These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Iterum Therapeutics (ITRM), 12,880% surge in interest
- IMV (IMV), 4,082% surge in interest
- Axcella Health (AXLA), 1,614% surge in interest
- Hoth Therapeutics (HOTH), 1,243% surge in interest
- Moleculin Biotech (MBRX), 947% surge in interest
Pipeline and key clinical candidates for these companies:
Iterum Therapeutics is dedicated to developing differentiated anti-infectives aimed at combatting multi-drug resistant pathogens to improve the lives of people affected by related diseases. Iterum 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. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the company’s immune-educating platform, DPX.
Axcella is "pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators," or EMMs, the company states. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence.
Hoth Therapeutics refers to itself as "a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing." Hoth "collaborates and partners with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options," the company states.
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.
Recent news on these stocks:
December 16
IMV Inc. announced that it has entered into definitive agreements for the sale of an aggregate of 3.45M common shares and warrants to purchase up to an aggregate of 3.45M common shares at a purchase price of $2.61 per common share and accompanying warrant in a registered direct offering priced at-the-market under the Nasdaq Capital Market rules.
December 15
Iterum Therapeutics announced that the United States Patent and Trademark Office has issued Iterum a Notice of Allowance for U.S. patent application number 16/372,075 entitled "Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof" that covers the use of Iterum’s candidate combination of sulopenem etzadroxil and probenecid in treating multiple diseases, including uncomplicated urinary tract infections. This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire April 1, 2039, absent any extensions.
H.C. Wainwright analyst Ed Arce downgraded Axcella Health to Neutral from Buy without a price target. The company announced a strategic repositioning and restructuring plan to focus solely on its long COVID program, and as a result is discontinuing its ongoing Phase 2b trial of AXA1125 in nonalcoholic steatohepatitis, Arce tells investors in a research note. The analyst regards the discontinuation of the AXA1125 program to be a "major detriment" to the valuation of Axcella shares. He also sees a limited number of options for Axcella to successfully finance a planned Phase 2b long COVID study due to a lack of near-term catalysts.
Moleculin Biotech provided an update on its clinical programs evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia – AML – and soft tissue sarcoma – STS – lung metastases. Key updates made during the presentation include: 80% overall response rate in final cohort of the European trial of Annamycin as a single agent for the treatment of relapsed/refractory acute myeloid leukemia with one complete response with incomplete recovery of peripheral blood count and three Partial Responses. Of 42 subjects in the company’s Annamycin clinical trials, 100% demonstrated no signs of cardiotoxicity. In two Annamycin clinical trials, 32 subjects have been, as allowed by the trial protocol, safely treated above the current FDA lifetime maximum anthracycline dose with up to 1800 mg/m2 of Annamycin treatment with no evidence of cardiotoxicity. Based on additional preclinical animal data from sponsored research, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival vs. Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. The company has begun screening in Poland for a Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of R/R AML. The company is looking to expand this trial into other countries in Europe to potentially improve recruitment rates. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.
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 15-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.
Published first on TheFly
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