ASRT Assertio Holdings Inc.

1.29
-0.05  -4%
Previous Close 1.34
Open 1.31
52 Week Low 1.15
52 Week High 5.8
Market Cap $56,046,822
Shares 43,447,149
Float 43,282,359
Enterprise Value $77,882,407
Volume 363,347
Av. Daily Volume 1,114,025
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Drug Pipeline

Drug Stage Notes
Cosyntropin depot
Adrenocortical insufficiency screening
CRL
CRL
CRL announced October 21, 2019.
SEFELSA
Hot flashes
CRL
CRL
CRL issued May 31, 2013.
GRALISE
Postherpetic neuralgia - shingles
Approved
Approved
Approved January 28, 2011.

Latest News

  1. LAKE FOREST, Ill., July 20, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that it will release second quarter 2021 financial results on Thursday, August 5, 2021, after the close of markets. Following the release of its financial results, Assertio's management will host a conference call beginning at 4:30 p.m. eastern time.

    Date:Thursday, August 5, 2021
    Time:4:30 p.m. Eastern Time
    Dial-in numbers:1 (888) 771-4371 (domestic)
     1 (847) 585-4405 (international)
    Conference number:50199336

    The live webcast and replay may be accessed at https://investor.assertiotx.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software…

    LAKE FOREST, Ill., July 20, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that it will release second quarter 2021 financial results on Thursday, August 5, 2021, after the close of markets. Following the release of its financial results, Assertio's management will host a conference call beginning at 4:30 p.m. eastern time.

    Date:Thursday, August 5, 2021
    Time:4:30 p.m. Eastern Time
    Dial-in numbers:1 (888) 771-4371 (domestic)
     1 (847) 585-4405 (international)
    Conference number:50199336

    The live webcast and replay may be accessed at https://investor.assertiotx.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. The replay will be available approximately two hours after the call on Assertio's investor website.

    About Assertio

    Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through business development including licensing, mergers, and acquisitions. To learn more visit www.assertiotx.com.

    Investor Contact

    Max Nemmers

    Head, Investor Relations and Administration

    Forward Looking Statements

    Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio. All statements other than historical facts may be forward-looking statements and can be identified by words such as "anticipate," ‘believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may," "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio.

    Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including risks related to the offering. These risks are more fully described in Assertio's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in other filings Assertio makes with the SEC from time to time. Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law. Nothing contained herein constitutes or will be deemed to constitute a forecast, projection or estimate of the future financial performance or expected results of Assertio.



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  2. LAKE FOREST, Ill., June 04, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (the "Nasdaq") indicating that the Company has regained compliance with the minimum bid price requirement set forth in Rule 5550(a)(2) of the Nasdaq Listing Rules (the "Minimum Bid Price Requirement").   Accordingly, the Company has regained compliance with the Minimum Bid Price Requirement and this matter is now closed.

    About Assertio

    Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription…

    LAKE FOREST, Ill., June 04, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (the "Nasdaq") indicating that the Company has regained compliance with the minimum bid price requirement set forth in Rule 5550(a)(2) of the Nasdaq Listing Rules (the "Minimum Bid Price Requirement").   Accordingly, the Company has regained compliance with the Minimum Bid Price Requirement and this matter is now closed.

    About Assertio

    Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through business development including licensing, mergers, and acquisitions. To learn more visit www.assertiotx.com.

    Investor Contact

    Max Nemmers

    Head, Investor Relations and Administration

    Forward Looking Statements

    Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio. All statements other than historical facts may be forward-looking statements and can be identified by words such as "anticipate," ‘believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may," "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio.

    Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including risks related to the offering. These risks are more fully described in Assertio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC, and in other filings Assertio makes with the SEC from time to time. Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law. Nothing contained herein constitutes or will be deemed to constitute a forecast, projection or estimate of the future financial performance or expected results of Assertio.



