Biovie Inc.’s double-barrelled blast of positive data with insulin sensitizer NE-3107 in Alzheimer’s disease (AD) and Parkinson’s disease (PD) launched shares (NASDAQ:BIVI) on a wild ride to close March 1 at $2.23, up 99 cents, or almost 80%, after trading as high as $3.31.
Positive phase III data from Ironwood Pharmaceuticals Inc. with once-weekly glucagon-like peptide-2 analogue apraglutide failed to impress Wall Street, and shares of the Boston-based firm (NASDAQ:IRWD) closed Feb. 29 at $9.43, down $5.69, or 37.6%. The experiment called Stars tested apraglutide to reduce parenteral support in adults with short bowel syndrome with intestinal failure. Rare and severe, the condition affects about 18,000 adults in the U.S., Europe and Japan. Based on the latest data, Ironwood plans to submit an NDA to the U.S. FDA and other regulatory filings.
After trading as low as $2.04, shares of Palatin Technologies Inc. (NYSE:PTN) closed Feb. 28 down $1.57, or 39.7%, ending at $2.39 on word of results from the phase III pivotal Melody-1 trial with melanocortin pan-agonist PL-9643 vs. vehicle in dry eye disease.
The enticing prospect – and proven worth – of dually agonizing the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors gained more evidence in a big way from Viking Therapeutics Inc. with VK-2735 in a phase II weight loss study. Shares of San Diego-based Viking Therapeutics Inc. (NASDAQ:VKTX) closed Feb. 27 at $85.05, up $46.57, or 121%, as investors learned that the drug achieved the primary and all secondary endpoints in the phase II study called Venture, with significant body-weight drops at all doses compared to placebo.
The first – and handsomely upsized – IPO of this year by CG Oncology Inc., along with the sizeable financing Feb. 14 by Engene Holdings Inc., proved Wall Street’s interest in non-muscle invasive bladder cancer, where a number of other players also are busy.
On the verge of top-line data from its phase IIb trial with oral small-molecule CC chemokine receptor 4 (CCR4) antagonist zelnecirnon in atopic dermatitis (AD), due around the middle of this year, Rapt Therapeutics Inc. said the U.S. FDA has imposed a clinical hold on that study with the otherwise promising drug, also known as RPT-193, in AD as well as the phase IIa trial with the same compound in asthma.
Kalvista Pharmaceuticals Inc.’s positive phase III news Feb. 13 with sebetralstat, an oral on-demand kallikrein inhibitor, in hereditary angioedema (HAE), sparked Wall Street speculation about competitor Pharvaris BV with deucrictibant, a bradykinin B2 receptor antagonist.
Bioage Labs Inc.’s $170 million series D financing will pay for phase II trials with azelaprag, an apelin receptor agonist, to be tried in combination with Zepbound (tirzepatide), the glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist from Bioage partner Eli Lilly and Co.
Seeking to rejuvenate itself after recent disappointments, Gilead Sciences Inc. proposes to bolster its liver portfolio by taking over Cymabay Therapeutics Inc. for $32.50 per share in cash, a total equity value of $4.3 billion. The arrangement brings aboard seladelpar for second-line primary biliary cholangitis (PBC) including pruritis (itch), which is under priority review by the U.S. FDA, with a decision due this year.
Synlogic Inc. jolted Wall Street with news that the firm is scrapping for futility Synpheny-3, its pivotal study with labafenogene marselecobac (SYNB-1934) for phenylketonuria, and will evaluate strategic options. Shares of the Cambridge, Mass.-based firm (NASDAQ:SYBX) fell 48.7%, or $1.68, to end Feb. 9 at $1.77. Synlogic will cease operations and reduce its workforce by more than 90%, retaining only certain employees to help with the wind-down.
