Track market-moving stories before they get noisy

If you had invested in Krystal Biotech (KRYS +2.34%), Exelixis (EXEL -0.52%), or CVS Health (CVS +0.70%) at the beginning of the year, you'd be sitting pretty. All three companies have outpaced the market, which has itself proved resilient amid macroeconomic problems, fears of a recession, and other problems. However, all three of these healthcare stocks have important catalysts ahead that may allow them to maintain their momentum for much longer and continue delivering market-beating returns. Here's why these stocks are still worth serious consideration.

Image source: Getty Images.

1. Krystal Biotech Krystal Biotech, a drugmaker that focuses on developing medicines for rare diseases, is performing well thanks to its only approved product, Vyjuvek. This therapy treats a condition called dystrophic epidermolysis bullosa (DEB), which causes the skin to blister and tear very easily, often from minor rubbing or bumps. Vyjuvek, a topical gel applied directly onto wounds, helps patients' cells produce a protein that strengthens and repairs fragile skin. Krystal Biotech is posting strong financial results thanks to Vyjuvek, with the company's revenue and profits growing at a good clip in recent years.

KRYS Revenue (Quarterly) data by YCharts

Krystal Biotech has earned approval for Vyjuvek in other regions, notably Europe and Japan. The company making headway in these regions will help drive sales even higher. Krystal Biotech is also developing several pipeline candidates for other rare diseases, including cystic fibrosis. Clinical and regulatory progress over the next few years could jolt the stock.

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Krystal Biotech could have a much larger portfolio of approved products by the end of the decade while still delivering consistent top and bottom-line growth. There is some risk, particularly if the company encounters commercial setbacks with Vyjuvek, as biotech stocks sometimes do. But given the medicine's position in this small, high-unmet-need area, the company should continue riding this tailwind over the medium term. That's why there may be plenty more upside potential.

2. Exelixis Exelixis is on the verge of entering a new era. The company's current crown jewel, Cabometyx, a cancer medicine, has received approval across multiple indications and has been highly successful. But the biotech is close to launching a new therapy called zanzalintinib, which could earn approval by the end of the year for treating metastatic colorectal cancer. Once Cabometyx starts facing generic competition in the U.S., probably in 2030, zanzalintinib should be ready to take over.

Here are two reasons why. First, it targets an area with a significant need. Colorectal cancer is the second-leading cause of cancer death in the world, despite having high five-year survival rates when caught early. So, there should be a large market for patients with stage 4 colorectal cancer.

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Second, zanzalintinib should earn important label expansions beyond this area. The medicine is being investigated across meningioma, some forms of kidney cancer, and more. Zanzalintinib appears to have pipeline-in-a-drug potential, just like Cabometyx. In the meantime, Exelixis' revenue and earnings should continue growing at a good clip. And beyond zanzalintinib, the company is also working on other oncology candidates that are in the early stages of development. The company's medium-term prospects look bright.

3. CVS Health CVS Health's rebound continues. After lagging the market for a few years, it has been performing well since 2025. But the company may not be done yet. CVS Health has worked hard to stabilize expenses in its health insurance business, and we are still seeing the results of these efforts, which could continue to drive higher profits and margins for the company. It is also pursuing initiatives that could boost sales.

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For instance, CVS Health recently announced a platform that will help patients access GLP-1 medicines more easily while benefiting from support from healthcare professionals on their weight-loss journey. Anti-obesity drugs have risen in popularity, but they remain hard to access for many patients because of their high prices and spotty insurance coverage. CVS Health could help fill this need, potentially leading to meaningfully higher sales within its pharmacy segment. The company has other projects that may also boost revenue and earnings over the medium term. And that's before we factor in its strong dividend program, all of which suggests that CVS Health could perform well over the next five years.

PITTSBURGH, July 23, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that it will report its second quarter 2026 financial results on Monday, August 3, 2026, prior to the open of U.S. markets.

Krystal Biotech (KRYS) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

As Big Pharma braces for a looming patent cliff that threatens billions in revenue, a different group of companies is chasing the opposite story: a single breakthrough that could define their future. For these smaller players, one strong trial readout or FDA approval can mean the difference between a breakout and a bust.

