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: 

• Neurocrine Biosciences (NBIX), 131% surge in interest
• Eton Pharmaceuticals (ETON), 123% surge in interest
• Cassava Sciences (SAVA), 108% surge in interest
• Leap Therapeutics (LPTX), 95% surge in interest
• Eyepoint Pharmaceuticals (EYPT), 93% surge in interest
• Cabaletta Bio (CABA), 82% surge in interest
• Fibrogen (FGEN), 80% surge in interest
• Axcella Health (AXLA), 71% surge in interest
• Atossa Genetics (ATOS), 44% surge in interest

Pipeline and key clinical candidates for these companies:

Neurocrine Biosciences describes itself as “a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options.” The company’s portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, Parkinson’s disease, endometriosis and uterine fibroids, as well as “a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas,” the company states.

Eton Pharmaceuticals is focused on developing, acquiring, and commercializing treatments for rare diseases. The company currently commercializes ALKINDI SPRINKLE and Carglumic Acid tablets and has four additional rare disease products under development, including dehydrated alcohol injection and the ZENEO hydrocortisone autoinjector.

Cassava Sciences is a clinical-stage biotechnology company that says its mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. “Its novel science is based on stabilizing—but not removing—a critical protein in the brain. The company’s product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established,” Cassava has stated.

Leap Therapeutics is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. Leap has entered into a strategic collaboration with BeiGene (BGNE) for the rights to develop DKN-01 in Asia excluding Japan, Australia, and New Zealand.

EyePoint Pharmaceuticals is committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The company’s pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been “safely administered to thousands of patients’ eyes” across four U.S. FDA approved products, including Yutiq for the treatment of posterior segment uveitis, EyePoint said.

Cabaletta Bio is focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompasses chimeric antigen receptor T cells for autoimmunity and Cabaletta Bio’s proprietary chimeric autoantibody receptor T cells.

FibroGen is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.

Axcella is “pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators,” or EMMs, the company states. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence.

Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

Recent news on these stocks:

September 14

Neurocrine announced the FDA has accepted its New Drug Application – NDA – for Ingrezza oral granules, a new sprinkle formulation of Ingrezza capsules for oral administration. The agency set a Prescription Drug User Fee Act target action date of April 30, 2024. The Ingrezza oral granules capsules are intended to be opened for sprinkling on soft foods prior to administration. The NDA filing included chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of the Ingrezza oral granule sprinkle capsules compared to the currently approved Ingrezza capsules. Ingrezza is currently available as the only one-capsule, once-daily treatment option with no complex titration for adults with tardive dyskinesia and the treatment of chorea associated with Huntington’s disease.

September 11

Cassava Sciences announced the publication of new research that confirms the biological activity of simufilam. Simufilam is Cassava Sciences’ novel drug candidate for people with Alzheimer’s disease dementia and is currently under evaluation in a pair of global Phase 3 clinical trials. Researchers at the Cochin Institute used a highly precise cell-based assay to show that simufilam interrupts amyloid binding to the alpha7 nicotinic acetylcholine receptor. Cassava Sciences believes this protein interaction underlies simufilam’s mechanism of action in Alzheimer’s disease. The research appears in a special issue of International Journal of Molecular Sciences, a peer-reviewed scientific publication. “Four academic institutions have now generated data in support of the biological activity of simufilam,” said CEO Remi Barbier, “They can’t all be wrong.”

EyePoint Pharmaceuticals announced positive interim masked safety data for its lead product candidate EYP-1901 from the Company’s ongoing Phase 2 PAVIA trial evaluating EYP-1901 as a potential nine-month treatment for moderately-severe to severe non-proliferative diabetic retinopathy and DAVIO 2 trial as a potential six-month sustained delivery maintenance treatment for wet age-related macular degeneration. All treatment arms in the PAVIA trial have reached at least 3-months post-dosing follow-up as of September 1, 2023. Approximately 170 patients have received EYP-1901 with a minimum of three months of follow-up post injection from the ongoing Phase 2 PAVIA and DAVIO 2 clinical trials and the completed DAVIO 1 trial with no reported drug-related ocular severe adverse events and no reported drug-related systemic SAEs. In the PAVIA clinical trial, there have been no reported drug-related ocular SAEs and no reported drug-related systemic SAEs.

September 8

Cantor Fitzgerald initiated coverage of Atossa Therapeutics with an Overweight rating and $5 price target. The firm believes that the peak sales potential of Atossa’s pipeline is underappreciated, and expects positive data readouts to drive upward earnings estimate revisions and the stock higher, the analyst tells investors in a research note.

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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.