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), 3,975% surge in interest
• ChromaDex (CDXC), 711% surge in interest
• Pieris Pharma (PIRS), 613% surge in interest
• Cerus Corp (CERS), 575% surge in interest
• Crinetics Pharmaceuticals (CRNX), 513% surge in interest
• Actinium Pharmaceuticals (ATNM), 407% surge in interest
• Alpine Immune Sciences (ALPN), 405% surge in interest
• Atreca (BCEL), 188% surge in interest
• Seelos Therapeutics (SEEL), 172% surge in interest
• AIM ImmunoTech (AIM), 164% 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.

ChromaDex Corporation says it is “dedicated to healthy aging.” ChromaDex says it is pioneering research on nicotinamide adenine dinucleotide, NAD+, an essential coenzyme that is a key regulator of cellular metabolism. “ChromaDex is the innovator behind the NAD+ precursor nicotinamide riboside, commercialized as the flagship ingredient Niagen. Nicotinamide riboside and other NAD+ precursors are protected by ChromaDex’s patent portfolio,” the company has stated.

Pieris is a clinical-stage biotechnology company that says it “combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients.” Its pipeline has historically focused on inhalable Anticalin proteins to treat respiratory diseases and locally-activated bispecifics for immuno-oncology.

Cerus Corporation is dedicated to “safeguarding the world’s blood supply and aims to become the preeminent global blood products company,” it has said. The company develops and supplies technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and “remains the only pathogen reduction system with both CE Mark and FDA approval for these two blood components,” Cerus states. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.

Crinetics Pharmaceuticals is focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Paltusotine, an investigational, oral somatostatin receptor type 2 agonist, is in Phase 3 clinical development for acromegaly and Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics has demonstrated pharmacologic proof-of-concept in Phase 1 clinical studies for CRN04777, an investigational, oral somatostatin receptor type 5 agonist in development for congenital hyperinsulinism, and for CRN04894, an investigational, oral ACTH antagonist in development for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH.

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B, an induction and conditioning agent prior to bone marrow transplant, and Actimab-A, a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.

Alpine Immune Sciences says it is “committed to leading a new wave of immune therapeutics.” Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives, the company states. Alpine has entered into strategic collaborations with global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development, the company adds.

Atreca is a biopharmaceutical company developing novel antibody-based therapeutics generated by its differentiated discovery platform, with a focus on antibody-drug conjugates. Atreca’s platform allows access to an unexplored landscape in oncology through the identification of unique antibody-target pairs generated by the human immune system during an active immune response against tumors. These antibodies provide the basis for a pipeline of first-in-class oncology programs led by APN-497444, an ADC targeting a novel tumor glycan, in addition to MAM01/ATRC-501, a clinical candidate licensed to the Bill & Melinda Gates Medical Research Institute for the prevention of malaria.

Seelos Therapeutics is focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system, or CNS, disorders and other rare diseases. The company’s portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior in Major Depressive Disorder, amyotrophic lateral sclerosis, or ALS, and spinocerebellar ataxia, or SCA, as well as early-stage programs in Huntington’s disease, Alzheimer’s disease, and Parkinson’s disease.

AIM ImmunoTech is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The company’s lead product is a first-in-class investigational drug called Ampligen, a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

Recent news on these stocks:

March 19

Hoth Therapeutics unveiled “positive” pre-clinical research involving HT-ALZ, an Alzheimer’s disease therapeutic. HT-ALZ combats neuroinflammation and cognitive deficits associated with Alzheimer’s Disease. By antagonizing the NK1 receptor, HT-ALZ reduces soluble Abeta levels in the brain’s interstitial fluid and diminishes anxiety-like behavior and enhances cognitive function in preclinical models. The research presents evidence of HT-ALZ’s capacity to improve memory tasks related to the hippocampus and sensorimotor gating. While the effects on plaque deposition and Abeta levels were inconclusive, the treatment’s cognitive benefits suggest that HT-ALZ’s mode of action may involve a reduction in brain inflammation, thereby improving cognitive outcomes for Alzheimer’s patients. Hoth Therapeutics remains committed to further research and development of HT-ALZ, including analyses of its effects on microglial activation and brain inflammation.

Cerus announced topline results for ReCePI, a Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells transfused to complex cardiac surgery patients. The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury, or AKI, following transfusion of study RBCs. AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery. In transfused subjects, by modified intent to treat the incidence of AKI was 29.3% for INTERCEPT RBC recipients compared to 28% for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14%. The safety endpoint of the proportion of patients with any related treatment-emergent adverse events, or TEAEs, within 28 days of last transfusion was not significantly different for INTERCEPT RBCs compared to conventional RBCs. There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs. The trial’s independent Data Safety and Monitoring Board, or DSMB, evaluated these patients and was supportive of continued transfusion, having found no adverse health effects from trial transfusions. This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs. Cerus plans to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular premarket approval, or PMA, submission. Cerus anticipates initiating a modular PMA application to the FDA in the second half of 2025, with the final PMA module submission planned for the second half of 2026, upon the anticipated completion of the RedeS clinical trial. Data from preclinical studies, manufacturing information, previously reported Phase 1 and Phase 2 clinical trials in the U.S., and the successfully completed Phase 3 clinical trials in the EU will be included in the modular PMA submission. Cerus expects the data from the ReCePI clinical trial to be presented at upcoming medical conferences as well as to be submitted for peer reviewed publication.

