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: 

• Hoth Therapeutics (HOTH), 1,543% surge in interest
• Journey Medical (DERM), 454% surge in interest
• Applied Therapeutics (APLT), 404% surge in interest
• Sage Therapeutics (SAGE), 246% surge in interest
• Vistagen (VTGN), 216% surge in interest
• Genfit (GNFT), 209% surge in interest
• Tonix Pharmaceuticals (TNXP), 160% surge in interest
• NanoViricides (NNVC), 144% surge in interest
• Jazz Pharmaceuticals (JAZZ), 137% surge in interest
• Madrigal Pharmaceuticals (MDGL), 133% surge in interest

Pipeline and key clinical candidates for these companies:

Hoth Therapeutics refers to itself as “a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing.” Hoth “collaborates and partners with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options,” the company stated.

Journey Medical says it is focused on identifying, acquiring, developing and strategically commercializing “innovative, differentiated dermatology products through its efficient sales and marketing model.” The company currently markets eight branded and three generic products that help treat and heal common skin conditions.

Applied Therapeutics is “developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.” The company’s lead drug candidate, AT-007, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart.

Sage Therapeutics is a biopharmaceutical company “fearlessly leading the way to create a world with better brain health.” The company’s mission is to “pioneer solutions to deliver life-changing brain health medicines, so every person can thrive,” Sage has stated.

Vistagen is a late clinical-stage biopharmaceutical company whose clinical-stage candidates are targeting multiple types of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain.

Genfit is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs. Genfit’s R&D pipeline covers six therapeutic areas via seven programs which explore the potential of differentiated mechanisms of action, across a variety of development stages, including acute on-chronic liver failure, hepatic encephalopathy, cholangiocarcinoma, urea cycle disorder, organic acidemias and primary biliary cholangitis. Beyond therapeutics, Genfit’s pipeline also includes a diagnostic franchise focused on NASH and ACLF.

Tonix is focused on central nervous system, rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA.

NanoViricides is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The company’s novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The company’s lead drug candidate is NV-CoV-2 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Its other advanced candidate is NV-HHV-1 for the treatment of Shingles. The company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.

Jazz Pharmaceuticals is a biopharmaceutical company who says its purpose is to “innovate to transform the lives of patients and their families.” The company has a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, Jazz says it is “identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science.”

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis, also known as metabolic dysfunction associated steatohepatitis. Madrigal has advanced its once daily, oral, liver-directed thyroid hormone receptor β-selective agonist, into multiple Phase 3 clinical trials in NASH. Based on Phase 3 results reported to date, the U.S. FDA granted accelerated approval for the therapy for the treatment of adults with NASH with moderate to advanced liver fibrosis.

Recent news on these stocks:

June 11

Sage Therapeutics announced topline results from the Phase 2 SURVEYOR Study. The study met its primary endpoint demonstrating a statistically significant difference between healthy participants and participants with Huntington’s Disease – HD – prior to any treatment with dalzanemdor or placebo. SURVEYOR was a small study with three objectives: to determine the magnitude of cognitive impairment in HD compared to healthy participants; to evaluate the safety of dalzanemdor in participants with HD; and to better understand the relationship between changes in cognition and changes in function. Dalzanemdor was generally well-tolerated and no new safety signals were observed. A total of 11 participants with HD experienced treatment emergent adverse events, the vast majority of which were mild to moderate in severity. There were no discontinuations related to TEAEs. There was a small numerical difference observed between dalzanemdor and placebo on the HD-CAB composite score at Day 28. Other prespecified analyses suggested the potential for directionally positive signals in a number of individual component tests of the HD-CAB and in some functional assessments. Additional work is ongoing to further analyze and understand the data including the relationship of changes in cognition to changes in function. The company expects dalzanemdor program milestones in late 2024: report topline data from LIGHTWAVE Study in mild cognitive impairment and mild dementia in Alzheimer’s Disease, and report topline data from DIMENSION Study in cognitive impairment associated with HD.

Vistagen reported FY24 EPS ($1.52) vs. ($8.51) last year, and reported FY24 revenue of $1.06M. “Vistagen’s fiscal 2024 proved to be a year full of remarkable accomplishments. Most notably, with our PALISADE-2 trial of fasedienol, we became the first company to report positive results of a Phase 3 trial for the acute treatment of social anxiety disorder, a mental health disorder affecting the lives of over 30 million adults in the U.S for which there is no FDA-approved acute treatment option. In addition, we recently initiated our PALISADE-3 Phase 3 trial, which, if successful, has the potential to complement PALISADE-2 in support of a fasedienol U.S. New Drug Application submission,” said Shawn Singh, CEO of Vistagen. “Our primary focus is on the high-quality execution of our registration-directed PALISADE Phase 3 program for fasedienol in social anxiety disorder, as well as the further progression of our non-systemic, neurocircuitry-focused pherine development programs involving itruvone for major depressive disorder and hormone-free PH80 for menopausal hot flashes. We are well-positioned on a path toward achieving multiple potential value-creating catalysts during the year ahead as we pursue our mission to develop and commercialize differentiated neuroscience therapies to improve patients’ lives worldwide.”

H.C. Wainwright raised the firm’s price target on Genfit to $13 from $11 and kept a Buy rating on the shares after the company’s partner Ipsen announced the FDA has granted accelerated approval of Iqirvo once-daily for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid. The firm says Iqirvo has a favorable label to support trial and uptake.

Tonix Pharmaceuticals announced that it was offering to sell common stock, no amount given, adding that it intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness. Dawson James Securities is acting as the sole placement agent for the offering.

June 10

Hoth Therapeutics announced the entry into a joint development agreement with Wise Systems International SRL to leverage artificial intelligence utilizing the BioNeMo AI platform of Nvidia (NVDA). BioNeMo provides researchers and developers a fast and easy way to build and integrate state-of-the-art generative AI applications across the entire drug discovery pipeline-from target identification to lead optimization-with AI workflows. With the help of SRL, Hoth Therapeutics will have the ability to identify, create and leverage its pipeline for additional therapeutics and to further increase value of its assets.

Wolfe Research initiated coverage of Madrigal Pharmaceuticals with an Outperform rating and $382 price target. The company has “only one critical driver” — how well its Rezdiffra performs on launch, the analyst told investors in a research note. The firm is bullish on the drug as it is the first oral drug with no competition and offers “excellent pharmacy strategy”, which unintendedly creates economic incentives for PBMs to cover Rezdiffra broadly. Akero (AKRO) is the strongest upcoming competitor, but Madrigal is about four years ahead of it with its Rezdiffra launch and can create a strong moat, Wolfe added.

June 5

Goldman Sachs initiated coverage of Jazz Pharmaceuticals with a Buy rating and $169 price target. Jazz has a diversified global portfolio of commercial assets across two verticals of neuroscience and oncology, with the company on track to achieve its “Vision 2025” goal of $5B revenue, the analyst told investors in a research note. The firm says that while the investor debate has been on the outlook for the company’s sleep business, it is optimistic on Jazz’s emerging pipeline to support its longer-term growth profile. It sees the stock as attractive at current levels.

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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.