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: 

• Assembly Biosciences (ASMB), 11,820% surge in interest
• Evelo Biosciences (EVLO), 2,286% surge in interest
• Summit Therapeutics (SMMT), 723% surge in interest
• Moleculin Biotech (MBRX), 550% surge in interest
• Harpoon Therapeutics (HARP), 466% surge in interest
• Ardelyx (ARDX), 352% surge in interest
• Evofem Biosciences (EVFM), 327% surge in interest
• Athersys (ATHX), 294% surge in interest
• Aravive (ARAV), 275% surge in interest

Pipeline and key clinical candidates for these companies:

Assembly Biosciences is a biotechnology company that says it is “dedicated to the development of innovative small molecule antiviral therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide.” Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus and hepatitis delta virus infections, the company states.

Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The company’s product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles, or EVs. Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. “If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease,” the company says.

Summit Therapeutics is initiating development activities for SMT112 and will do so first in NSCLC indications. Summit plans to start treating patients in clinical studies by the second quarter of 2023.

Moleculin Biotech is focused on the development of a portfolio of drug candidates for the treatment of highly resistant tumors and viruses. The company’s lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia, or AML, and soft tissue sarcoma lung metastases.

Harpoon Therapeutics is developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. “Using its proprietary Tri-specific T cell Activating Construct, or TriTAC, platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. Harpoon’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome,” the company states.

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.

Evofem Biosciences is developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health. The company’s first FDA-approved product, Phexxi, is a hormone-free, on-demand prescription contraceptive vaginal gel.

Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. Athersys is developing its MultiStem cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the neurological, inflammatory and immune, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product.

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.

Recent news on these stocks:

October 17

Gilead Sciences (GILD) and Assembly Biosciences announced that the companies have entered into a 12-year partnership to advance the research and development of novel antiviral therapies, with an initial focus in Assembly Bio’s established areas of herpesviruses, hepatitis B virus HBV and hepatitis D virus HDV . Assembly Bio’s current portfolio of small molecule antiviral therapeutics includes both clinical and preclinical programs, including next-generation core inhibitor ABI-4334 for the treatment of HBV, long-acting helicase-primase inhibitor ABI-5366 for herpes simplex virus , an orally bioavailable HDV entry inhibitor ABI-6250, and a pan-herpes polymerase inhibitor program…Under the terms of the agreement, Assembly Bio will receive $100M, consisting of an $84.8M upfront payment and a $15.2M equity investment from Gilead. Gilead’s initial equity investment at a premium represents 19.9 percent of the outstanding voting stock of Assembly Bio as of the date of closing. In addition, subject to certain conditions, Gilead has agreed to purchase up to 29.9% of Assembly Bio’s outstanding voting stock at a premium. ..Following Gilead’s exercise of its option for an Assembly Bio program, Assembly Bio will have the right to opt-in to share profits and costs in the United States. For future new programs, Assembly Bio will also have an option to co-promote those products in the United States.

Evelo Biosciences announced top-line results from its Phase 2 clinical study with EDP2939 in moderate psoriasis. The study’s primary endpoint, the difference in the proportion of patients who achieved an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index score between EDP2939 and placebo after 16 weeks of daily treatment, was not achieved. The Company is continuing to gather and analyze the study data. Simba Gill, Ph.D., Chief Executive Officer of Evelo, commented, “Whilst we are disappointed with the results of the Phase 2 study with EDP2939, we continue to believe in the value of our Small Intestinal Axis platform and in our potential product, EDP1815. We previously reported positive efficacy and safety data in a Phase 2 study of mild to moderate psoriasis with EDP1815. We will cease development of EDP2939, given the results of this study, and are conducting a review of potential strategic alternatives, including seeking to partner EDP1815 and the SINTAX platform.” In the EDP2939-101 Phase 2 study, the primary endpoint was the difference in the proportion of patients who reached at least PASI-50 reductions between EDP2939 and placebo after 16 weeks of daily treatment. A PASI-50 response was chosen as this is clinically meaningful for patients with moderate psoriasis and had been positive in the previous study with EDP1815. Although there was no statistically significant difference between the proportion of patients who achieved a PASI-50 response on EDP2939 compared to placebo, it was notable that such numeric proportion went from being inferior to placebo at week 16 to being superior at the week 20 follow-up visit. Ongoing analysis of the secondary endpoints continues. Overall safety data was consistent with what was previously reported in the Phase 1 portion of this study: EDP2939 was well-tolerated with adverse events comparable to placebo. There were no related serious adverse events. Based on these results, Evelo has initiated a process to explore strategic alternatives.

Ardelyx announced that the FDA has approved XPHOZAH, or tenapanor, the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway. FDA approval of XPHOZAH is based on a comprehensive development program, including a diverse population of more than 1,000 patients in three Phase 3 clinical trials evaluating the efficacy and safety of XPHOZAH, as monotherapy and in combination with phosphate binder therapy, all of which met their primary and key secondary endpoints. Data from the three clinical trials demonstrated that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis. Diarrhea, which occurred in 43 to 53 percent of patients, was the only adverse reaction reported in at least five percent of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in five percent of XPHOZAH-treated patients in these trials. Ardelyx also completed two open-label clinical trials to evaluate different options for integrating XPHOZAH into clinical practice.

October 16

Summit Therapeutics announced that Manmeet Soni has been appointed as the company’s COO, effective immediately. Soni will remain a member of the company’s board of directors. Soni has over 20 years of financial and operational leadership experience and joins Summit from Reata Pharmaceuticals, where he was president, COO & CFO.

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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.