.07 on word of the failure of the trial.
Stoke Therapeutics Inc.’s stock tumbled 32% after the company reported phase I/IIa data of its antisense oligonucleotide, STK-001, in Dravet syndrome, showing it reduced convulsive seizures in children most consistently at the highest dose, with benefits increasing as time progressed.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
Unexpected cataract cases in top-line data from two of three phase III trials for eye diseases is leading Kodiak Sciences Inc. to quit work with tarcocimab tedromer, an antibody biopolymer conjugate also known as KSI-301.
Artificial intelligence (AI) drug discovery specialist Insilico Medicine Inc. is progressing INS018-055, its lead compound to phase II trials for idiopathic pulmonary fibrosis, a chronic lung disease that results in progressive and irreversible decline in lung function.
Vir Biotechnology Inc. said it won’t be discussing further the phase II data from the influenza A prevention study called Peninsula until the company’s second-quarter earnings update Aug. 3, and a closer look at the results has yet to decide the fate of monoclonal antibody VIR-2482, which missed its primary and secondary endpoints.
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