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: 

• Tenax Therapeutics (TENX), 12,690% surge in interest
• Biocardia (BCDA), 9,345% surge in interest
• Aclaris Therapeutics (ACRS), 697% surge in interest
• Moleculin Biotech (MBRX), 453% surge in interest
• Harpoon Therapeutics (HARP), 279% surge in interest
• CorMedix (CRMD), 242% surge in interest
• Gamida Cell (GMDA), 240% surge in interest
• Ultragenyx (RARE), 234% surge in interest
• Journey Medical (DERM), 205% surge in interest

Pipeline and key clinical candidates for these companies:

Tenax Therapeutics is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. Tenax Therapeutics is developing a unique oral formulation of imatinib. The company also owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan.

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.

Aclaris Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation.

Moleculin Biotech is focused on the development of a portfolio of drug candidates for the treatment of highly resistant tumors and viruses. The company’s lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia, or AML, and soft tissue sarcoma lung metastases.

Harpoon Therapeutics is developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. “Using its proprietary Tri-specific T cell Activating Construct, or TriTAC, platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. Harpoon’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome,” the company states.

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 developing its lead product DefenCath, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. 

Gamida Cell is at work on an immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies.

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultrarare genetic diseases. The company says it has “built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.”

Journey Medical says it is focused on identifying, acquiring, developing and strategically commercializing “innovative, differentiated dermatology products through its efficient sales and marketing model.” The company currently markets eight branded and three generic products that help treat and heal common skin conditions.

Recent news on these stocks:

November 15

RBC Capital raised the firm’s price target on CorMedix to $10 from $6 and kept an Outperform rating on the shares. The company reported Q3 “with optimism” heading into its key DefenCath PDUFA in catheter-related blood stream infections prevention in hemodialysis, the analyst tells investors in a research note. All signals appeared positive on the prospects of an approval outcome, which is now seen as increasingly likely this time around, the firm added.

Piper Sandler lowered the firm’s price target on Gamida Cell to $2 from $5 and kept an Overweight rating on the shares. The firm noted that Gamida Cell recorded revenues of $673,000 having delivered two Omisirge units in Q3, and guided to ship 4-6 units this year. Piper now forecasts Omisirge revenues of $1.0M in Q4 totaling $1.68M this year, growing to $13.5M in 2024. Gamida Cell is exploring strategic alternatives to fund full launch of Omisirge, Piper added.

November 14

BioCardia announced the FDA approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. BioCardia announces that the Food and Drug Administration, FDA, has approved its proposed CardiAMP Heart Failure II study protocol. The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024. In an interim analysis of available data to date for study patients followed up through two years, those having N-terminal pro B-type natriuretic peptide levels consistent as demarcating heart failure at screening-baseline showed meaningful clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events. Further, all clinical outcome measures evaluated at follow-up for this interim subset favored cell therapy over guideline directed medical therapy, including having improved quality-of-life as measured using the Minnesota Living with Heart Failure Questionnaire, reduced NT-proBNP levels, greater walk distance as measured using the 6-minute walk distance test, and improved cardiac measures such as left ventricular ejection fraction and left ventricular end systolic and end diastolic volumes. Statistical significance was noted for both the reduced heart death equivalents measure and the improved quality of life measure. The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The proposed primary efficacy endpoint is also modified from that in the currently ongoing study. The CardiAMP Heart Failure II endpoint is a similar hierarchical composite assessment but consists of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months.

November 13

Tenax Therapeutics announced that the FDA has reviewed and cleared the company’s Investigational New Drug, or IND, Application for TNX-103 oral levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction, enabling Tenax to proceed with the first of two Phase 3 studies. The LEVEL Study is expected to launch in Q4.

Cantor Fitzgerald analyst Louise Chen downgraded Aclaris Therapeutics to Neutral from Overweight without a price target after the company announced that zunsemetinib did not meet the primary or secondary efficacy endpoints for its rheumatoid arthritis study. The firm is moving to the sidelines until the company’s go-forward strategy becomes more clear.

Moleculin Biotech provided a preliminary update on recent clinical activity and expected near term milestones across its clinical development pipeline in its quarterly filing with the Securities and Exchange Commission. “Having 38% of subjects with a median age of 68 in our MB-106 AML study receiving a full course of Annamycin show a complete response with durability of up to approximately 8 months and counting, we believe, is exceptional while also demonstrating no cardiotoxicity,” Dr. Paul Waymack, Senior Chief Medical Officer said. “Adding to this, we are showing in our Phase 1B/2 study with Annamycin treating soft tissue sarcoma with pulmonary metastases for subjects with no limit on prior therapies PFS of 2.2 months or better for 59% of the subjects. In subjects with fewer prior therapies and dosed with Annamycin at or below 330 mg/m2, this increased to 78% and, additionally, we are showing PFS of 3.4 months for 56% of these subjects. Having a preliminary median of 11.3 months of overall survival once the subject has entered into our Phase 1B study, is exciting as these subjects were heavily pre-treated. For the overall study, we have an opportunity for the Extended OS and PFS data to get better as subjects continue to be monitored.”

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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.