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: 

• Harpoon Therapeutics (HARP), 5,210% surge in interest
• Cellectar Biosciences (CLRB), 546% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 504% surge in interest
• Ardelyx (ARDX), 389% surge in interest
• Innoviva (INVA), 320% surge in interest
• Heron Therapeutics (HRTX), 256% surge in interest
• BioCryst Pharmaceuticals (BCRX), 211% surge in interest
• Mesoblast (MESO), 162% surge in interest
• Ampio Pharmaceuticals (AMPE), 142% surge in interest
• Exelixis (EXEL), 113% surge in interest

Pipeline and key clinical candidates for these companies:

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. Merck (MRK) and Harpoon announced that the companies have entered into a definitive agreement under which the former will acquire the latter for $23 per share in cash.

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.

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the epigenetic/anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications.

Ardelyx says it was founded with “a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.” Ardelyx’s first approved product, Ibsrela is available in the United States and Canada. Ardelyx is developing Xphozah, a novel product candidate to control serum phosphorus in adult patients with chronic kidney disease on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.

Innoviva is a diversified holding company with a portfolio of royalties and other healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited, including RELVAR/BREO/ELLIPTA and ANORO/ELLIPTA. Innoviva’s other healthcare assets include infectious disease and critical-care assets stemming from acquisitions of Entasis Therapeutics, including its lead asset sulbactam-durlobactam, and La Jolla Pharmaceutical Company, including GIAPREZA, approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA, for the treatment of complicated intra-abdominal infections in adults.

Heron Therapeutics is a commercial-stage biotechnology company that says its “advanced science, patented technologies, and innovative approach to drug discovery and development have allowed it to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.”

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily Orladeyo is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. Rapivab is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing.

Mesoblast refers to itself as “a world leader in developing allogeneic cellular medicines for the treatment of severe and life-threatening inflammatory conditions.” The company states: “Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets… Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets.”

Ampio Pharmaceuticals is focused on the development of a potential treatment for osteoarthritis as part of its OA-201 program. The OA-201 development program is seeking to advance Ampio’s unique and proprietary small molecule formulation to take forward through pain and chondroprotection pre-clinical studies and the next phases of drug development. Ampio’s primary strategy is to address the large and attractive opportunity for treatment of osteoarthritis of the knee and other joints.

Exelixis is an oncology company that says it is “innovating next-generation medicines and regimens at the forefront of cancer care.” The company says it is rapidly evolving its product portfolio to target an expanding range of tumor types and indications with its clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics.

Recent news on these stocks:

January 8

Merck (MRK) and Harpoon Therapeutics announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon for $23.00 per share in cash for an approximate total equity value of $680M. Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Harpoon Therapeutics for a price per share of $23.00 in cash. The board of directors of Harpoon has unanimously approved the transaction. The transaction is expected to close in the first half of 2024 and will be accounted for as an asset acquisition. Merck expects to record a charge of approximately $650M, or approximately 26c per share, that will be included in non-GAAP results in the quarter that the transaction closes.

Cellectar Biosciences announced data from its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors. CLOVER WaM is the largest study to date in relapsed or refractory WM patients post-BTKi therapy and represents the most refractory population ever tested in clinical studies based upon a review of published literature. The CLOVER WaM study met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, and 100% of patients experienced disease control. Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months. These outcomes exceed real world data, which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and less refractory to multiple classes of drugs. Notably, iopofosine monotherapy achieved an 8% stringent complete remission in this highly refractory WM population.

Cyclacel Pharmaceuticals announced that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market on January 4, indicating that the company has regained compliance with the minimum bid price requirement set forth in Rule 5550(a)(2) of the Nasdaq Listing Rules.

Ardelyx provided an update on the company’s progress in 2023 and initial expectations for 2024. U.S. net product sales revenue for the first full calendar year of commercialization of IBSRELA is expected to be approximately $80M, subject to adjustment in connection with preparation of audited financial statements, following consistent quarter-over-quarter growth and strong performance across all key indicators, including new and repeat writers and new and refill prescriptions. Ardelyx expects IBSRELA to achieve greater than ten percent market share at peak and generate more than $1.0B in annual U.S. net product sales revenue before patent term expiration. In 2024, the company will continue to invest to support future realization of the full potential for IBSRELA, including the expansion of the IBSRELA sales team, additional promotional programming and omnichannel digital capabilities, increased sampling availability, and expanded support provided by the ArdelyxAssist patient services program. Ardelyx currently expects FY24 U.S. net product sales revenue for IBSRELA to be between $140.0M-$150.0M. Following approval by the FDA of XPHOZAH in October 2023 and launch in November 2023, Ardelyx has seen a strong initial response from the nephrology community. U.S. net product sales revenue for the first quarter of commercialization of XPHOZAH is expected to be approximately $2.5M, subject to adjustment in connection with preparation of audited financial statements. As of December 31, 2023, the company had total cash, cash equivalents and short-term investments of approximately $184M. Ardelyx had approximately 232M shares outstanding as of December 31, 2023.

January 5

BioCryst reported preliminary Q4 ORLADEYO revenue of $89.9M (+27 percent y-o-y). Preliminary, unaudited ORLADEYO net revenue for FY23 was $325M (+29 percent y-o-y). The company expects FY24 global net ORLADEYO revenue to be between $380M-$400M. The general pattern of revenue throughout 2024 is expected to be similar to past years, with the seasonal impact of prescription reauthorizations and the potential impact of the Inflation Reduction Act in the first quarter driving a quarter-over-quarter revenue decline in the first quarter, followed by a strong return to growth in the second quarter.

Hear more from InvestingChannel by signing up for The Spill.

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.