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: 

• Milestone Pharmaceuticals (MIST), 2,418% surge in interest
• Coherus Bio (CHRS), 1,677% surge in interest
• Hoth Therapeutics (HOTH), 1,664% surge in interest
• Moleculin Biotech (MBRX), 981% surge in interest
• Brainstorm Cell (BCLI), 694% surge in interest
• Iterum Therapeutics (ITRM), 624% surge in interest
• Atreca (BCEL), 559% surge in interest
• Cytokinetics (CYTK), 553% surge in interest
• Acasti Pharma (ACST), 518% surge in interest

Pipeline and key clinical candidates for these companies:

Milestone Pharmaceuticals is a biopharmaceutical company developing and commercializing cardiovascular solutions for people living with complex and life-altering heart conditions. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR.

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of immunotherapies to treat cancer. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer.

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 stated.

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.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

Iterum Therapeutics is dedicated to developing differentiated anti-infectives aimed at combating 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. Iterum has received Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Atreca is a biopharmaceutical company developing novel antibody-based therapeutics generated by its differentiated discovery platform, with a focus on antibody-drug conjugates. Atreca’s platform allows access to an unexplored landscape in oncology through the identification of unique antibody-target pairs generated by the human immune system during an active immune response against tumors. These antibodies provide the basis for a pipeline of first-in-class oncology programs led by APN-497444, an ADC targeting a novel tumor glycan, in addition to MAM01/ATRC-501, a clinical candidate licensed to the Bill & Melinda Gates Medical Research Institute for the prevention of malaria.

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. 

Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. Acasti’s three lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provide the assets with seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents.

Recent news on these stocks:

December 27

Hoth Therapeutics announced that it has received approval from the University of Miami to enroll patients for its first in human clinical trial of HT-001. This First-in-Human Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitor. “We are very pleased to have received approval for our FIH clinical trial,” said Hoth Therapeutics Chief Executive Officer, Robb Knie. “We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001. Coupled with approval at Washington University of St. Louis and MD Anderson Cancer Center, University of Miami will be our third site approved to host our trial and bring hope to cancer patients suffering from skin toxicities associated with EGFRi treatments. I look forward to updating our investors and patients on this ongoing trial in the first quarter of 2024.”

Cytokinetics announced topline results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy. The results of SEQUOIA-HCM show that treatment with aficamten significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake measured by cardiopulmonary exercise testing by a least square mean difference of 1.74 mL/kg/min. The treatment effect with aficamten was consistent across all prespecified subgroups reflective of patient baseline characteristics and treatment strategies, including patients receiving or not receiving background beta-blocker therapy. Statistically significant and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints, including Kansas City Cardiomyopathy Questionnaire Clinical Summary Score at weeks 12 and 24, the proportion of patients with greater than or equal to1 class improvement in New York Heart Association functional class at weeks 12 and 24, change in provoked left ventricular outflow tract gradient and proportion less than30 mmHg at weeks 12 and 24, as well as exercise workload and guideline-eligibility for septal reduction therapy. Aficamten was well-tolerated in SEQUOIA-HCM with an adverse event profile comparable to placebo. Treatment emergent serious adverse events occurred in 8 and 13 patients on aficamten and placebo, respectively. Core echocardiographic left ventricular ejection fraction was observed to be less than50% in 5 patients on aficamten compared to 1 patient on placebo. There were no instances of worsening heart failure or treatment interruptions due to low LVEF.

December 26

Milestone Pharmaceuticals received a Refusal to File letter from the FDA for the New Drug Application for self-administered etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia. Upon preliminary review, the FDA determined that the NDA, submitted in October 2023, was not sufficiently complete to permit substantive review. The FDA requested clarification about the time of data recorded for adverse events in Phase 3 clinical trials; FDA did not express concerns about the nature or severity of adverse events. Milestone will seek clarification and is in the process of planning a meeting with the FDA.

Coherus BioSciences announced that the FDA approved UDENYCA ONBODY, the company’s on-body injector presentation of UDENYCA, a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The approval of UDENYCA ONBODY was supported by a comprehensive analytical and clinical data package, including pharmacokinetic (PK) and pharmacodynamic bioequivalence data as well as adhesive performance and tolerability data. Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.

Brainstorm Cell Therapeutics provided an update on the grant and allowance of three patent applications for NurOwn and NurOwn-Exosomes. The European Patent office granted patent No. 3105587 titled ‘Method of Qualifying of Cells’ for a method of qualifying whether a cell population is a suitable therapeutic for treating ALS. The patent also grants claims for an isolated population of mesenchymal stem cells for use in treating ALS. The Australian patent Office granted patent No. 2019252987 titled ‘Cell-Type Specific Exosomes and Use Thereof’ for an isolated Exosomes population derived from MSC-NTF cells as well as a pharmaceutical composition for the treatment of neurodegenerative diseases. The Israel Patent Office announced the allowance of the same claims for application No. 277447 with an Acceptance date on December 01, 2023.

Atreca entered into a definitive asset purchase agreement with Immunome (IMNM) to sell a collection of antibody-related assets and materials. Under the terms of the agreement, Immunome would pay Atreca up to $12.5M, consisting of a $5.5M upfront payment and up to $7.0M in clinical development milestones. The asset sale will require approval from Atreca stockholders holding at least a majority of the outstanding shares of Atreca’s Class A common stock entitled to vote. A stockholder vote will be sought by proxy solicitation which will include a plan of dissolution calling for the liquidation of any remaining assets, satisfying or making reasonable provisions for any remaining obligations, and making distributions to our stockholders of available proceeds, if any. The board of directors of Atreca intends to seek to distribute remaining funds to its stockholders as quickly as possible, as permitted by law and the plan of dissolution.

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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.