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: 

• NeurAxis (NRXS), 30,883% surge in interest
• Eyenovia (EYEN), 1,273% surge in interest
• NLS Pharmaceuticals (NLSP), 885% surge in interest
• Relmada Therapeutics (RLMD), 700% surge in interest
• Akero Therapeutics (AKRO), 654% surge in interest
• Aptevo Therapeutics (APVO), 482% surge in interest
• Instil Bio (TIL), 472% surge in interest
• CEL-SCI (CVM), 289% surge in interest
• 89bio (ETNB), 241% surge in interest

Pipeline and key clinical candidates for these companies:

NeurAxis is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis’ IB-Stim therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation technology, is FDA cleared for functional abdominal pain associated with irritable bowel syndrome in adolescents 8-21 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.

Eyenovia is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

NLS Pharmaceutics is a Swiss-based clinical-stage biopharmaceutical company that says it is “dedicated to the development of groundbreaking therapies for rare and complex CNS disorders.” The company collaborates with scientists and pharmaceutical partners to advance treatments in areas such as addiction medicine, sleep disorders, and cognitive dysfunction.

Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for central nervous system and oncology-related conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs.

Akero Therapeutics is developing “transformational treatments for patients with serious metabolic diseases marked by high unmet medical need,” including NASH, a disease without any approved therapies. Akero’s lead product candidate, EFX, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body.

Aptevo Therapeutics is focused on developing novel immunotherapies for the treatment of cancer. APVO436 is a bispecific CD3xCD123 ADAPTIR currently in Phase 1b development in a multi-center, multi-cohort trial designed to evaluate safety, tolerability and efficacy in combination therapy and monotherapy for patients with acute myeloid leukemia, or AML. The company plans to initiate a Phase 2 trial, evaluating APVO436 in combination with venetoclax and azacitidine in patients with AML who are venetoclax treatment naive, in 2H23.

Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil’s lead asset, AXN-2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors.

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.” CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients.

89bio is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases. The company’s lead product candidate, pegozafermin, is currently being developed for the treatment of NASH and SHTG.

Recent news on these stocks:

May 22

Aptevo Therapeutics will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20. The split is expected to become effective on May 23, at 5:01 p.m. ET with shares expected to begin trading on the Nasdaq Capital Market, on a split-adjusted basis, at market open on May 27. In connection with the split, every 20 shares of common stock issued and outstanding will be automatically converted into one share of common stock. No change will be made to the trading symbol for the stock, “APVO,” in connection with the split. The split is part of the company’s plan to maintain compliance with the continued listing standards of The Nasdaq Capital Market, among other benefits.

Instil Bio and ImmuneOnco announced clinical trial updates of AXN-2510 and NSCLC clinical development strategy. The companies anticipate sharing further clinical data in the second half of 2025. ImmuneOnco expects to complete enrollment of approximately 60 patients in Q3 2025 in its Phase 2 trial of ‘2510 in combination with chemotherapy in patients with NSCLC in the first-line setting in China. Among more than 30 NSCLC patients enrolled, more than 20 first-line NSCLC patients have been treated since the end of March. The objective response rate is similar to datasets from competitor PD-(L)1xVEGF bispecific antibodies at a similar stage of development in patients with previously treated NSCLC, showing ORR of 23%. Instil’s Phase 1b/2 trial of ‘2510 in the United States is expected to be initiated before the end of 2025, assuming necessary regulatory approvals. Instil believes that this may accelerate the path to initiating a potential global Phase 3 trial in first-line NSCLC.

May 21

NeurAxis entered into definitive agreements for the purchase and sale of an aggregate of 1.54M shares of its common stock at a purchase price of $3.25 per share in a registered direct offering priced at the market under NYSE American rules. The offering is expected to close on or about May 22, subject to the satisfaction of customary closing conditions. Craig-Hallum Capital Group is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $5M, before deducting placement agent fees and other offering expenses payable by the company. NeurAxis said it intends to use the net proceeds from the offering for working capital and general corporate purposes.

NLS Pharmaceutics announces that it will present new preclinical data on Mazindol ER at the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology, or ASCP. ASCP Annual Meeting will be held at the Fairmont Scottsdale Princess in Scottsdale, Arizona in May 27-30. NLS intends to present its poster titled, ‘Evaluating the Effects of Mazindol on Fentanyl Reward and Dependence in C57BL/6J Mice and Sprague-Dawley Rats during the poster session on May 29. The preclinical study to be featured in the poster was conducted by Key-Obs SAS in collaboration with NLS and other European academic institutions. The study results demonstrate that Mazindol significantly reduced both the rewarding effects of fentanyl and the severity of its withdrawal symptoms in validated rodent models. Highlights from Study KO-943 include: In C57BL/6J mice, Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced conditioned place preference, effectively neutralizing the behavioral reward effects typically observed with fentanyl exposure. Sprague-Dawley rats, Mazindol administered at 0.5 and 1.0 mg/kg dose-dependently reduced fentanyl withdrawal symptoms, including agitation, salivation, and motor disturbances, as measured by the Gellert-Holtzman scale. While standard stimulant and non-stimulant medications approved for ADHD have shown no significant efficacy in addressing opioid withdrawal or reward, Mazindol’s ability to reduce both in fentanyl-exposed animals suggests it may offer advantages over conventional treatments. This aligns with clinical observations that differentiate the pharmacodynamic profile of Mazindol from traditional monoaminergic agents, as discussed in comparative studies such as Wigal, CNS Drugs.

CEL-SCI announced it has completed its Breakthrough Medicine Designation application for Multikine for submission to the Saudi Food and Drug Authority in Saudi Arabia. Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. The Breakthrough Designation Application is expected to be formally submitted to the SFDA on CEL-SCI’s behalf within the next few weeks by the Company’s prospective Saudi partner, one of the country’s premier pharmaceutical and healthcare companies. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days.

May 20

Akero Therapeutics has hired an investment bank and is exploring a potential sale after being approached by a strategic buyer about a takeover, according to Street Insider, citing a source.

May 19

Eyenovia provided updates on its potential merger with Betaliq and the ongoing development of its novel Optejet user filled device or UFD. Negotiations continue towards a binding merger agreement with Betaliq, a clinical-stage private pharmaceutical company focused on glaucoma with access to Eyesol, a non-aqueous technology that may address many of the needs of these patients. The companies have agreed to extend the binding exclusivity period set forth in the Letter of Intent until June 7 to allow more time to complete and execute the anticipated merger agreement. Progress in the development of the Optejet UFD continues and remains on track to file for U.S. regulatory approval in September of this year. An approval would provide for potential multiple commercial opportunities either directly with consumers or through eye care practitioner offices as well as potential and existing license partners, including Arctic Vision in China and Korea. A broad restructuring of the company was implemented, reducing overall cash burn by approximately 70% versus one year ago and entering into a debt restructuring agreement earlier this year which defers certain repayment obligations until October 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.