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:

• Cyclacel Pharmaceuticals (CYCC), 282% surge in interest
• Tevogen Bio (TVGN), 272% surge in interest
• Larimar Therapeutics (LRMR), 247% surge in interest
• Immunic (IMUX), 243% surge in interest
• Tharimmune (THAR), 200% surge in interest
• Regeneron (REGN), 196% surge in interest
• Atossa Therapeutics (ATOS), 121% surge in interest

Pipeline and key clinical candidates for these companies:

Cyclacel is a clinical-stage, biopharmaceutical company developing cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the epigenetic/anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications.

Tevogen Bio is a clinical-stage specialty immunotherapy company that says it is “harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders, aiming to address the significant unmet needs of large patient populations.”

Larimar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar’s lead compound, nomlabofusp, is being developed as a potential treatment for Friedreich’s ataxia. Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds.

Immunic has a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products. Its lead development program, vidofludimus calcium, is a selective immune modulator that is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935 is targeted for development in psoriasis and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.

Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick Technology. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers.

Regeneron is a biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. The company’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Atossa Therapeutics is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company’s lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders.

Recent news on these stocks:

May 1

Regeneron Pharmaceuticals announced new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology Annual Meeting, taking place from May 30 to June 3 in Chicago, IL. Eighteen presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. “Our broad oncology and hematology programs are uniquely designed to investigate regimens that could provide meaningful impact for people living with difficult-to-treat cancers across all stages of the treatment paradigm,” said George D. Yancopoulos, Board co-Chair, President and CSO. “Our PD-1 inhibitor Libtayo is the standard of care in advanced cutaneous squamous cell carcinoma, and in clinical trials, our investigational BCMAxCD3 bispecific antibody linvoseltamab has demonstrated a compelling profile in relapsed or refractory multiple myeloma. At ASCO, our presentations showcase how we are seeking to further transform the treatment of these diseases with updates from two key programs – our Phase 3 trial exploring adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma and early data from investigational combinations of linvoseltamab and different proteasome inhibitors in third-line or higher multiple myeloma.”

April 30

Larimar Therapeutics reported lower-than-expected Q1 earnings. “Our strong execution across our nomlabofusp clinical development program continues and we are focused on delivering the first potential disease modifying therapy to patients with FA. Importantly, with the robust preclinical and clinical data package we have in hand and the additional clinical data readouts coming later this year, coupled with the positive FDA feedback and recommendations in line with our current approach, we are on track to submit our planned Biologics License Application by the end of 2025 to seek accelerated approval,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “We continue to have frequent communication with the FDA via our START pilot program participation including interactions regarding the adequacy of the safety data set required to support BLA submission. In mid-2025 we expect to initiate our global Phase 3 study following global regulatory feedback on the study protocol, and we also expect to transition to the lyophilized formulation of nomlabofusp. We completed dosing of adolescents in our pharmacokinetic run-in study and expect to report adolescent data from that study, along with data from participants receiving the 50 mg dose of nomlabofusp daily in our long-term open label extension study. This program update will be in September 2025. We look forward to these important near-term catalysts as we work to bring nomlabofusp towards potential registration.”

Immunic announced positive data from its phase 2 CALLIPER trial of nuclear receptor related 1, or Nurr1, activator, vidofludimus calcium, in patients with progressive multiple sclerosis, or PMS. In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening events based on changes in the expanded disability status scale by 20% compared to placebo. Vidofludimus calcium was associated with a 30% reduction in the relative risk of 24wCDW events in the primary progressive multiple sclerosis study population vs. placebo and a respective 15% reduction in the non-active secondary progressive multiple sclerosis study population. Vidofludimus calcium reduced the relative risk of 24wCDW events in patients without gadolinium-enhancing lesions at baseline by 29% compared to placebo. In Immunic believes the substantial effect in these patients, therefore, underlines the previously observed neuroprotective effect of Nurr1 activation by vidofludimus calcium. Vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% in patients with PMS compared to placebo. The top-line CALLIPER data set confirmed the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials. No new safety signals were identified.

Atossa Therapeutics announced that the United States Patent and Trademark Office has granted a new patent directed to highly pure and stable enteric oral formulations comprising (Z)-endoxifen as well as therapeutic methods of using those oral formulations. The newly granted patent includes 58 claims covering (Z)-endoxifen formulations, including various levels of purity and stability as well as methods of using those formulations. This patent provides additional support for Atossa’s intellectual property portfolio surrounding its proprietary (Z)-endoxifen formulations, a potent Selective Estrogen Receptor Modulator.

April 28

Tevogen reaffirms its top-line revenue forecast for its oncology pipeline, projecting $1B in revenue in its launch year and a cumulative five-year estimate of between $10B and $14B. The forecast reflects the company’s drug development model. “With our intellectual property secured, Tevogen continues to build its U.S.-based cell therapy manufacturing capabilities, and I look forward to updating our shareholders on our forecasts and internal assets valuation,” commented Ryan Saadi, founder and CEO of Tevogen.

Tharimmune announced feedback from the U.S. Food and Drug Administration regarding TH104. The agency confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application submission. TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism. This allows TH104 to be suitable for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues. This significant regulatory milestone underscores the urgent need for specialized medical countermeasures highlighted in a recent market assessment concerning the United States Strategic National Stockpile. This assessment specifically addressed the growing threat posed by chemicals of concern, with a primary focus on the increasing risk of high-potency synthetic opioids like fentanyl and its numerous derivatives being weaponized and deployed as aerosolized agents. The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and the potential for mass casualty incidents if weaponized. These substances, significantly more potent than traditional opioids, pose a grave risk through inhalation, dermal contact, or ingestion. The 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents in a mass casualty scenario. This event, alongside intelligence indicating potential adversary interest in opioid-based chemical weapons, has heightened the priority for developing effective prophylactic measures for frontline personnel/first responders. SNS market assessment identified a critical need for countermeasures that can be administered prior to or immediately upon potential exposure to these agents, preventing or mitigating the rapid onset of respiratory and nervous system depression. Key findings from this analysis further emphasize the importance of Tharimmune’s work: The Department of Defense is proactively addressing this threat through its procurement of a naloxone auto-injector, explicitly indicated for temporary prophylaxis against high-potency opioids for military personnel and chemical incident responders operating under their authority. SNS, managed by the Administration for Strategic Preparedness and Response, a part of Department of Health and Human Services. ASPR maintains over 1974 containers in 1330 locations throughout the USA, to ensure timely availability of antidotes to chemicals of concern to civilian population. Tharimmune’s TH104, with its buccal film delivery and potential for a longer duration of action compared to existing naloxone formulations, offers a promising investigational countermeasure tailored to the demanding operational environments faced by military and civilian responders. Compared with current administration modes, the buccal administration route is potentially advantageous when personnel are wearing full protective gear.

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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.