CALT Calliditas Therapeutics AB

29.65
+0.52  (+2%)
Previous Close 29.13
Open 29.98
52 Week Low 19
52 Week High 38
Market Cap $740,383,983
Shares 24,970,792
Float 24,970,792
Enterprise Value $608,441,886
Volume 23,820
Av. Daily Volume 26,986
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Drug Pipeline

Drug Stage Notes
Nefecon (NefIgArd)
IgA nephropathy
Phase 3
Phase 3
Phase 3 trial met primary endpoint in Part A portion of trial - November 10, 2020. Part B part fully enrolled - January 21, 2021.
Setanaxib
Primary biliary cholangitis (PBC)
Phase 2/3
Phase 2/3
Phase 2/3 trial to be initiated 2H 2021.

Latest News

  1. STOCKHOLM, Feb. 18, 2021 /PRNewswire/ -- "On November 8, 2020, we announced positive topline readout of Part A of our Phase 3 pivotal trial, NefIgArd. The results were statistically significant and clinically relevant: proteinuria showed a 31% reduction versus baseline, a stronger effect than what was seen in the Phase 2b (27%), which is generally not expected when moving from Phase 2 to Phase 3. In addition, eGFR was stabilised in the treated patient population, which in the end is the true treatment goal. This potentially disease modifying effect is to our knowledge unique to Nefecon, which we find extremely exciting, and we look forward to our interactions with regulators during the year as we progress towards potential approval.

    We also…

    STOCKHOLM, Feb. 18, 2021 /PRNewswire/ -- "On November 8, 2020, we announced positive topline readout of Part A of our Phase 3 pivotal trial, NefIgArd. The results were statistically significant and clinically relevant: proteinuria showed a 31% reduction versus baseline, a stronger effect than what was seen in the Phase 2b (27%), which is generally not expected when moving from Phase 2 to Phase 3. In addition, eGFR was stabilised in the treated patient population, which in the end is the true treatment goal. This potentially disease modifying effect is to our knowledge unique to Nefecon, which we find extremely exciting, and we look forward to our interactions with regulators during the year as we progress towards potential approval.

    We also concluded the purchase of a controlling block in Genkyotex in Q4. This is a company we had followed and where we found the clinical data intriguing and their approach clearly differentiated. Genkyotex had positive interactions with the FDA in 2020, which resulted in an adaptive pivotal Phase 2/3 design in PBC and they also initiated a Phase 1 PK study to look into higher dosing, which read out positively in early 2021. We feel excited about taking on a pioneering role in the area of NOX inhibitors and to initiate studies in PBC, as well as on the basis of comprehensive and compelling animal-based data launch a proof of concept trial in head and neck cancer where today's immunotherapy has limited reach."

    Renée Aguiar-Lucander, CEO

    Summary of Q4 2020

    October 1 - December 31, 2020           

    • Net sales amounted to SEK 0.4 million and SEK 46.6 million for the three months ended December 31, 2020 and 2019, respectively.
    • Operating loss amounted to SEK 135.9 million and SEK 18.0 million for the three months ended December 31, 2020 and 2019, respectively.
    • Loss before income tax amounted to SEK 173.3 million and SEK 23.0 million for the three months ended December 31, 2020 and 2019, respectively.
    • Loss per share before and after dilution amounted to SEK 3.41 and SEK 0.60, for the three months ended December 31, 2020 and 2019, respectively.
    • Cash amounted to SEK 996.3 million and SEK 753.5 million as of December 31, 2020 and 2019, respectively

    Significant events during Q4 2020, in summary           

    • In November 2020, Calliditas announced positive topline results from Part A from the pivotal Phase 3 NefIgArd trial.
    • In November 2020, Calliditas acquired a controlling interest in Genkyotex SA followed by a simplified mandatory offer to the shareholders of Genkyotex, after which Calliditas controlled 86.2 percent of the shares in Genkyotex.

    Significant events after the end of reporting period, in summary           

    • In January 2021, Calliditas shared the clinical development plan for setanaxib and additional data from Part A of the NefIgArd study at the R&D Day

    Investor Presentation February 18, 14:30 CET

    Audio cast with teleconference, Q4 2020, February 18, 2021, 14:30 (Europe/Stockholm)

    Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q4-2020

    Teleconference: SE: +46850558356 UK: +443333009262 US: +18338230586

    Financial calendar

    Publication of the Annual Report 2020                                                                    April 27, 2021

    Interim Report for the period January 1 - March 31, 2021                                      May 13, 2021

    Interim Report for the period January 1 - June 30, 2021                                    August 19, 2021

    Interim Report for the period January 1 - September 30, 2021                     November 18, 2021

    Year-end Report for the period January 1 - December 31, 2021                     February 24, 2022

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Email:

    Mikael Widell, Investor Relations

    Email:

    Telephone: +46 703 11 99 60

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on February 18, 2021.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas'' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas'' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

     

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  2. STOCKHOLM, Feb. 4, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the first patient has been dosed in the global open-label extension (OLE) of the Phase 3 NefIgArd study. OLE offers a 9-month treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of Nefecon treatment in patients with IgA Nephropathy (IgAN).

