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: 

• Titan Pharma (TTNP), 25,250% surge in interest
• Nucana (NCNA), 5,836% surge in interest
• ARCA Biopharma (ABIO), 1,902% surge in interest
• Liquida (LQDA), 856% surge in interest
• Redhill Biopharma (RDHL), 453% surge in interest
• Tonix Pharmaceuticals (TNXP), 442% surge in interest
• TG Therapeutics (TGTX), 229% surge in interest
• Chimerix (CMRX), 227% surge in interest
• Viking Therapeutics (VKTX), 213% surge in interest
• Soligenix (SNGX), 197% surge in interest

Pipeline and key clinical candidates for these companies:

Titan Pharmaceuticals is a development stage company previously focused on developing proprietary therapeutics utilizing ProNeura long-term, continuous drug delivery technology. In December 2021, Titan commenced a process to explore and evaluate strategic alternatives to enhance shareholder value.

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying its ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines.

ARCA Biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.

Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT Technology. Liquidia Technologies has developed Yutrepia inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Liquidia Technologies is also developing L606, an investigational liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, for use in North America.

RedHill Biopharma is primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori infection in adults, and Aemcolo for the treatment of travelers’ diarrhea in adults.

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 with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA.

TG Therapeutics is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for Briumvi, for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma.

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases. Their Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, their first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn’s disease.

Recent news on these stocks:

August 20

Tonix Pharmaceuticals announced the first patient has been dosed in the Phase 2, single-blind, placebo-controlled, proof of concept trial of TNX-1300 for the treatment of acute cocaine intoxication in the emergency department. TNX-1300 is a recombinant enzyme that rapidly and efficiently degrades and metabolizes cocaine in cocaine users, as demonstrated in a prior Phase 2a randomized, double-blind, placebo-controlled, laboratory-based clinical study, providing support for the use of TNX-1300 as a treatment for life-threatening cocaine intoxication. Tonix has been awarded a Cooperative Agreement Grant from National Institute on Drug Abuse, part of the National Institutes of Health, to support development of TNX-1300 for the treatment of cocaine intoxication. In addition, TNX-1300 has been granted Breakthrough Therapy designation by the FDA. The Phase 2 trial is a single-blind, open-label, placebo-controlled, randomized study comparing the safety of a single 200 mg dose of TNX-1300 to placebo injection plus standard of care alone for the treatment of signs and symptoms of acute cocaine intoxication. The study is being conducted in the EDs of six academic medical centers in the U.S. It will include approximately 60 subjects presenting to the ED with cocaine intoxication. During the treatment period, subjects randomized to receive TNX-1300 will receive a single i.v. injection of TNX-1300 administered over two minutes or less; whereas subjects randomized to receive standard of care alone will receive a single i.v. saline injection over two minutes or less. For both study arms, signs and symptoms of cocaine intoxication will be assessed at pre-determined time points after treatment. After randomization, blood samples will be drawn at specific time points to assess the pharmacokinetics of TNX-1300 and levels of cocaine and its metabolites in the plasma. The primary endpoint of the study is reduction of systolic blood pressure associated with acute cocaine intoxication identified at study baseline comparing TNX-1300 to placebo with standard of care after 60 minutes. A variety of secondary endpoints will be measured, including reduction of circulating cocaine and levels of its metabolites at multiple post-baseline timepoints

August 19

Titan Pharmaceuticals announced that it has entered into a merger and contribution and share exchange agreement regarding a business combination with KE. The merger agreement was approved by Titan’s board. If the merger agreement is approved by the stockholders of Titan and KE, and upon consummation of the transactions contemplated by the merger agreement, Titan will be combined with KE in a “reverse merger” transaction consisting of two steps: TTNP Merger Sub, a wholly owned subsidiary of BSKE, will merge with and into Titan; the separate existence of merger sub will cease; and Titan will be the surviving corporation of the merger and a direct wholly owned subsidiary of BSKE. Within five business days of the filing by Titan and BSKE of a proxy statement/prospectus relating to the proposed transaction, shareholders of KE may elect to enter into a share exchange agreement with Titan and BSKE, pursuant to which, immediately following the merger, each KE shareholder entering into the share exchange agreement will contribute and exchange all of his KE shares in exchange for ordinary shares of BSKE. Titan may terminate the merger agreement if fewer than all KE shareholders enter into the share exchange agreement within the specified period. Dato’ Seow Gim Shen, chairman of the board and CEO of Titan, is the holder of 47.4% of the outstanding shares of KE. In addition, Seow is the sole stockholder of The Sire Group, which is the holder of Series AA Preferred Stock currently convertible into 150,087 shares of Titan common stock. Upon completion of the merger, the existing security holders of KE and Titan expect to own approximately 86.7% and 13.3%, respectively, of the outstanding shares of the combined company. It is expected that Seow will own 48.9% of the outstanding shares of the combined company following the merger. Such ownership percentages could be subject to proportional dilution for any required financing in connection with the closing. Completion of the merger is subject to the approval of the merger by Titan’s stockholders and issuance of shares related to the merger, approval of the listing by Nasdaq of BSKE on the Nasdaq Capital Market, post-merger, and satisfaction or waiver of other customary conditions set forth in the merger agreement. Accordingly, there can be no assurance that the proposed merger will be consummated.

Oppenheimer analyst Leland Gershell kept an Outperform rating on NuCana with a $150 price target following the company’s Q2 report. The firm sees the first look from the randomized Phase 2 trial in metastatic colorectal cancer as a key catalyst. The data could show meaningful clinical differentiation for NUC-3373 versus 5-fluorouracil as part of the standard-of-care regimen for second-line disease, the analyst tells investors in a research note. Opco believes the stage is set for ‘3373 to at least show better safety and tolerability. An efficacy advantage on progression-free survival “would be a home run,” it contends. With the shares seeming to reflect little credit for any future success potential, investors should “take a close look heading into this fall ’24 readout, which we believe could ignite investor interest in NCNA,” the firm added.

Liquidia announced that the FDA has granted tentative approval of YUTREPIA inhalation powder to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States but must await the expiration of regulatory exclusivity of a competing product before final approval can be granted.

RedHill Biopharma announced positive results from multiple in vivo studies, undertaken by RedHill’s partner, Apogee Biotechnology Corporation, showing the impact of opaganib on weight gain and glucose tolerance in a high fat diet,or HFD model, supporting the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders. The studies were designed to examine some of the most fundamental aspects of diabetes and obesity-related disease. The encouraging outcomes showed the benefit of opaganib therapy in suppression of HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib treatment reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders. The global obesity-diabetes drugs market is projected to be worth around $100B by 2034 – largely driven by Glucagon-like peptide-1 inhibitors like Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s (LLY) Trulicity and Mounjaro and sodium glucose cotransporter-2 inhibitors such as Boehringer Ingelheim’s Jardiance. Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

August 16

ARCA biopharma announced that its board has declared a special cash dividend in connection with the previously announced merger with Oruka Therapeutics, pursuant to the agreement and plan of merger and reorganization, dated April 3. The special dividend, which ARCA estimates will be $1.59 per share of ARCA’s common stock, will be payable in cash to the stockholders of record as of August 26, 2024. Closing of the merger is expected to occur on August 29, 2024 assuming that the transaction is approved by ARCA’s stockholders and the satisfaction or waiver of all conditions under the merger agreement.

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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.