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:

• Aravive (ARAV), 235% surge in interest
• BioLineRx (BLRX), 163% surge in interest
• Mannkind (MNKD), 112% surge in interest
• Capricor Therapeutics (CAPR), 85% surge in interest
• Esperion Therapeutics (ESPR), 85% surge in interest
• Emergent Biosolutions (EBS), 69% surge in interest
• BioXcel Therapeutics (BTAI), 48% surge in interest
• CRISPR Therapeutics (CRSP), 33% surge in interest
• Intellia (NTLA), 32% surge in interest
• Cassava Sciences (SAVA), 32% surge in interest

Pipeline and key clinical candidates for these companies:

Aravive is developing targeted therapeutics to treat metastatic disease. The company’s lead product candidate, batiraxcept, formerly AVB-500, is an ultra-high affinity decoy protein that binds to GAS6, the sole ligand that activates AXL, inhibiting metastasis, tumor growth, and restoring sensitivity to anti-cancer agents. Batiraxcept has been granted Fast Track Designation by the FDA and Orphan Drug Designation by European Commission in PROC. Batiraxcept is in an active registrational Phase 3 trial in platinum resistant ovarian cancer, a Phase 1b/2 trial in clear cell renal cell carcinoma, and a Phase 1b/2 trial in pancreatic adenocarcinoma.

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. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of metastatic pancreatic cancer, or mPDAC, in combination with the PD-1 inhibitor pembrolizumab and chemotherapy and is currently being studied in combination with the PD-1 inhibitor cemiplimab and chemotherapy as a first line mPDAC therapy.

MannKind Corporation focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.

Capricor Therapeutics is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in late-stage clinical development for treating Duchenne muscular dystrophy. Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd., subject to regulatory approval. Capricor is also developing its exosome technology as a next-generation therapeutic platform. The company’s proprietary StealthX exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.

Esperion discovers, develops, and commercializes innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren’t being met by the status quo.

Emergent provides solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that the company develops and manufactures for governments and consumers. Emergent also offers a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

BioXcel Therapeutics is utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The company’s drug re-innovation approach “leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices,” BioXcel states. The company’s commercial product, IGALMI, developed as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

CRISPR Therapeutics is a leading gene editing company focused on developing transformative 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.

Intellia Therapeutics, a clinical-stage genome editing company, is developing novel, potentially curative therapeutics using CRISPR/Cas9 technology. “Intellia’s deep scientific, technical and clinical development experience, along with its robust intellectual property portfolio, have enabled the company to take a leadership role in harnessing the full potential of CRISPR/Cas9 to create new classes of genetic medicine,” the company says.

Cassava Sciences is a clinical-stage biotechnology company that says its mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. “Its novel science is based on stabilizing—but not removing—a critical protein in the brain. The company’s product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established,” Cassava has stated.

Recent news on these stocks:

August 30

Emergent BioSolutions announced Narcan Naloxone HCl Nasal Spray 4 mg will be available on shelves nationwide and online beginning in September.

August 27

Esperion announced the presentation of results from two oral presentations at the Late-Breaking Science Session entitled, “Clinical trial updates on prevention and lipid lowering” at the European Society of Cardiology 2023 Congress, taking place August 25-28, 2023, in Amsterdam, Netherlands. The results reflect the totality of the benefit of bempedoic acid on CV risk reduction, not just the first event. Treatment with bempedoic acid is associated with a risk reduction of 20% in total MACE-4 events, 17% in total MACE-3 events, 31% in total myocardial infarctions, and 22% in total coronary revascularizations. A second late-breaker presentation, titled “Cardiovascular Benefits and Risk of New Onset Diabetes by Glycaemic Status with Bempedoic Acid: Prespecified Analyses of the CLEAR OUTCOMES trial,” was also presented. Of the 13,970 patients included in CLEAR Outcomes, 45.6% had diabetes, 41.5% were pre-diabetic, and 12.9% had normoglycemia. In this pre-specified analysis, bempedoic acid demonstrated a benefit in patients with diabetes at baseline, showing a 17% reduction in risk of MACE-4 and 20% reduction in risk of MACE-3. In addition, bempedoic acid did not increase rates of new onset diabetes in patients without diabetes, and was generally comparable to placebo. Finally, bempedoic acid did not result in increased HbA1c levels at 12 months or at end of study in patients considered to have pre-diabetes or normoglycemia.

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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.