DRRX DURECT Corporation

1.41
-0.1  -7%
Previous Close 1.51
Open 1.47
52 Week Low 1.28
52 Week High 2.947
Market Cap $320,642,717
Shares 227,406,182
Float 197,734,763
Enterprise Value $271,946,334
Volume 954,955
Av. Daily Volume 587,185
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Drug Pipeline

Drug Stage Notes
DUR-928
Nonalcoholic steatohepatitis (NASH)
Phase 1b
Phase 1b
Phase 1b top-line data released May 26, 2020.
DUR-928
COVID-19 Patients with Acute Liver or Kidney Injury
Phase 2
Phase 2
Phase 2 trial to be discontinued due to limited number of patients eligible or willing to enroll.
POSIMIR
Post-operative pain relief
Approved
Approved
FDA approval announced February 2, 2021.
DUR-928 (AHFIRM)
Alcoholic hepatitis (AH)
Phase 2b
Phase 2b
Phase 2b initiation of dosing announced January 25, 2021.
DUR-928
Psoriasis
Phase 2a
Phase 2a
Phase 2 top-line data did not meet endpoints - January 2, 2020.
RBP-7000
Schizophrenia
Approved
Approved
FDA Approval announced July 27, 2018.
Posidur
Post-operative pain relief
CRL
CRL
CRL issued February 12, 2014.

Latest News

  1. CUPERTINO, Calif., July 29, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months ended June 30, 2021 and provided a corporate update.

    Q2 2021 Accomplishments:

    We expanded the number of U.S. clinical trial sites to 26 in the Phase 2b AHFIRM clinical study of DUR-928 in severe alcohol-associated hepatitis (AH), and we are enrolling at a good rate. We have now opened about 75% of the U.S. sites we plan to open. We expect to open our first ex-U.S. clinical sites (in the UK, Europe and Australia) in the coming months. In addition, we presented further encouraging DUR-928 clinical data from the completed NASH Phase 1b trial showing trends for reduction in insulin resistance and liver fibrosis…

    CUPERTINO, Calif., July 29, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months ended June 30, 2021 and provided a corporate update.

    Q2 2021 Accomplishments:

    We expanded the number of U.S. clinical trial sites to 26 in the Phase 2b AHFIRM clinical study of DUR-928 in severe alcohol-associated hepatitis (AH), and we are enrolling at a good rate. We have now opened about 75% of the U.S. sites we plan to open. We expect to open our first ex-U.S. clinical sites (in the UK, Europe and Australia) in the coming months. In addition, we presented further encouraging DUR-928 clinical data from the completed NASH Phase 1b trial showing trends for reduction in insulin resistance and liver fibrosis biomarkers. Data from a Pharmacokinetic trial in patients with moderate and severe liver impairment showed a reduction in an important apoptosis biomarker with no adverse events or dose-limiting toxicity in these severely ill liver patients. We were also invited to present at the 2021 Epigenetic Therapeutic Targets Virtual Summit, which is for leading companies in the field of Epigenetics to present to their peers. To our knowledge, we were the only presenter utilizing an epigenetic regulator to restore function in injured cells as opposed to most who are using epigenetics to kill cancer cells. Our presentation was well received.

    "Executing on the AHFIRM trial to the highest level of quality and in a timely fashion is our highest priority and we are pleased with the progress made this quarter," stated James E. Brown, D.V.M, President and CEO of DURECT.  "Discussions with potential POSIMIR partners are ongoing." 

    Financial highlights for Q2 2021:

    • Total revenues were $2.3 million and net loss was $9.1 million for the three months ended June 30, 2021 as compared to total revenues of $24.5 million and net income of $14.3 million for the three months ended June 30, 2020. Total revenues and net income for the three months ended June 30, 2020 included the recognition of $23.1 million in deferred revenue related to the termination of a license agreement during that period.
    • At June 30, 2021, cash and investments were $88.6 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at June 30, 2021 was $20.4 million, compared to $20.8 million at December 31, 2020.

    Update on Selected Programs:

    Epigenetic Regulator Program. DUR-928, the lead product candidate in the Company's Epigenetic Regulator Program, is an endogenous, orally bioavailable, first-in-class small molecule, which may have broad applicability in acute organ injuries such as alcohol-associated hepatitis (AH) as well as in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).

