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: 

• Lexicon Pharmaceuticals (LXRX), 469% surge in interest
• TG Therapeutics (TGTX), 435% surge in interest
• BioXcel Therapeutics (BTAI), 432% surge in interest
• Syros Pharmaceuticals (SYRS), 375% surge in interest
• Fortrea Holdings (FTRE), 297% surge in interest
• Tenaya Therapeutics (TNYA), 281% surge in interest
• Pliant Therapeutics (PLRX), 246% surge in interest
• Aldeyra Therapeutics (ALDX), 245% surge in interest
• Adma Biologics (ADMA), 236% surge in interest
• Biohaven (BHVN), 219% surge in interest
• Longeveron (LGVN), 189% surge in interest
• Allarity Therapeutitcs (ALLR), 178% surge in interest
• NanoViricides (NNVC), 143% surge in interest

Pipeline and key clinical candidates for these companies:

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000 program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. “Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively,” the company states.

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.

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.

Syros says it is “committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies, driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches.” Syros is developing tamibarotene, an oral selective RARalpha agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

Fortrea is a global provider of clinical development solutions to the life sciences industry. The company partners with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.

Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya employs a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of genetic medicines aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. Tenaya’s pipeline includes TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy, TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, TN-301, a small molecule HDAC6 inhibitor intended for heart failure with preserved ejection fraction, and multiple early-stage programs in preclinical development.

Pliant Therapeutics is a late-stage biopharmaceutical company and “leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases,” the company states. Pliant’s lead product candidate, bexotegrast, is in development in the lead indication for the treatment of idiopathic pulmonary fibrosis, or IPF.

Aldeyra is a clinical-stage biotechnology company whose pre-commercial product candidates are reproxalap, a potential treatment for dry eye disease and allergic conjunctivitis, and ADX-2191, a potential treatment for primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and other rare sight-threatening retinal diseases. In addition, Aldeyra is developing other product candidates, including ADX-629 and chemically related molecules, for the potential treatment of systemic and retinal immune-mediated diseases.

Adma Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Adma currently manufactures and markets three United States Food and Drug Administration-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases. Through its Adma BioCenters subsidiary, Adma also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products.

Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven’s clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; and antibody recruiting, bispecific molecules and antibody drug conjugates for cancer.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s lead investigational product is Lomecel-B, an allogeneic medicinal signaling cell therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas.

Allarity Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment.

NanoViricides is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The company’s novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The company’s lead drug candidate is NV-CoV-2 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Its other advanced candidate is NV-HHV-1 for the treatment of Shingles. The company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.

Recent news on these stocks:

March 6

Allarity Therapeutics announced plans for a Phase 2 trial evaluating the combination of stenoparib with temozolomide, a DNA-alkylating chemotherapy agent, for the treatment of recurrent Small Cell Lung Cancer. The trial is fully funded by the U.S. Veterans Administration through the Special Emphasis Panel on Precision Oncology and is being led by the VA and Academic Medical Oncologists at Indianapolis and Pittsburgh VA Medical Centers. This phase 2 trial builds on the mechanistic synergy of temozolomide with a PARP inhibitor and selection of patients most likely to respond to this combination. Prior clinical studies had shown that PARP inhibitors combined with temozolomide provide clinical benefit as evidenced by ~40% response rates in recurrent SCLC patients but that these prior clinical studies showed dose-limiting hematologic toxicity.

March 3

Adma Biologics reported better-than-expected Q4 earnings and revenue and provided upbeat revenue guidance for fiscal 2025. “ADMA delivered exceptional operating and financial results in 2024, with total revenues and Adjusted EBITDA growing 65% and 309% year-over-year, respectively. These results reflect our commitment to operational and financial excellence, as well as the meaningful impact our therapies continue to have on immunocompromised patients,” said Adam Grossman, president and CEO of Adma. “We believe our recently secured long-term high-titer plasma supply agreements mark a transformative milestone, as they significantly expanded our plasma sourcing capacity and are expected to further de-risk both our near-term and long-term growth trajectories. Coupled with record internal high-titer plasma collections, these third-party agreements should provide the critical supply foundation to support our continued commercial expansion. These benefits are anticipated to be favorably compounded with the potential mid-2025 regulatory approval of our enhanced yield production process, which would provide for approximately 20% more finished IG from the same starting plasma.”

Biohaven highlighted the success of BHV-1300, its potential first-in-class IgG selective degrader, in achieving rapid and deep reductions in total IgG, advancing a novel and transformative MoDE platform molecule for the potential treatment of autoimmune disease. In the four-week Phase 1 study, subcutaneously administered BHV-1300 at a dose of 1000 mg weekly achieved rapid, deep and sustained reductions in total IgG of up to 84%, with a median reduction of 80%. Reductions occurred within hours of each dose, were progressive, and were sustained compared to baseline over the four-week period. Tova Gardin, MD, MPP, Chief Translational Officer at Biohaven, commented, “BHV-1300 has demonstrated remarkable efficacy in deep lowering of total IgG, leveraging the groundbreaking technology of the MoDE platform, to potentially revolutionize treatment of patients with autoimmune disease. Biohaven’s unique extracellular degrader technology leverages the body’s natural hepatic clearance mechanism to remove targeted antibodies contributing to disease and promises to usher in a new era of tunable, selective and self-administered immune therapy.”

