Calliditas Therapeutics AB (publ), a clinical-stage biopharmaceutical company, focused on identifying, developing, and commercializing pharmaceuticals products for treatments in orphan indications with initial focus on renal and hepatic diseases. The company's lead product candidate is Nefecon, a oral formulation of budesonide that is an immunosuppressant for the treatment of the autoimmune renal disease IgA nephropathy. Calliditas Therapeutics AB (publ) was founded in 2004 and is headquartered in Stockholm, Sweden.
IPO Year: 2020
Exchange: NASDAQ
Website: calliditas.se
Date | Price Target | Rating | Analyst |
---|---|---|---|
6/20/2023 | $60.00 | Buy | H.C. Wainwright |
3/1/2023 | $18.00 | Neutral | Guggenheim |
12/20/2021 | $52.00 → $62.00 | Buy | HC Wainwright & Co. |
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Submission status for CALLIDITAS THERAPEUTICS AB's drug TARPEYO (ORIG-1) with active ingredient BUDESONIDE has changed to 'Approval' on 12/15/2021. Application Category: NDA, Application Number: 215935, Application Classification: Type 5 - New Formulation or New Manufacturer
STOCKHOLM, July 4, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (STO: CALTX) ("Calliditas") today announces that its partner Viatris Pharmaceutical Japan G.K. ("Viatris") has initiated a phase III clinical trial in Japan with Nefecon, named VR-205 in the Japanese market, in Japanese patients with IgA nephropathy (IgAN). The clinical trial is a bridging study requiring a limited number of Japanese patients to participate in a study similar in design to that of the global NefIgArd trial. IgA nephropathy is a designated retractable disease in Japan, with an estimated 33,000 patients in Japan* assumed to be suffering from this disease and with limited treatment options for IgAN
STOCKHOLM, June 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) has issued a patent for application no. 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer." The patent covers a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent will have an expiration date in 2039. Calliditas has corresponding applications and patents in several additional territories around the world, including a pending patent application in Europe. "We are delig
STOCKHOLM, June 17, 2024 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on 17 June 2024, in Stockholm. Adoption of income statement and balance sheet for the financial year 2023 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2023 as well as the balance sheet and consolidated balance sheet as of 31 December 2023. The members of the Board of Directors and the CEO were discharged from liability for the financial year 2023. Allocation of profit or loss
STOCKHOLM, May 30, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and UK. The full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (
STOCKHOLM, May 28, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced the presentations of an additional efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) as well as a real-world analysis of the use of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN). These were presented at ERA 2024 virtually and in Stockholm on May 23 - 26, 2024. The presented efficacy analysis of Nefecon and sparsentan showed that treatment with Nefecon for 9 months was associated with estimated glomerular filtration rate (eGFR) benefit compared with continuous treatment with sparsentan. Additionally, the findings of
STOCKHOLM, May 28, 2024 /PRNewswire/ -- The Board of Directors of Calliditas Therapeutics AB (publ) unanimously recommends that the shareholders and holders of American Depositary Shares ("ADS") of Calliditas Therapeutics AB (publ) (jointly the "Securityholders") accept the public tender offer by Asahi Kasei Corporation. Background This statement is made by the Board of Directors (the "Board") of Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") pursuant to section II.19 of the Nasdaq Stockholm takeover rules ("Section II.19") and Regulation 14D under the Securities Exchange Act of 1934, as amended (together with Section II.19, the "Takeover Rules"). Asahi Kasei Corporat
STOCKHOLM, May 23, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALTX) (STOCKHOLM: CALTX): Target market expansion following full approval in the US JANUARY - MARCH 2024 (COMPARED TO JANUARY - MARCH 2023) Net sales amounted to SEK 295.5 million, of which TARPEYO® net sales amounted to SEK 278.3 million, for the three months ended March 31, 2024. For the three months ended March 31, 2023, net sales amounted to SEK 191.4 million, of which TARPEYO net sales amounted to SEK 185.7 million.Operating loss amounted to SEK 203.8 million and SEK 180.1 million for the three months ended March 31, 2024, and 2023, respectively.Loss per share before and after dilution amounted to SEK 4.59 and