    Clinical Development

    Alcohol-associated Hepatitis (AH)

    • Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM).  AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH.  The study is comprised of three arms targeting enrollment of approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) DUR-928 (30 mg); and (3) DUR-928 (90 mg).  All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC.  The Company is targeting approximately 50 to 60 clinical trial sites in the U.S., U.K., E.U. and Australia.
    • Given the high mortality rate in severe AH patients and the absence of an approved therapeutic, we believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing.
    • Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA granted DUR-928 Fast Track Designation for the treatment of AH in December 2020.
    • In March 2021, a peer-reviewed research paper describing the binding sites and proposed mechanism of action of DUR-928 was published in The Journal of Lipid Research. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs) DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH).
    • In July 2021 we presented DUR-928's mechanism of action, the previously reported positive results from our Phase 2a clinical study in alcohol-associated hepatitis (AH), and an overview of the AHFIRM trial at the 2021 Epigenetic Therapeutic Targets Virtual Summit.
    • In the Phase 2a clinical trial of DUR-928 in patients with AH, all 19 patients treated with DUR-928 survived the 28-day follow-up period, 74% of patients (14/19) were discharged in ≤ 4 days after receiving a single dose of DUR-928, and there were no drug-related serious adverse events.
    • Alcohol-associated hepatitis (also called alcoholic hepatitis or AH) is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by a recent onset of jaundice and hepatic failure. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were approximately 132,000 hospitalizations for patients with AH in 2018. From a 2018 publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $875,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days and 29% at 90 days after admission.

    Non-Alcoholic Steatohepatitis (NASH)

    • In June 2021, we presented new data showing additional signals of potential efficacy from the NASH Phase 1b study of DUR-928 at the 2021 International Liver Conference (EASL) . This was a randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. Subjects in the 50 mg and 150 mg groups had 22% and 18% median reductions (not statistically significant) of homeostatic model assessment (HOMA-IR) from baseline, respectively, after 4 weeks of daily oral dosing of DUR-928. NASH subjects also had improvement from baseline in liver stiffness, assessed by transient elastography (TE), magnetic resonance elastography (MRE) and the liver fibrosis marker pro-C3. Positive topline results from this study were previously reported in May 2020.
    • We have also conducted a Phase 1b open-label, multi-center U.S. study to evaluate the safety, tolerability, and pharmacokinetics (PK) of DUR-928 in subjects with moderate (Child-Pugh B scores, n=10) and severe (Child-Pugh C scores, n=7) hepatic function impairment (HI), and matched control subjects (MCS, n=10) with normal hepatic functions. Each subject received a single oral dose of 200 mg DUR-928. Results from this study were presented at the International Liver Conference 2021 (EASL) in June 2021. DUR-928 was safe and well-tolerated by all moderate and severe HI subjects with no adverse events and no dose-limiting toxicity reported throughout the study. As expected, clearance of DUR-928 was decreased in HI subjects compared to MCS with normal hepatic function, resulting in a 4-10 fold higher drug exposure (Cmax and AUC) in HI subjects. Additionally, a single oral dose of 200 mg of DUR-928 in subjects with HI resulted in statistically significant median reductions from baseline of the apoptosis biomarker M30 (cCK-18) at 12 hours post-dose.
    • We are working with a number of disease experts to determine next steps for DUR-928 in NASH.

    POSIMIR® (bupivacaine solution) Post-Operative Pain Relief Depot.  POSIMIR is DURECT's post-operative pain relief depot that uses the Company's patented SABER® technology that delivers bupivacaine to provide up to 3 days of post-surgical analgesia.

    • In February 2021, POSIMIR was granted U.S. FDA approval in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
    • The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies. Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com.
    • DURECT is in discussions with potential commercial partners for POSIMIR, for which DURECT currently holds worldwide rights.

    Debt Amendment.  In May 2021, the Company amended its existing $20 million term loan with Oxford Finance such that principal payments will commence 18 months later than previously scheduled (i.e., commencing June 1, 2023 rather than December 1, 2021) and the final maturity date has been moved back by 16 months (i.e., from May 1, 2024 to September 1, 2025). The interest rate and final payment remain unchanged, and the Company paid Oxford Finance an amendment fee of $712,500.

