Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:

• MeiraGTx Holdings (MGTX), 3,009% surge in interest
• Deciphera Pharmaceuticals (DCPH), 1,544% surge in interest
• Coherus Bio (CHRS), 429% surge in interest
• Cymabay Therapeutics (CBAY), 21% surge in interest

Pipeline and key clinical candidates for these companies:

MeiraGTx is a vertically integrated, clinical-stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: ocular diseases, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. The company is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK is Deciphera’s switch-control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Israel, Macau, New Zealand, Singapore, Switzerland, Taiwan, the United Kingdom, and the United States.

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer.

CymaBay Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. According to the company, its deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped it receive breakthrough therapy designation, Priority Medicines status and orphan drug status for seladelpar, a first-in-class investigational treatment for people with PBC.

Recent news on these stocks:

November 1
CymaBay Therapeutics announced that two-year safety and efficacy results of seladelpar for primary biliary cholangitis have been published in Alimentary Pharmacology & Therapeutics: Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis This open-label, international, long-term extension study, evaluated the efficacy and safety of seladelpar a potent, selective, orally active PPARdelta agonist, or delpar, through 2 years of treatment in patients with PBC. Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar. Adults from the lead-in studies had enrolled having a diagnosis of PBC after persistent elevation in the cholestatic marker alkaline phosphatase despite current or prior treatment with first-line ursodeoxycholic acid. The objectives were to evaluate the long-term safety, tolerability, and efficacy of seladelpar at 5 mg and 10 mg once daily throughout 2-years. A composite of alkaline phosphatase and bilirubin previously accepted for regulatory approval served as an endpoint. The composite was achieved by 63% and 79% of patients after one and two years, respectively. In addition, ALP normalization was achieved in 23% and 42% in patients at one and two years, respectively. Over two years, there were sustained reductions in ALT and AST, recognized markers of liver injury. Seladelpar appeared safe and well-tolerated. In the study long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis and liver injury in the second year of treatment.

October 30
MeiraGTx Holdings announced strategic updates including that Sanofi (SNY) has made a $30M strategic investment in the company through the purchase of 4.0M ordinary shares at a price of $7.50 per share.

Deciphera Pharmaceuticals announced positive top-line results from the MOTION pivotal Phase 3 study of vimseltinib in patients with TGCT not amenable to surgery. Vimseltinib is the company’s investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R. The results for Part 1 of the study are based on a data cutoff date of August 22. In addition to meeting the primary endpoint, the study also achieved statistically significant and clinically meaningful improvements versus placebo in all key secondary endpoints assessed at Week 25 including ORR per tumor volume score active range of motion physical function, stiffness, quality of life, and pain.

October 27
Coherus BioSciences and Shanghai Junshi Biosciences announced that the U.S. FDA approved LOQTORZI in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. LOQTORZI is a next-generation, programmed death receptor-1 monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor. LOQTORZI is expected to be available in the United States in Q1 2024.

Hear more from InvestingChannel by signing up for The Spill.

About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.