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KALA

Kala Pharmaceuticals

$13.36

-0.38 (-2.77%)

16:03
06/19/18
06/19
16:03
06/19/18
16:03

Kala Pharmaceuticals to submit NDA for KPI-121 to FDA in H2

Kala Pharmaceutical provided an update on the development plan for KPI-121 0.25%, which if approved could be the first FDA-approved product for the short-term treatment of dry eye disease. The company announced that it plans to submit a New Drug Application to the U.S. Food and Drug Administration during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2000 patients, including one Phase 2 trial and two Phase 3 efficacy and safety trials. In addition, based upon the recommendation of the FDA, Kala plans to initiate an additional Phase 3 clinical trial evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The company plans to initiate the new trial, STRIDE 3, in the third quarter of 2018. Top-line results for STRIDE 3 are anticipated in the fourth quarter of 2019. The company has conducted a comprehensive analysis of data generated in its previous three clinical trials and believes it has identified key factors that contributed to the differences observed in the results from STRIDE 2 compared to those of STRIDE 1 and Phase 2. The company has integrated these factors into the trial design of STRIDE 3, which the company believes will improve the probability of success for the trial. Kala remains committed to developing KPI-121 0.25% for the millions of patients suffering from dry eye disease for whom there is currently no product approved for the temporary relief of signs and symptoms of the disease.

  • 24

    Aug

KALA Kala Pharmaceuticals
$13.36

-0.38 (-2.77%)

01/25/18
WELS
01/25/18
NO CHANGE
Target $19
WELS
Outperform
Kala Pharmaceuticals price target lowered to $19 from $24 at Wells Fargo
Wells Fargo analyst David Maris lowered his price target for Kala Pharmaceuticals to $19 from $24 on valuation after the shares dropped following mixed results from the two pivotal Phase III trials of its dry eye treatment, KPI-121. The analyst believes Kala's shares have the opportunity to outperform as investors shift their near-term focus to the company's post-surgical ocular steroid which has an August 2018 PDUFA. He reiterates an Outperform rating on the stock.
01/05/18
WELS
01/05/18
NO CHANGE
WELS
Outperform
Kala dry eye trial results mixed but positive, says Wells Fargo
After Kala Pharmaceuticals reported that KPI-121 demonstrated statistically significant improvements in the primary sign and symptom endpoints in one Phase 3 trial but missed for the primary symptom endpoint in another trial, Wells Fargo analyst David Maris said the mixed data "complicates things" but still show a positive drug profile for KPI-121. He would expect the shares to be down on this data, but also believes some of the risk seems to have been in expectations given the stock having been down recently. Maris keeps an Outperform rating on Kala shares, which are down 24% in morning trading.
11/17/17
JPMS
11/17/17
NO CHANGE
Target $35
JPMS
Overweight
Kala offers 'compelling' risk/reward into dry eye data, says JPMorgan
After meeting with management, JPMorgan analyst Chris Schott continues to see a "compelling" risk/reward for Kala Pharmaceuticals shares ahead of Phase 3 data for KPI-121 0.25% reading out later this year. The shares can rally to $40-plus share on positive Phase 3 dry eye data, versus downside to high single digits or low teens on a negative readout, Schott tells investors in a research note. The analyst views Kala as an attractive ophthalmology pure play and keeps an Overweight rating on the shares with a $35 price target.
10/25/17
WELS
10/25/17
NO CHANGE
Target $24
WELS
Outperform
Kala new drug application an 'important milestone,' says Wells Fargo
Wells Fargo analyst David Maris calls Kala Pharmaceuticals' on-time new drug application for Inveltys an "important milestone" since the company is development-stage beginning the transition to a commercially-focused business. The topical has the potential to be the first FDA approved ocular corticosteroid with two-times per day dosing for the treatment of inflammation and pain following ocular surgery, Maris tells investors in a research note. He sees lower than average commercial and regulatory risk for Inveltys as the active steroid is well-known and already approved in postsurgical ocular pain and inflammation. He sees sales of the topical growing to $100M in 2021 and keeps an Outperform rating Kala with a $24 price target.

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LOXO

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LOXO

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$160.01

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MRTX

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RHHBY

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