Below, we look at several companies that investors willing to take a bit of a risk on the pharma industry may want to keep watch over. Two have key upcoming FDA decisions looming, although on slightly different timelines. The third offers a varied approach: as a company with multiple products already on the market, it doesn't rely quite so heavily on a single strong data release or FDA announcement, though it can still benefit from such developments.

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Vera Makes Big Moves in the Nephrology SpaceA clinical-stage biotech company creating immunotherapies for autoimmune and inflammatory diseases, Vera Therapeutics NASDAQ: VERA has a major pending FDA decision that could be instrumental for the company. Vera is working toward a Biologics License Application (BLA) for atacicept, an investigational drug with the potential to address IgA nephropathy, an autoimmune kidney disease.

Vera Therapeutics Today

VERA

Vera Therapeutics

$39.79 +1.59 (+4.16%)

As of 11:09 AM Eastern

This is a fair market value price provided by Massive. Learn more.

52-Week Range$19.07▼

$56.05Price Target$78.00

Early in June, the company reported an optimistic update, including its alignment with the FDA on a revised ORIGIN 3 eGFR analysis plan with an accelerated timeline. Assuming this goes well in Q3, Vera will likely submit its BLA before the end of the year.

If atacicept receives full approval, it could open up major commercial potential in the fast-growing, $20-billion global nephrology market. On the other hand, a negative decision or even a delay in the eGFR process could be detrimental to VERA shares.

For the time being, analysts are bullish: 10 out of 12 ratings are Buys, and Wall Street anticipates the stock to climb by 120%.

A Gene Therapy Winner Awaits 2 New Sets of DataKrystal Biotech NASDAQ: KRYS is a gene therapy company creating novel therapies for dermatological diseases. The company has already seen significant success with Vyjuvek, the first gene therapy ever approved for a skin condition. This may give investors additional optimism as the company prepares for two upcoming data readouts that could provide even more momentum. Vyjuvek revenue was $116 million in the first quarter, up 32% year-over-year (YOY).

Krystal Biotech Today

$350.46 +10.25 (+3.01%)

As of 11:09 AM Eastern

This is a fair market value price provided by Massive. Learn more.

52-Week Range$130.50▼

$356.50P/E Ratio46.70

Price Target$340.56

The firm's KB803 is currently in trials related to its potential as a treatment for corneal abrasion for patients with dystrophic epidermolysis bullosa, with top-line results expected by the end of this year. Additionally, Krystal has a second candidate in line for a registrational data readout in 2026: KB801 is in studies for its potential as a treatment for neurotrophic keratitis.

Though niche, each of these drugs has the potential to address previously underserved corners of the market and could strengthen Krystal's overall portfolio significantly.

Ten out of 12 analysts call KRYS shares a Buy, although with more than 40% returns year-to-date (YTD), investors may be concerned about how much upside potential remains in the near term.

An Established Player With a Promising Long-Horizon ProspectADMA Biologics NASDAQ: ADMA is a biopharma firm that develops plasma-based biologics to treat immunodeficiency and infectious diseases. The company is in a different place from others in the field because it already has multiple products on the market and strong revenue (including 28% YOY growth last quarter from ASCENIV).

ADMA Biologics Today

$8.82 +0.14 (+1.55%)

As of 11:09 AM Eastern

This is a fair market value price provided by Massive. Learn more.

52-Week Range$7.21▼

$20.46P/E Ratio12.96

Price Target$19.67

As such, ADMA is less reliant on promising news from the FDA or from data readouts from its clinical trials, although these kinds of updates can still catalyze new growth. Instead, some of the appeal of ADMA is its margin expansion, which is possible thanks to a new set of manufacturing efficiencies begun in the last several quarters.

That's not to say that the company has no products on the horizon, though, and SG-001—an investigative hyperimmune globulin candidate for pneumococcal disease—is among the most promising.

Investors might expect a boost to ADMA stock if and when positive results are released about this candidate, but in the meantime, the draw may be more focused on the stability that ADMA's preexisting products already offer.

ADMA shares are down considerably YTD, falling by over 50% in that period. However, this makes the company's value prospects more attractive, particularly as its price-to-earnings (P/E) ratio of 12 is considerably lower than the broader sector. Plus, analysts feel there is plenty of room for growth based on upside forecasts of more than 130%.

Should You Invest $1,000 in Vera Therapeutics Right Now?Before you consider Vera Therapeutics, you'll want to hear this.

