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Krystal Biotech (KRYS) Gains 36% Year to Date: Here's Why
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Shares of the commercial-stage biotechnology company, Krystal Biotech, Inc. (KRYS - Free Report) , surged 36.5% year to date against the industry’s decline of 4.3%. This was due to the strong uptake of its newly approved drug Vyjuvek and encouraging pipeline progress.
In May 2023, the FDA approved Vyjuvek, the first ever redosable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB).
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1.
Image Source: Zacks Investment Research
The drug, launched in the second quarter of 2023, generated sales of $45.3 in the first quarter of 2024.
Krystal has made steady progress, securing access and reimbursement for Vyjuvek since its launch. In January 2024, the U.S. Centers for Medicare & Medicaid Services assigned a permanent and product-specific J-code (J3401) for Vyjuvek, effective Jan 1. As of April 2024, positive access was achieved for 96% of lives covered under commercial and Medicaid plans.
In the same month, Krystal secured more than 330 reimbursement approvals for Vyjuvek in the United States.
Vyjuvek is referred to as B-VEC outside the country. In February, Krystal aligned with the FDA on the proposed single-arm, open-label study in approximately 10 patients to enable the approval of B-VEC eyedrops to treat ocular complications, deemed to affect more than 25% of DEB patients. The company plans to initiate this study in the second half of the year.
Krystal is also advancing a robust preclinical and clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics.
Krystal is evaluating KB407 for the treatment of cystic fibrosis. The company completed dosing in Cohort 2 of the phase I CORAL-1 study of KB407 and intends to initiate the third cohort shortly.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). Krystal dosed the first patient in phase I SERPENTINE-1 study in adult patients with AATD. Recruitment is ongoing and the company remains on track to report interim data from the study in the second half of 2024.
Krystal dosed the first patient in the open-label, multi-center, monotherapy, dose escalation and expansion phase I KYANITE-1 study in patients with locally advanced or metastatic solid tumors of the lung. Enrollment for the study is ongoing.
Other pipeline candidates, KB707 for the treatment of injectable solid tumors and KB301 for the treatment of aesthetic indications, are also progressing well.
With a cash balance of $622.3 million as of Mar 31, 2024, the company seems to be in a good position to develop its pipeline candidates.
In brief, the prospects for Krystal look good as Vyjuvek is the first FDA-approved gene therapy treatment for DEB and the successful development of other pipeline candidates should bode well too.
Zacks Rank & Other Stocks to Consider
Krystal Biotech (KRYS - Free Report) carries a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have gained 3.2%.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.82 to $1.95. ANVS beat on earnings in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
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Krystal Biotech (KRYS) Gains 36% Year to Date: Here's Why
Shares of the commercial-stage biotechnology company, Krystal Biotech, Inc. (KRYS - Free Report) , surged 36.5% year to date against the industry’s decline of 4.3%. This was due to the strong uptake of its newly approved drug Vyjuvek and encouraging pipeline progress.
In May 2023, the FDA approved Vyjuvek, the first ever redosable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB).
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1.
Image Source: Zacks Investment Research
The drug, launched in the second quarter of 2023, generated sales of $45.3 in the first quarter of 2024.
Krystal has made steady progress, securing access and reimbursement for Vyjuvek since its launch. In January 2024, the U.S. Centers for Medicare & Medicaid Services assigned a permanent and product-specific J-code (J3401) for Vyjuvek, effective Jan 1. As of April 2024, positive access was achieved for 96% of lives covered under commercial and Medicaid plans.
In the same month, Krystal secured more than 330 reimbursement approvals for Vyjuvek in the United States.
Vyjuvek is referred to as B-VEC outside the country. In February, Krystal aligned with the FDA on the proposed single-arm, open-label study in approximately 10 patients to enable the approval of B-VEC eyedrops to treat ocular complications, deemed to affect more than 25% of DEB patients. The company plans to initiate this study in the second half of the year.
Krystal is also advancing a robust preclinical and clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics.
Krystal is evaluating KB407 for the treatment of cystic fibrosis. The company completed dosing in Cohort 2 of the phase I CORAL-1 study of KB407 and intends to initiate the third cohort shortly.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). Krystal dosed the first patient in phase I SERPENTINE-1 study in adult patients with AATD. Recruitment is ongoing and the company remains on track to report interim data from the study in the second half of 2024.
Krystal dosed the first patient in the open-label, multi-center, monotherapy, dose escalation and expansion phase I KYANITE-1 study in patients with locally advanced or metastatic solid tumors of the lung. Enrollment for the study is ongoing.
Other pipeline candidates, KB707 for the treatment of injectable solid tumors and KB301 for the treatment of aesthetic indications, are also progressing well.
With a cash balance of $622.3 million as of Mar 31, 2024, the company seems to be in a good position to develop its pipeline candidates.
In brief, the prospects for Krystal look good as Vyjuvek is the first FDA-approved gene therapy treatment for DEB and the successful development of other pipeline candidates should bode well too.
Zacks Rank & Other Stocks to Consider
Krystal Biotech (KRYS - Free Report) carries a Zacks Rank #2 (Buy) at present.
Some other top-ranked stocks in the biotech sector are ALX Oncology Holdings (ALXO - Free Report) and Annovis Bio (ANVS - Free Report) , both carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have gained 3.2%.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.82 to $1.95. ANVS beat on earnings in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.