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KALA

Kala Pharmaceuticals

$13.38

-0.36 (-2.62%)

21:04
06/19/18
06/19
21:04
06/19/18
21:04

Kala Pharma's KPI-121 update suggests faster market entry, Wells Fargo says

Wells Fargo analyst David Maris kept his Outperform rating and $19 price target on Kala Pharmaceuticals, saying its announced plans to submit a new drug application for KPI-121 to the FDA in the second half of the year may expedite its market entry. The analyst adds that the most likely scenario is for the FDA to accept the company's NDA for review but ultimately consider the Stride 3 data and issue a Complete Response Letter for an additional study, which will likely lead to a class 2 resubmission and a shortened 6-month review period. Maris contends that it is also possible that the FDA "accepts Kala's NDA, finds the existing data to be sufficient, and approves KPI-121 0.25% in its first review cycle, leading to a late-2019 or early 2020 commercialization.

  • 24

    Aug

KALA Kala Pharmaceuticals
$13.38

-0.36 (-2.62%)

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.
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.
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.
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.

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