    This study will evaluate patients who have completed the Phase 3 study NefIgArd, which achieved both its primary and key secondary endpoints in the Part A topline data read out on November 8, 2020. All patients will continue on RAS inhibitor therapy (ACEs and/or ARBs) and be treated for 9 months with Nefecon in the OLE study…

    STOCKHOLM, Feb. 4, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the first patient has been dosed in the global open-label extension (OLE) of the Phase 3 NefIgArd study. OLE offers a 9-month treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of Nefecon treatment in patients with IgA Nephropathy (IgAN).

    This study will evaluate patients who have completed the Phase 3 study NefIgArd, which achieved both its primary and key secondary endpoints in the Part A topline data read out on November 8, 2020. All patients will continue on RAS inhibitor therapy (ACEs and/or ARBs) and be treated for 9 months with Nefecon in the OLE study.

    At the end of the treatment period, change in urine protein to creatinine ratio (UPCR) and change in estimated glomerular filtration rate (eGFR) will be evaluated. Further, a comparison between treatment naïve and those patients who received Nefecon in the Phase 3 NefIgArd study will be made. Three months after completion of treatment, all patients have a scheduled follow up visit.

    "This trial will provide us with information regarding retreatment and will add to the sizeable data set of patients which have already completed efficacy and safety related trials with Nefecon.  We are also glad to be able to provide the active drug to all patients having completed the NefIgArd trial, irrespective of treatment arm, following the positive topline data readout in Part A of the NefIgArd study showing stabilization of eGFR in the treatment arm at 36 weeks", said CEO Renée Aguiar-Lucander.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845, email:

    The information was sent for publication, through the agency of the contact persons set out above, on February 4, 2021 at 8:30 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    Forward-Looking Statements 

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial and the OLE clinical trial, Calliditas' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to regulatory filings submissions for Nefecon, the continuation of Part B of the NefIgArd study and the OLE study, Calliditas'' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports and other filings filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas'' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

     

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  3. STOCKHOLM, Jan. 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; Nasdaq - CALT) today announced that despite significant interest, it will not pursue the previously announced proposed global offering due to deterioration in market conditions.

    "This was an opportunistic capital raise against the backdrop of a strong overall market and communicated support from institutions. However, following the sudden and significant market deterioration seen yesterday, we no longer believe that it is in the interest of the company and its current shareholders to pursue the financing at this time," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

    "Calliditas is well capitalized with a cash runway into…

    STOCKHOLM, Jan. 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; Nasdaq - CALT) today announced that despite significant interest, it will not pursue the previously announced proposed global offering due to deterioration in market conditions.

    "This was an opportunistic capital raise against the backdrop of a strong overall market and communicated support from institutions. However, following the sudden and significant market deterioration seen yesterday, we no longer believe that it is in the interest of the company and its current shareholders to pursue the financing at this time," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

    "Calliditas is well capitalized with a cash runway into Q3 of 2022 and we believe there are financing options which are more attractive than an equity issuance in the present volatile market circumstances. This decision does not have any impact on the our previously communicated plans with regards to our operations or development pipeline."

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46 722 52 10 06, e-mail:

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail:

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on January 28, 2021 at 2:40 p.m (CET).

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    Safe Harbor/Forward-Looking Statements

    This announcement contains forward-looking statements, including as to the Company's capital requirements and expected cash runway. These statements are based on expectations in light of the information that is currently available, as well as assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from such statements. These risks and uncertainties include, but are not limited to, domestic and international economic conditions, industry and market conditions, and changes of interest rate and currency exchange rate, in general, and completion and discontinuation of clinical trials, obtaining regulatory approvals, claims and concerns about product safety and efficacy, technological advances, domestic and foreign healthcare reforms, and changes of laws and regulations, in particular, with respect to Nefecon and setanaxib. Calliditas disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. This announcement contains information on pharmaceuticals (including pharmaceuticals under development) but is not intended to, and does not, make any representations, warranties or claims regarding the efficacy or effectiveness of these pharmaceuticals or provide medical advice of any kind.

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  4. STOCKHOLM, Jan. 26, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) will today launch a proposed public offering of American Depositary Shares ("ADSs"), in the United States for trading on The Nasdaq Global Select Market in the United States (the "U.S. Offering") and a concurrent private placement of common shares to certain qualified investors in Europe and other countries outside of the United States (the "Private Placement", and together with the U.S. Offering, the "Global Offering"). The target size of the Global Offering is 4,500,000 common shares plus a potential 30-day over-allotment option of 15 percent of the common shares (including common shares in the form of ADSs) offered by

    STOCKHOLM, Jan. 26, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) will today launch a proposed public offering of American Depositary Shares ("ADSs"), in the United States for trading on The Nasdaq Global Select Market in the United States (the "U.S. Offering") and a concurrent private placement of common shares to certain qualified investors in Europe and other countries outside of the United States (the "Private Placement", and together with the U.S. Offering, the "Global Offering"). The target size of the Global Offering is 4,500,000 common shares plus a potential 30-day over-allotment option of 15 percent of the common shares (including common shares in the form of ADSs) offered by Calliditas at the U.S. Offering price. The Global Offering is subject to market conditions and investor demand and the number of ADSs (which represents two common shares) and common shares that may be offered and the price for such instruments have not yet been determined.

