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: 

• Tenax Therapeutics (TENX), 8,500% surge in interest
• VBI Vaccines (VBIV), 878% surge in interest
• Citius Pharmaceuticals (CTXR), 793% surge in interest
• Actinium Pharmaceuticals (ATNM), 417% surge in interest
• Biomarin Pharmaceuticals (BMRN), 219% surge in interest
• TG Therapeutics (TGTX), 178% surge in interest
• Axsome Therapeutics (AXSM), 135% surge in interest
• Arcturus Therapeutics (ARCT), 134% surge in interest
• Cassava Sciences (SAVA), 107% surge in interest

Pipeline and key clinical candidates for these companies:

Tenax Therapeutics is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. Tenax Therapeutics is developing a unique oral formulation of imatinib. The company also owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan.

VBI Vaccines is a biopharmaceutical company focused on virus-like particles, or VLPs, including a proprietary enveloped VLP, eVLP, platform technology. VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. “VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus, as well as aggressive cancers including glioblastoma,” the company says.

Citius Pharmaceuticals is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a pipeline of anti-infectives in oncology, adjunct cancer care, stem cell therapy and unique prescription products. Its diversified pipeline of therapies targeting unmet medical needs includes three potential first-and-only prescription treatments in their indications, and a next-generation single-donor, allogeneic, clonal and scalable stem cell therapy program.

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B, an induction and conditioning agent prior to bone marrow transplant, and Actimab-A, a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.

BioMarin is a biotechnology company “dedicated to transforming lives through genetic discovery.” The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin’s robust research and development capabilities have resulted in multiple innovative commercial therapies for patients with rare genetic disorders, the company says.

TG Therapeutics is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for Briumvi, for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Axsome Therapeutics is developing and delivering novel therapies for central nervous system, or CNS, conditions that have limited treatment options. AXS-05 is a novel, oral, patent protected, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease agitation and other central nervous system disorders.

Arcturus Therapeutics is a late-stage clinical mRNA medicines and vaccines company whose pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for COVID-19 and Influenza, and other programs to potentially treat ornithine transcarbamylase, or OTC, deficiency, and cystic fibrosis, or CF. The company’s partnered programs include glycogen storage disease type III and hepatitis B virus.

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 6

Tenax Therapeutics has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $100M to the company, before deducting placement agent fees and other private placement expenses. The private placement was led by new investor BVF Partners LP, with participation from other new investors, including Venrock Healthcare Capital Partners, Vivo Capital, Janus Henderson Investors, a large investment management firm, Vestal Point Capital, Velan Capital, ADAR1 Capital Management, LLC, Stonepine Capital Management, and Sphera Biotech. Leerink Partners is acting as the lead placement agent for the private placement and is joined by Guggenheim Securities and William Blair as joint placement agents. ROTH Capital Partners is acting as financial advisor to the company. The company intends to use the net proceeds from the private placement to complete its ongoing Phase 3 LEVEL trial, to initiate all sites and advance enrollment in a second planned Phase 3 trial of oral levosimendan, and for working capital, capital expenditures, and other general corporate purposes. The proceeds from the private placement, combined with the company’s current cash and cash equivalents, are expected to fund the company’s operations through the end of 2027.

TG Therapeutics reported Q2 EPS 4c against a consensus of (5c), and reported Q2 revenue of $72.596M against a consensus of $65.89M. Michael Weiss, the company’s chairman and CEO stated, “We are pleased to report another quarter of outperformance across all aspects of our business. From a financial standpoint, our second quarter U.S. BRIUMVI net revenues exceeded expectations, leading us to raise our full year guidance. On the R&D side, we also had an exciting quarter with the first patients now treated with subcutaneous ublituximab in a newly launched Phase 1 study and clearance of our IND for azer-cel, our allogeneic “off-the-shelf” CD19 CAR-T, for patients with progressive MS.” Weiss continued, “We are also excited to announce our new $250 million credit facility with HealthCare Royalty and Blue Owl Capital that enables us to accelerate the initiation of a share repurchase program and pay down our current debt, while preserving our current cash to continue building our commercial infrastructure, ramping up our marketing efforts, and investing in our R&D programs. We look forward to continuing the positive momentum into the second half of 2024.”

August 5

TenX Keane Acquisition (TENK) announced that on August 2, at the extraordinary general meeting, its shareholders voted to approve the previously announced business combination with the wholly owned oncology subsidiary of Citius Pharmaceuticals.The newly combined public company will continue to trade on the Nasdaq stock exchange and is to be renamed Citius Oncology. The transaction has been unanimously approved by the board of TenX, Citius Pharma, and Citius Pharma’s oncology subsidiary. Subject to certain contractual as well as customary closing conditions, the merger is expected to be completed in the coming weeks. The transaction is expected to provide Citius Oncology with improved access to the public equity markets, support the commercialization of LYMPHIR, if approved, and position the company to explore additional targeted oncology opportunities. As a result, upon closing, Citius Pharma would hold approximately 65.6M shares of common stock of Citius Oncology which would represent approximately 90% of the newly public company. As part of the transaction, Citius Pharma will contribute $10M in cash to Citius Oncology.

