FDA Selects Seven Companies for PreCheck Pilot Program
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 29 2026
0mins
The U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative "designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain." The following companies have been selected to participate in the pilot: Amneal Pharmaceutical - Amneal's facility in Long Island, NY will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases; Cellares Corp. - Cellares's facility in Bridgewater, NJ will manufacture cell-based gene therapy products for oncology and hematology diseases; Eli Lilly and Company - Eli Lilly's facility in Lebanon, IN will manufacture drug substance in support of the company's existing and future medicines; FUJIFILM Biotechnologies - FUJIFILM's facility in Holly Springs, NC will support commercial-scale cell culture biomanufacturing; Kriya Therapeutics - Kriya's facility in Durham, NC will manufacture AAV-based gene therapy products to address chronic disease conditions; Kyowa Kirin - Kyowa's facility in Sanford, NC will manufacture biotechnology drug substance for rare diseases; Regeneron Pharmaceuticals - Regeneron's facility in Saratoga Springs, NY will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases."
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Analyst Views on LLY
Wall Street analysts forecast LLY stock price to fall
20 Analyst Rating
18 Buy
2 Hold
0 Sell
Strong Buy
Current: 1200.060
Low
950.00
Averages
1192
High
1500
Current: 1200.060
Low
950.00
Averages
1192
High
1500
About LLY
Eli Lilly and Company is a medicine company, which discovers, develops, manufactures, and market products in a single business segment called human pharmaceutical products. The Company manufacture and distribute its products through facilities in the United States, including Puerto Rico, and in Europe and Asia. The Company’s products are sold in approximately 90 countries. Its Cardiometabolic Health products Basaglar; Humalog, Humalog Mix 75/25, Humalog U-100, Humalog U-200, Humalog Mix 50/50, insulin lispro, and others; Humulin, Humulin 70/30, and others; Jardiance; Mounjaro; Trulicity; Zepbound, and others. Its oncology products include Cyramza, Erbitux, Tyvyt, Verzenio, Retevmo, Jaypirca, and others. Its immunology products include Ebglyss, Olumiant, Omvoh, and Taltz. Its neuroscience products include Emgality and Kisunla. Its LillyDirect, a direct-to-patient digital health care platform, provides delivery of select Lilly medicines dispensed by third-party pharmacies to patients.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Results: Eli Lilly's Retatrutide, a next-generation subcutaneous triple-receptor agonist currently in late-stage clinical trials, has shown strong weight-loss results, and if approved, could lead to significant sales growth for the company.
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- Obesity Drug Market Expansion: With the new GLP-1 Bridge program reducing Zepbound and Foundayo's monthly costs to $50, an estimated 20 million Medicare patients may qualify, further driving Eli Lilly's sales and profit growth.
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See More
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- Investor Sentiment: Market expectations for future economic growth have become more cautious, especially with pressure on tech stocks, prompting investors to reassess their portfolios in response to potential market volatility.
See More
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- Becton, Dickinson Expansion Investment: Becton, Dickinson announced a $110 million investment to expand production capacity for injectable drugs to meet the soaring demand for GLP-1 medications, which is expected to enhance its competitiveness in the medical device market.
- Abbott Laboratories Growth Potential: Despite the rise of GLP-1 drugs, demand for Abbott's continuous glucose monitoring device, FreeStyle Libre, remains strong, and the combined use with GLP-1 medications may drive higher adoption rates for CGM devices.
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