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Despite economic headwinds and geopolitical tensions, equities have performed fairly well so far this year. The S&P 500 is up by a solid 8% to date. Some companies are doing an even more impressive job of overcoming all the challenges and volatility. Consider these three stocks that have left broader equities in the dust this year: Moderna (MRNA +3.50%), Krystal Biotech (KRYS +1.87%), and Advanced Micro Devices (AMD +5.27%). Despite their strong performances this year, these companies are still worth investing in.

Image source: Getty Images.

1. Moderna Moderna, the famous vaccine maker that was one of the leaders in the coronavirus market, is making significant progress toward important new approvals. The company is inching closer to earning the green light for its influenza vaccine, mRNA-1010. This product could help address an unmet market need, as the low effectiveness of current flu vaccines leaves many patients -- particularly the elderly, whom Moderna is targeting with mRNA-1010 -- at risk of severe cases of the disease and hospitalization. An approval here would be an important step forward for the vaccine maker.

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The company expects several other catalysts over the next two years, including the launch of its norovirus vaccine and several data readouts. Moderna's pipeline includes several highly promising candidates. One of them is mRNA-4157, an investigational personalized cancer vaccine currently undergoing several phase 2 and phase 3 studies. Over the next few years, Moderna could make significant clinical and regulatory progress while also posting much stronger financial results. That's why, even though its shares are up 100% this year, it could still deliver solid returns over the next decade.

2. Krystal Biotech Krystal Biotech is performing well thanks to Vyjuvek, a medicine for a rare disease called dystrophic epidermolysis bullosa (DEB). This genetic condition leads to extremely fragile skin. Patients with DEB get painful blisters from otherwise minor friction. Vyjuvek, a gene therapy for DEB, was the first medicine to be approved by the U.S. Food and Drug Administration for this disease. It has helped Krystal Biotech generate rapidly growing revenue and earnings. The drugmaker is on an 11-quarter streak of positive earnings per share, which is fairly impressive for a biotech company of this size with only a single product on the market.

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The good news is that Krystal Biotech still has a large addressable market to tap into with Vyjuvek, as it continues to expand to new regions in Europe and elsewhere. Expect the company's top line to continue moving in the right direction for the foreseeable future. Further, Krystal Biotech boasts over half a dozen pipeline candidates, and we should see clinical trial data for at least some of them over the next few years. Between the strong performance of its leading product, Vyjuvek, and potential clinical catalysts that could lead to brand-new approvals, Krystal Biotech looks likely to continue beating the market. The stock is up 38% this year. But it's not too late to buy.

3. Advanced Micro Devices Shares of AMD have soared by 129% year to date. The company is posting strong financial results, but that's only part of the story. AMD looks increasingly attractive as a pick to capitalize on the rapidly growing artificial intelligence (AI) field. Here are two reasons why. First, AMD is a leader in the server CPU (Central Processing Unit) market. As we move into the world of agentic AI -- self-directed systems that can work toward a goal with limited human intervention -- CPUs will become increasingly more important. That puts AMD, whose EPYC processors are among the market leaders, in a great position. Note that Nvidia (NVDA +3.08%) has argued that we could be looking at a $200 billion CPU total addressable market due to the rise of agentic AI, a number that dwarfs AMD's trailing-12-month revenue of $37.5 billion.

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Second, AMD has been gaining ground on one of its biggest competitors in its niche, Intel (INTC +10.75%). In the first quarter, AMD's share of the desktop CPU market was 33.2%, up about 5% from the same period in the previous fiscal year. AMD also had a 46.2% revenue share, a record for the company and clear evidence of its stronger pricing power. These factors suggest that AMD can continue riding the AI wave for a while, making it a top stock to buy now, even after its impressive run this year.

April 30, 2026 08:00 ET  | Source: Krystal Biotech, Inc.

PITTSBURGH, April 30, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the Company will be presenting on multiple programs at upcoming scientific conferences being held in May and June.

Presentation details are outlined below.

