Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Summit Therapeutics is a clinical stage biotech company targeting treatment of various cancers.
Trevena is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The company has one approved product in the United States, OLINVYK injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The company's novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning "cold" tumors "hot" — through innate and adaptive immune responses to treat a variety of cancers.
Wave Life Sciences is a biotechnology company "focused on unlocking the broad potential of RNA medicines to transform human health" whose RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders, the company says. Wave's pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a preclinical program in obesity.
Avid Bioservices is a dedicated contract development and manufacturing organization, or CDMO, focused on development and CGMP manufacturing of biologics. Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs, the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization.
Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises.
BioNTech is "pioneering novel therapies for cancer and other serious diseases." BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab (GMAB), Sanofi (SNY), Genentech, a member of the Roche Group (RHHBY), Regeneron (REGN), Genevant, Fosun Pharma, and Pfizer (PFE).
Tonix is focused on central nervous system, rare disease, immunology and infectious disease product candidates. Tonix's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia.
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Adma currently manufactures and markets three United States Food and Drug Administration-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases. Through its Adma BioCenters subsidiary, Adma also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products.
Recent news on these stocks:
September 10
RBC Capital raised the firm's price target on Avid Bioservices to $12 from $8 and kept an Outperform rating on the shares. The company's Q1 results missed on revenue and EBITDA, but its bookings were "well ahead of estimates", with "broad-based" contributions coming from a combination of new customers, early and late-stage work and even a commercial mandate, the analyst told investors in a research note. The management also said the increased mix of early work this quarter should slightly accelerate the near-term burn rates, which improves visibility on the management's reaffirmed $160M-168M FY25 revenue guidance, RBC added.
September 9
Summit Therapeutics over the weekend presented data from a Phase 3 Study of ivonescimab versus Merck's (MRK) Keytruda as first-line treatment for PD-L1- positive advanced non-small cell lung cancer. Ivonescimab demonstrated a statistically significant 5.3 months of improvement in progression free survival versus Keytruda, the company said.
According to post on the FDA's website, Wave Life Sciences' treatment of Duchenne muscular dystrophy was designated for orphan status.
JPMorgan initiated coverage of Wave Life Sciences with an Overweight rating and $10 price target. The company's pipeline assets, WVE-006 and WVE-007, both present "compelling, potentially differentiated interventions for blockbuster market opportunities," and are maturing toward value accretive catalysts over the next three to fifteen months, the analyst tells investors in a research note. The firm sees the direct SERPINA1 transcript editing approach behind WVE-006 "going somewhat underappreciated" for its disease modifying potential in the treatment of alpha-1 antitrypsin deficiency.
Ionis Pharmaceuticals announced a proposed underwritten public offering of $500M of its common stock. Ionis intends to use the net proceeds from the offering to fund its independent commercial launches, late-stage clinical programs, earlier pipeline programs, and research and development activities, as well as for working capital and general corporate purposes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Morgan Stanley and Goldman Sachs & Co. are acting as joint book-running managers for the offering.
