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: 

• Cellectar Biosciences (CLRB), 6,982% surge in interest
• Insmed (INSM), 1,669% surge in interest
• Intellia (NTLA), 308% surge in interest
• BioLineRx (BLRX), 151% surge in interest
• Ideaya Biosciences (IDYA), 136% surge in interest
• Vanda Pharmaceuticals (VNDA), 102% surge in interest
• Zai Lab (ZLAB), 94% surge in interest
• Catalyst Pharm (CPRX), 74% surge in interest
• Harpoon Therapeutics (HARP), 66% surge in interest
• NeuBase Therapeutics (NBSE), 61% surge in interest

Pipeline and key clinical candidates for these companies:

Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Insmed Incorporated is a biopharmaceutical company that says its on “a mission to transform the lives of patients with serious and rare diseases.” Insmed’s first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. 

Intellia Therapeutics, a clinical-stage genome editing company, is developing novel, potentially curative therapeutics using CRISPR/Cas9 technology. “Intellia’s deep scientific, technical and clinical development experience, along with its robust intellectual property portfolio, have enabled the company to take a leadership role in harnessing the full potential of CRISPR/Cas9 to create new classes of genetic medicine,” the company says.

BioLineRx is a pre-commercial-stage biopharmaceutical company focused on oncology. The company’s lead development program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, may support diverse therapeutic approaches in oncology and other diseases. APHEXDA was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous transplantation for multiple myeloma patients, has reported positive results from a pre-planned pharmacoeconomic study in the U.S., and has had its NDA submission accepted by the FDA with an assigned PDUFA date of September 9, 2023. 

Ideaya Biosciences is a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. Ideaya says it is applying its research and drug discovery capabilities to synthetic lethality, which “represents an emerging class of precision medicine targets.”

Vanda Pharmaceuticals is focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.

Zai Lab Limited is a commercial-stage biopharmaceutical company based in China and the United States focused on bringing medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world.

Catalyst says it is “committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic diseases”. Catalyst’s flagship U.S. commercial product is Firdapse tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome for adults and for children ages six to seventeen. In January 2023, Catalyst acquired the U.S. commercial rights to Fycompa CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. 

Harpoon Therapeutics is developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. “Using its proprietary Tri-specific T cell Activating Construct, or TriTAC, platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. Harpoon’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome,” the company states.

NeuBase Therapeutics is a biotechnology company developing Stealth Editors to perform in vivo gene editing without triggering the immune system.

Recent news on these stocks:

September 6

Symetryx Corporation announced that it has acquired 20% of the issued and outstanding common stock in Neubase Therapeutics. Symetryx is now urging the Board to issue a special $1 per share dividend. Symetryx has bought these shares on the open market and intends to engage with the management of Neubase to chart the best path forward for shareholders. Neubase, as disclosed in its previous news releases, is currently undergoing a strategic review of the company’s operations. Symetryx notes that for the quarter ended June 30, Neubase reported an approximate cash balance of $14.M. Symetryx is of the view that the cash position of the company makes Neubase a very attractive merger candidate, and it does not believe that a $1 per share dividend would make the company any less attractive. The shareholder base of the company invested in Neubase for the exciting work they were doing, not in a shell looking for a target. With the strategic review underway, we believe both rewarding shareholders with a dividend, and looking for a merger candidate is a true win-win for shareholders. Symetryx notes that the Company has met with Symetryx and is receptive to ongoing discussions. Symetryx is encouraged by the actions the Company has taken. Symetryx is of the view that many companies exhaust their cash balances in similar strategic alternative reviews and it would like to work closely with Neubase to ensure that assets of the company are utilized judiciously to maximize shareholder value. We believe all options should be available for the board to consider, whether that be a merger, acquisition, special dividend to shareholders, or a winding down of the company and return of capital to shareholders.

September 5

Cellectar Biosciences entered into a securities purchase agreement with certain institutional investors for a private placement financing that is expected to result in gross proceeds of up to $102.9M, including an initial funding of $24.5M priced at the company’s common stock closing price on September 1 of $1.82 per share.

Insmed announced positive topline results from its Phase 3 ARISE study of ARIKAYCE in patients with newly diagnosed or recurrent nontuberculous mycobacterial, NTM, lung infection caused by Mycobacterium avium complex, MAC, who had not started antibiotics. The study met its primary objective of demonstrating that the Quality of Life – Bronchiectasis respiratory domain works effectively as a patient-reported outcome instrument in patients with MAC lung disease. Based on these results, Insmed plans to propose to the U.S. Food and Drug Administration that the QOL-B respiratory domain PRO be the primary endpoint for the ENCORE study without any modifications. Patients in ARISE were randomized 1:1 to treatment with ARIKAYCE plus macrolide-based background regimen or placebo plus macrolide-based background regimen for six months, followed by one month off treatment. ARIKAYCE-treated patients performed better than those in the comparator arm as measured by the QOL-B instrument, with 43.8% of patients achieving an improvement in QOL-B respiratory score above the estimated meaningful within-subject score difference of 14.8, compared with 33.3% of patients in the comparator arm. While the study was not powered to show a statistically significant difference between treatment arms, a strong trend toward significance was observed for improvement from baseline at Month 7. Patients in the ARIKAYCE arm also achieved nominally statistically significantly higher culture conversion rates at Month 7 versus patients in the comparator arm, and culture conversion was faster and more likely to persist through Month 7 for the ARIKAYCE arm. Based on the results of ARISE, Insmed plans to explore with global regulators accelerating the filing for approval of ARIKAYCE in newly infected patients with MAC lung disease. In parallel, the Company continues to enroll patients in ENCORE, which will use the PRO tool that has been validated in ARISE, with 250 patients expected to be enrolled by the end of 2023. Enrollment in ENCORE is expected to continue into 2024 to ensure a high degree of statistical powering and Insmed anticipates reporting topline data from ENCORE in 2025.

August 30

Zai Lab announced that the Center for Drug Evaluation, CDE, of the National Medical Products Administration, NMPA, granted Breakthrough Therapy Designation, BTD, for investigational repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with TRK tyrosine kinase inhibitors. The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study. “We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China. Today’s recognition further supports repotrectinib as a potential first-in-class treatment for patients with NTRK-positive, TKI-pretreated solid tumors in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “NTRK is estimated to be an oncogenic driver in approximately 0.5 percent of patients with a variety of advanced solid tumors.1 There remains an unmet medical need for NTRK-positive, TKI-pretreated advanced solid tumor patients where there are no targeted therapies currently approved. We look forward to working with regulatory authorities in China to bring this important medicine to patients in need as soon as possible.”

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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.