These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Entero Therapeutics (ENTO), 16,782% surge in interest
- Alto Neurosciences (ANRO), 1,238% surge in interest
- GeoVax Lab (GOVX), 411% surge in interest
- BioXcel Therapeutics (BTAI), 319% surge in interest
- Lexicon Pharmaceuticals (LXRX), 287% surge in interest
- TG Therapeutics (TGTX), 258% surge in interest
- Fortrea Holdings (FTRE), 203% surge in interest
- Pliant Therapeutics (PLRX), 145% surge in interest
- Longeveron (LGVN), 131% surge in interest
- Aldeyra Therapeutics (ALDX), 121% surge in interest
Pipeline and key clinical candidates for these companies:
Entero Therapeutics is a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal diseases. The company’s programs address significant unmet needs in GI health and include: latiglutenase, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist for indications including gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency.
Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, schizophrenia, and other mental health conditions.
GeoVax Labs is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, a booster vaccine in patients with chronic lymphocytic leukemia and a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers.
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.
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.
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.
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.
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.
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.
Recent news on these stocks:
March 3
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
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.”
February 27
D. Boral Capital says GeoVax Labs’ GEO-MVA vaccine, designed to target both Clade 1 and Clade 2 strains of Mpox, “presents a timely and critical solution to address this global health threat.” The Mpox epidemic, specifically driven by the newly emerging Clade 1b strain, continues to pose a significant health threat, the analyst tells investors in a research note. D. Boral believes the GEO-MVA vaccine offers a scalable and cost-effective alternative to current vaccines. As the governments talk with GeoVax, this program could rise in importance, the firm contends. It keeps a Buy rating on the shares with an $18 price target.
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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.