Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Artelo Biosciences is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is "advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation," the company states.
Aslan Pharmaceuticals is a clinical-stage, immunology-focused biopharmaceutical company developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b dose-ranging study in moderate-to-severe AD patients. Aslan is currently investigating eblasakimab in dupilumab-experienced, moderate-to-severe AD patients in the TREK-DX Phase 2 trial, with topline data expected at the end of 2024. Aslan is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase as a potential first-in-class treatment for alopecia areata in a Phase 2a, proof-of-concept trial with an interim readout expected in Q3 2024.
Theravance Biopharma developed FDA-approved YUPELRI inhalation solution, indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease, or COPD. Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension in patients with Multiple System Atrophy, has "the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients.," the company says.
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.
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.
Atara Biotherapeutics is "harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions, including multiple sclerosis, that can be rapidly delivered to patients within days. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy," the company states.
Precigen's AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen's gorilla adenovectors, part of the AdenoVerse library, "have potentially superior performance characteristics as compared to current competition. AdenoVerse immunotherapies have been shown to generate high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration," the company says.
Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell products for cancer and autoimmune disease. Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with "the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients," the company states.
Checkpoint Therapeutics is focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naive patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma, or "cSCC," intended to support one or more applications for marketing approval. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, formerly CK-101, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer.
Arca Biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.
Recent news on these stocks:
July 17
Aslan Pharmaceuticals announced that its Singapore-incorporated, sole operating subsidiary, Aslan Pharmaceuticals, has filed for voluntary liquidation. The decision follows a comprehensive review by the board of the company of Aslan SG's financial position and strategic alternatives. Effective immediately, all employees of Aslan SG and fellow subsidiary Aslan Pharmaceuticals have been terminated. By a resolution in writing passed by the directors of Aslan SG on July 17, 2024, it was resolved that Aslan SG cannot by reason of its liabilities continue its business, and Mr Luke Anthony Furler and Mr Tan Kim Han of Quantuma were appointed as joint and several provisional liquidators of Aslan SG. The Provisional Liquidators will be responsible for the orderly winding up of Aslan SG's affairs, including seeking potential strategic alternatives for its development programs and the company's primary assets, eblasakimab and farudodstat, settling outstanding obligations, and distributing any remaining proceeds, if any, to creditors and shareholders, including the company, in accordance with Singaporean law. Following the resolution in writing of the directors of Aslan SG, the board of the company also resolved by a resolution in writing that the company cannot by reason of its liabilities continue its business and that the company will apply for liquidation under Cayman law procedures. As previously disclosed on July 15, 2024, the company has received a staff delisting determination from the Nasdaq Stock Market due to its failure to meet continued listing requirements, and determined not to request a hearing before the Nasdaq Hearings Panel. As such, the company expects its American Depository Shares will be suspended from trading in due course with trading moved to the over-the-counter market.
BioCardia announces that the United States Patent Office has granted Patent No: 12,036,371 titled "Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter," with a patent term that will expire in 2035. The present invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company's Morph DNA technology. This additional patent protection for BioCardia's current and future products in this important existing market enhances shareholder value. "All of the biotherapeutic interventions we support for treatment of heart failure, refractory angina, and acute myocardial infarction going forward are expected to utilize this same introducer technology platform," said Peter Altman, PhD, BioCardia's President and Chief Executive Officer. "This is an elegant solution to a long-standing technical issue. The solution enhances the level of physician control in our procedures, and BioCardia is working to provide or partner this solution for the roughly five hundred thousand transseptal procedures performed in the United States each year, and for other vascular access markets that can benefit from the advantages our patented solution provides."
Atara Biotherapeutics announced that the FDA has accepted the filing of its Biologics License Application, or BLA, or tabelecleucel, tab-cel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease or EBV+ PTLD, who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting. The BLA has been granted Priority Review with a Prescription Drug User Fee Act PDUFA target action date of January 15. "The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.," said Pascal Touchon, CEO of Atara. "The FDA's granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial."
July 15
Artelo Biosciences announced that the FDA has issued a "Study May Proceed" letter for the company's Investigational New Drug, IND, application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy, CIPN. FDA clearance of the ART26.12 IND application enables the company to initiate its first-in-human Phase 1 single ascending dose study. "Receiving IND clearance validates our development efforts and underscores the potential impact of ART26.12 to improve patients' lives," said Gregory Gorgas, CEO of Artelo Biosciences. "We look forward to sharing the initial clinical results with ART26.12 next year. As the leading company pursuing FABP inhibiton we are committed to building on the unique, lipid-modulating mechanism of our FABP inhibitor platform to address life-altering pathologies for which there are few, if any, safe and effective pharmaceutical treatments."
GC Cell and Checkpoint Therapeutics have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction. Positive preliminary data from these studies could potentially pave the way for future in vivo research and clinical studies. James Oliviero, CEO of Checkpoint Therapeutics, concurred: "Both cosibelimab, with its dual mechanism of action, and Immuncell-LC show great promise as potential immuno-oncologic therapies. We are pleased to work in collaboration with GC Cell to determine if using the two therapies in combination may offer even greater potential benefits than being used singly."
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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.
