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: 

• Plus Therapeutics (PSTV), 386% surge in interest
• Repligen (RGEN), 352% surge in interest
• Bio-Techne (TECH), 247% surge in interest
• CASI Pharmaceuticals (CASI), 173% surge in interest
• Ardelyx (ARDX), 143% surge in interest
• Incyte (INCY), 126% surge in interest
• BioLineRx (BLRX), 125% surge in interest
• Cymabay Therapeutics (CBAY), 116% surge in interest
• CRISPR Therapeutics (CRSP), CRSP% surge in interest

Pipeline and key clinical candidates for these companies:

Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma and leptomeningeal metastases.

Repligen Corporation develops and commercializes bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. The customers served are primarily biopharmaceutical drug developers and contract development and manufacturing organizations, or CDMOs.

Bio-Techne is a developer and manufacturer of purified proteins and reagent solutions – notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, T-Cell activation and gene editing technologies. Bio-Techne’s product portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name.

CASI Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The company says it intends to execute its plan to become a leader by launching medicines in the greater China market, leveraging the company’s China-based regulatory and commercial competencies and its global drug development expertise.

Ardelyx says it was founded with “a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.” Ardelyx’s first approved product, Ibsrela is available in the United States and Canada. Ardelyx is developing Xphozah, a novel product candidate to control serum phosphorus in adult patients with chronic kidney disease on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.

Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

BioLineRx is a pre-commercial-stage biopharmaceutical company focused on oncology. The company’s lead development program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, may support diverse therapeutic approaches in oncology and other diseases. APHEXDA was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous transplantation for multiple myeloma patients, has reported positive results from a pre-planned pharmacoeconomic study in the U.S., and has had its NDA submission accepted by the FDA with an assigned PDUFA date of September 9, 2023.

CymaBay Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. According to the company, its deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped it receive breakthrough therapy designation, Priority Medicines status and orphan drug status for seladelpar, a first-in-class investigational treatment for people with PBC.

CRISPR Therapeutics is a gene editing company focused on developing gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. “CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte,” the company states.

Recent news on these stocks:

November 2

Repligen announced the commercial launch of TangenX SC, the industry’s first holder-free, self-contained Tangential Flow Filtration, TFF, device. The technology is especially suited to the manufacture of biologics where fully closed systems are critical or ideal, including antibody drug conjugates, viral vectors, nucleic acids and lipid nanoparticles, and can also be applied to monoclonal antibody, and recombinant protein production. Christine Gebski, Senior Vice President, Filtration and Chromatography at Repligen, said, “TangenX SC pushes the boundaries of TFF innovation, offering clear advantages to virtually any user of flat sheet TFF. The holder-free TangenX SC device simplifies and streamlines downstream flat sheet UF/DF processes like never before. Users can trust that the quality and consistency of their TFF processes remain uncompromised while enjoying the benefits of this innovative technology.”

November 1

CymaBay Therapeutics announced that two-year safety and efficacy results of seladelpar for primary biliary cholangitis have been published in Alimentary Pharmacology & Therapeutics: Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis This open-label, international, long-term extension study, evaluated the efficacy and safety of seladelpar a potent, selective, orally active PPARdelta agonist, or delpar, through 2 years of treatment in patients with PBC. Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar. Adults from the lead-in studies had enrolled having a diagnosis of PBC after persistent elevation in the cholestatic marker alkaline phosphatase despite current or prior treatment with first-line ursodeoxycholic acid. The objectives were to evaluate the long-term safety, tolerability, and efficacy of seladelpar at 5 mg and 10 mg once daily throughout 2-years. A composite of alkaline phosphatase and bilirubin previously accepted for regulatory approval served as an endpoint. The composite was achieved by 63% and 79% of patients after one and two years, respectively. In addition, ALP normalization was achieved in 23% and 42% in patients at one and two years, respectively. Over two years, there were sustained reductions in ALT and AST, recognized markers of liver injury. Seladelpar appeared safe and well-tolerated. In the study long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis and liver injury in the second year of treatment.

