When Nektar Therapeutics Inc. decided to push ahead with development of Treg stimulator rezpegaldesleukin (rezpeg) in atopic dermatitis despite what appeared to be middling early stage data, investors weren’t exactly jumping up and down. But it turns out those data are more promising than originally thought.
Wall Street cheered Vistagen Therapeutics Inc.’s first positive phase III trial with a drug for social anxiety disorder (SAD) in 15 years and sent the South San Francisco-based firm’s shares (NASDAQ:VTGN) on a rocket ride to close Aug. 7 at $13.05, up $11.37, or 677%. Vistagen unveiled top-line data from the phase III study called Palisade-2 testing the efficacy, safety, and tolerability of lead asset fasedienol (PH-94B) nasal spray in adults with SAD.
The dent made in Bavarian Nordic A/S’ future revenues after it dropped development of late-stage respiratory syncytial virus (RSV) contender MVA-BN-RSV could be offset by potential sales of its chikungunya virus vaccine, PXVX-0317, if recent phase III immunogenicity data manage to persuade the U.S. FDA that it’s as worthy as Valneva SA’s VLA-1553, the other chikungunya vaccine racing to be first to market.
More than two months after Blueprint Medicines Corp. gained a broadened label for Ayvakit (avapritinib), the company is “really pleased to see the diversity of revenue this early in the launch across specialties and across both the academic and community settings,” said Philina Lee, chief commercial officer. The situation “bodes very well for a continued cadence of prescribing [into] the foreseeable future,” she said.
Aravive Inc.’s sole asset missed a phase III primary endpoint in ovarian cancer but the company still has studies planned for treating renal cell carcinoma and pancreatic cancer. Aravive’s stock (NASDAQ:ARAV) dwindled dramatically on Aug. 3, with shares closing 77.2% lower at 28 cents each. That’s a massive drop from heights seen in the past 12 months, as shares hit $2.46 each in March 2023 and $2.09 each in November 2022. The company plans to study the data and make a decision about whether to proceed with the other studies.
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
South Korean pharmaceutical company Hanmi Pharmaceutical Co. Ltd. may have found its footing after its misstep with Sanofi SA in 2020 for efpeglenatide, its glucagon-like peptide-1 (GLP-1) receptor agonist. On July 31, Hanmi announced that the once-dropped drug would be developed to treat obesity in the Korean population, submitting an IND application to the MFDS on July 28 to examine the once-a-week injection efpeglenatide in a phase III trial.
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
The notion of taking aim at the galectin pathway across varied therapeutic areas has gained major traction in recent years, with a handful of companies drawing Wall Street’s interest as efforts plow forth in conditions as varied as cancer, liver fibrosis and Alzheimer’s disease.
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.
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