Intra-Cellular, Kiniksa hit on catalysts; updates for Ocular, Applied Thera | $ITCI, $KNSA, $OCUL, $APLT
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) on April 16, 2024, said its phase III study evaluating Caplyta (lumateperone) as a treatment for major depressive disorder (MDD) met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
In the modified intent-to-treat population in Study 501, the least squares (LS) mean reduction from baseline for 42 mg of lumateperone was 14.7 points, versus 9.8 points for placebo (LS mean difference = -4.9 points; p<0.0001).
After the success in Study 501, Intra-Cellular now expects to release data on Study 502 before the end of second quarter which should further strengthen the company’s plans to file an NDA for lumateperone to become an adjunctive therapy for MDD. The drug already is approved to treat schizophrenia and bipolar depression. Both studies 501 and 502 are enrolling MDD adult patients who are experiencing an inadequate response to current antidepressant monotherapy (ADT).
Biotech Currents/SanaCurrents issued a report on Intra-Cellular’s studies 501 and 502 last month.
Intra-Cellular's push into MDD with its anti-psychotic Caplyta | $ITCI
SUMMARY Over the past four years, Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) successfully launched Caplyta (lumateperone) to treat schizophrenia and bipolar depression. Net product sales of Caplyta reached $462.2 million in 2023, reflecting 86% growth from 2022. Starting at zero in March 2020, Caplyta sales increased slowly in 2020-21 during the pandemic when the drug was indicated only for schizophrenia. Annual sales in 2021 approximated $20 million. The drug, however, took off when it was indicated for bipolar depression in December 2021.
At the time of the report, Intra-Cellular’s stock traded at $69.06 per share. The company’s stock closed on April 16 at $79.84 per share, a 15.6% gain from the time of the report.
Earlier this month, Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) reported positive data from the first 3 cohorts of KPL-404 to treat rheumatoid arthritis. Biotech Currents/SanaCurrents issued a report on the KPL-404 trial in December 2023. As of April 16, Kiniksa’s stock climbed 4.1% from the company’s share price at the time of the report.
SanaCurrents on Kiniksa's under-the-radar play in rheumatoid arthritis | $KNSA
SUMMARY Prior to the Covid-19 pandemic, Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) licensed a few advanced-stage drugs and partnered with Regeneron Pharmaceuticals (NASDAQ:RGEN) to develop Arcalyst (rilonacept) to treat recurrent pericarditis. Kiniksa’s efforts with
Biotech Currents/SanaCurrents is discontinuing coverage and closing its position in Ocular Therapeutics. In the past two months, the company made two major adjustments to senior management. In the most recent, executive chairman Praven Dugel assumed the duties of CEO and president, while retaining executive chairman responsibilities. Antony Mattessich stepped down as president and CEO effective April 15. While Ocular’s portfolio is impressive, the company’s current state of management likely will suppress investor support of any success from the trial of Ocular’s Axpaxli implant to treat non-proliferative diabetic retinopathy. Ocular’s shares are down about 20% from the time of Biotech Currents/SanaCurrents’ February 2024 report.
SanaCurrents on Ocular's long-term implant to treat NPDR and wet AMD | $OCUL
SUMMARY The market for new treatments for “back of the eye” diseases surged in recent years, driven in part by the need to move beyond injections required to be administered every 4-8 weeks. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a nearly 20-year-old company, develops drugs for eye diseases based on its Elutyx bioresorbable hydrogel-based formulation technology. While it has two drugs on the market, the company attracted a $325 million private placement on February 22 based on advancing Axpaxli (axitinib intravitreal implant) to treat wet age-related macular degeneration (wet AMD).
Related
In late March, the FDA informed Applied Therapeutics, Inc. (NASDAQ:APLT) the PDUFA decision for the company’s drug govorestat would be delayed by three months. The new PDUFA date is November 28, 2024, instead of the original assigned date of August 28, 2024.
SanaCurrents on Applied Thera's govorestat to treat rare metabolic disease in infants | $APLT
SUMMARY Applied Therapeutics, Inc. (NASDAQ:APLT) is advancing govorestat to treat the rare metabolic disease classic galactosemia. Children inherit the disease, which results in the inability to metabolize galactose. Eventually, galactose converts to a toxic and aberrant metabolite named galactitol.
The FDA said it needed additional time to review supplemental analyses which the company sent to the agency in response to routine information requests. The FDA determined the additional information constitutes a major amendment to the NDA. Biotech Currents/SanaCurrents is maintaining its coverage and position in Applied Therapeutics.