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: 

• Armata Pharmaceuticals (ARMP), 22,850% surge in interest
• NeurAxis (NRXS), 17,567% surge in interest
• Protagenic Therapeutics (PTIX), 10,169% surge in interest
• Eyenovia (EYEN), 3,761% surge in interest
• Brainstorm Cell Therapeutics (BCLI), 3,040% surge in interest
• NLS Pharmaceuticals (NLSP), 2,300% surge in interest
• Tango Therapeutics (TNGX), 1,708% surge in interest
• Instil Bio (TIL), 693% surge in interest
• Novavax (NVAX), 454% surge in interest
• Prime Medicine (PRME), 365% surge in interest

Pipeline and key clinical candidates for these companies:

Armata is a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. 

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, the company says.

Protagenic Therapeutics is committed to pioneering neuro-active peptides into therapeutics to mitigate stress-related disorders.

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.

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. 

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.

Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

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.

Novavax says it promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response.

Prime Medicine is a biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The company is deploying its proprietary Prime Editing platform, which it says “could unlock opportunities across thousands of potential indications.”

Recent news on these stocks:

May 22

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.

Tango Therapeutics announced that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma. TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5 inhibitor.

May 19

Armata Pharmaceuticals announced positive topline results from its Phase 1b/2a diSArm trial which evaluated AP-SA02, a novel intravenous, or IV, administered multi-phage therapeutic for the treatment of Staphylococcus aureus bacteremia, or SAB, in the intent-to-treat, or ITT, population. The diSArm study was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy, or BAT, compared to BAT alone (placebo) for the treatment of adults with complicated SAB. Safety and efficacy were assessed in the ITT population, which included all subjects who received at least one dose of AP-SA02 or placebo. The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at Test of Cure for AP-SA02, defined as one week following the end of IV treatment with AP-SA02, TOC for BAT, defined as one week following the end of IV BAT, and end of study, defined as four weeks following the end of IV BAT. A statistically significant increase in investigator-assessed responder rate was observed at TOC for AP-SA02 in AP-SA02 treated subjects versus placebo. At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent phase 3 trials. Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive S. aureus or methicillin-resistant S. aureua. All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above.

Protagenic Therapeutics and Phytanix Bio have entered into a definitive share exchange agreement pursuant to which the two entities will combine in an all-stock transaction. The combined entity, to be called Phytanix, Inc., will bring together two pipelines focused on stress-related and CNS disorders, five preclinical assets and one clinical-stage asset. Under the terms of the exchange agreement, the company, in exchange for all of the outstanding shares of Phytanix Bio, issued on a pro rata basis to each of the common stockholders of Phytanix Bio, an aggregate of 117,690 shares of the company’s common stock, par value $0.0001 per share, which shares represent a number equal to no more than 19.99% of the outstanding shares of common stock as of immediately before the closing on May 16, 5,705 shares of the company’s Series C Convertible Preferred Stock and 950,000 shares of the company’s Series C-1 Convertible Preferred Stock. In addition, in exchange for all of the outstanding preferred stock of Phytanix Bio, the company issued on a pro rata basis to each of PHX’s preferred stockholders an aggregate of 20,000 shares of Series D Preferred Stock, and common stock purchase warrants to purchase up to 715,493 shares of common stock. The issuance of the shares of common stock, the preferred stock, and the warrants occurred on May 16. Each share of preferred stock is convertible into one of common stock, subject to certain conditions described in the exchange agreement. As calculated on a fully diluted basis, post-combination pre-financing ownership will be approximately 35% for the pre-combination stockholders of the company and approximately 65% for Phytanix Bio stockholders.

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.

BrainStorm Cell Therapeutics announced that the FDA has cleared the company to initiate its Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis. The trial design was previously agreed upon with the FDA under a Special Protocol Assessment, confirming the study’s endpoints and statistical methodology are appropriate to support a future Biologics License Application submission. This clearance allows the company to proceed with patient enrollment.

Novavax announced that the FDA has approved the Biologics License Application for Nuvaxovid for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Achievement of the U.S. license approval has triggered a $175M milestone payment from Sanofi (SNY). The approval triggers a $175M milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in May 2024. The agreement has layers of value for Novavax. Sanofi is leading on commercialization efforts starting this year and Novavax is eligible to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons.

