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: 

• Vaccinex (VCNX), 511% surge in interest
• Amicus Therapeutics (FOLD), 144% surge in interest
• Ionis Pharmaceuticals (IONS), 100% surge in interest
• Navidea Biopharmaceuticals (NAVB), 78% surge in interest
• Apellis Pharmaceuticals (APLS), 16% surge in interest
• Miratai Therapeutics (MRTX), 14% surge in interest

Pipeline and key clinical candidates for these companies:

Vaccinex says it is “pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D.” The company’s lead drug candidate, pepinemab, is designed to block SEMA4D, a potent biological effector that is believed to trigger damaging inflammation in chronic diseases of the brain and inhibit immune infiltration and activation in tumors. In neurodegenerative diseases, pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer and in combination with BAVENCIO in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma. 

Amicus Therapeutics is focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. “With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases,” the company states.

Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises.

Navidea Biopharmaceuticals is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform.

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

Mirati Therapeutics is focused on bringing forward therapies that address areas of high unmet medical need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer.

Recent news on these stocks:

October 8

Ionis Pharmaceuticals announced new results from a 66-week analysis of exploratory cardiac endpoints in the Phase 3 NEURO-TTRansform study of eplontersen, an investigational treatment for hereditary transthyretin-mediated amyloid polyneuropathy. In a pre-defined cardiac subpopulation of ATTRv-PN patients, treatment with eplontersen showed stabilization or improvement in cardiac function and structure relative to external placebo, including levels of N-terminal prohormone of brain natriuretic peptide, a measure of cardiac stress, and a trend towards improvement in echocardiographic parameters. The results were presented during a rapid-fire oral session at the 2023 Heart Failure Society of America Annual Scientific Meeting. Transthyretin-mediated amyloid cardiomyopathy is a systemic, progressive and fatal condition that typically leads to progressive heart failure and often death within three-to-five years from disease onset. Data from the study are expected as early as the first half of 2025. As part of a global development and commercialization agreement, Ionis and AstraZeneca (AZN) are seeking regulatory approval for eplontersen for the treatment of ATTRv-PN in the U.S. and plan to seek regulatory approval in Europe and other parts of the world. This agreement was recently expanded to include exclusive rights for AstraZeneca to commercialize eplontersen in Latin America and all other countries outside the US. Eplontersen was granted Orphan Drug Designation in the U.S. for the treatment of transthyretin-mediated amyloidosis. The FDA granted a PDUFA action date of December 22, 2023.

Bristol Myers Squibb (BMY) and Mirati Therapeutics announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Mirati for $58.00 per share in cash, for a total equity value of $4.8B. Mirati stockholders will also receive one non-tradeable Contingent Value Right for each Mirati share held, potentially worth $12.00 per share in cash, representing an additional $1B of value opportunity. The transaction was unanimously approved by both the Bristol Myers Squibb and the Mirati Boards of Directors. Through this acquisition, Bristol Myers Squibb will add KRAZATI, a lung cancer medicine, to its commercial portfolio. The company gains access to other clinical assets that complement its oncology pipeline and are candidates for single agent development and combination strategies. The transaction is expected to be treated as a business combination and to be dilutive to Bristol Myers Squibb’s non-GAAP earnings per share by approximately 35c per share in the first 12 months after the transaction closes. The transaction is anticipated to close by the first half of 2024, subject to fulfillment of customary closing conditions, including approval of Mirati’s stockholders and receipt of required regulatory approvals. Bristol Myers Squibb expects to finance the acquisition with a combination of cash and debt.

October 6

Navidea announced that the Listings Qualifications Panel of the Committee for Review of the board of directors of the NYSE American upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the company’s common stock. Accordingly, the staff of NYSE Regulation has suspended trading in the common stock of Navidea from the NYSE American. The company anticipates that its common stock will begin trading on the over-the-counter markets.

JPMorgan upgraded Apellis to Overweight from Neutral with a price target of $81, up from $60. The Q3 Syfovre beat underscores a return to growth for the product, even in the face of retinal vasculitis headwinds from the summer, the analyst tells investors in a research note. The firm sees improving Syfovre fundamentals “steadily shifting” investor sentiment heading into 2024 and being an upside driver for the shares.

October 2

Amicus Therapeutics has entered into a definitive agreement for a $430M financing collaboration with funds managed by Blackstone (BX). As part of the collaboration, Blackstone Life Sciences and Blackstone Credit have agreed to provide Amicus with a $400M senior secured term loan facilitating a refinancing of existing debt and a $30M strategic investment in Amicus’s common stock. The financing collaboration allows Amicus to grow revenues and move toward profitability while delivering on its mission for patients and its vision of being one of the leading biotechnology companies focused on rare diseases. Key features of this transaction include: $400M senior secured term loan facility; interest rate at adjusted Term SOFR plus 6.25%, subject to a 2.50% floor on Term SOFR; $30M investment in Amicus common stock; Requires interest-only payments until late 2026 and matures in October 2029; The full amount of the loan and equity purchase will be available and fully drawn at the initial funding; The proceeds will be used to refinance Amicus’s existing debt and fund ongoing operations. Subject to completion of customary conditions, the loan is expected to be funded and the equity investment is expected to close on October 5.

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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.