    Calliditas announces that it has today commenced an underwritten global offering with a target size of 4,500,000 common shares, plus a potential 30-day over-allotment of 15 percent of the common shares (including common shares in the form of ADSs) offered by Calliditas at the U.S. Offering price.

    Calliditas will announce the outcome of the Global Offering after pricing in a subsequent press release; however, any further details regarding the offering remain subject to market conditions and investor demand and the Global Offering may not be consummated. Calliditas' common shares are currently listed on Nasdaq Stockholm under the symbol "CALTX", and Calliditas' ADSs are currently listed on The Nasdaq Global Select Market under the symbol "CALT". 

    This company announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    A registration statement relating to the ADSs referred to herein has been filed with the SEC, but has not yet been declared effective. These ADSs may not be sold, nor may offers to buy these ADSs be accepted prior to the time such registration statement becomes effective. Citigroup Global Markets Inc., Jefferies LLC and Stifel, Nicolaus & Company, Incorporated are acting as the global coordinators and joint book-running managers of the Global Offering. Kempen & Co, LifeSci Capital LLC and Carnegie will act as co-managers for the Global Offering. Citigroup Global Markets Inc. and Jefferies LLC are acting as representatives of the underwriters in the U.S. Offering. Citigroup Global Markets Limited, Jefferies International Limited and Jefferies GmbH are acting as representatives of the underwriters in the Private Placement. Copies of the preliminary prospectus related to the U.S. Offering are available at www.sec.gov. Alternatively, copies of the preliminary prospectus relating to the U.S. Offering may be obtained from Citigroup Global Markets Inc., Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at +1 (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: +1 877-821-7388 or via email: or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at +1 (415) 364-2720 or by email at .

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46 722 52 10 06, e-mail:

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail:

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on January 26, 2021 at 10:10 p.m (CET).

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    Important information

    No announcements or information regarding the proposed public offering may be disseminated to the public in jurisdictions where a prior registration or approval is required for such purpose. No steps have been taken, or will be taken, for the offering of common shares or ADSs in any jurisdiction where such steps would be required. The issue or sale of common shares or ADSs, and the subscription for or purchase of common shares or ADSs, are subject to special legal or statutory restrictions in certain jurisdictions. Calliditas is not liable if these restrictions are not complied with by any other person.

    This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. Calliditas has not authorized any offer to the public of shares or rights in any member state of the EEA and no prospectus has been or will be prepared in connection therewith. In any EEA member state, this communication is only addressed to and is only directed at qualified investors in that member state within the meaning of the Prospectus Regulation.

    In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, "qualified investors" who are (i) persons having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this document and should not act or rely on it.

    Safe Harbor/Forward-Looking Statements

    This announcement contains forward-looking statements, including as to the intended use of net proceeds from the Global Offering described herein and the timing of the closing of the Global Offering. These statements are based on expectations in light of the information that is currently available, as well as assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from such statements. These risks and uncertainties include, but are not limited to, domestic and international economic conditions, industry and market conditions, and changes of interest rate and currency exchange rate, in general, and completion and discontinuation of clinical trials, obtaining regulatory approvals, claims and concerns about product safety and efficacy, technological advances, domestic and foreign healthcare reforms, and changes of laws and regulations, in particular, with respect to Nefecon and setanaxib. Calliditas disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. This announcement contains information on pharmaceuticals (including pharmaceuticals under development) but is not intended to, and does not, make any representations, warranties or claims regarding the efficacy or effectiveness of these pharmaceuticals or provide medical advice of any kind.

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  5. STOCKHOLM, Jan. 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

    The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR.  It…

    STOCKHOLM, Jan. 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

    The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR.  It also showed that Nefecon was generally well-tolerated.

    Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the Phase 3 trial includes the further 160 patients enrolled in addition to the 200 patients from Part A.  

    "To have fully enrolled our Phase 3 pivotal trial is a great milestone, even more so as we achieved this during the pandemic, which reflects the commitment of investigators and patients, as well as that of our experienced clinical team." said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email:

    The information was sent for publication, through the agency of the contact persons set out above, on January 21, 2021 at 08:30 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    Forward-Looking Statements 

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial, Calliditas' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to regulatory filings and submissions for Nefecon, the continuation and prospects for the success of Part B of the NefIgArd study, Calliditas'' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports and other filings filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas'' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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    SOURCE Calliditas Therapeutics

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