American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting
Poster Presentation

Title: Evaluation of KB409 and KB410, two HSV-1-based gene therapy vectors for the treatment of primary ciliary dyskinesia (PCD)Presenter: Bruce Nmezi, PhDDate and Time: May 12, 2026 from 5:00PM to 6:30PM ET American Thoracic Society (ATS) International Conference 2026
Oral Presentation

Title: Interim results of the CORAL-1 trial of KB407 for the treatment of cystic fibrosisPresenter: Jorge Lascano, MD, Professor of Medicine, Associate Director of the Adult Cystic Fibrosis Program, and Director of the Cystic Fibrosis Therapeutics Development Center at the University of FloridaDate and Time: May 20, 2026 at 10:03AM ET 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Poster Presentation

Title: Inhaled delivery of KB707, a novel HSV-based immunotherapy, in combination with pembrolizumab in advanced non-small cell lung cancer: a phase 1/2 studyPresenter: Wen Wee Ma, MBBS, Enterprise Vice Chair for Research and Director of the Novel Cancer Therapeutics Center at Cleveland Clinic Cancer InstituteDate and Time: May 31, 2026 from 9:00AM to 12:00PM CT Additional presentation details will be available to conference attendees. Following completion of each conference, presentation slides or posters, as applicable, will also be available to view online on the Investor section of the Company’s website.

About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn more or follow us on LinkedIn and X.

CONTACT
Investors and Media:                                                             
Stéphane Paquette, PhD
Krystal Biotech
[email protected]                            

$116.4 million in 1Q VYJUVEK global revenue and $846.7 million since launch

Enrollment complete in KB803 (corneal abrasions in DEB patients) registrational study

On track for KB803 and KB801 (NK) registrational data readouts in 2026

FDA grants platform technology designation for KB407 (CF) and KB111 (HHD)

Strong balance sheet, ending the quarter with $1.0 billion in cash and investments

PITTSBURGH, May 04, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today reported financial results for the first quarter ending March 31, 2026 and provided a business update.

“Following a successful 2025, we are entering 2026 with strong momentum, including two potential registrational study readouts and continued global expansion for VYJUVEK,” said Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech. “With three pipeline products receiving platform designation, each development milestone strengthens the regulatory dataset, which could accelerate future programs and potentially reduce development risk. This compounding advantage underscores the value of the platform model we have been building since day one.”

VYJUVEK® (beremagene geperpavec-svdt, or B-VEC)
for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

The Company recorded $116.4 million in VYJUVEK net product revenue for the first quarter of 2026, an increase of 32% compared to the prior year first quarter. Gross margin for the first quarter of 2026 was 95%.

In the United States, the Company has secured over 695 reimbursement approvals for VYJUVEK and continues to broaden the prescriber base across the country, with over 60 new prescribers in the first quarter of 2026 and over 570 unique prescribers since launch. The Company has also launched patient support initiatives that leverage the recent VYJUVEK label update and increased administration flexibility to help DEB patients and their families conveniently integrate VYJUVEK into lifelong wound healing routines as their standard of care.

Overseas, the Company estimates that over 140 patients in Germany, France and Japan have been prescribed VYJUVEK. Pricing discussions with German and French reimbursement authorities are ongoing. The Company expects negotiations to continue until at least 2H 2026 in Germany and 2027 in France. The Company is also advancing pricing discussions with reimbursement authorities in Italy to enable a potential launch in 2H 2026 and recently initiated pricing discussions with Spanish reimbursement authorities. Based on initial interactions with Spanish authorities, the Company now expects to launch in Spain in 2H 2026. The timing of launch in other European jurisdictions will depend on the cadence and outcomes of regulatory interactions and pricing negotiations.

Ophthalmology

Two registrational readouts anticipated in 2026

KB803 for the treatment and prevention of corneal abrasions in DEB patients

The Company’s registrational, intra-patient, double-blind, decentralized, placebo-controlled study (IOLITE) with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients is now fully enrolled. A total of 16 patients have been enrolled in the study. The primary efficacy endpoint of IOLITE will be the change in the average number of days per month with corneal abrasion symptoms while receiving KB803 versus placebo. The Company estimates that, as enrolled, IOLITE has at least 90% power to detect an effect size of at least 25% reduction in symptom days, allowing for a dropout rate up to 20%. Powering assumptions are based on the average symptomatic days per month and standard deviation data from subjects enrolled in the natural history study who would be eligible for IOLITE. The Company expects to report top-line results in 4Q 2026. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07016750.

KB801 for the treatment of neurotrophic keratitis (NK)

The Company continues to enroll in EMERALD-1, the Company’s registrational, 1:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of NK. The Company expects to complete full enrollment of 60 patients in EMERALD-1 and announce data before year end. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06999733.