    Conference Call

    We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss second quarter 2021 results and provide a corporate update:

    Thursday, July 29 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:                       877-407-0784

    International:                 201-689-8560

    Conference ID:             13721980

    Webcast:                       http://public.viavid.com/index.php?id=145979

    The conference call will also be available by webcast on DURECT's homepage at www.durect.com  under the "Investors" tab.  If you are unable to participate during the webcast, the call will be archived on DURECT's website under "Event Calendar" in the "Investors" section.

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation; non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com.  For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding the potential for DUR-928 to treat patients with AH and NASH, clinical trial plans, the potential benefits of Fast Track Designation, the potential for the AHFIRM trial to support an NDA filing for DUR-928 in AH, plans to develop DUR-928 in NASH, and plans to seek a commercial licensee for POSIMIR and its commercial launch, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the AHFIRM trial takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that ongoing and future clinical trials of DUR-928 do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life-saving potential of DUR-928 in a statistically significant manner, the risk that Fast Track designation for DUR-928 in AH may not actually lead to faster FDA review or an approval, risks that biomarker data in earlier trials of DUR-928 may not predict clinical efficacy, risks that we may not enter a commercial license for POSIMIR on favorable terms, if at all, risks that we or a licensee may not commercialize POSIMIR successfully, if at all, and risks related to entering into new agreements or our ability to obtain capital to fund operations and expenses.  Further information regarding these and other risks is included in DURECT's Form 10-K filed on May 5, 2021 and in our Form 10-Q for the quarter ended June 30, 2021 when filed with the Securities and Exchange Commission under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.posimir.com.

    DURECT CORPORATION

     

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME

    (in thousands, except per share amounts)

    (unaudited)















































    Three months ended



    Six months ended







     June 30 



     June 30 







    2021



    2020



    2021



    2020





















    Collaborative research and development and other revenue

    $       735



    $    23,347



    $    1,309



    $    23,317

    Product revenue, net

    1,568



    1,151



    3,206



    2,776



    Total revenues

    2,303



    24,498



    4,515



    26,093





















    Operating expenses:

















    Cost of product revenues 

    359



    253



    711



    649



    Research and development

    7,433



    6,567



    15,408



    14,154



    Selling, general and administrative 

    3,168



    3,337



    6,699



    6,768

    Total operating expenses

    10,960



    10,157



    22,818



    21,571





















    (Loss) income from operations

    (8,657)



    14,341



    (18,303)



    4,522





















    Other income (expense):

















    Interest and other income

    39



    135



    76



    393



    Interest and other expense

    (528)



    (552)



    (1,053)



    (1,144)

    Net other expense

    (489)



    (417)



    (977)



    (751)

    (Loss) income from continuing operations

    (9,146)



    13,924



    (19,280)



    3,771

    Income from discontinued operations

    -



    414



    -



    619

    Net (loss) income

    $   (9,146)



    $    14,338



    $  (19,280)



    $      4,390





















    Net (loss) income per share

















    Basic and Diluted

















        (Loss) income from Continuing operations

    $     (0.04)



    $       0.07



    $     (0.09)



    $       0.02



        Income from discontinued operations

    $         -



    $       0.00



    $         -



    $       0.00





















    Weighted-average shares used in computing net (loss) income per share

















    Basic



    227,428



    196,866



    222,510



    196,306



    Diluted



    227,428



    207,477



    222,510



    206,111





















    Total comprehensive (loss) income

    $   (9,133)



    $    14,427



    $  (19,276)



    $      4,464

     

    DURECT CORPORATION

     

    CONDENSED BALANCE SHEETS

    (in thousands)















    As of



    As of





    June 30, 2021



    December 31, 2020(1)





    (unaudited)





    ASSETS









    Current assets:









