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: 

• Ayala Pharmaceuticals (ADXS), 2,614% surge in interest
• InVivo Therapeutics (NVIV), 2,272% surge in interest
• Morphosys (MOR), 2,070% surge in interest
• Tenax Therapeutics (TENX), 1,680% surge in interest
• Exicure (XCUR), 1,574% surge in interest
• Karyopharm Therapeutics (KPTI), 1,143% surge in interest
• Equillium (EQ), 794% surge in interest
• Adverum Biotechnologies (ADVM), 783% surge in interest
• NanoString Technologies (NSTG), 566% surge in interest
• BioXcel Therapeutics (BTAI), 449% surge in interest

Pipeline and key clinical candidates for these companies:

Ayala Pharmaceuticals is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for people living with rare tumors and aggressive cancers and is also developing proprietary Lm-based antigen delivery products for patients suffering from more common cancers. The company’s lead candidates under development are the oral gamma secretase inhibitor, AL102, for desmoid tumors; ADXS-504, a Lm-based therapy for early-stage prostate cancer; and the intravenous gamma secretase inhibitor, AL101, for adenoid cystic carcinoma. 

InVivo is focused on redefining the treatment of spinal cord injury. By modulating the healing environment to facilitate cell survival and growth, the company has the opportunity to change the treatment of spinal cord injury. InVivo has steadily advanced its scaffold technology through years of research and development with encouraging clinical data. The team is united in its commitment to bring the Neuro-Spinal Scaffold to patients and to deliver meaningful improvements to their daily lives.

MorphoSys is a global commercial-stage biopharmaceutical company, focused on developing and delivering innovative medicines, and aspiring to redefine how cancer is treated.

Tenax Therapeutics is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. Tenax Therapeutics is developing a unique oral formulation of imatinib. The company also owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan.

Exicure is an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. The company says it continues to actively pursue out-licensing opportunities for its clinical asset, cavrotolimod, as well as for its preclinical candidates, including the SCN9A program for neuropathic pain, and to pursue all strategic alternatives with the goal of maximizing stockholder value.

Karyopharm Therapeutics is a commercial-stage pharmaceutical company pioneering novel cancer therapies. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export compound technology, which was developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm’s lead SINE compound and first-in-class, oral exportin 1 inhibitor, XPOVIO, is approved in the U.S. and marketed by the company in three oncology indications and has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the United Kingdom and China. 

Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata being conducted in Australia and New Zealand by Equillium’s Australian subsidiary as the trial sponsor. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21; currently in pre-clinical development. 

Adverum Biotechnologies is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec, as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration.

NanoString Technologies says it offers “an ecosystem of innovative discovery and translational research solutions” to map the universe of biology – including the GeoMx Digital Spatial Profiler, the CosMx Spatial Molecular Imager and the AtoMx Spatial Informatics Platform.

BioXcel Therapeutics is utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The company’s drug re-innovation approach “leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices,” BioXcel states. The company’s commercial product, IGALMI, developed as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Recent news on these stocks:

February 7

Tenax Therapeutics announced that the first patient has enrolled in the company’s Phase 3 LEVEL Study. As previously disclosed, the FDA does not require Tenax conduct a long-term, cardiovascular outcomes trial in this population, significantly reducing the costs and time for the registration of TNX-103. The extensive levosimendan patent estate includes protections through at least 2040 of all therapeutic doses of the proprietary oral formulation being evaluated in LEVEL, as well as I.V. and subcutaneous formulations, in patients with PH-HFpEF. We believe this positions Tenax, and potential strategic partners, to maximize the commercial potential of this unique, first-in-class therapy. The LEVEL study is the first of two planned Phase 3 studies that will evaluate TNX-103 for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction. The LEVEL study will evaluate six-minute walking distance as the primary endpoint, and will enroll a total of 152 patients. The Phase 3 program for TNX-103 has been designed to exceed the minimal clinically important difference, and satisfy the FDA’s request for subject drug exposure of 300 patients for 6 months and 100 patients for 1 year.

February 6

Immunome (IMNM) entered into a definitive asset purchase agreement with Ayala Pharmaceuticals, a clinical-stage oncology company, to acquire AL102 and related drug candidate AL101 from Ayala. Based on the terms of the agreement, Immunome will pay Ayala $20M in cash and $30M in Immunome common stock at the closing and will pay up to an additional $37.5M in development and commercial milestone payments. Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval. AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy. AL102 is a potential once-daily oral treatment for desmoid tumors. Data from clinical trials have shown AL102 may be more effective in treating desmoid tumors than OGSIVEO, which recently became the first treatment approved for desmoid tumors by the U.S. Food and Drug Administration in November 2023. The Phase 2 portion of the RINGSIDE study demonstrated clinically meaningful anti-tumor activity across multiple parameters. The data showed high objective response rates, including 75% of evaluable patients in the 1.2 mg once daily arm, the dose being evaluated in the current Phase 3 trial. Furthermore, patients receiving the 1.2 mg daily dose experienced a median best reduction in tumor volume of 88% as measured by serial MRI exams, as of the previously reported July 5, 2023 data cut-off, and also demonstrated improvement in other radiographic parameters.