STOCKHOLM, May 16, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that it will hold an in-person and virtual R&D day on Thursday, May 30, 2024 at 3:00 PM CET (9:00 AM ET). The event will be held at Inderes Event Studio, Västra Trädgårdsgatan 19, Stockholm. The event will feature Gareth J. Thomas, PhD (University Hospital Southampton) and Jonathan Barratt, PhD, FRCP (University of Leicester) with the following program: Supportive preclinical data and Phase 2 POC trial evaluating setanaxib, the Company's lead candidate from its NOX platform, in patients with squamous cell carcinoma of the head and neck (SCCHN)The anti
STOCKHOLM, May 16, 2024 /PRNewswire/ -- Calliditas's interim report for the first quarter, January - March 2024 will be published in Swedish and English on Thursday 23 May 2024 at 07.00 a.m. CET. A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, CMO Richard Philipson and President North America Maria Törnsén. The presentation will be given in English. Link to the webcast: Calliditas Therapeutics Q1 Report 2024 (financialhearings.com) To participate via conference call please register via this link: https://conference.financialhearings.com/teleconfere
STOCKHOLM, May 15, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (NASDAQ STOCKHOLM: CALTX) ("Calliditas"), today announced upcoming data presentations and a sponsored symposium at the 61st European Renal Association (ERA) Congress, in Stockholm, Sweden on May 23 - 26, 2024. Data presentations will include an efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) in primary immunoglobulin A nephropathy (IgAN) as well as a real-world analysis of the challenges associated with the use of systemic glucocorticoids (SGC) in IgAN. "We are delighted to participate in ERA and look forward to engaging with the leaders in the renal space," said Richard Philipson
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STOCKHOLM, Jan. 7, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today announced that Maria Törnsén has been appointed to the position of President North America. Ms Törnsén will be responsible for all US based operations and will report to the CEO. Maria Törnsén has broad commercial leadership experience having spent more than 20 years in the biopharma industry in senior commercial roles. Most recently Ms Törnsén held the position of Chief Commercial Officer at Passage Bio, prior to which she was SVP General Manager US at Sarepta Therapeutics. Prior to joining Sarepta she serv
FLORHAM PARK, N.J., June 03, 2022 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ:CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced the appointment of Diane Parks to its Board of Directors. Ms. Parks, an executive with deep experience in the commercialization of novel immuno-oncology therapies, has led the successful launch of numerous hematology and cancer therapies at large pharmaceutical and biotech companies, including Kite Pharma, Inc. (now part of Gilead Sciences, Inc.), Amgen Inc., and Genentech, Inc. (now part of Roche Holdings, Inc.). "It is with great pleasure we welcome Diane to the Cel
FLORHAM PARK, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced the appointment of Molly Henderson to the position of Chief Financial and Business Officer. Ms. Henderson will join the Company effective April 5, 2022. Ms. Henderson most recently served as Chief Financial Officer of UroGen Pharma (NASDAQ:URGN), a commercial-stage biopharmaceutical company focused on building novel treatments for specialty cancers and urologic disease. She brings over two decades of global finance expertise and has
STOCKHOLM, June 17, 2024 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on 17 June 2024, in Stockholm. Adoption of income statement and balance sheet for the financial year 2023 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2023 as well as the balance sheet and consolidated balance sheet as of 31 December 2023. The members of the Board of Directors and the CEO were discharged from liability for the financial year 2023. Allocation of profit or loss
STOCKHOLM, May 23, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALTX) (STOCKHOLM: CALTX): Target market expansion following full approval in the US JANUARY - MARCH 2024 (COMPARED TO JANUARY - MARCH 2023) Net sales amounted to SEK 295.5 million, of which TARPEYO® net sales amounted to SEK 278.3 million, for the three months ended March 31, 2024. For the three months ended March 31, 2023, net sales amounted to SEK 191.4 million, of which TARPEYO net sales amounted to SEK 185.7 million.Operating loss amounted to SEK 203.8 million and SEK 180.1 million for the three months ended March 31, 2024, and 2023, respectively.Loss per share before and after dilution amounted to SEK 4.59 and
STOCKHOLM, May 16, 2024 /PRNewswire/ -- Calliditas's interim report for the first quarter, January - March 2024 will be published in Swedish and English on Thursday 23 May 2024 at 07.00 a.m. CET. A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, CMO Richard Philipson and President North America Maria Törnsén. The presentation will be given in English. Link to the webcast: Calliditas Therapeutics Q1 Report 2024 (financialhearings.com) To participate via conference call please register via this link: https://conference.financialhearings.com/teleconfere
