Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics (NASDAQ: APLT) has completed a public offering of 3,000,000 shares at $23.00 each, raising approximately $64.6 million net of expenses. The offering closed on February 17, 2021, with underwriters exercising an option for an additional 450,000 shares. The funds will be utilized to advance clinical and preclinical development of its drug candidates and general corporate purposes. The offering was managed by Goldman Sachs & Co. LLC, Cowen, and UBS Investment Bank.

Applied Therapeutics, Inc. (NASDAQ: APLT) has priced its underwritten public offering of 3,000,000 shares at $23.00 per share, expected to generate gross proceeds of $69 million. The offering, which could increase by an additional 450,000 shares if underwriters exercise their options, will close on February 17, 2021. The funds will be utilized for advancing clinical and preclinical developments as well as general corporate purposes. Goldman Sachs, Cowen, and UBS are the joint book-running managers for this offering.

Applied Therapeutics (NASDAQ: APLT) announced a public offering of 3,000,000 shares of its common stock, with an additional 450,000 shares available for underwriters. The company plans to use the proceeds for clinical and preclinical development, commercialization efforts, and general corporate purposes. Goldman Sachs, Cowen, and UBS are the joint book-running managers for this offering. The offering's completion is subject to market conditions, and the company emphasizes that this press release does not constitute an offer to sell these securities.

Applied Therapeutics announced that the FDA has lifted the clinical hold on its AT-007 ACTION-Galactosemia Kids study, allowing it to resume immediately. The study is now a combined two-part trial to ensure seamless treatment for patients. All randomized patients can return, with full enrollment expected within weeks. The company targets an NDA submission by Q3 2021. AT-007 aims to treat Galactosemia, having shown positive results in reducing toxic galactitol levels in preliminary studies, and holds Orphan Designation and Pediatric Rare Disease Voucher status.

Applied Therapeutics (Nasdaq: APLT) announced its selection for the NASDAQ Biotechnology Index effective December 21, 2020. This index tracks biotechnology and pharmaceutical securities on NASDAQ, with companies meeting specific market value and volume criteria. Applied Therapeutics focuses on developing novel drug candidates for unmet medical needs, including its lead candidate AT-007 for Galactosemia. The addition to the index may enhance visibility and attract investment due to the index's association with notable ETFs like the iShares NASDAQ Biotechnology ETF.

Applied Therapeutics (Nasdaq: APLT) has launched the "Galactosemia Together" campaign, marking the first industry-led initiative aimed at raising awareness and educating the public about Galactosemia. This campaign, developed with the Galactosemia community, aims to provide reliable resources for families affected by the disease. Galactosemia is a rare genetic metabolic disorder affecting approximately 3,000 individuals in the U.S. The company is also advancing its lead drug candidate, AT-007, for Galactosemia treatment, alongside other drug candidates for different metabolic conditions.

Applied Therapeutics (Nasdaq: APLT) announced promising magnetic resonance spectroscopy (MRS) data from its ACTION-Galactosemia study, showing significant reductions in galactitol levels in the brains of Galactosemia patients treated with AT-007. Patients receiving 20 and 40 mg/kg doses experienced a 61.94% to 69.80% reduction in plasma galactitol. Chief Medical Officer Riccardo Perfetti highlighted this as a significant advancement in Galactosemia research. A conference call is scheduled to discuss the findings in detail.

Applied Therapeutics (Nasdaq: APLT) continues to advance its pipeline in the third quarter of 2020, focusing on Diabetic Cardiomyopathy with robust enrollment in the ARISE-HF Phase 3 study. The company also plans to initiate rare disease programs for SORD Deficiency and PMM2-CDG in 2021. Financially, APLT reported a net loss of $29.8 million, up from $10.7 million in the same quarter last year, with research and development expenses increasing significantly to $19.9 million. Cash reserves stood at $116.5 million as of September 30, 2020, indicating a strong financial position for ongoing projects.

Applied Therapeutics (Nasdaq: APLT) announced pre-clinical data showing that AT-001, an Aldose Reductase inhibitor, normalizes cardiac energetics and improves cardiac function in a mouse model of Diabetic Cardiomyopathy (DbCM). AT-001 treatment led to decreased cardiac fatty acid oxidation rates and improved cardiac efficiency. This promising data supports the ongoing Phase 3 ARISE-HF study targeting patients at high risk for heart failure. The findings indicate AT-001's potential to shift cardiac cells towards a non-diabetic state, offering meaningful implications for DbCM patients.