        Cash and cash equivalents



    $          56,073



    $                   21,312

        Cash held in escrow



    -



    14,979

        Short-term investments



    32,357



    19,421

        Accounts receivable



    816



    940

        Inventories, net



    1,918



    1,864

        Prepaid expenses and other current assets



    4,192



    4,545

    Total current assets



    95,356



    63,061











    Property and equipment, net



    211



    251

    Operating lease right-of-use assets



    4,120



    4,749

    Goodwill



    6,169



    6,169

    Long-term investments 



    -



    1,000

    Long-term restricted Investments



    150



    150

    Other long-term assets



    261



    261

    Total assets



    $        106,267



    $                   75,641











    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









        Accounts payable



    $            1,086



    $                     1,678

        Accrued liabilities



    5,114



    5,801

        Contract research liability



    192



    545

        Deferred revenue, current portion



    5



    -

        Term loan, current portion, net



    -



    884

        Operating lease liabilities, current portion



    1,821



    1,795

    Total current liabilities



    8,218



    10,703











    Deferred revenue, noncurrent portion



    812



    812

    Operating lease liabilities, noncurrent portion



    2,542



    3,202

    Term loan, noncurrent portion, net



    20,360



    19,936

    Other long-term liabilities



    873



    873











    Stockholders' equity



    73,462



    40,115

    Total liabilities and stockholders' equity 



    $        106,267



    $                   75,641





















    (1)  Derived from audited financial statements.









     

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  2. CUPERTINO, Calif., July 22, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its second quarter 2021 financial results and host a conference call after the market close on Thursday, July 29, 2021.

    Thursday, July 29 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:

    877-407-0784

    International:

    201-689-8560

    Conference ID:

    13721980

    Webcast:

    http://public.viavid.com/index.php?id=145979

    About DURECT Corporation
    DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate is in clinical…

    CUPERTINO, Calif., July 22, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its second quarter 2021 financial results and host a conference call after the market close on Thursday, July 29, 2021.

    Thursday, July 29 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:

    877-407-0784

    International:

    201-689-8560

    Conference ID:

    13721980

    Webcast:

    http://public.viavid.com/index.php?id=145979

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's life saving potential compared to the current standard of care in patients with severe AH. Non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding the potential for DUR-928 to treat patients with AH, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life saving potential of DUR-928 in a statistically significant manner, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-K filed on March 5, 2021 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.posimir.com.

     

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  3. CUPERTINO, Calif., July 14, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present at the Epigenetic Therapeutic Targets Summit, being held virtually July 13-15, 2021. 

    Our President and Chief Executive Officer, James E. Brown, D.V.M., will discuss the mechanism of action of our lead drug candidate and epigenetic regulator (DUR-928), the previously reported positive results from our Phase 2a clinical study in alcohol-associated hepatitis (AH), in addition to providing an overview of our ongoing randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 hospitalized subjects with severe AH .

    Presentation Details:

    CUPERTINO, Calif., July 14, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present at the Epigenetic Therapeutic Targets Summit, being held virtually July 13-15, 2021. 

    Our President and Chief Executive Officer, James E. Brown, D.V.M., will discuss the mechanism of action of our lead drug candidate and epigenetic regulator (DUR-928), the previously reported positive results from our Phase 2a clinical study in alcohol-associated hepatitis (AH), in addition to providing an overview of our ongoing randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 hospitalized subjects with severe AH .

    Presentation Details:

    Title:                   DUR-928, DNMTs and Alcohol-Associated Hepatitis

    Presenter:          James Brown, D.V.M., President and CEO of DURECT

    Date/Time:         July 15, 2021, 1 p.m. EST

    A copy of the presentation will be available on DURECT's corporate website here at the conclusion of the conference.

    About DUR-928

    DUR-928 is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), DUR-928 inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing DUR-928 for the treatment of acute organ injury and certain chronic diseases.

    About Epigenetic Regulation

    Epigenetic regulation influences the expression of genes through the silencing or initiation of gene activity without modifying the DNA sequence. For instance, methylation of cytosine nucleotides in promoter regions of DNA, facilitated by DNA methyltransferases (DNMTs), will generally result in downregulation of gene expression, while demethylation generally results in upregulation. DNA methylation/demethylation can thus regulate the expression of relevant genes, especially clusters of master genes that further modulate crucial cellular activities.

