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: 

• Pieris (PIRS), 115% surge in interest
• Zymeworks (ZYME), 108% surge in interest
• EyePoint (EYPT), 80% surge in interest
• Axsome (AXSM), 72% surge in interest
• BioNTech (BNTX), 69% surge in interest
• Emergent Biosolutions (EBS), 68% surge in interest
• Editas Medicines (EDIT), 67% surge in interest
• Oncolytics (ONCY), 63% surge in interest
• Ocugen (OCGN), 48% surge in interest
• Geron (GERN), 45% surge in interest

Pipeline and key clinical candidates for these companies:

Pieris is a clinical-stage biotechnology company that says it “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. 

Zymeworks is committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. “Zymeworks’ mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates,” the company states. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using Zymeworks’ proprietary Azymetric technology.

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.

Axsome Therapeutics is developing and delivering novel therapies for central nervous system, or CNS, conditions that have limited treatment options. AXS-05 is a novel, oral, patent protected, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease agitation and other central nervous system disorders.

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).

Emergent provides solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that the company develops and manufactures for governments and consumers. Emergent also offers a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

Editas Medicine is a clinical stage genome editing company focused on CRISPR/Cas9 and CRISPR/Cas12a genome editing systems with an aim to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute’s and Harvard University’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines.

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.

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.

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

Recent news on these stocks:

August 22

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 16

EyePoint Pharmaceuticals announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2023 Long-Term Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4). The Company granted stock options to purchase up to an aggregate of 8,500 shares of EyePoint Pharmaceuticals common stock to two new employees. The stock options were granted on August 15, 2023. The grants were approved by the Compensation Committee and made as an inducement material to each employee entering into employment with EyePoint Pharmaceuticals in accordance with NASDAQ Listing Rule 5635(c)(4). The option awards have an exercise price of $14.19 per share, the closing price of EyePoint Pharmaceuticals’ common stock on August 15, 2023. The options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee’s date of grant and the remainder vesting in equal monthly installments over the following three years. Vesting of the options is subject to the employee’s continued service with EyePoint Pharmaceuticals through the applicable vesting dates.

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.