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Krystal Biotech's Heavy Reliance on Vyjuvek: Growth Driver or Risk Factor?
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Key Takeaways
Vyjuvek is now approved for DEB patients from birth, with self-administration at home allowed.
Vyjuvek posted $184.2M in 1H25 sales, with growth expected from the U.S., EU, and Japan labels.
KRYS prioritizes oncology candidate KB707, with an FDA end-of-phase II meeting set for October.
Krystal Biotech, Inc.’s (KRYS - Free Report) lead drug Vyjuvek is a non-invasive, topical, redosable gene therapy approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa (DEB).
Krystal Biotech has made steady progress, securing access and reimbursement for Vyjuvek since its launch in the United States. As of July, Krystal secured over 575 reimbursement approvals for Vyjuvek in the United States.
The company recently received a significant boost when the FDA approved a label update for Vyjuvek (beremagene geperpavec-svdt) that expands the drug’s label.
The FDA expanded Vyjuvek’s eligible patient population to include DEB patients from birth. The latest update also provides patients with greater flexibility in using Vyjuvek, including the ability to manage wound dressings. Patients and caregivers can now administer Vyjuvek at home, making it more convenient.
We remind investors that Vyjuvek received approval in the United States in 2023.
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues, caused by one or more mutations in the COL7A1 gene. Vyjuvek delivers two copies of the COL7A1 gene to DEB wounds, enabling skin cells to produce normal type VII collagen and thereby addressing the root cause of the disease.
Vyjuvek recorded sales worth $184.2 million during the first half of 2025. The latest label update in the United States, along with the recent approval in Europe and Japan, is likely to boost sales further in the upcoming quarters.
KRYS Looks to Develop Other Candidates
While Vyjuvek’s sales are encouraging, KRYS is a one-trick pony as of now, as its other candidates are in development.
Competition in the DEB space is also heating up. In April 2025, the FDA approved Abeona Therapeutics Inc.’s Zevaskyn (prademagene zamikeracel) for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Per ABEO, Zevaskyn is the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB.
KRYS is making efforts to develop treatments for other diseases as well. The company recently announced an update on development plans for KB707, its redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 (IL-2) and interleukin-12 (IL-12) in the tumor microenvironment and promote systemic immune-mediated tumor clearance following inhaled or intratumoral delivery to solid tumors.
KRYS will likely meet the FDA in October for end of phase II meeting to discuss potential development pathways to support the registration of inhaled KB707, based on promising early evidence of efficacy in the treatment of non-small cell lung cancer (NSCLC).
Enrollment is ongoing in the phase I/II open label, multi-center, dose escalation and expansion KYANITE-1 study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung.
With the prioritization of inhaled KB707, KRYS paused enrollment in the phase I/II OPAL-1 study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies.
While oncology is a lucrative space, competition is stiff with bigwigs like Merck (MRK - Free Report) and Bristol Myers (BMY - Free Report) .
Both MRK and BMY have strong and broad portfolio of oncology drugs. MRK’s Keytruda is approved for several types of cancer. BMY also has Opdivo in its portfolio, approved for various oncology indications. Krystal Biotech is evaluating KB407 for the treatment of cystic fibrosis. Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency.
KRYS dosed the first patient in EMERALD-1, a randomized, double-blind, placebo-controlled, multi-center phase I/II study evaluating KB801 in moderate-to-severe neurotrophic keratitis patients.
KRYS’ wholly owned subsidiary, Jeune Aesthetics, is currently developing a décolleté-specific photo numeric scale for advanced clinical development of KB301.
The successful development of other candidates is imperative for Krystal Biotech.
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Krystal Biotech's Heavy Reliance on Vyjuvek: Growth Driver or Risk Factor?
Key Takeaways
Krystal Biotech, Inc.’s (KRYS - Free Report) lead drug Vyjuvek is a non-invasive, topical, redosable gene therapy approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa (DEB).
Krystal Biotech has made steady progress, securing access and reimbursement for Vyjuvek since its launch in the United States. As of July, Krystal secured over 575 reimbursement approvals for Vyjuvek in the United States.
The company recently received a significant boost when the FDA approved a label update for Vyjuvek (beremagene geperpavec-svdt) that expands the drug’s label.
The FDA expanded Vyjuvek’s eligible patient population to include DEB patients from birth. The latest update also provides patients with greater flexibility in using Vyjuvek, including the ability to manage wound dressings. Patients and caregivers can now administer Vyjuvek at home, making it more convenient.
We remind investors that Vyjuvek received approval in the United States in 2023.
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues, caused by one or more mutations in the COL7A1 gene. Vyjuvek delivers two copies of the COL7A1 gene to DEB wounds, enabling skin cells to produce normal type VII collagen and thereby addressing the root cause of the disease.
Vyjuvek recorded sales worth $184.2 million during the first half of 2025. The latest label update in the United States, along with the recent approval in Europe and Japan, is likely to boost sales further in the upcoming quarters.
KRYS Looks to Develop Other Candidates
While Vyjuvek’s sales are encouraging, KRYS is a one-trick pony as of now, as its other candidates are in development.
Competition in the DEB space is also heating up. In April 2025, the FDA approved Abeona Therapeutics Inc.’s Zevaskyn (prademagene zamikeracel) for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Per ABEO, Zevaskyn is the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB.
KRYS is making efforts to develop treatments for other diseases as well. The company recently announced an update on development plans for KB707, its redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 (IL-2) and interleukin-12 (IL-12) in the tumor microenvironment and promote systemic immune-mediated tumor clearance following inhaled or intratumoral delivery to solid tumors.
KRYS will likely meet the FDA in October for end of phase II meeting to discuss potential development pathways to support the registration of inhaled KB707, based on promising early evidence of efficacy in the treatment of non-small cell lung cancer (NSCLC).
Enrollment is ongoing in the phase I/II open label, multi-center, dose escalation and expansion KYANITE-1 study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung.
With the prioritization of inhaled KB707, KRYS paused enrollment in the phase I/II OPAL-1 study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies.
While oncology is a lucrative space, competition is stiff with bigwigs like Merck (MRK - Free Report) and Bristol Myers (BMY - Free Report) .
Both MRK and BMY have strong and broad portfolio of oncology drugs. MRK’s Keytruda is approved for several types of cancer. BMY also has Opdivo in its portfolio, approved for various oncology indications. Krystal Biotech is evaluating KB407 for the treatment of cystic fibrosis. Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency.
KRYS dosed the first patient in EMERALD-1, a randomized, double-blind, placebo-controlled, multi-center phase I/II study evaluating KB801 in moderate-to-severe neurotrophic keratitis patients.
KRYS’ wholly owned subsidiary, Jeune Aesthetics, is currently developing a décolleté-specific photo numeric scale for advanced clinical development of KB301.
The successful development of other candidates is imperative for Krystal Biotech.