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: 

• Citius Pharmaceuticals (CTXR), 674% surge in interest
• Actinium Pharmaceuticals (ATNM), 249% surge in interest
• Cassava Sciences (SAVA), 37% surge in interest

Pipeline and key clinical candidates for these companies:

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. The company’s “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,” it has said.

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.

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 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.

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.”

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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.