Respiratory

KB407 for the treatment of cystic fibrosis (CF)

In April, the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 viral vector used in KB407, providing the program with the same potential development and manufacturing efficiencies previously granted to KB801. Potential benefits of the designation include shortening of preclinical and chemistry, manufacturing, and controls (CMC) review cycles during development for follow-on products, creating a compounding regulatory advantage.

Based on interactions with the FDA, the Company is initiating an open label, single-arm study to evaluate safety of repeat dose KB407 for 24 weeks in five patients with CF who are ineligible for, do not tolerate, or do not benefit from modulator therapy. Dosing is expected to start later this month. Details of the study can be found at www.clinicaltrials.gov under NCT identifier: NCT05504837. The Company expects to complete enrollment in 2Q 2026 and report results before year end.

Concurrently, the Company is working closely with the FDA and the Cystic Fibrosis Foundation (CFF) on an innovative registrational study design and statistical analysis plan that explores using prospectively collected natural history data from the CFF to supplement placebo control data for evaluation of KB407 treatment effect. The Company will share the design and associated statistical analysis of the registrational study following alignment with the FDA, which is anticipated in 2H 2026, and expects to initiate the registrational study in 2027.

Previously, in January, the Company announced the successful delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator protein in the lungs of patients with CF treated with KB407.

KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease

The Company continues to enroll in repeat dose Cohort 2B of SERPENTINE-1, the Company’s open label dose escalation study evaluating KB408 in adult patients with AATD with a Pi*ZZ or a Pi*ZNull genotype and expects to report interim data for this cohort in 2026. Cohort 2B is designed to evaluate the safety and tolerability of repeat KB408 dosing at the same dose level that was previously shown to safely deliver SERPINA1 to the lungs of AATD patients after a single dose. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT06049082.

Dermatology

KB111 for the treatment of Hailey-Hailey disease (HHD)

In April, the FDA also granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 viral vector used in KB111, providing the program with the same regulatory efficiencies available for KB801 and KB407. The Company is developing an HHD-specific severity scale necessary for the clinical evaluation of KB111 and expects to complete scale development and validation in 1H 2026. Later this month, the Company also expects to initiate HALITE-1, an open-label study evaluating the safety of repeat dose KB111, administered once weekly for 12 weeks, in approximately seven patients with HHD. The Company expects to report HALITE-1 study results in 2H 2026. The Company also plans to submit the results from HALITE-1 along with the registrational study design for discussions with the FDA in 2H 2026 to enable a potential registrational study start in 2027.

Oncology

Inhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)

The Company is enrolling patients with advanced NSCLC in a dose expansion cohort of KYANITE-1 evaluating inhaled KB707 in combination with chemotherapy. KYANITE-1 is a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707, either as monotherapy or in combination, in patients with locally advanced or metastatic solid tumors of the lung. The Company expects to report interim efficacy data and potential registrational study plans later this year. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

Intratumoral KB707 for the treatment of injectable solid tumors

The Company continues to follow patients previously enrolled in OPAL-1, the Company’s Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies. The Company will update development plans for intratumoral KB707 as additional safety and efficacy data are collected from the study. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT05970497.

Aesthetics

KB304 for the treatment of wrinkles of the décolleté

Jeune Aesthetics, Inc., a wholly owned subsidiary of the Company, expects to initiate a Phase 2 study of its lead program KB304 in 2027.

Financial Results for the Three Months Ended March 31, 2026:

Product revenue, net totaled $116.4 million and $88.2 million for the three months ended March 31, 2026 and March 31, 2025, respectively.Cost of goods sold totaled $6.3 million and $5.0 million for the three months ended March 31, 2026 and March 31, 2025, respectively.Research and development expenses for the three months ended March 31, 2026 were $15.3 million, inclusive of $2.2 million of stock-based compensation, compared to $14.3 million, inclusive of stock-based compensation of $2.5 million for the three months ended March 31, 2025.Selling, general, and administrative expenses for the three months ended March 31, 2026 were $41.0 million, inclusive of stock-based compensation of $11.4 million, compared to $32.6 million, inclusive of stock-based compensation of $11.0 million, for the three months ended March 31, 2025.Net income for the three months ended March 31, 2026 was $55.9 million, or $1.91 per common share (basic) and $1.83 per common share (diluted). Net income for the three months ended March 31, 2025 was $35.7 million, or $1.24 per common share (basic) and $1.20 per common share (diluted).For additional information on the Company’s financial results for the three months ended March 31, 2026, please refer to the Form 10-Q filed with the SEC. Financial Guidance