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  3. LAKE FOREST, Ill., May 17, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that it has filed a Certificate of Amendment to its certificate of incorporation (the "Certificate of Amendment") to implement a one-to-four reverse split of its issued and outstanding common stock (the "Reverse Split"). The Reverse Split will become effective as of 12:01 a.m. Eastern Time on May 18, 2021, and the Company's common stock will begin trading on a split-adjusted basis when the market opens on May 18, 2021.

    When the Reverse Split becomes effective, every four shares of the Company's issued and outstanding common stock will automatically be converted into one share of common stock, without any…

    LAKE FOREST, Ill., May 17, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that it has filed a Certificate of Amendment to its certificate of incorporation (the "Certificate of Amendment") to implement a one-to-four reverse split of its issued and outstanding common stock (the "Reverse Split"). The Reverse Split will become effective as of 12:01 a.m. Eastern Time on May 18, 2021, and the Company's common stock will begin trading on a split-adjusted basis when the market opens on May 18, 2021.

    When the Reverse Split becomes effective, every four shares of the Company's issued and outstanding common stock will automatically be converted into one share of common stock, without any change in the par value per share. In addition, proportionate adjustments will be made to (i) the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options and warrants to purchase shares of common stock, (ii) the number of shares issuable upon the vesting of all restricted stock units and (iii) the number of shares reserved for issuance pursuant to the Company's equity incentive compensation plans. Any fraction of a share of common stock that would be created as a result of the Reverse Split will be cashed out at a price equal to the product of the closing price of the Company's common stock on May 17, 2021 and the amount of the fractional share.

    The Company's common stock will continue to trade on The Nasdaq Stock Market LLC ("Nasdaq") under the symbol "ASRT." The new CUSIP number for the common stock following the Reverse Split will be 04546C 205.

    Continental Stock Transfer & Trust, has been appointed by the Company to act as exchange agent for the Reverse Split. Stockholders owning shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the Reverse Split and will not be required to take further action in connection with the Reverse Split, subject to brokers' particular processes. Holders of certificated shares will be contacted by the Company or its exchange agent with further details about how to surrender old certificates in exchange for new ones.

    About Assertio

    Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through business development including licensing, mergers, and acquisitions.

    Investor Contact  

    Max Nemmers

    Head, Investor Relations and Administration



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  4. - Adjournment Solely to Vote on the Reverse Split and Proportional Authorized Shares Reduction Proposal (Proposal 2) and Increase in Authorized Shares Proposal (Proposal 3)

    - Both Leading Independent Advisory Firms have Issued Favorable Recommendations on Proposal 2 and Proposal 3

    LAKE FOREST, Ill., May 17, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced partial results and the partial adjournment of the Company's 2021 Annual Meeting of Shareholders (the "Annual Meeting"), which was held at 1:00 p.m. Central Time on May 11, 2021 and at which time all director nominees were elected and Proposals 4 and 5, as set forth in the Company's Definitive Proxy Statement, were approved…

    - Adjournment Solely to Vote on the Reverse Split and Proportional Authorized Shares Reduction Proposal (Proposal 2) and Increase in Authorized Shares Proposal (Proposal 3)

    - Both Leading Independent Advisory Firms have Issued Favorable Recommendations on Proposal 2 and Proposal 3

    LAKE FOREST, Ill., May 17, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced partial results and the partial adjournment of the Company's 2021 Annual Meeting of Shareholders (the "Annual Meeting"), which was held at 1:00 p.m. Central Time on May 11, 2021 and at which time all director nominees were elected and Proposals 4 and 5, as set forth in the Company's Definitive Proxy Statement, were approved by stockholders.

    The Company adjourned the meeting with respect to Proposal 2 (the "Reverse Split and Proportional Authorized Shares Reduction Proposal") and Proposal 3 (the "Increase in Authorized Shares Proposal") for the limited purpose of allowing additional time for stockholders to vote.

