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KRYS

Krystal Biotech

$42.19

0.84 (2.03%)

08:35
11/04/19
11/04
08:35
11/04/19
08:35

Krystal Biotech expects interim results from GEM-3 trial in 1H20

The company said, "In September 2019, we initiated a Phase 1/2, first in-human trial of our second product candidate, KB105, an HSV-1 based gene therapy engineered to deliver a human transglutaminase-1 gene to patients with TGM1-deficient autosomal recessive congenital ichthyosis. TGM1-deficient ARCI is a debilitating rare skin disease characterized by excessive, thick scaling of the skin, causing multiple chronic health conditions. There are approximately 23,000 cases of TGM1-deficient ARCI worldwide and about 400 new cases per year globally. We have dosed two patients in the GEM-3 trial and anticipate announcing interim results in 1H 2020. In October 2019, the FDA granted Fast Track designation to KB105, the company's HSV-1 based gene therapy engineered to deliver a functional human TGM1 gene in patients with TGM1 deficient ARCI. KB105 is currently in a Phase 1/2 clinical study with interim data expected in mid-2020. Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions. Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program. These can include meetings to discuss study design, data required to support approval, or other aspects of the clinical program. Additionally, products that have been granted Fast Track Designation may be eligible for priority review of a New Drug Application and the FDA may consider reviewing portions of an NDA before the sponsor submits the complete application. In October 2019, the European Medicines Agency Committee for Orphan Medicinal Product granted orphan drug designation to KB105 for the treatment of TGM1 deficient ARCI. Orphan designation in the EU allows Krystal Biotech to benefit from a number of key incentives, including reduced regulatory fees, protocol assistance, and market exclusivity, to develop a medicine for the treatment of a rare disease affecting not more than five in 10,000 people in the European Union. KB105 was previously granted orphan drug designation by the FDA in August 2018 and is eligible for the pediatric review voucher."

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KRYS Krystal Biotech
$42.19

0.84 (2.03%)

06/24/19
CHDN
06/24/19
NO CHANGE
Target $75
CHDN
Buy
Krystal Biotech price target raised to $75 from $57.50 at Chardan
Chardan analyst Gbola Amusa raised his price target for Krystal Biotech to $75 from $57.50 after the company announced positive results from its GEM-2 study of KB103 in patients with Recessive Dystrophic Epidermolysis Bullosa as well as a positive update on the GEM-1 Phase 1 trial of KB103. In a research note to investors, Amusa says Krystal's market cap is "modest" relative to companies with PRIME and/or RMAT/BTD designations, and says he still would not be surprised if Krystal's market cap crosses $1B by the end of 2020.
06/25/19
GUGG
06/25/19
NO CHANGE
Target $73
GUGG
Buy
Krystal Biotech price target raised to $73 from $48 at Guggenheim
Guggenheim analyst Whitney Ijem raised the price target on Krystal Biotech shares to $73 from $48 after KB103 data that the analyst called "close to a best case scenario" Ijem thinks the data, plus the new RMAT designation granted by the FDA, "puts to rest any lingering efficacy questions" Ijem keeps a Buy rating on Krystal Biotech shares.
09/24/19
GSCO
09/24/19
INITIATION
Target $60
GSCO
Neutral
Krystal Biotech initiated with a Neutral at Goldman Sachs
Goldman Sachs analyst Graig Suvannavejh started Krystal Biotech with a Neutral rating and $60 12-month price target. The company has a differentiated gene therapy platform with a pipeline in dermatology, but upside potential is largely priced in at current share levels, Suvannavejh tells investors in a research note.
09/26/19
GUGG
09/26/19
NO CHANGE
Target $81
GUGG
Buy
Krystal Biotech has 'room to run' despite doubling year-to-date, says Guggenheim
Guggenheim analyst Whitney Ijem noted that data released over the summer on Krystal Biotech's KB103 came in ahead of her expectations and now the company has initiated a Phase 1/2 study of KB105 in TGM1 deficient autosomal recessive congenital ichthyosis, or ARCI. After adding KB105 to her model, Ijem raised her price target on Krystal shares to $81 from $73 and named the stock as her top pick headed into the fourth quarter and 2020 given upcoming catalysts that she thinks will put to rest some continued controversy and further de-risk its platform. The analyst, who sees "more room to run" for the stock despite the fact that it is up 100% year-to-date, keeps a Buy rating on Krystal Biotech shares.

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