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: 

• DBV Technologies (DBVT), 9,940% surge in interest
• CNS Pharmaceuticals (CNSP), 2,388% surge in interest
• Allakos (ALLK), 1,127% surge in interest
• Mustang Bio (MBIO), 669% surge in interest
• Sangamo (SGMO), 659% surge in interest
• Immunic (IMUX), 574% surge in interest
• Akebia Therapeutics (AKBA), 351% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 330% surge in interest
• Genprex (GNPX), 236% surge in interest
• CorMedix (CRMD),190 % surge in interest

Pipeline and key clinical candidates for these companies:

DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. The company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers and children.

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The company’s lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme, or GBM, an aggressive and incurable form of brain cancer.

Allakos is a clinical stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The company’s most advanced antibody in ongoing clinical development is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed selectively on mast cells.

Mustang Bio is a clinical-stage biopharmaceutical company that says it is “focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers.” Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with medical institutions to advance the development of CAR-T therapies, the company notes.

Sangamo Therapeutics is a genomic medicine company that says it is “dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options.” Sangamo’s zinc finger epigenetic regulators are being studied to potentially address neurological disorders and Sangamo’s capsid discovery platform is “making progress toward potentially expanding delivery beyond currently available intrathecal delivery capsids, including in the central nervous system,” Sangamo says.

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.

Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is “to better the lives of people impacted by kidney disease.”

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.

Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options, the company says.

CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The company is focused on commercializing its lead product DefenCath, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations.

Recent news on these stocks:

October 24

Cyclacel Pharmaceuticals received a written notice from The Nasdaq Stock Market granting the company an extension until December 24 to regain compliance with Nasdaq’s minimum stockholders equity requirement under Nasdaq Listing Rule 5550(b)(1). This notice has no immediate effect on the listing of the company’s common stock on Nasdaq. As previously reported, on August 26, the Listing Qualifications Staff of Nasdaq determined that the company was not in compliance with the Equity Standard Rule because the company reported stockholders’ equity of less than $2.5M as of June 30.

CorMedix announced new hospital admission and health economic data presented at the American Society of Nephrology Kidney Week 2024 in San Diego, CA from October 24 – 27. This retrospective analysis, using data from the Premier Healthcare Database, evaluated hospital admissions from 2020 to 2022 to examine the demographics, clinical characteristics, and outcomes of adult HD-CVC patients hospitalized for bloodstream infections. Key findings include: The patient population was 58.2% white, 27.1% black, and 56.6% male, with 59.3% aged 60 years or older. The median length of stay for BSI-related hospitalizations was 16 days, with 53.8% of admissions involving time in the ICU. The study reported an all-cause in-hospital mortality rate of 10.3%. Patients had extensive comorbidities, with 87.8% having three or more Charlson comorbidity conditions, and 42.6% had six or more. The median total cost of admission was $157,000, with $65,000 attributed to ICU care alone. Healthcare utilization, including readmissions, placed a significant financial burden resulting from these infections.

October 22

DBV Technologies announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to guidance provided by the FDA on a pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the EMA on a 1-7 year-old indication in Europe. DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request. serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. DBV intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. DBV expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.

Mustang Bio was granted orphan designation from the FDA for a treatment of malignant glioma, according to a post to the agency’s website.

Sangamo announced the outcome of a recent interaction with the FDA, providing a clear regulatory pathway to accelerated approval for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease. The FDA has agreed in a Type B interaction that data from the ongoing Phase 1/2 STAAR study can serve as the primary basis for approval under the accelerated approval program, using eGFR slope at 52 weeks across all patients as an intermediate clinical endpoint. The complete dataset to support an accelerated approval pathway will be available in the first half of 2025. This approach unlocks a potential BLA submission in the second half of 2025, three years ahead of previous estimates, and avoids the requirement for an additional registrational study to establish clinical efficacy. Sangamo engaged with the FDA on alternative pathways to potential approval following analysis of clinical data from the Phase 1/2 STAAR study showing encouraging safety and efficacy data, including promising preliminary evidence of improved kidney function. Based on these latest data, the FDA agreed that eGFR slope at 52 weeks can serve as an intermediate clinical endpoint to support a potential accelerated approval. The FDA also advised that eGFR slope at 104 weeks may be assessed to verify clinical benefit.

Immunic announced the outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1, or Nurr1, activator, vidofludimus calcium, or IMU-838, for the treatment of relapsing multiple sclerosis, or RMS. Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee, or IDMC, has recommended that the trials are not futile and should continue as planned. The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with “futility criteria have not been met.” The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with “continue as planned.” Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations. The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.

Akebia Therapeutics announced that it has signed a multi-year commercial contract with one of the nation’s leading providers of kidney care services, expanding access to Vafseo for patients on dialysis. The contract enables physicians to prescribe Vafseo to patients on dialysis as deemed clinically appropriate. Akebia expects Vafseo will be available in the U.S. in January 2025.

October 15

Genprex has completed the 0.09 mg/kg dose group of the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa Gene Therapy in combination with Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer. In addition, the Safety Review Committee has approved escalation to the highest dose group of 0.12 mg/kg. The combination of REQORSA and atezolizumab previously received FDA Fast Track Designation for the treatment of the Acclaim-3 patient population and the FDA has also granted Orphan Drug Designation to Reqorsa for the treatment of SCLC. There were no dose limiting toxicities in this dose group and the SRC recommended moving up to the highest dose group planned in the trial. The first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. The company believes this suggests that Reqorsa may be providing clinical benefit. The primary endpoint of the Phase 1 escalation portion is to determine the maximum tolerated dose or recommended Phase 2 dose. After the Phase 1 portion is complete, the Phase 2 expansion portion will enroll 50 patients at 10 to 15 U.S sites.

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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.