After Novartis (NVS) announced that it intends to buy MorphoSys, Adam Feuerstein, the Senior Writer in Biotech for STAT, argued that the “deal will not close.” Feuerstein forecasts: “Six months from now, or sooner, Novartis will walk away – slightly embarrassed but otherwise unscathed – happy to pay a small breakup fee to MorphoSys to avoid owning a drug for myelofibrosis that regulators turned away. MorphoSys will not fare as well from the breakup. Its future, and that of the drug called pelabresib at the center of the deal, will be thrown into limbo.”

After STAT News published a column by Adam Feuerstein that contended that Novartis is going to walk away from its just-announced deal to acquire MorphoSys, a spokesperson for the German drug developer said in an emailed statement to Bloomberg News that “This story is factually wrong.” Novartis didn’t immediately respond to a Bloomberg News request for comment, the news service noted. Feuerstein acknowledges the view in his report is speculation, but cites “separate conversations with two people familiar with pelabresib and the debate inside Novartis” over the deal, Bloomberg noted.

BioXcel Therapeutics announced the completion of patient enrollment in the safety lead-in portion of the investigator-sponsored Phase 2 trial of BXCL701 in combination with KEYTRUDA in previously treated metastatic pancreatic ductal adenocarcinoma, PDAC. BioXcel Therapeutics, through its OnkosXcel Therapeutics immuno-oncology subsidiary, is collaborating with Georgetown Lombardi’s Dr. Louis Weiner, director of the cancer center, and Dr. Benjamin Weinberg, the study’s principal investigator. BioXcel Therapeutics and Merck & Co. (MRK) are providing BXCL701 and KEYTRUDA for the trial, respectively. “Pancreatic cancer represents a significant unmet medical need, ranking as the third-leading cause of cancer deaths, yet remains an exceptionally difficult cancer to treat. No novel therapies have emerged in decades, and overall survival for advanced disease has not improved in over 10 years,” said Dr. Weiner. “Building on results from the preclinical work conducted in our lab, we are excited to evaluate BXCL701 in this important trial as a potential treatment for advanced pancreatic cancer.”

February 5

Novartis announced that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys AG, a Germany-based, global biopharmaceutical company developing innovative medicines in oncology. The acquisition, which is subject to customary closing conditions, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer and regulatory approvals, further expands and complements Novartis pipeline in oncology, one of its priority therapeutic areas, while also enhancing Novartis global footprint in hematology. Upon completion of the acquisition, Novartis will own pelabresib, a novel and potentially practice changing treatment option with a well-tolerated safety profile provided in combination with ruxolitinib for patients with myelofibrosis. It will also include tulmimetostat, an early-stage investigational dual inhibitor of enhancer of zeste homolog 1 and 2 proteins currently being tested in patients with solid tumors or lymphomas. Under the agreed transaction, which has been unanimously approved by the Board of Directors of both companies, Novartis will make a voluntary public takeover offer for all no-par value bearer shares of MorphoSys AG for EUR 68 per share, or an aggregate of EUR 2.7B. The transaction is subject to customary closing conditions, including acceptance of the takeover offer by at least 65% of MorphoSys AG’s outstanding shares and receipt of regulatory approvals and is expected to close in the first half of 2024. Until the transaction closes, MorphoSys AG will continue to operate as a separate, independent company.

Exicure and Bluejay Therapeutics announced they entered into a patent license agreement to develop cavrotolimod for potential treatment for hepatitis. Under the terms of the agreement, Bluejay will receive an exclusive license in the field of hepatitis to all of Exicure’s relevant patents. Bluejay paid Exicure an initial small, one-time payment after the execution of this Agreement. Exicure will also be entitled to modest royalties on future net sales on all licensed technology by Bluejay during the term of the licensed patents. Exicure will be responsible for, and make all decisions concerning, the preparation, filing, prosecution, and maintenance for each patent and patent application included within the licensed patents.

Adverum Biotechnologies has agreed to sell approximately 106.25M shares of its common stock to a select group of institutional and accredited healthcare specialist investors in a private placement, at a price per share of $1.20, representing a premium of approximately 20% to Adverum’s 30-day volume-weighted average price. The financing is expected to close on February 8, subject to customary closing conditions. Adverum anticipates the gross proceeds from the private placement to be approximately $127.5M, before deducting any offering related expenses. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, are expected to be sufficient to fund the current operating plan into late 2025. TD Cowen and Truist Securities acted as placement agents on the offering.

February 4

NanoString Technologies announced that steps are being taken “to protect its business, customers, employees and its mission to ‘Map the Universe of Biology.'” With support from key creditors, NanoString and certain of its subsidiaries have voluntarily initiated a chapter 11 restructuring proceeding in the United States Bankruptcy Court for the District of Delaware. Coincident with this proceeding, NanoString is exploring strategic alternatives in support of the company’s mission and for the benefit of its stakeholders, including the potential sale of the company or product lines. “The unexpected outcome of the November GeoMx patent litigation trial in Delaware and the unusually large magnitude of the damages awarded by the jury have forced us to take proactive steps to protect our stakeholders, customers and employees,” said Brad Gray, President and CEO of NanoString. “NanoString has powerful product platforms, strong relationships with our customers throughout the scientific community, an enviable workforce, and conviction in the integrity of our innovation process. We believe chapter 11 protection will provide us with the necessary breathing room to continue to serve our customers while we address our litigation and the related financial challenges.”

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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.