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: 

• Hoth Therapeutics (HOTH), 20,547% surge in interest
• Vir Biotechnology (VIR), 3,757% surge in interest
• Kamada (KMDA), 40% surge in interest
• CorMedix (CRMD), 752% surge in interest
• Matinas BioPharma (MTNB), 338% surge in interest
• Sol-Gel (SLGL), 326% surge in interest
• SpringWorks Therapeutics (SWTX), 307% surge in interest
• Novavax (NVAX), 278% surge in interest
• Moderna (MRNA), 271% surge in interest

Pipeline and key clinical candidates for these companies:

Hoth Therapeutics refers to itself as “a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing.” Hoth “collaborates and partners with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options,” the company stated.

Vir Biotechnology is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.

Kamada is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: KEDRAB, CYTOGAM, WINRHO SDF, VARIZIG, HEPAGAM B and GLASSIA, as well as KAMRAB, KAMRHO and two types of equine-based anti-snake venom products.

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.

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal platform delivery technology. Matinas’ lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent, can be associated with significant toxicity. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will be further evaluated as an oral step-down monotherapy treatment following IV amphotericin B in a single pivotal Phase 3 study in the treatment of aspergillosis in persons with limited treatment options who are unable to be treated with azoles for reasons related to drug-drug interactions, resistance or for whom these antifungal agents are unable to be used for other clinical reasons.

Sol-Gel Technologies is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed Twyneo which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and Epsolay, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults.

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. Ogsiveo, approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, is SpringWorks’ first FDA-approved therapy.

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.

Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA, or mRNA, to “an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale,” the company states. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of vaccines against the COVID pandemic. The company is pursuing the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Recent news on these stocks:

January 8

Hoth Therapeutics responded to recent market rumors and inquiries from shareholders regarding its financial plans and ongoing clinical trials. The company affirms that it has no plans for a public or private offering at this time. Hoth’s financial position remains robust, with a strong balance sheet that includes over $10M in cash and no debt. This fiscal strength positions the company well to execute its strategic initiatives and advance its pipeline without the immediate need for additional financing. “We want to assure our shareholders that Hoth remains focused on creating long-term value and advancing our clinical programs,” said Robb Knie, CEO of Hoth Therapeutics. “With our strong financial foundation, we are well-equipped to continue progressing our innovative therapies.” The company also provided an update on the clinical development of HT-001, its lead therapeutic candidate designed to treat rash and skin disorders associated with cancer therapy. Hoth is pleased to report that enrollment in the HT-001 clinical trial is proceeding as planned, with all trial sites now active and enrolling participants. “Activating all trial sites for HT-001 marks a significant milestone in the development of this promising therapy,” Robb Knie added. “We are excited about the progress and remain committed to addressing unmet needs for patients undergoing cancer treatment.” Hoth remains dedicated to transparency and will continue to provide updates as material developments occur.

Vir Biotechnology is presenting initial Phase 1 data from two of its dual-masked T-cell engagers: VIR-5818, targeting a variety of HER2-expressing solid tumors; and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer. Data show encouraging preliminary safety and efficacy profiles with no dose-limiting cytokine release syndrome, maximum tolerated dose not yet reached as dose escalation continues, and early clinical response signals observed in heavily pretreated participants. These initial results provide clinical support for Vir Biotechnology’s in-licensed PRO-XTEN masking technology, which is designed to enable the selective activation of TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity. Despite availability of HER2-targeting therapies, there remains a significant unmet need for treatments with novel mechanisms of action to improve tolerability and extend survival. Currently, no HER2-directed immunotherapies are approved for solid tumors. The preliminary safety and efficacy data of VIR-5818 support the tumor-specific activation of PRO-XTEN dual-masked TCEs and the potential of this technology to broaden the therapeutic index of TCEs. VIR-5818 is being evaluated in a Phase 1 clinical trial designed to study its safety and pharmacokinetics alone, and in combination with pembrolizumab, in participants with a variety of HER2-expressing cancers, including breast and colorectal cancer. The study has enrolled 79 heterogeneous and heavily pretreated participants in monotherapy cohorts. Early efficacy data indicate that 50% of participants receiving VIR-5818 doses of 400 microgram/kg experienced dose-dependent tumor shrinkage across multiple HER2-positive tumor types. This includes participants who had received up to nine prior lines of therapy. Strong anti-tumor activity was observed in a subset of participants with HER2-positive CRC who have exhausted standard of care. In this subset, confirmed partial responses were seen in 33% of participants at early doses, and one patient continued in cPR for more than 18 months as of the data cut-off. Preliminary safety data demonstrate that VIR-5818 is generally well-tolerated, with minimal grade 1 or 2 CRS and no grade 3 or greater CRS observed in any of the 79 participants across doses up to 1000 microgram/kg. Most treatment-emergent adverse events were low grade, reversible and manageable. The MTD has not yet been reached. Preliminary pharmacokinetics and safety data indicate low systemic unmasking of the TCE, suggesting tumor-specific activation. Dual masking results in a half-life of approximately 6 days, which may enable a less frequent dosing regimen. As a result, Vir Biotechnology is currently evaluating a Q3W dosing regimen. VIR-5500 is being evaluated in a Phase 1 clinical trial designed to assess its safety, pharmacokinetics, and preliminary efficacy in participants with mCRPC. The study has enrolled 18 participants with significant disease burden who have received 3 to 6 prior lines of therapy. Early efficacy data show encouraging signs of prostate-specific antigen responses, and PSA reductions were observed in 100% of participants after an initial dose 120 microgram/kg. PSA50 response was confirmed in 58% of participants receiving a first dose of 120 microgram/kg. Preliminary data show a promising safety profile, with no dose-limiting toxicities observed up to 1000 microgram/kg without prophylactic corticosteroids. Safety findings showed minimal grade 1 or 2 CRS and no grade 3 or greater CRS at any dose. Most TEAEs were low grade. No hearing loss has been reported, suggesting safety benefits of dual masking in preventing on-target, off-tumor toxicities. Dose escalation is ongoing, and the MTD for VIR-5500 has not yet been reached. Preliminary pharmacokinetics and safety data indicate tumor-specific activation with minimal unmasking outside the tumor. The dual-masked TCE shows a desirable half-life of 8-10 days, which is enabling Vir Biotechnology to evaluate a Q3W dosing regimen. The safety and tolerability profile observed for VIR-5500 in ongoing dose escalation, together with the observed signs of early anti-tumor activity at low doses, may enable a wide therapeutic index.

