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:

• Immunic (IMUX), 165% surge in interest
• ADMA Biologics (ADMA), 115% surge in interest
• Iovance Biotherapeutics (IOVA), 88% surge in interest
• Avidity Biosciences (RNA), 85% surge in interest

Pipeline and key clinical candidates for these companies:

Immunic has a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products. Its lead development program, vidofludimus calcium, is a selective immune modulator that is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935 is targeted for development in psoriasis and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.

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: BIVIGAM for the treatment of primary humoral immunodeficiency; ASCENIV for the treatment of PI; and NABI-HB to provide enhanced immunity against the hepatitis B virus. 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.

Iovance Biotherapeutics is focused on developing and delivering tumor infiltrating lymphocyte, or TIL, therapies for patients with cancer. Its lead late-stage TIL product candidate, lifileucel for metastatic melanoma, “has the potential to become the first approved one-time cell therapy for a solid tumor cancer,” said the company, adding that its TIL platform has “demonstrated promising clinical data across multiple solid tumors.”

Avidity Bioscience’s proprietary AOCs – Antibody Oligonucleotide Conjugates – are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to target the root cause of diseases previously untreatable with RNA therapeutics, the company says. Avidity’s advancing and expanding pipeline has three programs in clinical development. AOC 1001 is designed to treat people with myotonic dystrophy type 1 and is currently in Phase 1/2 development with the ongoing MARINA and MARINA-OLE trials. AOC 1020 is designed to treat people living with facioscapulohumeral muscular dystrophy and is currently in Phase 1/2 development with the FORTITUDE trial. AOC 1044 is designed for people with Duchenne muscular dystrophy mutations amenable to exon 44 skipping and is currently in Phase 1/2 development with the EXPLORE44 trial.

Recent news on these stocks:

August 12

H.C. Wainwright raised the firm’s price target on Adma Biologics to $18 from $10 and kept a Buy rating on the shares. the company reported substantial top- and bottom-line outperformance and its guidance was increased yet again, the analyst told investors in a research note.

August 9

Avidity Biosciences announced positive AOC 1044 5 mg/kg data demonstrated unsurpassed delivery of phosphorodiamidate morpholino oligomers concentrations to skeletal muscle, statistically significant increase of 25% of normal in dystrophin production and statistically significant increase of 37% in exon 44 skipping in people living with Duchenne muscular dystrophy mutations amenable to exon 44 skipping in the Phase 1/2 EXPLORE44 clinical trial. In addition, AOC 1044 5 mg/kg reduced creatine kinase levels to near normal with greater than 80% reduction compared to baseline. AOC 1044 demonstrated favorable safety and tolerability. Avidity also announced delpacibart zotadirsen as the approved international nonproprietary name of AOC 1044, abbreviated as del-zota. In the Phase 1/2 EXPLORE44 study, del-zota demonstrated: Unsurpassed delivery of PMO of 200 nM in skeletal muscle; Statistically significant 37% increase in exon 44 skipping and up to 66% exon 44 skipping; Statistically significant increase of 25% of normal in dystrophin production and restored total dystrophin up to 54% of normal; Reduction in creatine kinase levels to near normal with greater than 80% reduction compared to baseline; Favorable safety and tolerability with most treatment emergent adverse events mild or moderate in participants with DMD44.

Chardan raised the firm’s price target on Avidity Biosciences to $60 from $45 and kept a Buy rating on the shares after the company announced data from Part B of the Phase I/II EXPLORE44 trial evaluating delpacibart zotadirsen in DMD patients amenable to therapy that achieves exon 44 skipping. While the data is from a small number of patients receiving 5mg/kg doses, it does provide further validation of Avidity’s AOC design platform and positions the company to continue to evaluate additional DMD 44 patients in order to accumulate sufficient patient experience that could support a possible accelerated approval, the analyst told investors.

August 8

Immunic reported Q2 EPS of (21c) against a consensus of (23c). “During the second quarter and subsequent period, we continued to achieve clinical and operational progress, punctuated with the addition of Jason Tardio to our team, in the newly-created position of Chief Operating Officer and President. Jason’s proven experience in launching and commercializing multiple sclerosis drugs for major biotechnology and pharmaceutical companies, including Novartis and Biogen, as well as his extensive partnering experience, will be invaluable, especially as we move closer to the potential commercialization of our late-stage clinical asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor related 1 (Nurr1) activator. We also welcomed Simona Skerjanec to our board of directors, who most recently served as the senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she had a successful track record achieving double-digit sales growth, including with Ocrevus (ocrelizumab), one of the most successful medicines for MS,” stated CEO Daniel Vitt. “We plan to provide detail on our MS development program at our next MS R&D Day in New York City in September. The event will feature two renowned industry experts alongside Immunic’s management team to discuss the unique profile of vidofludimus calcium and its potential to become a groundbreaking treatment of choice for both relapsing MS and progressive MS patients. We believe that vidofludimus calcium could elevate today’s standard of care by providing a holistic solution for the full range of MS patients, given that it is designed to selectively manage all components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects.”

Iovance Biotherapeutics reported Q2 EPS of (34c) against a consensus of (35c), and reported Q2 revenue of $31.11M against a consensus of $24.59M. Frederick Vogt, Ph.D., J.D., interim president and CEO of Iovance, stated, “The first half of 2024 ushered in our first FDA approval and the start of our U.S. commercial launch of Amtagvi for patients with previously treated advanced melanoma. Amtagvi and Proleukin demand remains strong and continues to increase as authorized treatment centers adopt Amtagvi and community referral networks are mobilized to drive patients to ATCs. These demand trends, as well as broader utilization of Amtagvi among an expanding ATC network, are expected to accelerate quarterly growth throughout this year and next year. We expect this growth to continue in 2025, 2026 and beyond. Additionally, we continue to expand our global commercial footprint, proprietary manufacturing capabilities, and broad clinical pipeline. As a fully integrated company, Iovance is well positioned to remain the global leader in innovating, developing, and delivering TIL cell therapy for patients with cancer.”

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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.