These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- ESSA Pharma (EPIX), 26,047% surge in interest
- Merus (MRUS), 908% surge in interest
- Y-mAbs Therapeutics (YMAB), 215% surge in interest
- Hoth Therapeutics (HOTH), 86% surge in interest
- Seres Therapeutic (MCRB), 69% surge in interest
Pipeline and key clinical candidates for these companies:
ESSA is focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. ESSA is developing the first generation of ANITen bAsed Chimera degraders targeting the AR NTD. In preclinical models, the orally bioavailable ANITAC degraders can eliminate forms of AR protein found in castration-resistant prostate cancer that can potentially drive disease progression including LBD mutants and LBD truncated splice variants.
Merus is developing full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics. Multiclonics are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity, the company has said.
Y-mAbs is focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The company’s product pipeline includes one FDA-approved product, Danyelza, which targets tumors that express GD2, and one product candidate at the registration-stage, Omblastys, which targets tumors that express B7-H3.
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 says it 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."
Seres Therapeutics is a microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved "the first-ever positive pivotal clinical results for a targeted microbiome drug candidate," according to the company, and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced to prevent further recurrences of C. difficile infection. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients.
Recent news on these stocks:
October 28
An FDA committee will discuss Y-mAbs Therapeutics’ Biologics License Application for 131I-omburtamab solution for injection for treatment of neuroblastoma with central nervous system/leptomeningeal metastases in a virtual meeting to be held at 10 am.
BofA analyst Alec Stranahan, who maintains a Buy rating and $28 price target on Y-mAbs shares, noted on October 26 that Y-mAbs Therapeutics shares dropped after the FDA released briefing documents for the October 28 panel meeting that he said "many considered to be negative on omburtamab’s likelihood of approval" given that the documents question the baseline differences of the comparator arm. Despite the "bearish" briefing documents, he thinks there is enough evidence to say the drug can induce a shrinkage in tumors and he believes this, paired with the OS benefit and unmet need, should still warrant approval.
October 26
ESSA Pharma announced the presentation of updated clinical data from the first two cohorts of the Phase 1/2 study of ESSA’s lead candidate EPI-7386 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer, or mCRPC. Data will be presented in a poster format at the 2022 Prostate Cancer Foundation, or PCF, Scientific Retreat, taking place October 27-29, 2022 in Carlsbad, CA. In the multicenter, open-label Phase 1/2 dose escalation study, seven mCRPC patients naive to second generation antiandrogens were enrolled in the first two cohorts, with escalating doses of EPI-7386 and a fixed 120mg once a day, or QD, dose of enzalutamide. The study permitted one prior line of chemotherapy. Pharmacokinetic results from these first two cohorts demonstrated that enzalutamide exposure was minimally impacted by EPI-7386 while exposures of EPI-7386 were reduced by coadministration with enzalutamide, but remained in the clinically relevant range as suggested by preclinical xenograft studies. The safety of the combination was favorable with a safety profile consistent with second-generation antiandrogens and no dose limiting toxicities observed. One of the patients in the first cohort discontinued after one cycle of dosing due to a strong CYP3A inducer concomitant medication which lowered exposures to both EPI-7386 and enzalutamide and was therefore not evaluable for efficacy. Anti-tumor activity in the remaining six patients enrolled demonstrated that four of six of these patients achieved a PSA90 by 12 weeks of dosing and five of six patients to date have achieved a PSA90.
Seres Therapeutics announced the FDA has accepted for review a Biologics License Application for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection, or rCDI. The application has been granted Priority Review designation with a Prescription Drug User Fee Act, or PDUFA, action date of April 26, 2023. The FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application.
October 24
Hoth Therapeutics announced that it will effect a 1-for-25 reverse split of its issued and outstanding and authorized common stock effective on October 26. Commencing with the opening of trading on The Nasdaq Capital Market on October 26, the company’s common stock will trade on a post-split basis under the same trading symbol, "HOTH".
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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