Kamada announced that the company expects to achieve its 2024 financial guidance of $158M-$162M in revenues and $32M-$35M of adjusted EBITDA, with 2024 year-end cash of $78M. The company further announced that, based on its positive outlook for 2025, it is forecasting continued double-digit profitable growth, with 2025 annual guidance of $178M-$182M in revenues and $38M-$42M of adjusted EBITDA. The mid-point of the 2025 guidance represents an increase of 13% in revenues and 19% in adjusted EBITDA based on the mid-point of the 2024 guidance. “We enter 2025 from a position of significant strength and are pleased with the progress made over the past year. We look forward to achieving our value generating objectives for 2025 driven by our four strategic growth pillars, comprising of organic commercial growth, the execution of business development and M&A transactions, our plasma collection operations, and the further advancement of our pivotal Phase 3 Inhaled AAT program,” said Amir London, Kamada’s CEO. “Based on our robust operational and financial performance, we are affirming that 2024 revenue and adjusted EBITDA will both be in line with our previously provided guidance, and we expect continued double-digit profitable growth in 2025, driven by our diverse commercial portfolio marketed in over 30 countries. We continue to demonstrate our ability to convert adjusted EBITDA into operational cash, providing critical resources to enable us to secure compelling new business development and M&A transactions in 2025. These anticipated additions will enrich our portfolio of marketed products and leverage synergies with our existing commercial operations. We also expect to expand our plasma collection operations, including the opening of our third location in San Antonio, TX, by the end of the first quarter of 2025. Once at full collection capacity, we anticipate that each of the Houston and San Antonio centers will contribute annual revenues of $8M to $10M in sales of normal source plasma. Moreover, we are pleased to report that the U.S. FDA recently confirmed its agreement with our previously proposed relaxed two-sided Type 1 error rate control change from 5% to 10% (p-value of 0.1) for the ongoing pivotal Phase 3 InnovAATe clinical trial for our inhaled Alpha-1 Antitrypsin therapy. Based on the accepted change in the p-value, as well as additional expected revisions to the statistical analysis plan, we intend to reduce the study sample size from 220 patients to approximately 180 patients, while maintaining the statistical power of the trial, and conduct an interim futility analysis by the end of 2025.”

Guggenheim lowered the firm’s price target on SpringWorks Therapeutics to $78 from $80 and kept a Buy rating on the shares. The firm has “modestly adjusted” its Ogsiveo estimates, reflecting lower assumptions for ovarian granulosa cell tumor contribution and a more gradual sales ramp in 2025 in the EU, the analyst told investors.

January 7

Shares of Moderna, one of a few drugmakers currently developing a vaccine for the H5N1 bird flu, were up nearly 10% in early trading after the first death from the bird flu was reported in the U.S., Barron’s reported. As of Monday, there had been 66 confirmed human cases of H5N1 bird flu in the U.S. since 2024 and 67 since 2022, according to Centers for Disease Control and Prevention data. Pfizer (PFE) and GSK (GSK), in partnership with CureVac (CVAC) are also developing bird flu mRNA vaccines.

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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.