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: 

• Regeneron (REGN), 122% surge in interest
• BioNTech (BNTX), 118% surge in interest
• Geron (GERN), 81% surge in interest
• Moderna (MRNA), 76% surge in interest
• Vaxart (VXRT), 68% surge in interest
• Pieris Pharma (PIRS), 55% surge in interest
• Catalyst Bio (CBIO), 50% surge in interest
• Ocugen (OCGN), 44% surge in interest
• Oncolytics (ONCY), 37% surge in interest
• Savara (SVRA), 36% surge in interest

Pipeline and key clinical candidates for these companies:

Regeneron is a biotechnology company that invents, develops, and commercializes medicines for people with serious diseases. “The company is accelerating and improving the traditional drug development process through its proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world,” Regeneron says.

BioNTech is “pioneering novel therapies for cancer and other serious diseases.” BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab (GMAB), Sanofi (SNY), Genentech, a member of the Roche Group (RHHBY), Regeneron (REGN), Genevant, Fosun Pharma, and Pfizer (PFE).

Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. The company’s first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. Geron currently has two Phase 3 pivotal clinical trials underway evaluating imetelstat in lower risk myelodysplastic syndromes, and in relapsed/refractory myelofibrosis

Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA, or mRNA, to “an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale,” the company states. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has “allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.” Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of vaccines against the COVID pandemic. The company is pursuing the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart believes that its proprietary pill vaccine delivery platform is “suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications,” the company has stated. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus, or RSV, as well as a therapeutic vaccine for human papillomavirus, or HPV, Vaxart’s first immune-oncology indication.

Pieris is a clinical-stage biotechnology company that combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients. Its pipeline has historically focused on inhalable Anticalin proteins to treat respiratory diseases and locally-activated bispecifics for immuno-oncology. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by strong partnerships with leading pharmaceutical companies.

Catalyst Biosciences is a biopharmaceutical company focused on developing its recently acquired small molecule F351, or hydronidone, for the treatment of fibrotic diseases including hepatitis B associated fibrosis and non-alcoholic steatohepatitis. The company previously focused on protease engineering-based drug discovery and development to address unmet medical needs in disorders of the complement or coagulation systems and has been monetizing these assets to distribute cash to its stockholders.

Ocugen is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The company’s “breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product,” says Ocugen, which adds that it is advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces 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. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer.

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Its lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis, or aPAP.

Recent news on these stocks:

August 22

Novavax announced that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. XBB sublineage variants are overwhelmingly responsible for the majority of current COVID cases in the U.S. and European Union. “Our data have shown that Novavax’s protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6,” said Filip Dubovsky, President of Research and Development, Novavax. “We have a lot of confidence in our updated COVID vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall.” Non-clinical data previously showed that Novavax’s COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants. Novavax is in the process of submitting applications for its XBB.1.5 COVID vaccine candidate to regulatory authorities globally.

Geron announced that the United States Food and Drug Administration, FDA, has assigned a standard review and a Prescription Drug User Fee Act, PDUFA, action date of June 16 for Geron’s New Drug Application NDA for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes, MDS . In addition, the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review. “We look forward to working with the FDA to complete the NDA review process on a timely basis,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “With the PDUFA date now set, we continue to expect an imetelstat launch in the United States by the end of the first half of 2024, subject to FDA approval.”

August 21

Ocugen reported Q2 earnings per share of (10c), compared to Wall Street estimates of (7c). “We continue to advance our pipeline to provide solutions for patients living with serious diseases but without effective treatment options,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “It remains our plan to start dosing patients across all of our ophthalmology programs by the end of the year and we are very enthusiastic about the FDA clearance of our INDs for OCU410 and OCU410ST for a form of Geographic Atrophy and Stargardt disease, respectively.”

August 17

Pieris Pharmaceuticals announced that the Company has achieved an undisclosed milestone payment from Boston Pharmaceuticals. The milestone is based on dosing the first patient in a Boston Pharmaceutical-sponsored phase 1/2 study of BOS-342, a 4-1BB/GPC3 immuno-oncology antibody-Anticalin fusion bispecific protein, which was discovered by Pieris and licensed to Boston Pharmaceuticals and designed to provide a potent costimulatory bridge to exert tumor killing activity through the recruitment of T-cells. The open-label phase 1/2 study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BOS-342. The Phase 1 dose escalation portion of the study is expected to enroll adults with hepatocellular carcinoma that progressed on at least one prior treatment and establish a recommended Phase 2 dose. If pursued, the Phase 2 portion of the study will evaluate efficacy, as measured by overall response rate. The study is funded and conducted by Boston Pharmaceuticals, who exclusively licensed worldwide rights to BOS-342 in April 2021. In addition to the milestone announced today, Pieris could potentially be entitled to receive up to approximately $350 million in development, regulatory and sales-based milestone payments, and tiered royalties on sales of BOS-342.

August 14

BioNTech announced that the Supervisory Board has appointed James Ryan, Ph.D., to the Management Board as Chief Legal Officer, effective September 1. As part of the Management Board, James Ryan will continue to lead the company’s corporate legal strategy and global legal operations including transactions, corporate governance, securities, intellectual property, insurance, data privacy, among others. Prior to his appointment to the Management Board, James Ryan served as the company’s General Counsel and Senior Vice President Legal & IP.

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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.