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KRYS

Krystal Biotech

$42.19

0.84 (2.03%)

08:33
11/04/19
11/04
08:33
11/04/19
08:33

Krystal Biotech to initiate manufacturing of Phase 3 clinical material in Nov.

The company said, "CMC alignment with the U.S. Food and Drug Administration includes a) support for the proposed commercial manufacturing process, b) the proposed analytical methods and corresponding qualification and validation plans - inclusive of key release assays such as potency, purity and identity and c) the comparability protocol, which helps assess how similar the product derived from our GMP process runs in our Ancoris facility is to the original product used in the Phase 1/2 trial of KB103. Analytical methods are used to assess how reliably and consistently the key product characteristics can be determined in order to ensure patients receive safe and effective product.Following alignment with the FDA on our commercial process and engineering run, we plan to initiate manufacturing of our Phase 3 clinical material at Krystal's Ancoris GMP facility in early November. We anticipate releasing this Phase 3 clinical material in 1Q 2020 and will initiate the B-VEC Phase 3 pivotal trial following release of Phase 3 material. We expect to meet with the FDA before the end of 2019 to finalize trial design and endpoints for the upcoming pivotal trial of B-VEC. Earlier this year B-VEC received RMAT designation from the FDA and PRIME eligibility from the EMA."

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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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