|Bid||5.72 x 800|
|Ask||5.90 x 1100|
|Day's Range||5.72 - 6.00|
|52 Week Range||4.03 - 16.00|
|Beta (3Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Kala Pharma (KALA) delivered earnings and revenue surprises of 17.28% and 43.78%, respectively, for the quarter ended March 2019. Do the numbers hold clues to what lies ahead for the stock?
The Watertown, Massachusetts-based company said it had a loss of 75 cents per share. Losses, adjusted for stock option expense and non-recurring costs, came to 67 cents per share. The results topped Wall ...
Investors need to pay close attention to Kala Pharmaceuticals (KALA) stock based on the movements in the options market lately.
It is doubtless a positive to see that the Kala Pharmaceuticals, Inc. (NASDAQ:KALA) share price has gained some 42% in the last three months. But that's not enough to compensate for the decline over the last twelve months...
Kala Pharmaceuticals (KALA) needs investors to pay close attention to the stock based on moves in the options market lately.
On a per-share basis, the Waltham, Massachusetts-based company said it had a loss of 76 cents. Losses, adjusted to extinguish debt, were 75 cents per share. The results did not meet Wall Street expectations. ...
Kala Pharmaceuticals, Inc.'s (NASDAQ:KALA): Kala Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of therapies using its proprietary nanoparticle-based Mucus Penetrating Particles (MPP) technology for the treatment Read More...
The Waltham, Massachusetts-based company said it had a loss of 63 cents per share. The results did not meet Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment ...
Kala Pharmaceuticals Inc (NASDAQ:KALA) is a small-cap stock with a market capitalization of US$266.8m. While investors primarily focus on the growth potential and competitive landscape of the small-cap companies, they Read More...
The indices have been slowly drifting lower after a gap up open. Early breadth was around 3 to 1 positive but its now down to around 4-3 positive. The bulls are not producing much positive momentum but the bears are doing an even worse job of producing negative momentum.
Regulatory and pipeline updates comprise some of the key developments in the biotech sector this week. These include Gilead's Yescarta approval in Europe.
The U.S. Food and Drug Administration on Thursday approved Kala Pharmaceuticals Inc's treatment for reducing inflammation and pain following an eye surgery. The company said it expects to launch the drug, Inveltys, in the beginning of 2019, with Wedbush Securities estimating peak sales of about $271 million in 2027. The drug was found to have no serious side effects during clinical trials, Kala said.
H.C. Wainwright analyst Ram Selvaraju is out this morning with another bullish note on shares of Kala Pharmaceuticals (NASDAQ:KALA), reiterating a Buy rating and price target of $35, which represents a potential upside of 197% from where the stock is currently trading.Selvaraju continues to see a favorable risk/reward profile on Kala heading into the August 24 PDUFA date for lead candidate, INVELTYS. If approved, INVELTYS would be the first FDA-approved corticosteroid eye drop with a twice daily dosing regimen for the treatment of post-operative ocular inflammation and pain.Selvaraju wrote, "We project INVELTYS to be launched in 1H19 and generate $36M in revenue during 2019. In our view, the combination of LE’s safety profile and dosing convenience should allow INVELTYS to seize market share from branded eye drops such as Lotemax and Durezol, as well as generic prednisolone. INVELTYS would also hold a competitive advantage vs. Dextenza (PDUFA date December 28, 2018) and DEXYCU (FDA-approved), if the latter two were also to enter the market in 2019. We note that, at commercial launch, Dextenza would only be indicated for ocular pain, and DEXYCU would only be indicated for ocular inflammation. In addition, dexamethasone (the API in both Dextenza and DEXYCU) is known to induce increased intraocular pressure (IOP) more often than LE.""Our 12-month price target is derived from a market value of the firm at $1.0B, which includes a discounted cash flow-based asset value of $1.1B for INVELTYS (85% probability of success) and KPI-121 0.25% (65% probability of success), with a 15% discount rate and 0.5% terminal growth rate," the analyst added.When it comes to Wall Street’s bet, the odds are on this biotech player, with TipRanks analytics showcasing KALA as a Strong Buy. Out of 4 analysts polled in the last 12 months, all 4 are bullish on Kala stock. With a return potential of nearly 188%, the stock’s consensus target price stands at $34. More recent articles from Smarter Analyst: * Cantor Fitzgerald Thinks Aldeyra Therapeutics' Stock is Going to Recover * Roth Capital Keeps Their Buy Rating on Digital Turbine Inc (APPS) * McCormick & Company (MKC) Receives a Buy from Jefferies * Autodesk (ADSK) Received its Third Buy in a Row
The Waltham, Massachusetts-based company said it had a loss of 60 cents per share. The results missed Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research ...
