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: 

• Exicure (XCUR), 700% surge in interest
• Fate Therapeutics (FATE), 594% surge in interest
• Aclaris Therapeutics (ACRS), 499% surge in interest
• Regenxbio (RGNX), 176% surge in interest
• Protalix Biotherapeutics (PLX), 62% surge in interest

Pipeline and key clinical candidates for these companies:

Exicure is an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. The company says it continues to actively pursue out-licensing opportunities for its clinical asset, cavrotolimod, as well as for its preclinical candidates, including the SCN9A program for neuropathic pain, and to pursue all strategic alternatives with the goal of maximizing stockholder value.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, “the company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products,” the company states.

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.

Regenxbio is a clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. The company’s NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8 and AAV9. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates, including late-stage and commercial programs, in multiple therapeutic areas. 

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. “This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner,” the company states. Protalix has licensed to Pfizer (PFE) the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix’s first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix’s second product, Elfabrio, was approved by both the FDA and the European Medicines Agency in May 2023.

Recent news on these stocks:

November 18

Fate Therapeutics presented initial clinical and translational data from the company’s Phase 1 study of FT522 in relapsed / refractory B-cell lymphoma at the American College of Rheumatology Convergence in Washington, D.C. FT522 is the company’s off-the-shelf, CD19-targeted chimeric antigen receptor – CAR – natural killer – NK – cell product candidate that incorporates multiple novel synthetic controls of cell function designed to target and deplete pathogenic immune cells, and is the company’s first product candidate to integrate its alloimmune defense receptor technology to enable effective treatment of patients without administration of intense conditioning chemotherapy. The Phase 1 basket study for B cell-mediated autoimmune diseases is designed to assess FT522 as add-on to standard-of-care induction and maintenance regimens without conditioning chemotherapy. Initial Phase 1 clinical data in relapsed / refractory B-cell lymphoma show favorable safety profile, complete responses, and persistence of FT522 live cells. Selective targeting and reduction of CD19+ B cells was observed with each FT522 dose in the study’s first low-dose cohort without conditioning chemotherapy, supporting novel ADR technology.

Aclaris Therapeutics has entered into an exclusive license agreement with Biosion for worldwide rights to BSI-045B, a potential best-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. In a completed Phase 2a, single-arm, proof-of-concept trial in the United States in 22 patients with moderate to severe atopic dermatitis, BSI-045B was observed to have a pharmacodynamic, safety and efficacy profile that could position it as a potential best-in-class therapy. BSI-045B is also being advanced in multiple Phase 2 studies in China by Biosion’s regional partner, Chia Tai Tianqing Pharmaceutical Group, targeting both severe asthma and chronic rhinosinusitis with nasal polyps, accelerating the potential to show proof-of-concept across additional indications. Biosion is a global biotechnology company that has built a pipeline of innovative biologics through its internally derived proprietary technologies. Concurrent with the Biosion transaction, Aclaris has made two key additions to its leadership team: Hugh Davis, Ph.D., joins as President and COO, bringing over 35 years of experience in biologics development, clinical pharmacology, and business development from leadership roles at Biosion, Frontage, GSK, and Johnson & Johnson. Steven Knapp, PharmD, joins as Executive Vice President, Head of Regulatory & Quality, with over 35 years of regulatory and quality experience from senior positions at Biosion, Antares, Valeant, and BMS.

Regenxbio announced that AFFINITY DUCHENNE, the multi-center, open-label trial of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy, has advanced to pivotal stage and dosed its first patient. The company also announced new, positive efficacy and safety data from the Phase I/II portion of the study, including the first functional data. Affinity Duchenne data updates: Results include 12-month data from three dose level 1 patients aged 4-10 and nine-month data from two dose level 2 patients aged 8 and 12. RGX-202 was well tolerated with no serious adverse events and no AEs of special interest. Phase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomes: Functional improvements seen in all patients treated with dose level 1 and dose level 2 at 12 and 9 months respectively; New biomarker data confirms consistent robust expression of differentiated RGX-202 microdystrophin in the muscle; Favorable safety profile observed at both dose levels; no serious adverse events or AEs of special interest

November 14

Exicure entered into two share purchase agreements, stating, “Exicure has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. In September 2022, the company announced a significant reduction in force, suspension of preclinical activities and halting of all research and development, and that the company was exploring strategic alternatives to maximize stockholder value. In an agreement dated November 6, and executed on November 12, the company agreed to sell and issue to HiTron Systems 433K shares of common stock for $1.3M, at a purchase price of $3.00 per share. The closing of this transaction is expected to occur within 10 days from its execution. On November 13, in a subsequent agreement, the company agreed to sell and issue to HiTron 2.9M additional shares of common stock for $8.7M, at a purchase price of $3.00 per share. The closing of the investment pursuant to this subsequent agreement is conditioned on stockholder approval, among other customary conditions.”

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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.