These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
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- Iterum Therapeutics (ITRM), 1,042% surge in interest
- Elevai Labs (ELAB), 275% surge in interest
- Aclaris Therapeutics (ACRS), 148% surge in interest
Pipeline and key clinical candidates for these companies:
Iterum Therapeutics is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an IV formulation. Iterum has received Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Elevai Labs specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to obesity and metabolic health. Driven by a commitment to scientific research, Elevai aims to transform personal health and beauty, the company states.
Aclaris Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation.
Recent news on these stocks:
October 25
Iterum Therapeutics plc announced that the FDA has approved Iterum’s new drug application for Orlynvah for the treatment of uncomplicated urinary tract infections, or uUTIs, caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. “This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum,” the company stated. “We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of Orlynvah. Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like Orlynvah, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s CEO. “As the first oral penem approved in the U.S., Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders.”
October 22
Elevai Biosciences has engaged KCRN Research to support the company’s initial efforts to prepare for an Investigational New Drug application to the FDA for EL-22 in the treatment of obesity and muscle loss preservation. KCRN specializes in bridging the regulatory gap for Korean-originated assets like EL-22 and preparing early phase drug development projects for the FDA. The company and CRO partner KCRN are gathering the development work required for the IND submission, including preparing and scheduling a pre-IND meeting with the FDA to determine the path forward for EL-22. The company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity. EL-22, an engineered probiotic expressing myostatin on its surface, targets a clinically validated myostatin pathway that plays an important role in regulating muscle. Preclinical results of EL-22 from a 2022 study demonstrated physiological, physical and functional improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy. The company believes that EL-22 offers a differentiated, oral approach as compared to other injection myostatin strategies being tested in obesity. It is believed that the mechanism of EL-22 induces mucosal immunity through the body’s own anti-myostatin antibodies and has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
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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.