Applied Therapeutics 2.74M share Secondary priced at $45.50 » 23:5201/2301/23/20
The deal size was…
The deal size was increased from 1.75M shares and priced below the last close price of $48.85. Goldman Sachs, Cowen and UBS are acting as joint book running managers for the offering.
Applied Therapeutics files to sell 1.75M shares of common stock » 16:3801/2101/21/20
Goldman Sachs & Co.,…
Goldman Sachs & Co., Cowen and UBS Investment Bank are acting as joint book-running managers for the offering.
|Over a week ago|
Applied Therapeutics price target raised to $43 from $24 at Baird » 09:2501/0901/09/20
Baird analyst Brian…
Baird analyst Brian Skorney raised his price target on Applied Therapeutics to $43 from $24 following the release of its positive top-line data on adults with galactosemia. He raised his probability of success for AT-007 in galactosemia from 20% to 50%. Skorney reiterated his Outperform rating on Applied Therapeutics shares.
Applied Therapeutics price target raised to $44 from $29 at Citi » 06:5301/0901/09/20
Citi analyst Yigal…
Citi analyst Yigal Nochomovitz raised his price target for Applied Therapeutics to $44 from $29 saying he continues to see upside following the pivotal galactosemia data for AT-007. AT-007 now demonstrated activity in galactosemia patients, and the statistically significant 50% reduction in key biomarker plasma galactitol is sufficient for Applied to file for regulatory approval, Nochomovitz tells investors in a research note. The analyst keeps a Buy rating on the shares.
Fly Intel: Wall Street's top stories for Wednesday » 16:5401/0801/08/20
BA, WBA, M, GRUB, UBER, LYFT, TSLA, F, GM, APLT, SDC, TEN, LTHM
Stock futures plunged…
Fly Intel: Wall Street's top stories at midday » 12:3401/0801/08/20
BA, WBA, M, APLT, SDC, TEN, LTHM
Stocks looked like they…
Applied Therapeutics price target raised to $43 from $24 at Baird » 12:1201/0801/08/20
Baird analyst Brian…
Baird analyst Brian Skorney raised his price target for Applied Therapeutics to $43 from $24 and made no change to his Outperform rating after the company announced positive topline data from the pivotal portion of its study testing AT-007 in adults with galactosemia. Skroney tells investors in a research note that he was "encouraged" by the significant reductions in galactitol observed in the trial, which were at high end of expectations and, believes this will translate into clinical benefit. Based on the positive results, Skroney raised his probability of success for AT-007 in galactosemia to 50% from 20%.
Applied Therapeutics reports results of Phase 2 ACTION-Galactosemia study » 07:0401/0801/08/20
Applied Therapeutics announced topline results from the Pivotal Phase 2 portion of the ACTION-Galactosemia study of AT-007, a central nervous system penetrant Aldose Reductase inhibitor, in adult Galactosemia patients. ACTION-Galactosemia is a double-blind placebo-controlled trial evaluating safety and pharmacokinetics of AT-007 in healthy volunteers, as well as safety, pharmacokinetics, and biomarker effects in adult Galactosemia patients over 28 days of once daily oral dosing. The key biomarker outcome of the study was reduction in galactitol, an aberrant toxic metabolite of galactose, formed by Aldose Reductase in Galactosemia patients. AT-007 treatment resulted in a statistically significant and robust reduction in plasma galactitol vs placebo in adult Galactosemia patients. Reductions in galactitol were dose dependent, with higher concentrations of AT-007 resulting in a greater magnitude of reduction in galactitol. At the highest dose tested, AT-007 significantly reduced plasma galactitol 45-54% from baseline vs. placebo. Galactitol reduction was rapid and sustained over time. No substantial change from baseline was observed in placebo treated patients. AT-007 was well tolerated, with no drug-related adverse events noted to date in Galactosemia patients or in the 72 healthy volunteers treated in Part 1 of the trial. The company will present full data from the ACTION-Galactosemia trial at the Society for Inherited Metabolic Disorders Annual Meeting, April 26 - 29, 2020. Applied Therapeutics will continue to characterize AT-007 long-term safety in adult Galactosemia patients and intends to initiate a pediatric study in 2020. Based on these results, Applied Therapeutics believes that AT-007 represents a potentially compelling new therapeutic option for patients with Galactosemia. The company plans to utilize recent FDA guidance permitting biomarker-based development in low prevalence, slowly progressing rare metabolic diseases, such as Galactosemia, and expects to file for regulatory approval in the second half of 2020.
|Over a month ago|
Applied Therapeutics files to sell 1.38M shares of common stock for holders 16:5912/1312/13/19
Applied Therapeutics to present pre-clinical data highlighting AT-001 » 07:0212/0612/06/19
Applied Therapeutics announced the presentation of data at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles on AT-001, a novel, potent and selective aldose reductase inhibitor in Phase 3 clinical development for Diabetic Cardiomyopathy. Overcoming the Safety Challenges of Aldose Reductase Inhibition: Development of AT-001 for Diabetic Cardiomyopathy: AT-001 is logarithmically more potent than zopolrestat in inhibiting Aldose Reductase; The unique structure and activity of AT-001 provide selectivity for Aldose Reductase and avoid off-target inhibition of Aldehyde Reductase; The in vitro safety of this agent together with the positive safety data from the phase 1/2 program, support the ongoing pivotal study in DbCM.