Prime Medicine announced initial data from the first patient dosed in its ongoing Phase 1/2 clinical study of PM359 in Chronic Granulomatous Disease. Preliminary results from the first patient demonstrated that PM359 was well-tolerated, showed rapid engraftment and restored NADPH oxidase activity to well above the threshold for clinical benefit, as measured by the dihydrorhodamine assay. CGD is a rare inherited disease that leads to recurrent, debilitating and often life-threatening infections. It is caused by mutations in genes, including NCF1, that encode proteins that form the NADPH oxidase complex, an enzyme that kills bacteria and fungi to control infection. PM359, an ex vivo Prime Edited autologous hematopoietic stem cell product for the treatment of p47phox CGD and the first Prime Editor generated therapy to be administered in humans, is designed to correct the delGT mutation in NCF1, the most prevalent disease-causing mutation in the p47phox variant of CGD, thereby addressing its underlying pathophysiology. Prime Medicine estimates that CGD causative mutations occur in between one in 100,000 and one in 200,000 births in the United States, with approximately 25 percent of patients presenting with the p47phox form of the disease. PM359 is being evaluated in a Phase 1/2, multinational, first-in-human trial designed to assess safety, biological activity and preliminary efficacy in adult and pediatric study participants. Initial safety and efficacy data reported today are from the first adult patient treated in the trial. This patient was treated with a single dose of PM359, administered by intravenous infusion. NADPH oxidase activity was measured by the dihydrorhodamine assay at baseline, Day 15 and Day 30. Treatment with PM359 led to complete restoration of NADPH oxidase activity in 58% of neutrophils by Day 15 and 66% of neutrophils by Day 30, significantly exceeding the anticipated minimum threshold for clinical benefit of 20%. Additionally, this patient experienced rapid engraftment of his autologous transplant following myeloablative conditioning. Engraftment was confirmed in neutrophils on Day 14 and in platelets on Day 19. Of note, this is nearly two-times faster than approved gene editing technologies, where median engraftment has been reported to occur on Days 27 and 35 across these same measures. Treatment with PM359 was generally well-tolerated, with an acceptable safety profile. Adverse events were generally consistent with AEs otherwise observed during myeloablative conditioning with busulfan. No serious AEs related to PM359 were reported as of the data cutoff. Prime Medicine does not plan to independently advance its efforts in CGD. Prime Medicine is exploring options for the continued clinical development of PM359 external to the company and ceasing further efforts in X-linked CGD. Prime Medicine believes PM359 has the potential to transform the care of p47phox CGD and is committed to working with urgency to identify an appropriate partner to help ensure this important therapy is delivered to patients. Going forward, Prime Medicine will focus its resources on advancing its in vivo liver franchise, where the Company is advancing programs to cure two of the largest genetic liver diseases, Wilson’s Disease and Alpha-1 Antitrypsin Deficiency. Prime Medicine will also continue its in vivo Cystic Fibrosis program with support from the Cystic Fibrosis Foundation, and its efforts to develop Prime Edited CAR-T products for hematology, immunology and oncology in partnership with Bristol Myers Squibb. In addition, Prime Medicine will continue to pursue additional business development opportunities to accelerate innovation, ensure the broadest application of Prime Editing, and further bolster its financial resources.

Prime Medicine announced a strategic restructuring, including the deprioritization of its Chronic Granulomatous Disease programs, as well as a cost and workforce reduction to focus on its liver franchise and programs funded through external partnerships. Prime Medicine is currently advancing in vivo programs to cure two of the largest genetic liver diseases, Wilson’s Disease and Alpha-1 Antitrypsin Deficiency, with initial clinical data from both programs expected in 2027. Prime Medicine will also continue its in vivo Cystic Fibrosis program with support from the Cystic Fibrosis Foundation, and its efforts to develop Prime Edited CAR-T products for hematology, immunology and oncology in partnership with Bristol Myers Squibb. In addition, Prime Medicine will continue to pursue additional business development opportunities to accelerate innovation, ensure the broadest application of Prime Editing, and further bolster its financial resources. Prime Medicine will focus its internal efforts on the development of in vivo programs for the treatment of Wilson’s Disease and AATD, two of the largest genetic liver diseases. Prime Medicine expects to file an investigational new drug and/or clinical trial application for its Wilson’s Disease program in the first half of 2026 and for its AATD program in mid-2026; initial clinical data from both programs are expected in 2027. Wilson’s Disease: Wilson’s Disease is a rare and severe disorder caused by excess copper accumulation in the liver and brain that can lead to liver failure and neurocognitive decline and can be fatal without a liver transplant. There are currently no approved disease-modifying therapies for Wilson’s Disease, which affects more than 20,000 people in the United States and European Union. AATD: AATD is a progressive, genetic disorder caused by mutations in the SERPINA1 gene, which can result in both lung- and liver-related symptoms, including shortness of breath, wheezing, chronic cough and frequent chest colds, as well as jaundice, ascites, and cirrhosis. There are currently no disease-modifying or curative treatments approved for the approximately 200,000 people in the United States and European Union with AATD, of which 20,000-30,000 people are currently diagnosed. Many patients with AATD ultimately progress to liver failure or severe lung disease, eventually resulting in premature death. Prime Medicine will also continue its in vivo Cystic Fibrosis program with support from the Cystic Fibrosis Foundation, and its efforts to develop Prime Edited CAR-T products for hematology, immunology and oncology in partnership with Bristol Myers Squibb. As announced in conjunction with initial data for PM359 this morning, Prime Medicine is exploring options for the continued clinical development of PM359 external to the company and ceasing further efforts in X-linked CGD. Prime Medicine believes PM359 has the potential to transform the care of p47phox CGD and is committed to working with urgency to identify an appropriate partner to help ensure this important therapy is delivered to patients.Alongside the pipeline prioritization announced today, Prime Medicine is undertaking cost reduction measures and restructuring its team, including reducing its organizational headcount by approximately 25% percent. These initiatives are designed to significantly decrease Prime Medicine’s operating expenses and cash burn, reducing anticipated cash needs by almost half through 2027. Prime Medicine announced that it recently engaged in binding arbitration proceedings with Beam Therapeutics regarding the parties’ 2019 Collaboration and License Agreement and specific to its AATD program. Prime Medicine is committed to honoring the terms of the Agreement, and confident that it has the rights to pursue AATD under the agreement. Based on its current plans, Prime Medicine continues to expect that its cash, cash equivalents and investments as of March 31, 2025 will be sufficient to fund its operations and capital expenditure requirements into the first half of 2026.

Prime Medicine announced that Keith Gottesdiener has decided to step down as CEO and a member of the company’s board of directors, effective immediately. Allan Reine, M.D., Prime Medicine’s CFO, has been named CEO and member of the board and Jeff Marrazzo, member of the company’s board, has been named executive chair.

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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.