Tonix Pharmaceuticals announced data presented at a symposium hosted by the Department of Medical Microbiology & Immunology and the Li Ka Shing Institute of Virology to celebrate the career and honor the retirement of Tonix's collaborator, David Evans, Ph.D., FCAHS, Emeritus Professor, Department of Cell Biology, University of Alberta. The presentation titled, "Using Synthetic Biology to Battle Mpox", detailed the Company's vaccine platform, led by TNX-801 for preventing mpox. TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. TNX-801 is structurally closer to 19th century live-virus vaccinia vaccines than 20th century versions. Genomic sequencing of archaic smallpox vaccines has shown that vaccines used prior to 1900 would be called 'horsepox' today. While effective against smallpox as single-dose vaccines, 20th century vaccines have diverged from horsepox-like progenitors to have greater virulence and toxicity than TNX-801 in animals. The U.S. Food and Drug Administration recently approved ACAM2000 from Emergent Technologies for preventing mpox.4 ACAM200 is a live-virus vaccine derived from a 20th Century vaccinia vaccine. ACAM2000 carries a Black Box warning on its package insert labeling warning of tolerability issues, including myocarditis and pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major, eczema vaccinatum resulting in permanent sequelae or death, and risks in certain individuals that may result in severe disability, permanent neurological sequelae and/or death.5 The Jynneos vaccine from Bavarian Nordic is a non-replicating vaccinia vaccine that is FDA-approved for mpox with a two-dose regimen requiring sterile injection.6 Single-dose TNX-801 has advantages over non-replicating vaccinia vaccines which require two doses. Percutaneous TNX-801 has advantages over vaccines which require sterile injection. The durability of protection from 19th century live-virus vaccinia vaccines was believed to last decades or even be live-long. Consequently, single-dose TNX-801 is believed to stimulate long-lived T cell immunity. Consequently, TNX-801 will not require multiple repeated doses at six-month intervals like mRNA vaccines.7 Also, the stability of live-virus vaccines, particularly in lyophilized form, eliminates the need for ultra-cold storage which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now. Tonix's focus on single-dose vaccines adheres to recommendations by the Bipartisan Commission on Biodefense8, and the U.S. National Academies of Science. For example, the NAS report highlights the difficulty of a case-contact or "ring" vaccination strategy with even a two-dose regimen. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals against lethal challenge with intratracheal clade I monkeypox virus.10 An outbreak of Clade I mpox has recently been declared a Public Health Emergency of International Concern by the World Health Organization.11,12 Starting from an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to several Central African Countries and cases have been reported in Sweden, Thailand and Singapore. According to the U.S. Centers for Disease Control and Prevention and other experts, there is a significant risk that clade I strain may appear in the U.S.13 Clade I mpox is typically associated with higher case fatality rates than clade II mpox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of animals challenged with clade I monkeypox.10 These findings are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 has the ability to block forward transmission, similar to Dr. Edward Jenner's vaccinia vaccine, descendants of which eradicated smallpox and kept mpox out of the human population. The presentation at University of Alberta included results from Tonix scientists at the Research and Development Center (RDC) in Frederick, Md. Data from a manuscript showed that TNX-801 is highly attenuated relative to 20th century vaccinia vaccines in in immunocompromised animals.14 New data showed TNX-801 is unable to spread in blood or tissues in these animals, even at an approximately 100-Fold higher dose than 20th century vaccinia vaccines. In addition to characterizing TNX-801's activity and tolerability, Tonix scientists have explored the characteristics of the monkeypox virus. The prior 2022 global clade IIb mpox outbreak, affected over 90,000 persons in countries where mpox previously had not been endemic, including Europe and the US. The spread of clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Data presented show that monkeypox clade IIb from a 2022 isolate in Massachusetts is 10,000- to 100,000-fold more attenuated than clade IIa isolates from 2003. The attenuation of clade II monkeypox in the recent 2022 outbreak may have contributed to its greater dissemination. The new and more lethal clade I monkeypox has not yet been analyzed.
September 6
S&P announced that ADMA Biologics will join the S&P SmallCap 600. S&P Dow Jones Indices will make the changes to the S&P SmallCap 600 indices effective prior to the open of trading on Monday, September 23, to coincide with the quarterly rebalance.
September 5
BioNTech SE will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology Congress 2024 in Barcelona, Spain from September 13-17, 2024. The oral and poster presentations will feature programs across BioNTech's clinical pipeline, including mRNA-based cancer vaccines, next-generation immunomodulators and targeted therapy approaches. Highlights of BioNTech's clinical stage programs to be presented at ESMO Congress 2024: Updates on several Phase 2 and Phase 1/2 clinical trials evaluating BNT327/PM8002 in various indications as monotherapy and in combination with chemotherapy will be presented; Preliminary data from an ongoing clinical Phase 2 trial evaluating BNT113 in combination with PD-1 blockade and data from an investigator-initiated Phase 1/2 clinical trial ; Preliminary data of the randomized Phase 2 clinical trial with BNT316/ONC-392; Follow-up data of activity and immune responses from the ongoing first-in-human Phase 1 clinical trial.
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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.
