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), 3,150% surge in interest
• Kodiak Sciences (KOD), 1,145% surge in interest
• Biocardia (BCDA), 969% surge in interest
• Marker Therapeutics (MRKR), 245% surge in interest
• Verrica Pharmaceuticals (VRCA), 159% surge in interest

Pipeline and key clinical candidates for these companies:

Armata is a clinical-stage biotechnology company focused on the development of 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 pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is “committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage-specific GMP manufacturing,” the company states.

Kodiak is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. KSI-501 is their dual inhibitor antibody biopolymer conjugate targeting both VEGF and IL-6 for the treatment of retinal diseases. The company is expanding its early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma.

BioCardia is a developer of cell and cell-derived therapies for cardiovascular and pulmonary disease. The company has two biotherapeutic platforms, CardiAMP autologous bone marrow-derived mononuclear cell therapy for cardiovascular indications and the NK1R+ allogeneic bone marrow-derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases.

Marker Therapeutics is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. “Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies,” the company says.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica’s lead product, Ycanth, became the first treatment approved by the FDA to treat pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for dermatologic oncology conditions.

Recent news on these stocks:

July 24

Kodiak Sciences announced topline results from three Phase 3 studies of tarcocimab tedromer, a novel antibody biopolymer conjugate. The DAYLIGHT study was a randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of a high intensity dosing regimen of tarcocimab tedromer in 557 treatment-naive subjects with wet AMD. The DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every eight weeks following three monthly loading doses. Tarcocimab was safe and well tolerated in the study and with a low rate of intraocular inflammation. The GLEAM and GLIMMER studies are identically designed, randomized, double-masked, active comparator-controlled studies evaluating the efficacy, durability and safety of tarcocimab tedromer in 460 and 457 treatment-naive subjects with DME, respectively. Although high proportions of patients on meaningfully longer treatment intervals were observed with tarcocimab, with half of patients on every 24-week dosing at the primary endpoint, the GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every eight to 24 weeks after three monthly loading doses compared to aflibercept given every eight weeks after five monthly loading doses. An unexpected increase in cataracts was observed over time in the tarcocimab arms of both GLEAM and GLIMMER, and Kodiak’s initial evaluation suggests that this contributed meaningfully to the failure of each study. In the DAYLIGHT study, no imbalance in cataracts was observed between wet AMD patients receiving tarcocimab or aflibercept throughout the one-year study period despite the intensive monthly tarcocimab dosing regimen. Based on these data, and despite demonstrating great potential, Kodiak has made a business decision to discontinue further development of tarcocimab. It is anticipated that data from the DAYLIGHT study and additional results and insights from the tarcocimab development program, such as the pending BEACON study year one data in retinal vein occlusion and pending topline results of the GLOW study in non-proliferative diabetic retinopathy, will be presented at upcoming medical conferences.

BioCardia announces that the independent Data Safety Monitoring Board, DSMB, has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP Cell Therapy Heart Failure Trial, for which FDA granted Breakthrough Designation. Pursuant to the DSMB recommendation, BioCardia is pausing the trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated. The DSMB recommendation stated: “Based on an analysis of the trial data, the primary FS composite endpoint assessment and a supplemental analysis presented on 7/19/23, unrelated to any emergent safety events, the DSMB recommends pausing new patient enrollment and any potential crossover patient procedures pending an outcomes analysis of patients currently completing the one-year follow-up as well as the patients completing their imminently scheduled treatment… The DSMB recommends the blind not be broken at this time to protect the integrity of the outcomes yet to be collected and to ensure that the study may be restarted without compromise after completion of the one-year data analysis.”

July 21

Verrica Pharmaceuticals announced FDA approval of Ycanth topical solution for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. Ycanth is for topical use only. Ycanth is not for oral, mucosal, or ophthalmic use. Local skin reactions at the application site were observed in 97% of subjects treated with Ycanth during clinical trials. Local skin reactions included vesiculation, pruritus, pain, discoloration, and erythema. Ycanth is a proprietary drug-device combination product containing a GMP-controlled formulation of cantharidin delivered via a single-use applicator, allowing for precise topical dosing and targeted administration. Verrica plans to make Ycanth available by September.

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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.