These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Essa Pharma (EPIX), 7,060% surge in interest
- Chromadex (CDXC), 2,132% surge in interest
- Vir Biotechnology (VIR), 300% surge in interest
- Madrigal Pharmaceuticals (MDGL), 128% surge in interest
Pipeline and key clinical candidates for these companies:
Essa Pharma is focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. Essa is developing the first generation of ANITen bAsed Chimera degraders, or ANITAC degraders, which it says in preclinical models can eliminate forms of AR protein found in castration-resistant prostate cancer that can “potentially drive disease progression including LBD mutants and LBD truncated splice variants.”
ChromaDex Corporation says it is “dedicated to healthy aging.” ChromaDex says it is pioneering research on nicotinamide adenine dinucleotide, NAD+, an essential coenzyme that is a key regulator of cellular metabolism. “ChromaDex is the innovator behind the NAD+ precursor nicotinamide riboside, commercialized as the flagship ingredient Niagen. Nicotinamide riboside and other NAD+ precursors are protected by ChromaDex’s patent portfolio,” the company has stated.
Vir Biotechnology is an immunology company that has assembled two technology platforms that it says are designed to “stimulate and enhance the immune system by exploiting critical observations of natural immune processes.” Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.
Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis, or NASH, a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.
Recent news on these stocks:
November 1
Essa Pharma announced that it has made the decision to terminate the Phase 2 clinical trial evaluating in a 2:1 randomization masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer, or “mCRPC,” naive to second-generation antiandrogens. “This decision, mutually agreed upon by both senior management and the board of directors, was based on a protocol-specified interim review of the safety, PK and efficacy data, which showed a much higher rate of PSA90 response in patients treated with enzalutamide monotherapy (which is standard of care for this patient population) than were expected based upon historical data. In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent. A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study. The combination of masofaniten plus enzalutamide was well-tolerated with no new safety signals and a safety profile similar to that seen in Phase 1 studies,” the company stated. “Providing a meaningful clinical benefit to patients in our clinical trials, along with a robust safety profile, is of utmost importance to us at ESSA,” said David Parkinson, MD, President and CEO. “We designed this randomized study to rigorously evaluate the clinical benefit of adding masofaniten to enzalutamide. We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate. We would like to thank our partners, investigators, employees, and most importantly, the patients and their families involved in our clinical trials.” Richard Glickman, LLD, Chairman of the Board of Directors of ESSA, commented, “Senior management, together with the board of directors, are actively focused on preserving capital and will initiate a strategic process to explore and review a range of strategic options focused on maximizing shareholder value.”
Shares of companies developing therapies for the liver disease metabolic steatohepatitis, or MASH, including Madrigal Pharmaceuticals, rallied after Novo Nordisk (NVO) said its GLP-1 drug semaglutide showed “superior improvement” in treating the disease in a trial. Novo Nordisk announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis, or MASH, and moderate to advanced liver fibrosis. Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue compared to placebo on top of standard of care for the first 800 randomized people at 72 weeks. The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo. “We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH. Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need,” said Martin Holst Lange, executive VP and head of Development at Novo Nordisk. Madrigal Pharmaceuticals, which recently got approval for its drug Rezdiffra, rose 22% to $317.07 in Friday morning trading following Novo’s report.
October 31
ChromaDex reported Q3 EPS of 2c against a consensus of 0c, and reported Q3 revenue of $25.6M against a consensus of $23.64M. “We are proud to report our best quarter to date, achieving $25.6M in revenue, an impressive 31% increase year-over-year, supported by a strong gross margin of 63.5%, record-setting net income of $1.M, and healthy cash flows that have grown our operating cash to $32.M,” said ChromaDex CEO Rob Fried. “These results reflect our growing financial strength and set the stage for even greater success. This quarter also marks the first sales of our Niagen+ products, and we look forward to further extending their availability to more wellness clinics as we continue to deliver innovative health solutions to our customers.”
Vir Biotechnology reported Q3 EPS of ($1.56) against a consensus of ($1.05), and reported Q3 revenue of $2.4M against a consensus of $5.5M. “This quarter was transformational for Vir. We have bolstered our clinical pipeline with three potential best-in-class dual-masked T-cell engagers in oncology, and have sharpened our focus within infectious diseases to the areas where we believe we can make the most significant impact for patients. We are also thrilled to welcome Jason O’Byrne as our new CFO. Jason brings a wealth of financial leadership experience, further strengthening our ability to bring these potentially transformative therapies to patients as quickly as possible,” said Marianne De Backer, CEO of Vir Biotechnology. “Looking ahead, this is an exciting time for the company. We eagerly anticipate critical data in our hepatitis programs in the fourth quarter and look forward to sharing initial clinical data from our dual-masked T-cell engagers in the first quarter of 2025.”
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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.