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate, is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's lifesaving potential compared to the current standard of care in patients with severe AH. Non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding the potential for DUR-928 to treat patients with AH, NASH, and other diseases, such as acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the clinical trial of DUR-928 in AH (AHFIRM) takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the lifesaving potential of DUR-928 in a statistically significant manner, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on May 5, 2021 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.posimir.com.

     

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  4. CUPERTINO, Calif., June 9, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present two posters at the 2021 International Liver Conference (EASL) to be held virtually June 23-26, 2021. 

    The first poster will discuss additional efficacy signals from a Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Previously reported data showed that DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day) with overall improvement from baseline observed in liver enzymes, serum lipid profiles, liver fat by imaging, and  biomarkers of liver health. The poster will feature additional efficacy signal data including liver stiffness by…

    CUPERTINO, Calif., June 9, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present two posters at the 2021 International Liver Conference (EASL) to be held virtually June 23-26, 2021. 

    The first poster will discuss additional efficacy signals from a Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Previously reported data showed that DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day) with overall improvement from baseline observed in liver enzymes, serum lipid profiles, liver fat by imaging, and  biomarkers of liver health. The poster will feature additional efficacy signal data including liver stiffness by transient elastography (TE) and magnetic resonance elastography (MRE), liver fibrosis marker, pro-C3, and ELF scores, as well as insulin resistance (HOMA-IR).

    A second poster will provide data from a Phase 1 study assessing the safety, tolerability, pharmacokinetics (PK) of DUR-928 in subjects with moderate (Child-Pugh B scores) and severe (Child-Pugh C scores) hepatic impairment (HI), who received a single oral dose of 200mg DUR-928.

    Poster Presentation Details:

    Title:        

    Efficacy Signals of 4-Week Oral DUR-928 in NASH Subjects

    Poster #:             

    1198

    Presenter:         

    Eric Lawitz, M.D., Vice President, Scientific and Research Development, Texas Liver Institute

    Date/Time:        

    June 24-26, 2021





    Poster Presentation Details:

    Title:            

    Safety and pharmacokinetics of DUR-928 in hepatic function impaired subjects

    Session:              

    668

    Presenter:         

    Jaymin Shah, Ph.D., Executive Director, Clinical Pharmacology and Pharmacokinetics at DURECT

    Date/Time:        

    June 24-26, 2021

    Copies of the posters will be available on DURECT's corporate website here at the conclusion of the conference.

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's lifesaving potential compared to the current standard of care in patients with severe AH. Non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding the potential for DUR-928 to treat patients with AH, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the lifesaving potential of DUR-928 in a statistically significant manner, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on May 5, 2021 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.posimir.com.

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  5. CUPERTINO, Calif., May 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months ended March 31, 2021 and provided a corporate update.

    Q1 2021 Accomplishments:

    • Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe Alcohol-associated Hepatitis (AH)
    • FDA approval of POSIMIR in adults to produce post-surgical analgesia for up to 72 hours following Arthroscopic Subacromial Decompression
    • Publication of DUR-928's mechanism of action
    • Appointment of two highly experienced biopharmaceutical board members
    • Further strengthened our financial position by raising $47.8 million in equity and ending Q1 with $97.2 million in cash and investments

    "We are pleased with progress made…

    CUPERTINO, Calif., May 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months ended March 31, 2021 and provided a corporate update.

    Q1 2021 Accomplishments:

    • Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe Alcohol-associated Hepatitis (AH)
    • FDA approval of POSIMIR in adults to produce post-surgical analgesia for up to 72 hours following Arthroscopic Subacromial Decompression
    • Publication of DUR-928's mechanism of action
    • Appointment of two highly experienced biopharmaceutical board members
    • Further strengthened our financial position by raising $47.8 million in equity and ending Q1 with $97.2 million in cash and investments

    "We are pleased with progress made in opening clinical trial sites in the U.S. and early enrollment in the AHFIRM trial, our Phase 2b clinical trial designed to evaluate the potential life-saving capability of DUR-928 in patients with severe Alcohol-associated Hepatitis," stated James E. Brown, D.V.M, President and CEO of DURECT.  "We are also in discussions with multiple potential POSIMIR partners with a goal of enabling the partner to launch the product this year." 

