The FDA’s new PreCheck pilot is putting fresh attention on U.S. biopharmaceutical manufacturing stocks, as faster facility reviews could reshape how quickly companies bring complex therapies to market. With select facilities from Eli Lilly, Regeneron and others lined up for accelerated oversight, investors are watching which businesses might gain from quicker approvals, added capacity and stronger onshore supply chains, and which could be left waiting. This article walks through 3 stocks from the U.S. Biopharmaceutical Manufacturing screener that are directly exposed to this regulatory shift and explains why the same catalyst can look very different from one company to the next.

Krystal Biotech (KRYS)

Overview: Krystal Biotech is a commercial-stage biotechnology company that develops and manufactures genetic medicines, anchored by its approved therapy VYJUVEK for dystrophic epidermolysis bullosa, and is building a broad pipeline across respiratory, eye, skin, and oncology diseases from its base in Pittsburgh.

Operations: Krystal Biotech generates US$417.3m in revenue from the discovery, development, manufacturing and commercialization of genetic medicines, currently all from the United States.

Market Cap: US$11.0b

Investors watching the FDA’s new PreCheck pilot may consider Krystal Biotech because it already has US based facilities, a strong inspection history and is actively working with the FDA on a fourfold manufacturing scale up that could support faster, higher margin supply if reviews speed up. High gross margins around 93%, current profitability and existing earnings forecasts relative to the broader biotech sector are balanced by risks, including heavy reliance on VYJUVEK, revenue volatility and rising costs as the pipeline expands into new indications and geographies. With recent institutional interest and a clinical calendar that includes multiple potential catalysts, the key consideration is how much of this manufacturing and pipeline potential is already reflected in Krystal Biotech’s stock and what investors might be underestimating.

Krystal Biotech’s high gross margins, U.S. based manufacturing and reliance on VYJUVEK put a lot of weight on execution, so it is worth reading the 3 key rewards and 1 important warning sign

SpringWorks Therapeutics (SWTX)

Overview: SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on medicines for rare diseases and cancers, led by its approved oral therapies OGSIVEO for desmoid tumors and GOMEKLI for NF1-associated plexiform neurofibromas, with additional programs targeting ovarian granulosa cell tumors, low grade gliomas and BRAF driven tumors.

Operations: SpringWorks Therapeutics currently generates US$219.67m in revenue from developing and commercializing life changing medicines, all from the United States.

Market Cap: US$3.5b

Investors watching SpringWorks Therapeutics in light of the FDA’s PreCheck pilot may be drawn to its focus on oral targeted therapies for tightly defined patient groups. Analysts currently forecast strong revenue growth of 28.3% a year and expect earnings to turn positive within 3 years. At the same time, the stock trades on a premium P/S multiple, the business is still loss making with a declining return on equity and relies on higher risk external funding, so execution on upcoming trials, label expansions and any U.S. manufacturing scale up will matter. With experienced management, fast track regulatory designations and a pipeline aligned to areas of unmet need, the key question is whether the growth story justifies that premium and funding risk.

SpringWorks Therapeutics’ revenue story is accelerating, but the real question is whether current expectations fully capture the next leg of its growth. Before you decide, weigh that optimism against the analyst forecasts for SpringWorks Therapeutics

IVERIC bio (ISEE)

Overview: IVERIC bio is a biopharmaceutical company focused on developing treatments for serious retinal diseases, led by its complement C5 inhibitor Zimura for geographic atrophy secondary to dry age related macular degeneration and Stargardt disease, alongside a range of earlier stage programs for inherited retinal disorders.

Market Cap: US$5.5b

IVERIC bio stands out in the U.S. Biopharmaceutical Manufacturing screener as a focused retinal disease company. Analysts expect it to deliver earnings growth of 59.04% a year while it is currently trading around 68.2% below one estimate of fair value. That mix of growth expectations and apparent undervaluation sits next to real risks, including minimal current revenue, ongoing losses, shareholder dilution and a high P/B multiple that prices in a lot of future success. With funding reliant on higher risk borrowing and profitability not expected for several years, the key question for investors is how confident they are that IVERIC bio’s late stage programs and U.S. manufacturing footprint can justify those expectations before the cash and patience run thin.

IVERIC bio’s earnings story and its significant gap to one fair value estimate suggest the market may be missing something important. Before you move on, read the 2 key rewards and 2 important warning signs (1 is major!)

The three stocks in this article are only a starting point, and the full U.S. Biopharmaceutical Manufacturing screen on Simply Wall St highlights 25 more companies with equally compelling narratives that could be worth a closer look through the U.S. Biopharmaceutical Manufacturing screener. Use the Simply Wall St tools to identify, analyze and filter for the specific catalysts and storylines that matter most to you so you can focus on the highest conviction ideas in this space.

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If Krystal Biotech or any of these companies sound like a great opportunity, register for FREE with Simply Wall St and add your companies to a Watchlist to monitor the share price against the fair value the ideal entry point. Once you've made your move, manage your holdings with our Portfolio Command Center that filters out the noise to deliver only the most critical, actionable updates. Throughout your journey, our Community allows you to filter the best ideas from thousands of investor perspectives. By uncovering hidden catalysts and risks early, you'll accelerate your decision-making and stay one step ahead of the market.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.