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: 

• Soligenix (SNGX), 1,944% surge in interest
• Marinus Pharmaceuticals (MRNS), 1,089% surge in interest
• Biohaven Pharmaceutical (BHVN), 178% surge in interest

Pipeline and key clinical candidates for these companies:

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases. Their Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, their first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn’s disease.

Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The company’s commercial product, Ztalmy oral suspension CV, has been approved by the FDA for the treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older. The potential of ganaxolone is also being studied in other rare seizure disorders, including in Phase 3 trials in tuberous sclerosis complex and refractory status epilepticus. Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. It is being developed in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings.

Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of 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.

Recent news on these stocks:

April 16

Baird downgraded Marinus Pharmaceuticals to Neutral from Outperform with a price target of $2, down from $20. Even though the RAISE study will go on to a final analysis, the implications of the interim miss are that even a statistical win at the full analysis would not yield a significant commercial opportunity, given the delta over placebo implied by the interim, the analyst tells investors in a research note. The firm believes a lower treatment effect and higher placebo effect could both be seen, balancing out the two arms.

April 15

Soligenix announced that the Office of Orphan Products Development of the United States FDA has granted orphan drug designation to the active ingredient in MarVax, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus glycoprotein, for “the prevention and post-exposure prophylaxis against MARV infection.”

Marinus announced that an independent Data Monitoring Committee DMC has recommended continuing the pivotal Phase 3 RAISE trial evaluating intravenous IV ganaxolone for the treatment of refractory status epilepticus RSE following an interim analysis. Marinus has decided to complete enrollment in the RAISE trial at approximately 100 patients with topline results expected in the summer of 2024. Those results will be used to determine whether to continue development of IV ganaxolone. Marinus remains blinded to the RAISE trial data. “While we are disappointed that RAISE did not meet the early stopping criteria, we will only be able to determine the trial’s outcome once we unblind and analyze the full data set,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “We will also be evaluating potential cost-saving strategies to provide the strongest capital position as we approach enrollment completion in the global Phase 3 TrustTSC trial in tuberous sclerosis complex.” Ganaxolone development in the RAISE trial is being supported in part by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority BARDA under contract number 75A50120C00159.

In a regulatory filing, Biohaven disclosed that David Spiegel, M.D. Ph.D., inventor of Biohaven’s MoDE technology and Professor of Chemistry at Yale University, will present an update on Biohaven’s degrader platform and summary of progress to date in the Phase 1 single ascending dose, or “SAD,” study for BHV-1300 at the ABI Conference 2024 in Cambridge, United Kingdom starting April 15. A copy of the presentation was disclosed by the company in the filing with the SEC.

April 11

Soligenix announced that the Office of Orphan Products Development of the United States FDA has granted orphan drug designation to the active ingredient in SuVax, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus glycoprotein, for “the prevention and post-exposure prophylaxis against SUDV infection.”

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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.