    Financial highlights for Q1 2021:

    • Total revenues were $2.2 million and net loss was $10.1 million for the three months ended March 31, 2021 as compared to total revenues of $1.6 million and net loss of $9.9 million for the three months ended March 31, 2020.
    • At March 31, 2021, cash and investments were $97.2 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at March 31, 2021 was $21.0 million, compared to $20.8 million at December 31, 2020.

    Update on Selected Programs:

    Epigenetic Regulator Program. DUR-928, the lead product candidate in the Company's Epigenetic Regulator Program, is an endogenous, orally bioavailable, first-in-class small molecule, which may have broad applicability in acute organ injuries such as alcohol-associated hepatitis (AH) as well as in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).

    Clinical Development

    Alcohol-associated Hepatitis (AH)

    • Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study is comprised of three arms targeting approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) DUR-928 (30 mg); and (3) DUR-928 (90 mg). All patients in the trial receive supportive care. Patients receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure is 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting approximately 50-60 clinical trial sites in the U.S., U.K., Europe and Australia.
    • Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA granted DUR-928 Fast Track Designation for the treatment of AH in December 2020. The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track Designation may benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.
    • Given the high mortality rate in severe AH patients and the absence of an approved therapeutic, we believe demonstration of a robust survival benefit in the AHFIRM trial may support an NDA filing.
    • In March 2021, a peer-reviewed research paper describing the binding sites and proposed mechanism of action of DUR-928 was published in The Journal of Lipid Research. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs) DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH).
    • During 2019, we completed a Phase 2a clinical trial of DUR-928 in patients with AH. All 19 patients treated with DUR-928 survived the 28-day follow-up period, 74% of patients (14/19) were discharged in ≤ 4 days after receiving a single dose of DUR-928, and there were no drug-related serious adverse events.
    • Alcohol-associated hepatitis (also called alcoholic hepatitis or AH) is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by a recent onset of jaundice and hepatic failure. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were approximately 132,000 hospitalizations for patients with AH in 2018. From a 2018 publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $875,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days and 29% at 90 days after admission.

    Non-Alcoholic Steatohepatitis (NASH)

    • In May 2020, we reported positive topline results from a Phase 1b randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity (including clinical chemistry and biomarkers as well as liver fat content and liver stiffness by imaging) of DUR-928 in NASH patients with stage 1-3 fibrosis. In this 65-patient study, reductions from baseline (pre-treatment) levels were seen in liver enzymes, liver stiffness as measured by imaging, serum lipids and biomarkers. Many of these reductions were statistically significant and DUR-928 was well tolerated at all three doses evaluated.
    • We will present additional data from this trial at an upcoming medical conference and we are working with a number of disease experts to determine next steps for DUR-928 in NASH.
    • Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in both children and adults. It is estimated that NAFLD affects approximately 30% to 40% of adults and 10% of children in the United States. NASH, a more severe and progressive form of NAFLD, is one of the most common chronic liver diseases worldwide, with an estimated prevalence of 3-5% globally. No drug is currently approved for NAFLD or NASH.

    POSIMIR® (bupivacaine solution) Post-Operative Pain Relief Depot.  POSIMIR is DURECT's post-operative pain relief depot that uses the Company's patented SABER® technology that delivers bupivacaine to provide up to 3 days of post-surgical analgesia.

    • In February 2021, POSIMIR was granted U.S. FDA approval in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. POSIMIR is the only approved sustained-release bupivacaine product indicated for up to 72 hours of post-surgical analgesia from a single application.
    • The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies. Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com.
    • DURECT is in discussions with potential licensees of commercialization rights to POSIMIR, for which DURECT currently holds worldwide rights. Our goal is to put a commercial license in place in time for the licensee to launch the product in Q4 2021.
    • Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is typically performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera lens (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally considered outpatient surgery, and most patients go home within a few hours of surgery. The recovery period may extend from weeks to months, but the most intense pain typically occurs during the first 3 days after surgery and is often managed with oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.

    Conference Call

    We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss first quarter 2021 results and provide a corporate update:

    Tuesday, May 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:

    877-407-0784

    International:

    201-689-8560

    Conference ID:

    13718713

    Webcast:

    http://public.viavid.com/index.php?id=144373

    The conference call will also be available by webcast on DURECT's homepage at www.durect.com  under the "Investors" tab.  If you are unable to participate during the webcast, the call will be archived on DURECT's website under "Event Calendar" in the "Investors" section.