Crinetics Pharmaceuticals announced positive topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of oral, once-daily investigational paltusotine for the treatment of acromegaly, a serious rare disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. PATHFNDR-2 was a 24-week treatment period followed by an optional open-label extension study evaluating paltusotine in 111 participants with acromegaly who were not pharmacologically treated. The study met statistical significance on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 level less than or equal to 1.0 times the upper limit of normal vs. those taking placebo. All secondary endpoints also met statistical significance. In PATHFNDR-2, paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine. The PATHFNDR Program consists of two Phase 3 double-blind, placebo-controlled studies. Crinetics believes these studies could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from standard of care.

H.C. Wainwright said acquisitions in the radiopharma sector, including AstraZeneca’s (AZN) deal today to buy its partner in radiopharmaceuticals, Fusion Pharma (FUSN), for an upfront value of $2.0B in cash underscores Actinium Pharmaceuticals’ potential and business development prospects. A deal of this size underscores the continued interest in the radiopharmaceutical space as a whole, said the analyst, who sees a positive read-through for Actinium in particular. Actinium is well positioned “for a similar takeout route,” contended H.C. Wainwright. The firm has a Buy rating on the shares with a $50 price target.

Maxim raised the firm’s price target on Actinium Pharmaceuticals to $30 from $20 and kept a Buy rating on the shares following another Ac-225 acquisition with AstraZeneca to acquire Fusion Pharma. The firm noted that the acquisition comes amidst building momentum in the radiopharma space, in particular among alpha emitters, including the December acquisition of RayzeBio (RYZB) by Bristol Meyers (BMY) for $4.1B for its Ac-225 pipeline. Maxim also highlights Lilly (LLY) acquiring POINT Biopharma in October 2023 for $1.4B, which was centered around its pipeline of targeted beta – Lu-177 – and alpha – Ac-225 – emitting radio-pharmaceuticals. The Ac-225 focused M&A activity, which given the small number of companies in the space, places a potential “scarcity value” on Actinium, the firm argued.

Seelos Therapeutics provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. The company plans to request a meeting with the FDA to discuss potential next steps for the programThe study was designed to evaluate SLS-005, a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy, in decreasing the slope of the ALS Functional Rating Scale and separation from placebo in Function and Mortality in an all-comers population of Persons with ALS. While the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set, by showing a 13% improvement in Function and Mortality with an 88% success probability, vs. the pre-specified 98%, it showed a potential signal of efficacy in a pre-specified subgroup. In the pre-specified subgroup of PALS treated with SLS-005, without Relyvrio, the top-line data favored SLS-005 versus placebo in efficacy measures in the Efficacy Relyvrio Free data set, including: a 22% improvement in slope of change in ALSFRS-R assessment adjusted for mortality, with an 89% success probability, at 24 weeks the rate of decline in ALSFRS-R slope also favored the SLS-005 treatment group versus placebo over 6 months; a 25% slowing of Slow Vital Capacity decline versus placebo at 24 weeks. Seelos plans to run additional analyses, including biomarkers of neurodegeneration, neurofilament light chain, exploratory efficacy results, subgroups and post-hoc analyses. SLS-005 was generally well-tolerated and comparable to placebo in safety. There was an imbalance of deaths/death equivalents observed in the study, with more events seen in the SLS-005 group compared to placebo, all were considered unrelated to the study drug.

March 18

Alpine Immune Sciences reported FY23 EPS (64c), consensus ($1.10). As of December 31, 2023, Alpine’s cash and investments totaled $368.2M compared to $273.4M as of December 31, 2022. The company anticipates its current cash and investments are sufficient to fund planned operations into 2026. CEO Mitchell H. Gold stated: “2023 was a transformational year for Alpine, with initial IgA nephropathy data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor. With our encouraging data set in IgAN, convenient once monthly dosing regimen, and strong balance sheet, we are rapidly advancing development of povetacicept as a potentially meaningful new therapeutic option for patients living with IgAN, systemic lupus erythematosus, and multiple other autoantibody-related diseases. Looking ahead, Alpine is well positioned for a year of meaningful catalysts, with multiple updates for povetacicept in IgAN and other indications, and the planned initiation of RAINIER, a pivotal phase 3 study of povetacicept in IgAN, and DENALI, a phase 2 study of povetacicept in SLE. In addition to updates on our clinical studies, we look forward to sharing translational data that further supports the best-in-class potential of povetacicept in multiple inflammatory diseases.”

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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.