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: 

• Vistagen (VTGN), 16,281% surge in interest
• Nektar Therapeutics (NKTR), 5,257% surge in interest
• Sage Therapeutics (SAGE), 569% surge in interest
• Palatin Technologies (PTN), 500% surge in interest
• Protalix BioTherapeutics (PLX), 376% surge in interest

Pipeline and key clinical candidates for these companies:

Vistagen is a late clinical-stage biopharmaceutical company whose clinical-stage candidates are targeting multiple types of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain.

Nektar Therapeutics is a biopharmaceutical company that describes itself as having “a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines.”

Sage Therapeutics is a biopharmaceutical company “fearlessly leading the way to create a world with better brain health.” The company’s mission is to “pioneer solutions to deliver life-changing brain health medicines, so every person can thrive,” Sage has stated.

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. “Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential,” the company says.

Protalix is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. “Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix’s unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner,” the company stated.

Recent news on these stocks:

August 8

Nektar reported Q2 EPS (27c) against a consensus of (28c), and reported Q2 revenue of $20.5M against a consensus of $21.83M. “With new and corrected strong clinical data for REZPEG, we look forward to initiating a Phase 2b study of rezpegaldesleukin in patients with atopic dermatitis and achieving our objective to have initial data from this study in the first half of 2025,” said Howard Robin, CEO of Nektar. “We also are working to advance our next pipeline candidates in immunology with an IND filing in 2024. And finally, we are continuing our Phase 2 studies of NKTR-255 in liquid and solid tumors as we evaluate strategic partnership pathways.”

Palatin Technologies announced that Fosun Pharma, the licensee of Vyleesi in China, reported its first sale in the Hainan Province of China. Palatin also announced that their South Korean licensee, Kwangdong Pharmaceuticals, completed enrollment in its Phase 3 clinical trial evaluating the efficacy and safety of Vyleesi in premenopausal women with HSDD. Data from this trial is anticipated by year end with a potential regulatory submission in the first half of 2024.

August 7

Vistagen Therapeutics announced top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol nasal spray in adults diagnosed with social anxiety disorder, or SAD, earlier this morning. The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo. The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale. Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials, the company stated. “We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S. and millions more affected worldwide. As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas. At the head of that class, fasedienol’s potential, as demonstrated in this Phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years,” stated Shawn Singh, CEO of Vistagen.

August 4

Sage Therapeutics and Biogen (BIIB) announced that the FDA issued a Complete Response Letter for the New Drug Application for zuranolone in the treatment of adults with major depressive disorder. The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed, the companies said. Biogen and Sage “are reviewing the feedback and evaluating next steps.”

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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.