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: 

• Alterity Therapeutics (ATHE), 6,906% surge in interest
• EyePoint Pharmaceuticals (EYPT), 974% surge in interest
• Viking Therapeutics (VKTX), 461% surge in interest
• Ocular Therapeutix (OCUL), 262% surge in interest
• BrainStorm Cell (BCLI), 59% surge in interest
• CEL-SCI (CVM), 30% surge in interest

Pipeline and key clinical candidates for these companies:

Alterity Therapeutics is a clinical stage biotechnology company that says it is “dedicated to creating an alternate future for people living with neurodegenerative diseases.” The company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also has a drug discovery platform that it says is “generating patentable chemical compounds to treat the underlying pathology of neurological diseases.”

EyePoint Pharmaceuticals is developing and commercializing therapeutics for patients with serious eye disorders. The company says its 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 has said.

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

Ocular Therapeutix is focused on the formulation, development, and commercialization of therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, Dextenza, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets include: OTX-TKI, currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC, currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-CSI for the chronic treatment of dry eye disease and OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, both of which have completed Phase 2 clinical trials.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

CEL-SCI said it “believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, before they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy.” This approach is called neo-adjuvant. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients.

Recent news on these stocks:

December 4

Alterity Therapeutics announced that new data on the effect of ATH434 in a Parkinson’s disease primate model was presented at the Future of Parkinson’s Disease Conference 2023 that took place November 30 – December 3, 2023 in Austin, TX, USA. The poster, entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”, was presented by Margaret Bradbury, PhD, Vice President of Research and Nonclinical Development at Alterity and collaborators from Vanderbilt University Medical Center and the Florey Institute of Neuroscience in Melbourne. The presentation demonstrated that ATH434 treatment improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease. The favorable impact on Parkinson’s symptoms was associated with lower iron levels in the area of pathology. In addition, ATH434 treatment increased levels of synaptophysin, a protein marker that reflects functional connections between neurons. The study compared daily oral doses of ATH434 versus a vehicle for 12-14 weeks after parkinsonian symptoms were evident. Monkeys were assessed with the Parkinson Behavior Rating Scale before, during and after dosing. At Week 12, all evaluable ATH434-treated monkeys had stable or improving PBRS scores from Baseline to Week 12 whereas two of three vehicle-treated monkeys did not demonstrate improvement or worsened, as expected from the progressive nature of the Parkinson model. The components of the PBRS scale indicate that ATH434 reduced motor impairment and improved general functions such as posture, balance, activity, and gait. Favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were associated with lower iron in the right substantia nigra. In addition, monkeys with improved scores had higher right dorsal striatal synaptophysin, indicating functional recovery of nerve endings in this critical motor pathway.

 EyePoint Pharmaceuticals announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E. The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events. The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography. DAVIO 2 topline interim results include: Both EYP-1901 doses achieved all primary and secondary endpoints. Statistical non-inferiority in change in BCVA compared to aflibercept control, at weeks 28 and weeks 32 combined. The 2mg and 3mg doses were only -0.3 and -0.4 letters different, respectively, versus on-label aflibercept. The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart. Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs. 89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses. 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901. Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control. Patient discontinuation up to week 32 was low at 4%.

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.