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:

• Edgewise Therapeutics (EWTX), 563% surge in interest
• Veru (VERU), 560% surge in interest
• ABVC BioPharma (ABVC), 343% surge in interest
• Compass Therapeutics (CMPX), 325% surge in interest
• Cytokinetics (CYTK), 310% surge in interest
• Reviva (RVPH), 300% surge in interest
• Amicus (FOLD), 282% surge in interest
• Hepion Pharmaceuticals (HEPA), 261% surge in interest
• Hoth Therapeutitcs (HOTH), 245% surge in interest
• Oncolytics Biotech (ONCY), 217% surge in interest

Pipeline and key clinical candidates for these companies:

Edgewise Therapeutics is a muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The company’s deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases.

Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic diseases, oncology, and ARDS. The company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device under development. For its drug products, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus, the company intends to conduct global clinical trials through Phase III.

Compass Therapeutics is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data.

Cytokinetics is a specialty biopharmaceutical company building on its over 25-years of pioneering scientific innovation with intention to create a muscle biology franchise business focused on medicines designed to optimize muscle performance for patients with cardiac and other diseases of muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy. Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction, CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.

Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system, inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.

Amicus Therapeutics is a global, patient-dedicated biotechnology company 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.

Hepion Pharmaceuticals is a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis, hepatocellular carcinoma, and other chronic liver diseases. Hepion’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH.

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

Recent news on these stocks:

April 2

Edgewise Therapeutics announced top-line data of EDG-7500 from the Phase 2 CIRRUS-HCM four-week trial in participants with obstructive or nonobstructive HCM. EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM without impacting systolic function. CIRRUS-HCM is a multi-part, open-label trial of EDG-7500 in individuals with HCM. In September 2024, the company announced top-line data from Part A of the trial showing that a single oral dose of EDG-7500 in participants with obstructive HCM demonstrated robust reductions in left ventricular outflow tract gradient without meaningful changes in left ventricular ejection fraction. Part B of CIRRUS-HCM included 17 participants with obstructive HCM and Part C included 12 participants with nonobstructive HCM. Both parts of the trial evaluated the safety and efficacy of once-daily doses of 50 or 100 mg of EDG-7500 for four weeks. In participants with obstructive HCM, EDG-7500 demonstrated meaningful dose-dependent reductions in LVOT-G at rest and post Valsalva. Participants receiving 100 mg experienced mean reductions from baseline of 71% and 58% in resting and provokable gradients, respectively. Importantly, gradient reductions were achieved without meaningful changes in LVEF. Treatment with 100 mg of EDG-7500 also demonstrated a 62% mean reduction from baseline in NT-proBNP, a key biomarker of heart failure. In addition, positive trends in echocardiographic parameters of diastolic function were observed following treatment with EDG-7500. Clinically meaningful improvements were also observed on the Kansas City Cardiomyopathy Questionnaire Overall Summary Score, with a substantial mean increase of 23 points observed at the 100 mg dose. In addition, treatment with 100 mg of EDG-7500 over four weeks demonstrated improvements on the NYHA functional class score. Seventy-eight percent of participants improved by 1 NYHA Class, and 67% improved to NYHA Class I. In participants with nonobstructive HCM, EDG-7500 administration resulted in a dose-dependent reduction in NT-proBNP, with a 42% mean decrease from baseline at 100 mg. A positive trend in an echocardiographic parameter of diastolic function was observed in as early as one week. Substantial improvements in KCCQ-OSS and KCCQ-Clinical Summary Scores, with substantial mean increases of 17 points and 22 points, respectively, were observed at the 100 mg dose after only four weeks. The positive results observed in participants with obstructive HCM and nonobstructive HCM were achieved without meaningful reductions in LVEF. Importantly, there were no LVEF values less than50% at any measurement. The most frequently reported adverse events were dizziness, upper respiratory tract infection and atrial fibrillation; nearly all were considered mild to moderate in severity. Two participants experienced serious adverse events of AF requiring cardioversion. In Parts B and C, the rates of AF were in the range of those reported in other HCM Phase 2 clinical trials of cardiac myosin inhibitors. One participant discontinued treatment due to moderate dizziness.