($ in millions) FY 2026 GuidanceNon-GAAP Research and Development (“R&D”) and Selling, General and Administrative (“SG&A”) expense(1) $175.0 - $195.0 (1) Refer to Non-GAAP Financial Measures section below for additional information. Non-GAAP combined R&D and SG&A expense guidance does not include stock-based compensation as we are currently unable to confidently estimate Full Year 2026 stock-based compensation expense. As such, we have not provided a reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and SG&A Expense in the above. This could materially affect the calculation of forward-looking GAAP combined R&D and SG&A Expense as it is inherently uncertain.

Conference Call

The Company will host an investor webcast on May 4, 2026, at 8:30 am ET.

Investors and the general public can access the live webcast at:
https://www.webcaster5.com/Webcast/Page/3018/53916.

For those unable to listen to the live conference call, a replay will be available for 30 days on the Investors section of the Company’s website at www.krystalbio.com.

About VYJUVEK

VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVEK is approved in the United States, Europe, and Japan.

U.S. INDICATION

VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

Adverse Reactions

The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Contraindications

None.

Warnings and Precautions

VYJUVEK gel may be applied by a healthcare provider, a caregiver, or the patient.

After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.

Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.

Patients should avoid touching or scratching wound sites or wound dressings.

In the event of an accidental exposure flush with clean water for at least 15 minutes.

For more information, see full U.S. Prescribing Information.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn more or follow us on LinkedIn and X.

About Jeune Aesthetics, Inc.

Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is a biotechnology company leveraging a clinically validated gene delivery platform to develop products to fundamentally address – and reverse – the biology of aging and/or damaged skin. For more information, please visit http://www.jeuneinc.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans, and prospects, as well as statements that are not historical facts, including statements about, among other topics, our combined R&D and SG&A expense guidance; our commercial launch of VYJUVEK in the U.S., Europe, and Japan, including our expectations regarding timing of pricing discussions in Germany and France and pricing discussions with the reimbursement authorities in Italy and Spain and potential commercial launches in those countries in 2H 2026; and our expectations for our product pipeline, including our clinical trial plans, enrollment in our clinical trials, the timing of development and validation of an HHD-specific evaluation scale, and the timing of discussions with the FDA and data read-outs from our clinical trials may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Undue reliance should not be placed on the forward-looking statements in this press release. These statements are not guaranties of future performance and actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the availability and commercial potential of VYJUVEK or our product candidates; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. The Company is providing the information in this press release as of the date hereof and undertakes no duty to update this information unless required by law.

Non-GAAP Financial Measures

This press release includes forward-looking combined R&D and SG&A expense guidance that is not required by, or presented in accordance with, U.S. GAAP and should not be considered as an alternative to R&D and SG&A expense or any other performance measure derived in accordance with GAAP. The Company defines non-GAAP combined R&D and SG&A expense as GAAP combined R&D and SG&A expense excluding stock-based compensation expense. The Company cautions investors that amounts presented in accordance with its definition of non-GAAP combined R&D and SG&A expense may not be comparable to similar measures disclosed by competitors because not all companies calculate this non-GAAP financial measure in the same manner. The Company presents this non-GAAP financial measure because it considers this measure to be an important supplemental measure and believes it is frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in the Company’s industry. Management believes that investors’ understanding of the Company’s performance is enhanced by including this forward-looking non-GAAP financial measure as a reasonable basis for comparing the Company’s ongoing results of operations. Management uses this non-GAAP financial measure for planning purposes, including the preparation of the Company’s internal annual operating budget and financial projections; to evaluate the performance and effectiveness of the Company’s operational strategies; and to evaluate the Company’s capacity to expand its business. This non-GAAP financial measure has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for R&D and SG&A expense or other financial statement data presented in accordance with GAAP in the Company’s consolidated financial statements. The Company has not provided a quantitative reconciliation of forecasted non-GAAP combined R&D and SG&A expense to forecasted GAAP combined R&D and SG&A expense because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP combined R&D and SG&A expense, is inherently uncertain and depends on various factors, some of which are outside of the Company’s control.