STOCKHOLM, Feb. 21, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX) 2023: Full approval for TARPEYO in the US; a year of successes OCTOBER – DECEMBER 2023(COMPARED TO OCTOBER – DECEMBER 2022) Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales amounted to SEK 347.3 million, for the three months ended December 31, 2023. For the three months ended December 31, 2022, net sales amounted to SEK 429.0 million, of which TARPEYO net sales amounted to SEK 167.3 million.Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.Loss per share before and af
STOCKHOLM, Feb. 14, 2024 /PRNewswire/ -- Calliditas' Year-end report for January - December 2023 will be published in Swedish and English on Wednesday 21 February 2024 at 07.00 a.m. CET. A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, CMO Richard Philipson and President North America Maria Törnsén. The presentation will be given in English. Link to the webcast: https://ir.financialhearings.com/calliditas-therapeutics-q4-report-2023 To participate via conference call please register via this link: https://conference.financialhearings.com/teleconferen
STOCKHOLM, May 30, 2023 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on 30 May 2023, in Stockholm. Adoption of income statement and balance sheet for the financial year 2022 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2022 as well as the balance sheet and consolidated balance sheet as of 31 December 2022. The members of the Board of Directors and the CEO were discharged from liability for the financial year 2022. Allocation of profit or loss The annual general meeting resolved, in acco
STOCKHOLM, March 13, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO®/Kinpeygo® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN). The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of
STOCKHOLM, Dec. 21, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") announced today that CEO Renée Aguiar-Lucander has net purchased 50,000 shares through Calliditas' warrant program 2019/2022. Following the new subscription for shares, her shareholding in the company will amount to 643,000 common shares. The majority of the members of management who are eligible option holders in the program have today net purchased shares via the warrant program 2019/2022, which includes 422,500 warrants and can be exercised up to and including December 31, 2022. To partially finance the share purchases, the option holders in the program, inclu
STOCKLHOLM, May 19, 2022 /PRNewswire/ -- The meeting was held in accordance with sections §§ 20 and 22 of the Act (2022:121) on temporary exceptions to facilitate the execution of general meetings in companies and other associations and the shareholders solely exercised their voting rights at the general meeting through voting in advance, so-called postal voting. The following resolutions were passed at the annual general meeting. Adoption of income statement and balance sheet for the financial year 2021 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2021 as well as the balance shee
STOCKHOLM, March 24, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") announced today that CEO Renée Aguiar-Lucander has subscribed for 175,000 shares through Calliditas' warrant program 2018/2022. Following the new subscription for shares, Renée Aguiar-Lucander's shareholding in the company will amount to 593,000 common shares. All members of the management team who are warrant holders in the program have today exercised their opportunity to subscribe for shares in the 2018/2022 warrant program, which comprises 856,586 warrants and can be exercised until 31 March 2022. To partially finance the share subscriptions, warrant holder
H.C. Wainwright initiated coverage of Calliditas Therapeutics AB with a rating of Buy and set a new price target of $60.00
Guggenheim initiated coverage of Calliditas Therapeutics AB with a rating of Neutral and set a new price target of $18.00
HC Wainwright & Co. reiterated coverage of Calliditas Therapeutics with a rating of Buy and set a new price target of $62.00 from $52.00 previously
HC Wainwright initiated coverage of Calliditas Therapeutics AB (publ) with a rating of Buy
H.C. Wainwright initiated coverage of Calliditas Therapeutics AB with a rating of Buy and set a new price target of $52.00
The clinical trial is a bridging study requiring a limited number of Japanese patients to participate in a study similar in design to that of the global NefIgArd trial. IgA nephropathy is a designated retractable disease in Japan, with an estimated 33,000 patients in Japan* assumed to be suffering from this disease and with limited treatment options for IgAN patients in this country.
