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: 

• Akero Therapeutics (AKRO), 3,764% surge in interest
• Onconetix (ONCO), 2,246% surge in interest
• 89bio (ETNB), 1,646% surge in interest
• Allakos (ALLK), 1,012% surge in interest
• Tevogen Bio (TVGN), 165% surge in interest

Pipeline and key clinical candidates for these companies:

Akero Therapeutics is developing “transformational treatments for patients with serious metabolic diseases marked by high unmet medical need,” including NASH, a disease without any approved therapies. Akero’s lead product candidate, EFX, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH and the SYMMETRY study in patients with cirrhotic NASH. EFX is also being evaluated in an expansion cohort of the SYMMETRY study, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-cirrhotic NASH and Type 2 diabetes.

Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through its recent acquisition of Proteomedix, the company owns Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation. 

89bio is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases. The company’s lead product candidate, pegozafermin, is currently being developed for the treatment of NASH and SHTG.

Allakos is a clinical stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The company’s most advanced antibody in ongoing clinical development is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed selectively on mast cells.

Tevogen Bio is a clinical-stage specialty immunotherapy company that says it is “harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders.”

Recent news on these stocks:

January 27

Akero Therapeutics released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin, or EFX, in patients with biopsy-confirmed compensated cirrhosis, Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis, or MASH. 39% of patients treated with 50mg EFX experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo. In the Intent to Treat population, 29% of patients in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group. With more than a doubling of effect size from weeks 36 to 96 in the 50mg group, the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis. EFX was reported to be generally well-tolerated. There were no deaths on EFX, but one death in the placebo arm due to pneumonia. None of the Serious Adverse Events were determined to be related to study drug.

Onconetix filed to sell 50M shares of common stock for holders. The company is not selling any securities under this prospectus, and will not receive any proceeds from the sale of common stock by the selling stockholder.

89bio announced that it has commenced an underwritten public offering of $250M of shares of its common stock or, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. All of the securities to be sold in the offering are being offered by 89bio. 89bio intends to use the net proceeds from this proposed offering to fund ongoing clinical activities and development of pegozafermin, manufacturing related costs and other general corporate purposes, including working capital and operating expenses. Goldman Sachs & Co., Leerink Partners and BofA Securities are acting as lead book-running managers and Cantor is acting as book-running manager for the proposed offering.

Allakos announced it will discontinue further clinical development of AK006 after the preclinical inhibitory effects observed did not translate to clinical benefit in patients with CSU. In the CSU cohort, 34 adult patients with moderate-to-severe CSU refractory to antihistamines with or without prior exposure to omalizumab were enrolled and randomized 2:1 to receive 720 mg of intravenous AK006 or placebo once every four weeks . Eight of the 34 patients had previously received omalizumab. The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score-7 at 14 weeks. The company plans to discontinue AK006-related activities across clinical, manufacturing, research and administrative functions and reduce its workforce by approximately 75%. The company plans to retain approximately 15 employees to explore strategic alternatives, maintain compliance with regulatory and financial reporting requirements, and wind-down the phase 1 clinical trial. The company ended the fourth quarter of 2024 with approximately $81M in cash, cash equivalents, and investments. The company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors, will be approximately $34M-$38M. The company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025. The company estimates it will have cash, cash equivalents and investments in a range of approximately $35M-$40M at June 30, 2025.

January 24

Tevogen Bio Holdings announced that it has broadened its relationship with Microsoft (MSFT) to broaden its AI-focused collaboration and build its PredicTcell technology. PredicTcell is Tevogen Bio’s proprietary technology designed for predictive precision T cell targeting. This expanded relationship is designed to harness Microsoft’s cutting-edge AI, cloud capabilities, and Microsoft’s health and life sciences domain expertise to accelerate Tevogen Bio’s target identification and pre-clinical processes, strengthening the company’s pipeline of innovative immunotherapies. Tevogen.AI, Tevogen Bio’s artificial intelligence effort, will integrate Microsoft’s advanced AI tools and the Microsoft Azure cloud platform into two key objectives: Building on the successful trial results of TVGN 489, Tevogen Bio aims to utilize machine learning to perform critical simulations that will accelerate the identification of new targets. By leveraging Microsoft’s AI, the company can analyze large datasets across the genome with greater speed and accuracy. Also, Tevogen.AI, in collaboration with Microsoft domain experts, will create new algorithms to decode the interactions between human leukocyte antigens and T cells. This capability is expected to significantly enhance Tevogen Bio’s understanding of immune responses and open new therapeutic avenues, especially in areas with minimal existing data. “As we expand our AI efforts, this broader relationship with Microsoft represents a key milestone in our ongoing journey to revolutionize immunotherapy,” said Mittul Mehta, CIO of Tevogen Bio and Head of Tevogen.AI. “Through deeper collaboration with Microsoft domain experts, we will further harness the power of AI to bring more precise and personalized treatments to patients at an accelerated pace.”

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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.