In a research note issued Wednesday, H.C. Wainwright analyst Ram Selvaraju reiterated coverage on shares of Kala Pharmaceuticals (NASDAQ:KALA), with a Buy rating and price target of $35, which represents a potential upside of 173% from where the stock is currently trading. The reiteration follows the news that the company's third phase 3 trial (STRIDE 3) of KPI-121 0.25% for the treatment of dry eye disease (DED), had dosed its first patient.Selvaraju wrote, "The STRIDE 3 trial design has specific modifications to the inclusion/exclusion criteria to address key factors that could improve the probability of success, according to management. Investors may recall that KPI-121 0.25% did not meet the primary symptom endpoint in one of the two previously-completed Phase 3 trials. In our view, STRIDE 3 would need to meet the symptom endpoint, but not necessarily the sign endpoint, to be considered sufficient to complete the New Drug Application (NDA) package. Thus, the STRIDE 3 trial design could have been optimized to increase the probability of meeting the primary symptom endpoint. We continue to believe that KPI-121 0.25% could obtain regulatory approval in 2020 and become the first FDA-approved product for short-term treatment of DED."In addition, Kala has a key catalyst on its hands this summer when it comes to lead asset INVELTYS (KPI-121 1%), designed to treat patients with post-surgical ocular inflammation and pain. KALA's INVELTYS has a PDUFA date set for August 24 and the analyst expects 85% odds that the treatment gets a green light. If approved, INVELTYS would be the first FDA-approved corticosteroid eye drop with a twice-daily dosing regimen.The analyst also maintained coverage on Durect (NASDAQ:DRRX) with a Buy rating and a $3.00 price target, following the news that Durect partner Indivior received FDA approval for PERSERIS, the first once monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults.Finally, H.C. Wainwright's Andrew Fein affirmed a Buy rating on shares of Amarin (NASDAQ:AMRN), with a $10 price target, as he sees attractive risk/return profile ahead of REDUCE-IT topline data, which is about to be released this September. More recent articles from Smarter Analyst: * Stifel on Amarin (AMRN): Nothing Fishy About This Stock -- It's a Buy! * Amarin (AMRN): New Survey Offers Insight Into Vascepa Market Opportunity * Should You Buy Amarin (AMRN) Stock? 4 Pros, 4 Cons * Amarin (AMRN): Management Is Flying in the Dark
It's been tough sledding for Kala Pharmaceuticals (NASDAQ:KALA) shareholders. The company's share price has lost approximately 46% year-to-date due to the fact that its second Phase 3 trial in dry eye disease (DED) did not meet the symptom endpoint.However, H.C. Wainwright analyst Ram Selvaraju believes that Kala's current valuation provides an intriguing entry point for investors ahead of what the analyst considers to be a risk-mitigated catalyst—the potential approval of INVELTYS for post-surgical ocular inflammation and pain. Since this candidate is based on a well-known, validated corticosteroid that has been used for many years in ocular applications, and given the fact that the NDA was filed via the 505(b)(2) regulatory pathway, Selvaraju has high confidence that INVELTYS should be approved by August 24 (the PDUFA date).As such, Selvaraju launches coverage on KALA, awarding it a Buy rating with a $35 price target, which represents a 177% upside from current levels.Selvaraju wrote, "The potential approval of INVELTYS in August would be a major milestone for Kala, as it would turn the company into a commercial-stage organization. Kala plans to launch INVELTYS in the U.S. in 2019 with its own sales and marketing team, which could initially consist of 75 individuals. The company would also partner with potential distributors in other global markets. We estimate that peak sales of INVELTYS post-cataract surgery procedures in the U.S. alone could approach $280 million in 2029.""In our view, Kala constitutes an attractive opportunity in the ophthalmology space because of the late-stage status of INVELTYS and the potential for the company to build on the possible nearterm approval of this product by advancing its pipeline. We note that the DED and retinal disease arenas appear to be sparsely-populated and relatively inefficiently addressed with current therapy. Success on multiple fronts could make Kala attractive to more established companies in the ophthalmology domain, in our view," the analyst concluded.Overall, Wall Street’s confidence backing this biotech player is strong, with TipRanks analytics showcasing KALA as a Strong Buy. Based on 5 analysts polled in the last 12 months, all 5 rate a Buy on the stock. The 12-month average price target stands at $33.80, marking a nearly 168% upside from where the stock is currently trading.
Investors in Kala Pharmaceuticals (KALA) need to pay close attention to the stock based on moves in the options market lately.
Wedbush analyst Liana Moussatos is out today with a bullish note on shares of Kala Pharmaceuticals (NASDAQ:KALA), following the drug maker's announcement that it plans to submit a New Drug Application (NDA) to the FDA for its dry eye treatment KPI-121 0.25% during the second half of 2018, while initiating an additional Phase 3 trial (STRIDE 3) in the third-quarter of this year, as per FDA suggestion.Moussatos commented, "We view clinical risk for STRIDE-3 as reduced. Kala anticipates initiation of an additional Phase 3 trial (STRIDE 3) for KPI-121 0.25% in dry eye in Q3:18. The STRIDE 3 trial is expected to carry similar design characteristics as STRIDE 1 & 2 and a comparable sample size (around 900 subjects) with what we anticipate to be tighter inclusion/exclusion criteria to limit baseline variability and reduce clinical risk seen in STRIDE-2 resulting in the symptom miss. Top-line data for STRIDE-3 is anticipated in Q4:19, whereas the potential PDUFA date for KPI-121 0.25% is likely to occur in H2:19, by our estimates. Because regulatory review can begin while clinical trials are ongoing, the developmental timeline has not been extended beyond our expectation and KPI-121 0.25% could potentially be approved in the U.S. in H2:19 and launched in Q1:20."Meanwhile, Kala continues to prepare for the potential approval and launch of INVELTYS, which, if approved, is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018.Moussatos sees good chances for FDA approval, noting, "Based on the favorable safety and tolerability profile, and statistically significant Phase 3 results, we anticipate FDA to approve INVELTYS on or by the August 24, 2018 PDUFA deadline and conservatively have a U.S. launch date in January 2019 with peak sales of about $271 million in 2027."Net net, Moussatos reiterates an Outperform rating on Kala shares, with a price target of $47, which implies an upside of nearly 240% from current levels. More recent articles from Smarter Analyst: * The Sr. VP, Chief Global Dev. Ofc. of Denny's Corp (DENN) is Selling Shares * A Director at Kimco Realty is Exercising Options * A Director at Kimco Realty (KIM) is Selling Shares * What Did This CEO Just Do with Personal Shares of Puma Biotechnology (PBYI)?