In the last three months, 5 analysts have published ratings on Calliditas Therapeutics (NASDAQ:CALT), offering a diverse range of perspectives from bullish to bearish. The table below offers a condensed view of their recent ratings, showcasing the changing sentiments over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 1 0 4 0 0 Last 30D 0 0 1 0 0 1M Ago 1 0 3 0 0 2M Ago 0 0 0 0 0 3M Ago 0 0 0 0 0 Providing deeper insights, analysts have established 12-month price targets, indicating an average target of $40.4, along with a high estimate of $45.00 and a low estimate of $39.00. Highlig
Citigroup analyst Yigal Nochomovitz downgrades Calliditas Therapeutics (NASDAQ:CALT) from Buy to Neutral and announces $39 price target.
Jefferies analyst Maury Raycroft downgrades Calliditas Therapeutics (NASDAQ:CALT) from Buy to Hold and lowers the price target from $58 to $39.
U.S. stocks traded mixed toward the end of trading, with the Dow Jones index falling more than 250 points on Tuesday. The Dow traded down 0.69% to 38,798.34 while the NASDAQ rose 0.41% to 16,990.44. The S&P 500 also fell, dropping, 0.11% to 5,298.87. Check This Out: This Airbnb Analyst Turns Bullish; Here Are Top 5 Upgrades For Tuesday Leading and Lagging SectorsInformation technology shares jumped by 1.5% on Tuesday. In trading on Tuesday, health care shares fell by 1.4%. Top Headline Shares of Elbit Systems Ltd. (NASDAQ:ESLT) fell around 2.5% on Tuesday after the company reported results for the first quarter. The company reported first-quarter FY24 revenue of $1.554 b
Stifel analyst Annabel Samimy downgrades Calliditas Therapeutics (NASDAQ:CALT) from Buy to Hold and lowers the price target from $55 to $40.
Shares of Applied DNA Sciences, Inc. (NASDAQ:APDN) fell sharply during Tuesday's session after the company announced the pricing of a $12 million public offering. Applied DNA Sciences shares tumbled 67.5% to $0.6468 on Tuesday. Here are some other stocks moving in today’s mid-day session. Gainers Sharps Technology, Inc. (NASDAQ:STSS) shares climbed 207% to $0.6579 after jumping around 13% on Friday. Insmed Incorporated (NASDAQ:INSM) jumped 110% to $46.20 after the company announced topline results from ASPEN Phase 3 study met its primary endpoint. Pineapple Energy Inc. (NASDAQ:PEGY) shares gained 91.5% to $0.3411 after the company on Friday announced its SUNation subsidiar
Gainers Sharps Technology (NASDAQ:STSS) stock rose 140.0% to $0.51 during Tuesday's regular session. The company's market cap stands at $8.0 million. Insmed (NASDAQ:INSM) stock moved upwards by 112.72% to $46.8. The company's market cap stands at $6.9 billion. Calliditas Therapeutics (NASDAQ:CALT) shares moved upwards by 69.26% to $37.95. The company's market cap stands at $1.0 billion. The company's, Q1 earnings came out 3 days ago. Predictive Oncology (NASDAQ:POAI) shares rose 36.54% to $2.14. The company's market cap stands at $8.7 million. Semler Scientific (NASDAQ:SMLR) stock moved upwards by 28.55% to $29.98. The company's market cap stands at $211.8 million. Exicure (NASDAQ:XCUR
Japanese chemical company Asahi Kasei Corporation made a $1.1 billion (SEK 11.164 billion) takeover bid for Swedish pharmaceutical company Calliditas Therapeutics AB (NASDAQ:CALT). The deal offers 208 Swedish krona in cash per share and a concurrent offer for American Depositary Shares, each representing two Shares in Calliditas, for 416 Swedish krona in cash per ADS. The Calliditas board unanimously recommended that shareholders accept the deal. Asahi Kasei, especially the pharmaceutical business, aims to expand globally by specializing in immunology, transplantation, and adjacent diseases. Asahi Kasei continues to focus on maximizing the potential of Veloxis while pursuing add