October 31

Plus Therapeutics reported Q3 EPS of ($1.00), consensus ($1.12), and Q3 revenue of $1.24M, consensus $1.29M. Additionally, Plus Therapeutics announced that its board approved a share repurchase program, with authorization to repurchase up to $500K of the company’s outstanding common stock.

Bio-Techne reported Q1 adjusted EPS of 41c, consensus 44c, and Q1 revenue of $276.94M, consensus $287.77M. “The Bio-Techne team continues to execute in a challenging market, with our durable portfolio delivering 2% organic growth despite the soft biotech funding environment and evolving macroeconomic landscape in China. Our European team’s performance was particularly impressive with 15% growth in the region,” said Chuck Kummeth, president and CEO of Bio-Techne. “We delivered these results with a continued focus on profitability, as our disciplined approach led to an adjusted operating margin of 31.4%, in-line with our expectations.”

Ardelyx reported Q3 EPS of 3c, consensus (11c), and Q3 revenue of $56.391M, consensus $22.77M. “Ardelyx is effectively advancing on all fronts with clear focus, evidenced by the continued strong performance of IBSRELA as well as the approval and commercial launch of XPHOZAH,” said Mike Raab, president and chief executive officer. “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue. We continue to see an increase in new and repeat writers, as well as new and refill prescriptions increasing from established writers at a steady, meaningful trajectory. We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients. In addition, on October 17, we received our long sought after FDA approval of XPHOZAH. Our team is in the field and launch is underway. We anticipate having product in channel in early November.”

Incyte reported Q3 EPS of $1.10, consensus $1.02, and Q3 revenue of $919M, consensus $966.9M. Jakafi or ruxolitinib net product revenues of $636M +3% Y/Y in Q3’23, $1.9 B , +8% Y/Y YTD 2023, driven by growth in total patients across all indications; tightening full year 2023 guidance to a new range of $2.59 – $2.62 billion “Our double-digit revenue growth during the quarter was driven by sustained performance of Jakafi(R) (ruxolitinib) and an increasing contribution from Opzelura(R) (ruxolitinib) with continued strong patient demand and enhanced payer coverage,” said Herve Hoppenot, Chief Executive Officer, Incyte. “We made significant progress with our early programs in myeloproliferative neoplasms (MPNs), including mCALR and JAK2V617F, which have the potential to be disease modifying therapies that represent a fundamentally new approach to the way patients with MPNs are treated. Additionally, we recently received positive top line results from the Phase 2 study of povorcitinib in prurigo nodularis (PN) and plans are underway to initiate a Phase 3 study in 2024. With approximately 100,000 treated PN patients in the U.S., povorcitinib has the potential to be an efficacious therapy for those patients who currently have limited treatment options.”

BioLineRx has entered into an exclusive license agreement with Guangzhou Gloria Biosciences Co. and an associated investor for the development of motixafortide across all indications in Asia. The license agreement provides for a $15M upfront payment and an equity investment of $14.6M, up to $50M in potential development and regulatory milestones, up to $200M in potential commercial milestones and tiered double-digit royalties on sales.

CRISPR Therapeutics announced the completion of the U.S. Food and Drug Administration’s Cellular, Tissue, and Gene Therapies Advisory Committee meeting for exagamglogene autotemcel for the treatment of SCD in people ages 12 and older with recurrent vaso-occlusive crises. Exa-cel is the first potential therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals. If approved, exa-cel could be the first genetic therapy available to approximately twenty thousand people with severe SCD in the U.S. The FDA granted priority review for exa-cel in the treatment of people with SCD and assigned a Prescription Drug User Fee Act action date of December 8, 2023. Exa-cel’s Biologics License Application for transfusion-dependent beta-thalassemia was assigned a PDUFA date of March 30, 2024.

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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.