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: 

• Reata Pharma (RETA), 220% surge in interest
• Atossa Genetics (ATOS), 188% surge in interest
• Madrigal Pharmaceuticals (MDGL), 167% surge in interest
• Repligen (RGEN), 167% surge in interest
• Eyepoint Pharmaceuticals (EYPT), 127% surge in interest

Pipeline and key clinical candidates for these companies:

Reata Pharma is “committed to developing and commercializing novel therapeutics for patients with serious or life-threatening diseases with few or no approved therapies.” The company is focused on molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s first product, Skyclarys, has been approved by the FDA for the treatment of Friedreich’s ataxia and is under review in Europe by the EMA. In addition, Reata is developing cemdomespib for the treatment of patients with diabetic neuropathic pain. Cemdomespib is an investigational drug, and its safety and efficacy have not been established by any regulatory agency.

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis, or NASH, a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.

Repligen Corporation develops and commercializes bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. The customers served are primarily biopharmaceutical drug developers and contract development and manufacturing organizations, or CDMOs.

EyePoint Pharmaceuticals is committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The company’s pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been “safely administered to thousands of patients’ eyes” across four U.S. FDA approved products, including Yutiq for the treatment of posterior segment uveitis, EyePoint says.

Recent news on these stocks:

June 27

Reata Pharmaceuticals announced that the FDA has approved the Prior Approval Supplement to update the drug substance specification for SKYCLARYS, or omaveloxolone, the first and only FDA approved drug for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With the approval of the PAS, SKYCLARYS is now available to patients with Friedreich’s ataxia in the United States.

June 28

Atossa Therapeutics and Quantum Leap Healthcare Collaborative announced that six patients have been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator, or SERM, (Z)-endoxifen, in the ongoing Phase 2 I-SPY 2 clinical trial. (Z)-endoxifen is being evaluated as a neoadjuvant treatment for patients with newly diagnosed estrogen receptor-positive, or ER+, invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the FDA, and the Foundation for the National Institutes of Health, or FNIH, Cancer Biomarkers Consortium. The (Z)-endoxifen treatment arm, which is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol, or EOP. Patients will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior to surgery. Currently, there are 41 I-SPY 2 sites, all of which have the EOP program open.

June 30

Madrigal initiated a rolling submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis. Madrigal has submitted the majority of the NDA to the FDA and plans to submit the remaining components in July 2023. The company will request a priority review of the NDA. Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological improvement endpoints proposed by FDA as reasonably likely to predict clinical benefit and demonstrated a well-tolerated safety profile. We believe the positive results from MAESTRO-NASH support the potential of resmetirom to become a foundational therapy for NASH with liver fibrosis. The MAESTRO development program will provide a robust data package to support the FDA’s review of the resmetirom NDA.”

June 28

Stifel analyst Daniel Arias lowered the firm’s price target on Repligen to $200 from $210 and kept a Buy rating on the shares after having hosted a dinner with CEO Tony Hunt, who “provided a sobering view of the state of affairs in the bioprocess market.” Projects aren’t being cancelled, but translating planned work into orders and revenue is taking time and the “prospects for meaningful improvement by year-end are dim,” the analyst tells investors.The view on 2024 and 2025 growth is “far more positive,” but investors will need to be patient when it comes to tangible signs that the industry has worked its way through the current bout of inventory destocking and restrained spending for the time being, says the firm, which has trimmed its estimates for this year and flowed the changes through to next year.

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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.