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation; non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com.  For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding the potential for DUR-928 to treat patients with AH and NASH, clinical trial plans, the potential benefits of Fast Track Designation, the potential for the AHFIRM trial to support an NDA filing for DUR-928, and plans to seek a commercial licensee for POSIMIR and its commercial launch, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the AHFIRM trial takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that ongoing and future clinical trials of DUR-928 do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life-saving potential of DUR-928 in a statistically significant manner, the risk that Fast Track designation for DUR-928 in AH may not actually lead to faster FDA review or an approval, risks that we may not enter a commercial license for POSIMIR on favorable terms, if at all, risks that we or a licensee may not commercialize POSIMIR successfully, if at all, and risks related to entering into new agreements or our ability to obtain capital to fund operations and expenses.  Further information regarding these and other risks is included in DURECT's Form 10-K filed on March 5, 2021 and in our Form 10-Q for the quarter ended March 31, 2021 when filed with the Securities and Exchange Commission under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 is an investigational drug candidate under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.POSIMIR.com.

    DURECT CORPORATION

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amounts)

    (Unaudited)







    Three months ended





     March 31 





    2021



    2020











    Collaborative research and development and other revenue

    $      574



    $     (30)

    Product revenue, net

    1,638



    1,625



    Total revenues

    2,212



    1,595











    Operating expenses:









    Cost of product revenues 

    352



    396



    Research and development

    7,975



    7,587



    Selling, general and administrative 

    3,531



    3,431

    Total operating expenses

    11,858



    11,414











    Loss from operations

    (9,646)



    (9,819)











    Other income (expense):









    Interest and other income

    37



    258



    Interest and other expense

    (525)



    (592)

    Net other expense

    (488)



    (334)

    Loss from continuing operations

    (10,134)



    (10,153)

    Income from discontinued operations

    -



    205

    Net loss

    $(10,134)



    $ (9,948)











    Net income (loss) per share









    Basic and diluted









        Continuing operations

    $    (0.05)



    $   (0.05)



        Discontinued operations

    $        -



    $    0.00



    Net loss per common share, basic and diluted

    $    (0.05)



    $   (0.05)











    Weighted-average shares used in computing net income (loss) per share, basic and diluted

    217,537



    195,745











    Total comprehensive loss

    $(10,143)



    $ (9,963)

     

    DURECT CORPORATION

    CONDENSED BALANCE SHEETS

    (in thousands)





    As of



    As of



    March 31, 2021



    December 31, 2020(1)



    (unaudited)





    ASSETS







    Current assets:







        Cash and cash equivalents

    $         57,545



    $                   21,312

        Cash held in escrow

    -



    14,979

        Short-term investments

    39,538



    19,421

        Accounts receivable

    993



    940

        Inventories, net

    1,955



    1,864

        Prepaid expenses and other current assets

    4,780



    4,545

    Total current assets

    104,811



    63,061









    Property and equipment, net

    224



    251

    Operating lease right-of-use assets

    4,440



    4,749

    Goodwill

    6,169



    6,169

    Long-term investments 

    -



    1,000

    Long-term restricted Investments

    150



    150

    Other long-term assets

    261



    261

    Total assets

    $        116,055



    $                   75,641









    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







        Accounts payable

    $           2,150



    $                     1,678

        Accrued liabilities

    4,094



    5,801

        Contract research liability

    384



    545

        Deferred revenue, current portion

    373



    -

        Term loan, current portion, net

    2,895



    884

        Operating lease liabilities, current portion

    1,808



    1,795

    Total current liabilities

    11,704



    10,703









    Deferred revenue, noncurrent portion

    812



    812

    Operating lease liabilities, noncurrent portion

    2,881



    3,202

    Term loan, noncurrent portion, net

    18,062



    19,936

    Other long-term liabilities

    873



    873









    Stockholders' equity

    81,723



    40,115

    Total liabilities and stockholders' equity 

    $        116,055



    $                   75,641



    (1)  Derived from audited financial statements.

     

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