Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

Calliditas Therapeutics announced the randomization of the first patient in its pivotal Phase 2b/3 TRANSFORM study for primary biliary cholangitis (PBC). The trial will assess the efficacy of setanaxib at dosages of 1200 mg and 1600 mg daily, compared to a placebo, focusing on alkaline phosphatase reduction.

The study aims to involve ~318 patients and expects results in H2 2024/H1 2025. An interim analysis will help determine the dosage to continue into Phase 3. The FDA has granted Fast Track Designation for setanaxib in PBC.

Calliditas Therapeutics AB (Nasdaq: CALT) has announced the commercial launch of TARPEYO™ (budesonide), the first FDA-approved treatment for IgA nephropathy. This drug is indicated for the reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression, specifically those with a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. The launch follows accelerated FDA approval, and the company has initiated sales and a patient support program to enhance accessibility. Continued approval may depend on results from ongoing clinical trials.

Calliditas Therapeutics has received FDA approval for TARPEYO (budesonide) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This accelerated approval is based on the drug's success in a pivotal Phase 3 study, achieving a 34% reduction in proteinuria after nine months. While this marks Calliditas' transition to a commercial-stage biopharma, the long-term benefit on kidney function remains unverified. TARPEYO is expected to be available in early 2022, accompanied by a patient support program.

Calliditas Therapeutics reported significant developments in its press release dated November 18, 2021. Following promising Phase 3 study results for Nefecon, the company partnered with Stada Arzneimittel for commercialization in Europe. They also secured a $75 million credit line from Kreos. In Q3 2021, net sales reached SEK 198.2 million, a substantial increase from zero sales in Q3 2020. Operating profit improved to SEK 7.9 million from a loss of SEK 104.9 million year-on-year. However, the FDA extended the PDUFA date for Nefecon's NDA to December 15, 2021, necessitating further data analyses.

Calliditas Therapeutics (CALT) announced presentations concerning its lead product, Nefecon, at the American Society of Nephrology (ASN) annual Kidney Week 2021, held virtually from November 2-7. The posters will focus on the effects of Nefecon on IgA nephropathy and will be presented on November 4. Dr. Karen Molyneux and Laura Pérez-Alós will present findings on Nefecon's impact on immune cell trafficking and the complement system. The presentations aim to reinforce the therapeutic potential of Nefecon in addressing unmet medical needs in renal diseases, highlighted by positive biomarker data.

Calliditas Therapeutics has announced the composition of its nomination committee for the 2022 Annual General Meeting. The committee comprises four members: Patrick Sobocki (Stiftelsen Industrifonden), Karl Tobieson (Linc AB), Pär Sjögemark (Handelsbanken Fonder), and Elmar Schnee (chairman). The committee will propose candidates for board positions and auditors before the meeting scheduled for May 31, 2022. Shareholders can submit proposals to the committee until April 8, 2022.

On October 7, 2021, Calliditas Therapeutics (Nasdaq: CALT) announced the acquisition of 100% of Genkyotex SA's share capital, following a successful squeeze-out offer to minority shareholders. This acquisition enables Calliditas to fully integrate Genkyotex and leverage its platform. The lead candidate, setanaxib, a first-in-class NOX inhibitor, targets fibrogenesis and is set to enter a Phase 2b/3 trial for primary biliary cholangitis (PBC) in Q4 2021. Calliditas has received FDA fast track designation for setanaxib in PBC, indicating regulatory support for its potential.

Calliditas Therapeutics has confirmed that the EMA's Committee for Human Medicinal Products will continue the assessment of its marketing authorization application (MAA) for Nefecon, a treatment for IgA Nephropathy. Originally granted an accelerated assessment in April 2021, the revised standard procedure will delay the expected decision to Q1 2022, extending the timeline by approximately 3 months. If approved, Nefecon could be available in Europe by mid-2022, being the first approved therapy targeted at IgAN.

Calliditas Therapeutics AB announced that the FDA has extended the PDUFA goal date for the NDA of Nefecon to December 15, 2021. This extension follows the FDA's request for further analyses related to the NefIgArd trial data, which the company has submitted as a major amendment. Calliditas aims for Nefecon to serve as the first FDA-approved treatment for IgA nephropathy based on proteinuria as a surrogate endpoint. The original NDA was filed in March 2021, highlighting the company's ongoing cooperation with the FDA for timely approval.