CONTACT

Investors and Media:

Stéphane Paquette, PhD

Krystal Biotech

[email protected]

Condensed Consolidated Balance Sheet Data:

 March 31,
2026 December 31,
2025(in thousands)(unaudited)  Balance sheet data:   Cash and cash equivalents$501,313 $496,304Short-term investments 322,092  331,487Long-term investments 193,485  128,066Total assets 1,396,967  1,333,794Total liabilities 120,238  114,234Total stockholders’ equity$1,276,729 $1,219,560       Condensed Consolidated Statements of Operations:

 Three Months Ended March 31,    2026   2025  Change(in thousands, except per share data)(unaudited)  Revenue     Product revenue, net$116,357  $88,183  $28,174Operating Expenses     Cost of goods sold 6,323   5,028   1,295Research and development 15,331   14,256   1,075Selling, general, and administrative 41,014   32,647   8,367Total operating expenses 62,668   51,931   10,737Income from operations 53,689   36,252   17,437Other income     Interest and other income, net 7,753   7,345   408Income before income taxes 61,442   43,597   17,845Income tax expense (5,510)  (7,864)  2,354Net income$55,932  $35,733  $20,199      Net income per common share:     Basic$1.91  $1.24   Diluted$1.83  $1.20         Weighted-average common shares outstanding:     Basic 29,288   28,815   Diluted 30,507   29,871         

Krystal Biotech, Inc. (KRYS) Q1 2026 Earnings Call Transcript

Krystal Biotech Inc (NASDAQ:KRYS) reported upbeat earnings for the first quarter on Monday.

The company posted quarterly earnings of $1.83 per share which beat the analyst consensus estimate of $1.39 per share. The company reported quarterly sales of $116.357 million which beat the analyst consensus estimate of $112.132 million.

Krystal Biotech shares fell 1% to trade at $284.01 on Tuesday.

These analysts made changes to their price targets on Krystal Biotech following earnings announcement.

Evercore ISI Group analyst Gavin Clark-Gartner maintained Krystal Biotech with an Outperform rating and raised the price target from $295 to $300. Citigroup analyst Yigal Nochomovitz maintained the stock with a Buy and raised the price target from $371 to $378. Considering buying KRYS stock? Here’s what analysts think:

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May 07, 2026 08:00 ET  | Source: Krystal Biotech, Inc.

PITTSBURGH, May 07, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the BofA Securities 2026 Health Care Conference on May 13, 2026, in Las Vegas. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 11:20 am PT and host investor meetings throughout the day.

A webcast of the presentation will be available here beginning at 11:20 am PT on Wednesday, May 13, 2026 and will be posted on the Investors section of the Company’s website.

About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn more or follow us on LinkedIn and X.

CONTACT
Investors and Media:                                                             
Stéphane Paquette, PhD
Krystal Biotech
[email protected]                                    

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May 18, 2026 08:00 ET  | Source: Krystal Biotech, Inc.

VYJUVEK approved for the treatment of DEB from birth with flexible administration options similar to those already granted in the United States, European Union, and Japan 

VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB

PITTSBURGH, May 18, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.

VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers.

“This latest approval brings VYJUVEK closer to patients in the United Kingdom and advances our vision of providing corrective therapy to as many DEB patients as possible,” said Laurent Goux, Executive Vice President, Head of International at Krystal Biotech. “We are now focused on close collaboration with relevant authorities to support broad and rapid access across the United Kingdom.”

VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity.

The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK.

The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway.

“We are delighted that VYJUVEK is now approved in the United Kingdom as the first and only corrective therapy for the treatment of DEB,” said Suma Krishnan, President of Research and Development at Krystal Biotech. “This positive decision by the MHRA, our fourth approval following the United States, European Union, and Japan, reflects both the strength of our clinical dataset and our commitment to maximizing access to VYJUVEK worldwide.”

VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025.

UNITED KINGDOM INDICATION
VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.

About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn more or follow us on LinkedIn and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements regarding the timing of the launch of, and access to, VYJUVEK in the United Kingdom, and the completion of related reimbursement procedures; the potential duration of orphan market exclusivity in the United Kingdom; and the Company’s commitment to maximizing access to VYJUVEK worldwide. Words such as “anticipate,” “believe,” “expect,” “intend,” “plan,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to reimbursement for VYJUVEK; uncertainties associated with the maintenance of orphan designation and exclusivity in the United Kingdom; commercial and competitive risks; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements except as required by law.