Hoth Therapeutics announced groundbreaking preclinical data supporting the therapeutic potential of its lead Alzheimer’s candidate, HT-ALZ, in improving cognitive function and reducing neuroinflammation in Alzheimer’s disease, or AD. HT-ALZ, a proprietary formulation of an FDA-approved NK-1 receptor antagonist, has shown significant cognitive and behavioral benefits in APP/PS1 mouse models of Alzheimer’s disease. The study demonstrated that chronic oral administration of HT-ALZ led to marked improvement in memory, reduction of anxiety-like behavior, and enhanced sensorimotor gating, all without impairing motor function. Crucially, HT-ALZ significantly decreased the number of GFAP-positive reactive astrocytes, key contributors to neuroinflammation and cognitive decline in AD. These results suggest that HT-ALZ exerts its therapeutic effect through modulation of astrocyte activity via NK-1 receptor antagonism, presenting a novel mechanism for targeting Alzheimer’s-related neurodegeneration. Importantly, HT-ALZ is orally bioavailable, crosses the blood-brain barrier, and has an established safety record, making it a compelling candidate for rapid clinical advancement. Preliminary studies showed no therapeutic effect in healthy wild-type mice, indicating HT-ALZ selectively improves function in the presence of Alzheimer’s pathology. Hoth Therapeutics plans to advance HT-ALZ into clinical development to further evaluate its potential as a safe, effective treatment for early-stage Alzheimer’s disease.

April 1

Compass Therapeutics announced statistically significant top-line data on the primary efficacy endpoint for COMPANION-002, the Company’s ongoing Phase 2/3 randomized trial of tovecimig in combination with paclitaxel in patients with advanced BTC.Biliary tract cancer is estimated to affect approximately 23,000 patients annually in the United States. For the approximately 85% of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second line setting. The combinations of therapeutics used in this setting, which are not labeled for this indication, generally have an ORR of ~5% or less and patients face a median overall survival of approximately six months. COMPANION-002: Top-Line Results: The trial is a Phase 2/3 randomized, controlled study of tovecimig in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen. The study enrolled 168 adult patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel or paclitaxel alone. All patients were dosed with 80 mg/m2 of paclitaxel on days 1, 8 and 15 of every 28-day cycle. Patients in the tovecimig arm were also dosed with 10 mg/kg of tovecimig on days 1 and 15 of each 28-day cycle. The primary endpoint of the trial is ORR as confirmed by independent central radiology review and secondary endpoints include PFS, OS and DoR, among others. Patients in the paclitaxel-only arm who progressed could cross over to the tovecimig plus paclitaxel arm after centrally confirmed progression if they also still met the enrollment criteria for the study. Top-line results of the study are summarized below, and the Company expects to announce additional data, including key secondary endpoints, in Q4 2025: Primary Endpoint. 17.1% ORR for tovecimig in combination with paclitaxel including one complete response, compared to 5.3% for paclitaxel alone , in patients with BTC in the second line setting. This 11.8% relative improvement in ORR for those receiving the combination was statistically significant. Secondary Endpoints. The COMPANION-002 study is ongoing and the data are not yet mature for the analyses of the secondary outcome measures. The trial requires a threshold of events in 80% of patients to trigger the secondary endpoint analyses. Based on current projections, the Company anticipates this pre-specified number of events to be reached in Q3 2025, and expects to report data from the secondary endpoints in Q4 2025. Safety & Tolerability. The safety profile of tovecimig in this study to date is consistent with prior studies of tovecimig. An independent Data Monitoring Committee has reviewed safety data at four separate DMC meetings and, after each meeting, recommended continuation of the study without modification. The Company expects to report detailed safety data with the analyses of secondary endpoints in Q4 2025.

March 31

In a regulatory filing, Cytokinetics president and CEO Robert Blum disclosed the sale of 15,000 common shares of the company on March 31 at a price of $40.75 per share.

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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.