Yahoo Finance Biotech Stock Roundup: CTMX Surges on REGN's Deal, APLS Up on Regulatory Update
Drug approvals and other regulatory news are in focus in the biotech sector. Collaboration deals were also in the spotlight during the week.
Recap of the Week’s Most Important Stories:
CytomX Soars on Regeneron Deal: Shares of CytomX Therapeutics, Inc. CTMX surged after the company announced a collaboration and licensing agreement with biotech giant Regeneron Pharmaceuticals, Inc. REGN. The companies have collaborated to create conditionally-activated investigational bispecific cancer therapies, utilizing CytomX’s Probody therapeutic platform and Regeneron’s Veloci-Bi bispecific antibody development platform.
Per the agreement, REGN and CytomX will collaborate on the discovery activities to identify and validate conditionally active bispecific antibodies. Regeneron will be responsible for funding preclinical and clinical development and commercialization activities. In exchange, CTMX will receive an upfront payment of $30 million and be eligible to receive future target nomination payments and preclinical, clinical and commercial milestones of up to $2 billion. CytomX is also eligible to receive tiered global net sales royalties. Given Regeneron’s financial prowess and expertise, the collaboration is a positive for CTMX.
CytomX currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Apellis Gains on Regulatory Update: Apellis Pharmaceuticals, Inc. APLS gained after the company announced that the FDA has accepted its unsolicited major amendment to the new drug application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A decision from the regulatory body is now expected on Feb 26, 2023. The FDA also reaffirmed that it is not planning to hold an advisory committee meeting to discuss the above application.
In July, the FDA accepted and granted priority review to the NDA for pegcetacoplan to treat GA secondary to AMD. A decision from the regulatory body was expected on Nov 26, 2022. However, the latest major amendment to the NDA for pegcetacoplan extended the review period by three months. A marketing authorization application for the drug to treat GA is expected to be filed by 2022-end with the European Medicines Agency.
Regeneron’s Oncology Drug Label Expansion: Regeneron obtained the European Commission’s (“EC”) approval for the label expansion of Libtayo (cemiplimab-rwlc). The drug has been approved as a monotherapy for treating adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The EC approval was based on data from the global phase III EMPOWER-Cervical 1 study. The study evaluated Libtayo in comparison to an investigator's choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology.
We remind investors that the trial was stopped early in March 2021 based on the highly significant effect of Libtayo on overall survival (OS) among squamous cell carcinoma (SCC) patients following a unanimous recommendation by the Independent Data Monitoring Committee. Libtayo is already approved in the European Union (EU) for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).
InMed Pharmaceuticals Surges on Grant: Shares of InMed Pharmaceuticals Inc. INM surged after the company announced that it was awarded an Alliance grant from the Natural Sciences and Engineering Research Council of Canada (“NSERC”) to support the research and development of its cannabinoid drug candidates for the potential treatment of the aforementioned diseases. The NSERC grant funding supports InMed’s collaborative research projects with Dr. Kumar from the University of British Columbia. Consequently, the company announced the launch of its neurodegenerative disease program (INM-900 series), which will evaluate the effects of cannabinoid analogs in diseases such as Alzheimer’s, Huntington’s and Parkinson’s. The company has also identified two lead cannabinoid analog compounds for in vivo studies.
Performance
The Nasdaq Biotechnology Index lost 0.43% in the past five trading sessions. Among the biotech giants, Vertex has gained 5.31% during the period. Over the past six months, shares of Biogen have soared 58.82%. (See the last biotech stock roundup here: Biotech Stock Roundup: MACK Up on Study Data, MRNA Offers Vaccine Update & Others)
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What's Next in Biotech?
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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report
Apellis Pharmaceuticals, Inc. (APLS) : Free Stock Analysis Report
InMed Pharmaceuticals Inc. (INM) : Free Stock Analysis Report