    Support for Proposal 2 has exceeded 80% of the votes cast on the proposal, though approval of more than 50% of all of the Company's outstanding shares of common stock is necessary for the proposal to be approved. While the votes cast prior to adjournment strongly favor Proposal 2, approximately 86 million shares remained unvoted on the proposal at the time of adjournment. The principal reason for the Reverse Split and Proportional Authorized Shares Reduction Proposal is to give the Board discretion to increase the per-share trading price of the Company's common stock to meet the minimum bid price requirements for continued listing on Nasdaq.

    Support for Proposal 3 has exceeded 76% of the votes cast on the proposal. However, approval of more than 50% of all of the Company's outstanding shares of common stock is necessary for the proposal to be approved. While the votes cast prior to adjournment strongly favor Proposal 3, approximately 86 million shares remained unvoted at the time of adjournment.

    Both leading independent proxy advisory firms, Institutional Shareholder Services and Glass Lewis & Co., have recommended in favor of the Reverse Split and Proportional Authorized Shares Reduction Proposal and the Increase in Authorized Shares Proposal. If you have already voted your shares on Proposals 2 or 3, you do not need to vote again and we thank you for your vote.

    "I particularly appreciate the substantial shareholder support for the reverse split and authorized shares reduction proposal, as demonstrated by the affirmative vote of 80% of the votes cast to date on this matter," said Dan Peisert, President and Chief Executive Officer of Assertio. "Over the next few weeks, we will be reaching out to additional shareholders through various measures to seek additional votes on the proposal."

    If you have any questions or need assistance voting your shares, please call the firm assisting Assertio with the solicitation of proxies, Innisfree M&A Incorporated, toll-free at 1 888-750-5834.

    The adjourned 2021 Annual Meeting will be reconvened on June 9, 2021 at 1:00 p.m. (Central Time) for the sole purpose of allowing additional time for stockholders to vote on Proposals 2 and 3. The reconvened meeting will be held as a virtual (online) meeting, accessible by visiting https://www.cstproxy.com/assertiotx/2021, or by telephone (listen-only) as follows:

    Date:Wednesday, June 9, 2021
    Time1:00 p.m. Central Time
    Dial-in numbers:1 877-770-3647 (domestic)
     +1 312-780-0854 (international)
    Passcode:62782283#

    About Assertio

    Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through business development including licensing, mergers, and acquisitions.

    Investor Contact

    Max Nemmers

    Head, Investor Relations and Administration

    Additional Information and Where to Find It

    The Company has filed a definitive proxy statement on Schedule 14A and associated proxy card (the "Proxy Statement") with the U.S. Securities and Exchange Commission (the "SEC"), which was filed on April 12, 2020 and amended on April 30, 2020. The Company, its directors, its executive officers and certain other individuals set forth in the definitive proxy statement will be deemed participants in the solicitation of proxies from stockholders in respect of the Annual Meeting. Information regarding the names of the Company's directors and executive officers and certain other individuals and their respective interests in the Company by security holdings or otherwise is set forth in the Proxy Statement. BEFORE MAKING ANY VOTING DECISION, STOCKHOLDERS OF THE COMPANY ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR FURNISHED TO THE SEC, INCLUDING THE PROXY STATEMENT AND ANY SUPPLEMENTS THERETO AND ACCOMPANYING PROXY CARD. The Proxy Statement and a form of proxy have been mailed to shareholders of the Company. Investors and shareholders can obtain a copy of the documents filed by the Company with the SEC, including the Proxy Statement, free of charge by visiting the SEC's website, www.sec.gov.



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  5. LAKE FOREST, Ill. and NEW YORK, May 05, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or "the Company") (NASDAQ:ASRT), and Cove, a leading migraine telemedicine platform, today announced a collaboration to make CAMBIA (diclofenac potassium) for oral solution and SPRIX (ketorolac tromethamine) nasal spray available to Cove's patient population. This collaboration will make it easier for more patients to gain access to high-quality physician care.