Tenaya Therapeutics announced that it intends to offer and sell units consisting of common stock and Series A warrants and Series B warrants, each to purchase shares of common stock. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Leerink Partners and Piper Sandler are acting as joint bookrunning managers for the proposed offering.

BioXcel Therapeutics announced that it has entered into a securities purchase agreement with certain institutional investors for the purchase and sale in a registered direct offering of 4M shares of common stock and accompanying warrants to purchase up to 4M shares of common stock at a combined offering price of $3.50 per share and accompanying warrant, for aggregate gross proceeds to the company of approximately $14M before deducting the placement agent’s fees and other estimated offering expenses payable by the company. Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering. The offering is expected to close on March 4, subject to customary closing conditions. The company currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

Lexicon Pharmaceuticals announced topline results from the PROGRESS Phase 2b study evaluating pilavapadin, an oral, non-opioid investigational adaptor-associated kinase 1 inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain. Lexicon’s objective for the PROGRESS study was to identify a dose exhibiting meaningful pain reduction and improved tolerability compared to that observed in the previous Phase 2 RELIEF-DPN-1 study. All objectives for the PROGRESS study were achieved with respect to the 10 mg dose, which Lexicon has identified as the appropriate dose to advance into Phase 3 development based both on these PROGRESS results and the previous results from RELIEF DPN-1. As a result of the lack of separation in ADPS reduction between the 20 mg dose arm and placebo, the study results did not reach statistical significance on the primary endpoint. However, the 10 mg dose arm demonstrated clear evidence of effect by achieving early and clinically meaningful separation from placebo on ADPS that was maintained throughout the study duration.

TG Therapeutics reported lower-than-expected Q4 earnings but upbeat Q4 revenue. Looking ahead, the company provided upbeat revenue guidance for fiscal 2025. Chairman and CEO Michael Weiss said, “2024 was a year of significant outperformance and growth for TG, highlighted by the strong adoption of BRIUMVI for adult patients with relapsing forms of multiple sclerosis, which surpassed our initial expectations. Additionally, we made meaningful progress in strengthening our BRIUMVI patent portfolio through 2042, launching new clinical trials, including for subcutaneous BRIUMVI, and advancing our pipeline. These accomplishments provide a solid foundation as we look toward continued success in 2025.”

Fortrea reported a year-over-year increase in Q4 adjusted earnings per share but a year-over-year decrease in Q4 revenue. Looking ahead, the company provided a conservative revenue outlook for FY25. “Our intense focus on our customers’ success and creating a better customer experience has resulted in the stronger demand that is reflected in this quarter’s book-to-bill,” said Tom Pike, chairman and CEO of Fortrea. “Since we spun, our average book-to-bill has been 1.2x. Our positive progress is also reflected in our improving quality metrics and increasing customer satisfaction scores. We largely exited our Transition Services Agreement with our former parent company, including the migration of more than 27,000 computers, mobile phones, applications and servers. We are ready for the next phase in our journey, moving from transition to transformation, creating value for our customers, shareholders, employees and the patients we ultimately serve.”

Pliant Therapeutics announced that following a prespecified data review and recommendation by the trial’s independent Data Safety Monitoring Board, as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis. While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity endpoint was also observed. BEACON-IPF is the first late-stage IPF trial to be discontinued for safety while showing strong evidence of efficacy. The mean exposure duration in BEACON-IPF was approximately 17 weeks. Overall, the percentage of IPF-related adverse events in both dose groups was comparable. The imbalance between active and placebo appears to have been driven by a low IPF-related adverse event rate in the placebo group. In comparison, in the Phase 2a INTEGRIS-IPF trial, IPF-related adverse events were comparable in bexotegrast-treated across all doses and placebo-treated participants. The Company plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast’s development. Once the full analysis is completed, which should provide a better understanding of the benefit risk profile and therapeutic window of bexotegrast, the Company will consider additional dose-ranging Phase 2b studies with lower doses in pulmonary fibrosis and potentially, other non-respiratory indications, including liver diseases. Pliant is committed to the development of its other clinical and pipeline assets including PLN-101095 in oncology. The Company is currently enrolling the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Interim data from the first three cohorts is expected in the first quarter of 2025.

February 28

Syros Pharmaceuticals announced that its Board of Directors has approved and the company intends to proceed with the voluntary delisting of its common stock from the Nasdaq Stock Market and the deregistration of its common stock in order to terminate and suspend the company’s reporting obligations under the Securities and Exchange Act of 1934, as amended. The company notified Nasdaq of its intention to voluntarily delist its shares of common stock from the Nasdaq Global Select Market. The company intends to file a Form 25 with the SEC to effect the delisting and deregistration of its common stock on or about March 10, and the delisting is expected to become effective on or about March 20.

Longeveron reported better-than-expected Q4 revenue. “Throughout 2024, we continued to advance the development of our investigational cellular therapy candidate, Lomecel-B, as a potential treatment for both Hypoplastic Left Heart Syndrome, or HLHS, and mild Alzheimer’s disease,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We are now approaching multiple potentially transformational milestones over the next 12 months, including, completion of enrollment in our pivotal Phase 2b clinical trial in HLHS, which may establish the timeline for a potential Biological License Application, or BLA, submission for full traditional approval for HLHS, and our upcoming meeting with the FDA to determine the development pathway for the Alzheimer’s disease program. Our team’s expertise in clinical development and manufacturing, combined with several positive initial results across five clinical trials in three indications, continues to position Longeveron as a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics.”

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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.