CONTACT
Investors and Media:                                                             
Stéphane Paquette, PhD
Krystal Biotech
[email protected]                                    

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Stock to Watch: Krystal Biotech, Inc. (KRYS - Free Report) Krystal Biotech is a fully integrated, commercial-stage biotechnology company focused on the discovery, development, manufacturing and commercialization of genetic medicines to treat diseases with high unmet medical needs.

KRYS is a #3 (Hold) on the Zacks Rank, with a VGM Score of B.

Momentum investors should take note of this Medical stock. KRYS has a Momentum Style Score of B, and shares are up 9.8% over the past four weeks.

Three analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.05 to $7.98 per share. KRYS boasts an average earnings surprise of +47%.

With a solid Zacks Rank and top-tier Momentum and VGM Style Scores, KRYS should be on investors' short list.

Key Takeaways Krystal Biotech posted $116.4M in Q1 2026 Vyjuvek revenues, up 32% year over year.KRYS is advancing KB407, KB408, KB803 and KB801, with multiple data readouts expected in 2026.Krystal Biotech ended Q1 with about $1B in cash and investments, supporting pipeline growth. Shares of Krystal Biotech (KRYS - Free Report) have risen 16% over the past three months against the industry’s 9.4% decline, driven by robust commercial execution and continued revenue growth from its sole marketed drug, Vyjuvek. Investor sentiment has also been bolstered by positive regulatory progress across the company’s pipeline, strengthening confidence in its proprietary gene therapy platform and a strong financial position.

Image Source: Zacks Investment Research

Strong Growth of VyjuvekThe FDA approved Vyjuvek, the first-ever revocable gene therapy, in 2023 for the treatment of patients aged six months or older with dystrophic epidermolysis bullosa (DEB), a rare and severe monogenic disease that affects the skin and mucosal tissues. The drug has also been approved by the FDA for the treatment of DEB patients from birth, with authorization for at-home administration by patients or their caregivers. Beyond the U.S. market, robust patient demand continues to drive steady uptake internationally, following the launches in Germany, France and Japan.

In the first quarter of 2026, Krystal generated $116.4 million in product revenues from Vyjuvek, up 32% year over year, driven by strong patient uptake.

Pipeline Assets Are on the MoveKrystal is advancing a diversified pipeline of genetic medicines across respiratory, ophthalmology, oncology, and aesthetics indications. Key programs include KB407 for cystic fibrosis (CF), KB408 for alpha-1 antitrypsin deficiency lung disease (AATD), KB803 for corneal abrasions in DEB patients and KB801 for neurotrophic keratitis (NK).

The company is initiating an open-label study to test repeat-dose KB407 in CF patients who cannot use or benefit from existing therapies. Patient enrollment is expected to be completed in the second quarter of 2026 and results are anticipated by the end of the year.

KB408 is being evaluated in an ongoing repeat-dose SERPENTINE-1 study for the treatment of patients with AATD. Interim results are expected in 2026.

In the ophthalmology space, KB803 is being evaluated in IOLITE, a phase III study for the treatment and prevention of corneal abrasions in DEB patients. Top-line data are anticipated in the fourth quarter of 2026.

Krystal is developing KB801 in EMERALD-1, a registrational study, for the treatment of patients with NK. Patient enrollment is ongoing, and top-line data from the study are expected in 2026.    

In oncology, KB707 is being evaluated for advanced lung tumors, while its subsidiary, Jeune Aesthetics, is developing KB304 for wrinkle treatment.

The advancement of multiple clinical programs has strengthened confidence in Krystal's proprietary gene therapy platform and its potential to generate long-term growth beyond Vyjuvek.

KRYS’ Strong Financial PositionKrystal ended the first quarter of 2026 with approximately $1 billion in cash and investments. The cash-rich balance sheet reduces financing risk and supports continued investment in pipeline development and commercialization activities.

KRYS’ Zacks Rank & Stocks to ConsiderKrystal Biotech currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have lost 1.3% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.

Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 61.5% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.

Over the past 30 days, loss per share estimates for Immunocore’s 2026 have improved from 88 cents to earnings per share of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.5% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.