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: 

• RedHill Biopharma (RDHL), 13,692% surge in interest
• Xenon Pharmaceuticals (XENE), 489% surge in interest
• Abeona Therapeutics (ABEO), 384% surge in interest
• Journey Medical (DERM), 151% surge in interest
• Springworks Therapeutics (SWTX), 147% surge in interest
• Axcella Health (AXLA), 45% surge in interest
• Altimmune (ALT), 344% surge in interest

Pipeline and key clinical candidates for these companies:

RedHill Biopharma is primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori infection in adults, and Aemcolo for the treatment of travelers’ diarrhea in adults.

Xenon Pharmaceuticals is a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. The company is advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy.

Abeona Therapeutics is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s lead clinical program is pz-cel, its investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa. The company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. 

Journey Medical says it is focused on identifying, acquiring, developing and strategically commercializing “innovative, differentiated dermatology products through its efficient sales and marketing model.” The company currently markets eight branded and three generic products that help treat and heal common skin conditions.

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. Ogsiveo, approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, is SpringWorks’ first FDA-approved therapy. 

Axcella is “pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators,” or EMMs, the company states. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence.

Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation therapeutics for the treatment of patients with liver diseases and obesity. The company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B.

Recent news on these stocks:

November 27

RedHill Biopharma announced that the FDA has granted five years’ market exclusivity for Talicia under the Generating Antibiotic Incentives Now Act Qualified Infectious Disease Product designation, as recommended by the FDA Exclusivity Board. This grant is on top of three years’ exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034. “Talicia is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori. Its components and formulation are optimized to provide patients with the necessary medications for successful H. pylori eradication, an innovation rewarded by this market exclusivity and other IP, providing protection to 2034,” said Patricia Anderson, RedHill’s senior VP of Regulatory Affairs. “With significant concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, it is vital that the most effective options are utilized first line. Talicia’s favorable efficacy, tolerability, and resistance profile, in the only all-in-one formulation available, provides potential advantages over clarithromycin-based regimens for most patients.” The FDA recently approved a supplemental new drug application for Talicia, allowing a change to a more flexible three times daily, taken at least 4 hours apart with food, dosing regimen for H. pylori eradication enabling patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication.

Xenon Pharmaceuticals reported topline results from the randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept X-NOVA clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe major depressive disorder, or MDD. Summary of Efficacy Data: The primary endpoint of the study was a change in the Montgomery-Asberg Depression Rating Scale, or MADRS, at week 6. The mean reduction was 13.90 in the placebo group, 15.61 in the XEN1101 10 mg group and 16.94 in the XEN1101 20 mg group. A clear dose response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN1101 20 mg group was observed. Statistical significance was achieved on the pre-specified endpoint of the Hamilton Depression Rating Scale, or HAM-D17, at week 6 with a mean reduction of 10.18 in the placebo group and 13.26 in the XEN1101 20 mg group. Statistical significance was achieved on the key secondary endpoint of a change in the Snaith-Hamilton Pleasure Scale, or SHAPS, measuring anhedonia at week 6 with a reduction of 5.30 in the placebo group and 7.77 in the XEN1101 20 mg group. Statistical significance was achieved in MADRS at week 1 with a mean reduction of 4.88 in the placebo group and 7.54 in the XEN1101 20 mg group demonstrating early onset of efficacy. Statistical significance was achieved in reporting of at least minimally improved symptoms of depression as assessed by physicians using the Clinical Global Impression of Improvement in the XEN1101 20 mg group compared to placebo. Summary of Safety and Tolerability Data: XEN1101 was well tolerated with similar rates of adverse events reported across all treatment arms. The most commonly reported treatment-emergent adverse events in the XEN1101 20 mg group included dizziness, somnolence, headache and disturbance in attention, as compared to the placebo group which reported dizziness, somnolence, headache and disturbance in attention. Rates of discontinuation were similar across all treatment arms and rates of discontinuation due to TEAEs were low with three patients in the XEN1101 20 mg group, as compared to two patients in the placebo group. No serious adverse events were reported in the two XEN1101 treatment groups and there were two patients in the placebo group who experienced a treatment-emergent SAE. XEN1101 was not associated with clinically meaningful weight gain or sexual dysfunction.

Abeona Therapeutics announced that the FDA has accepted and granted Priority Review for the Biologics License Application, BLA for pz-cel, Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa. Under the Prescription Drug User Fee Act, PDUFA, the FDA has set a target action date of May 25, 2024. The FDA also advised that it does not currently plan to convene an Advisory Committee meeting to discuss the pz-cel application. “The FDA’s acceptance of our BLA for priority review underscores the high unmet need in RDEB and the potential for pz-cel to provide meaningful benefit to these patients,” said Vish Seshadri, CEO of Abeona. “We thank the FDA for their commitment and look forward to working with them through the BLA review, with the goal of bringing this therapy to patients as soon as possible.”

SpringWorks Therapeutics announced that the FDA has approved OGSIVEO, an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. The FDA previously granted breakthrough therapy, fast track and orphan drug designations to nirogacestat for the treatment of desmoid tumors.

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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.