Actinium Pharmaceuticals announced a regulatory update on the company’s planned Biologics License Application filing for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia. The company has now concluded both its clinical and Chemistry, Manufacturing and Controls interactions with the FDA regarding the BLA pathway for Iomab-B. Despite the SIERRA trial meeting the primary endpoint of durable Complete Remission with statistical significance and other positive secondary endpoints including Event Free Survival and safety, the FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing. The FDA has advised Actinium to conduct a study to evaluate allogeneic bone marrow transplant using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI, a difference from the SIERRA trial, which had allowed physician’s choice of salvage therapies and heterogenous conditioning regimens in the control arm. In February 2023, Actinium announced that the SIERRA trial met the primary endpoint with statistical significance as 22% of patients on the Iomab-B arm achieved dCR compared to 0% of patients on the control arm resulting in a p-value of less than 0.0001. However, the FDA has now determined that the analyses from the SIERRA trial do not adequately support a BLA filing for Iomab-B and requires an additional clinical study. Actinium expects the safety and efficacy data from the SIERRA trial will provide supportive evidence for a future Iomab-B BLA filing. Actinium intends to further discuss the specifics of the additional clinical trial including the patient population, which the FDA has suggested could include all adult AML patients. Upon conclusion of its interactions with the FDA, Actinium will seek a strategic partner for Iomab-B for the U.S.

BioMarin reported Q2 adjusted EPS 96c against a consensus of 35c, and reported Q2 revenue of $712M against a consensus of $662.05M. “Strong execution across our business resulted in record double-digit revenue growth in the second quarter and first half of 2024. These top-line results, along with a focus on operational efficiency, resulted in a 78% year-over-year improvement in quarterly non-GAAP earnings per share,” said Alexander Hardy, CEO of BioMarin. “Strong global demand for VOXZOGO led to nearly 900 new patient starts in the first half of 2024, the highest in VOXZOGO’s history. Record VOXZOGO contributions in the quarter, driven by patient growth in all geographies, combined with double-digit growth from our enzyme therapies drove today’s increased 2024 full-year guidance.”

Axsome Therapeutics reported Q2 EPS ($1.67) against a consensus of ($1.33), and reported Q2 revenue of $87.2M against a consensus of $86.92M. “We delivered another robust quarter driven by focused commercial execution and continued pipeline advancement,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We continue to see strong demand for Auvelity and increased commercial payer coverage by more than 22 million lives as of August 1st. The NDA for AXS-07 in migraine has been resubmitted, and we are tracking to submit the NDA for AXS-14 in fibromyalgia in the third quarter. Trials in four new indications for solriamfetol are now underway, and we remain on track to deliver topline results from the FOCUS Phase 3 trial in ADHD in the second half of this year. For our AXS-05 program in Alzheimer’s disease agitation, the ADVANCE-2 Phase 3 trial continues to progress, and the ACCORD-2 Phase 3 trial has reached target enrollment, positioning us to potentially report topline results for both of these pivotal trials in the second half of the year.”

Arcturus Therapeutics reported Q2 EPS of (64c) against a consensus of ($1.60), and reported Q2 revenue of $49.859M against a consensus of $21.7M. “We are pleased to remain on track for our first commercial product launch of Kostaive in Japan later this year,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “We are also encouraged by the clinical progress of our mRNA therapeutics pipeline, especially the collection of meaningful safety data for CF and OTC deficiency candidates, ARCT-032 and ARCT-810.”

Cassava Sciences said, “We are profoundly saddened by the passing of our dear friend and colleague, Sandy Robertson. Sandy served on the board of directors of Cassava Sciences since its inception as a public company in 1998. Sandy’s commitment to Cassava’s mission and success was unwavering. Sandy’s success in the business world is well recognized by the hundreds of companies that he helped build and the entrepreneurs who created those companies. Everyone who knew or worked alongside Sandy understood his powerful intelligence as well as his remarkable kindness. His success in business was legendary but what those who knew him will remember was who he was: Sandy was the personification of someone who would treat others as he would like to be treated. We will miss him terribly as will anyone who knew him.”

August 2

VBI Vaccines provided an update on the restructuring proceedings announced on July 30. On August 2, the United States Bankruptcy Court for the District of Delaware granted provisional relief under Chapter 15 of the U.S. Bankruptcy Code, and scheduled a further hearing to consider the recognition of the July 30, 2024, Ontario Superior Court of Justice order, which granted the company protection under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended. Additionally, he company received a letter from the listing qualifications department staff of the Nasdaq notifying the company that its common shares will be delisted from Nasdaq effective as of opening of business on August 8. The company does not intend to appeal the delisting determination.

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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.