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: 

• Adial Pharmaceuticals (ADIL), 8,918% surge in interest
• Pieris Pharmaceuticals (PIRS), 5,962% surge in interest
• Kiniksa Pharmaceuticals (KNSA), 2,605% surge in interest
• Hoth Therapeutics (HOTH), 2,030% surge in interest
• Sangamo Therapeutics (SGMO), 1,502% surge in interest
• Actinium Pharmaceuticals (ATNM), 1,476% surge in interest
• Jaguar Health (JAGX), 393% surge in interest
• Verastem (VSTM), 305% surge in interest
• Fortress Biotech (FBIO), 254% surge in interest

Pipeline and key clinical candidates for these companies:

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, or AUD, in heavy drinking patients and was recently investigated in the company’s ONWARD pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the company’s proprietary companion diagnostic genetic test. The company is also developing adenosine analogs for the treatment of pain and other disorders.

Pieris is a clinical-stage biotechnology company that says it “combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients.” Its pipeline has historically focused on inhalable Anticalin proteins to treat respiratory diseases and locally-activated bispecifics for immuno-oncology.

Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation.

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.

Sangamo Therapeutics is a genomic medicine company that says it is “dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options.” Sangamo’s zinc finger epigenetic regulators are being studied to potentially address neurological disorders and Sangamo’s capsid discovery platform is “making progress toward potentially expanding delivery beyond currently available intrathecal delivery capsids, including in the central nervous system,” Sangamo says.

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B, an induction and conditioning agent prior to bone marrow transplant, and Actimab-A, a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.

Jaguar Health is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Their crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.

Verastem Oncology is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. The company’s pipeline is focused on RAS/MAPK-driven cancers, specifically novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and FAK inhibition.

Fortress Biotech is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy.

Recent news on these stocks:

July 25

Actinium Pharmaceuticals announced the FDA clearance of an Investigational New Drug, IND, application to study Iomab-ACT for targeted conditioning prior to a bone marrow transplant, in patients with sickle cell disease. If successful, the trial is expected to inform a clinical trial to evaluate Iomab-ACT as a targeted conditioning agent prior to gene therapy for which there are two approved agents for patients with sickle cell disease, Casgevy and Lyfgenia. Iomab-ACT is an ARC that targets CD45, a marker expressed on blood cancer cells and immune cells that is intended to enable conditioning prior to cell and gene therapies replacing the non-targeted chemotherapy and total body irradiation that is currently used for conditioning. It is the only CD45 targeting conditioning agent in clinical development.

Fortress Biotech has entered into a new loan agreement for up to $50M with funds managed by Oaktree Capital Management. The company will receive an initial tranche of $35M and is eligible to draw an additional $15M at Oaktree’s discretion to support future business development activities. In connection with the new loan agreement, the company repaid its prior $50M term loan with Oaktree.

July 24

Palvella Therapeutics and Pieris Pharmaceuticals announced they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on developing and commercializing Palvella’s lead clinical product candidate, QTORIN 3.9% rapamycin anhydrous gel, for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin pathway. Upon completion of the proposed merger, the combined company will operate under the name Palvella Therapeutics and is expected to trade on The Nasdaq Capital Market.

A Wells Fargo analyst raised the firm’s price target on Kiniksa to $35 from $34 and kept an Overweight rating on the shares. Arcalyst revenues came out on top, and management upped its 2024 guidance range by +8% at the midpoint, the firm noted. Wells thought further commentary on treatment duration and growth of prescribers sounded positive.

Sangamo Therapeutics reported on Pfizer’s (PFE) announcement of positive topline results from the Phase 3 AFFINE trial evaluating giroctocogene fitelparvovec, an investigational gene therapy that Sangamo is co-developing with and licensing to Pfizer for the treatment of adults with moderately severe to severe hemophilia A. Sangamo is eligible to earn from Pfizer up to $220M in milestone payments upon the achievement of certain regulatory and commercial milestones for giroctocogene fitelparvovec and product sales royalties of 14%-20% if giroctocogene fitelparvovec is approved and commercialized, subject to certain reductions. Pfizer reported that the AFFINE trial achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate from Week 12 through at least 15 months of follow up post-infusion compared with routine Factor VIII replacement prophylaxis treatment. Giroctocogene fitelparvovec demonstrated a statistically significant reduction in mean total ABR compared to the pre-infusion period. Key secondary endpoints as defined by the trial protocol were met and also demonstrated superiority compared to prophylaxis. The goal of this investigational treatment for people living with hemophilia A is that a single infusion of giroctocogene fitelparvovec may allow them to produce FVIII themselves for an extended period of time, provide bleed protection and reduce the need for routine prophylaxis with intravenous infusions or injections.

Verastem priced a 13.333M share spot secondary offering at $3.00 per share. Guggenheim and Cantor Fitzgerald acted as joint book running managers for the offering.

July 23

Adial Pharmaceuticals announced the progression to the second cohort in the pharmacokinetics, PK, study of AD04, the company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, AUD, in heavy drinking patients, following the successful completion of the first cohort. Topline results from both cohorts are expected to be announced during the fourth quarter of 2024. Cary Claiborne, CEO of Adial commented, “We are pleased with the progress of our pharmacokinetics study of AD04. The successful completion of the first cohort allows us to advance to the second cohort as planned, staying on track with our projected timeline. The results from both cohorts will offer invaluable insights that are critical for the design of our upcoming Phase 3 Clinical Trial. We anticipate engaging with the FDA following receipt of the topline data from this study and seek their feedback on the overall design of our Phase 3 program.”

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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.