Syndax Pharmaceuticals Inc. is gearing up for a U.S. FDA filing by the end of 2023 on the back of positive data from a pivotal phase I/II study testing menin inhibitor revumenib in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia.

January-August 2023 saw clinical trial data up 1.22% compared to the same time period last year. In the first eight months of this year, BioWorld reported on 2,314 drugs in phase I-III, compared to 2,286 in the same timeframe in 2022. The number of trial updates is down 13.24% from the 2,667 in 2021 and down from 2020’s 2,363, but up 20.46% from 2019’s 1,921.

January-August 2023 saw clinical trial data up 1.22% compared to the same time period last year. In the first eight months of this year, BioWorld reported on 2,314 drugs in phase I-III, compared to 2,286 in the same timeframe in 2022. The number of trial updates is down 13.24% from the 2,667 in 2021 and down from 2020’s 2,363, but up 20.46% from 2019’s 1,921.

Structure Therapeutics Inc.’s stock climbed 34.6% following a readout of what analysts call “competitive” and “exceptional” phase Ib data at 28 days of oral small-molecule glucagon-like peptide 1 (GLP-1) receptor agonist GSBR-1290 in healthy overweight or obese individuals. Shares (NASDAQ:GPCR) rose $12.95 to close Sept. 29 at $50.42. At the same time as the data readout, the San Francisco-based company agreed to a $300 million private placement with several large health care institutional and mutual fund investors, extending Structure’s runway through the end of 2026.

Immunovant Inc. is seeking a $450 million windfall on the back of the “best-in-class potential” of its early stage monoclonal antibody for IgG-mediated autoimmune diseases, IMVT-1402, which a phase I readout demonstrated could supersede the firm’s lead, batoclimab.

Soleno Therapeutics Inc. (NASDAQ: SLNO) pulled off in a major way its randomized-withdrawal phase III study with DCCR (diazoxide choline) in Prader-Willi syndrome, boosting the shares by $22.37, or 505%, to close Sept. 26 at $26.80. “Our work is not done, but this was a big step,” said CEO Anish Bhatnagar.

Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01.