    Using Cove's online telemedicine platform, patients complete a consultation with a licensed physician who can prescribe a variety of treatment options, including CAMBIA for a patient's acute treatment of migraine attacks with or without aura in adults and SPRIX for short-term (up to…

    LAKE FOREST, Ill. and NEW YORK, May 05, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or "the Company") (NASDAQ:ASRT), and Cove, a leading migraine telemedicine platform, today announced a collaboration to make CAMBIA (diclofenac potassium) for oral solution and SPRIX (ketorolac tromethamine) nasal spray available to Cove's patient population. This collaboration will make it easier for more patients to gain access to high-quality physician care.

    Using Cove's online telemedicine platform, patients complete a consultation with a licensed physician who can prescribe a variety of treatment options, including CAMBIA for a patient's acute treatment of migraine attacks with or without aura in adults and SPRIX for short-term (up to 5 days) management of moderate to moderately severe pain which requires analgesia at the opioid level in adults.

    "We are thrilled to be working with Assertio to provide CAMBIA and SPRIX as options to the appropriate patients," said Caroline Hofmann, General Manager of Cove. "We know that patients need more options to treat their conditions and convenient access to quality care."

    "Partnering with Cove, a leading telemedicine platform, furthers our strategy by enhancing our foundational digital platform and virtual engagement efforts to better serve our patients," said Dan Peisert, President and Chief Executive Officer of Assertio. "This is an exciting direct to patient model for those who prefer a convenient, digital telemedicine option."

    CAMBIA and SPRIX each belong to a class of medications called non-steroidal anti-inflammatory drugs (NSAIDs) and have a Boxed Warning for serious cardiovascular and gastrointestinal events. Please see the indications and Important Safety Information below.

    CAMBIA INDICATIONS AND USAGE

    CAMBIA® (diclofenac potassium) for oral solution is indicated for the acute treatment of migraine attacks

    with or without aura in adults (18 years of age or older).

    Limitations of Use:

    • CAMBIA is not indicated for the prophylactic therapy of migraine.

    • The safety and effectiveness of CAMBIA have not been established for cluster headache.

    SPRIX INDICATIONS AND USAGE

    SPRIX® (ketorolac tromethamine) is indicated in adult patients for the short term (up to 5 days)

    management of moderate to moderately severe pain that requires analgesia at the opioid level.

    Limitations of Use

    • SPRIX is not for use in pediatric patients less than 2 years of age.

    CAMBIA IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Thrombotic Events

    • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

    • CAMBIA is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Bleeding, Ulceration, and Perforation

    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    Use the lowest effective dosage for the shortest duration consistent with individual patient

    treatment goals. The safety and effectiveness of a second dose have not been established. Different

    formulations of oral diclofenac (e.g., CAMBIA, diclofenac sodium enteric-coated tablets, diclofenac sodium

    extended-release tablets, or diclofenac potassium immediate-release tablets) may not be bioequivalent

    even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other

    formulation of diclofenac to CAMBIA.

    CONTRAINDICATIONS

    CAMBIA is contraindicated in the following patients:

    • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any

    components of the drug product.

    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe,

    sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.

    • In the setting of coronary artery bypass graft (CABG) surgery.

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of one or more liver tests may occur during therapy with CAMBIA. Postmarketing

    surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant

    hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities

    or liver transplantation. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if

    abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    Hypertension: NSAIDs, including CAMBIA, can lead to new onset of hypertension or worsening of preexisting

    Hypertension. Patients taking some antihypertensive medications may have impaired response to

    these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: Avoid use of CAMBIA in patients with severe heart failure unless benefits are

    expected to outweigh risk of worsening heart failure. If CAMBIA is used in patients with severe heart

    failure, monitor patients for signs of worsening heart failure.

    Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal papillary

    necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins

    have a compensatory role in the maintenance of renal perfusion. In these patients, administration of

    an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal

    blood flow, which may precipitate overt renal decompensation. Monitor renal function in patients with

    renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CAMBIA in patients

    with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

    Increases in serum potassium concentration, including hyperkalemia, have been reported with use of

    NSAIDs, even in some patients without renal impairment.

    Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: CAMBIA is contraindicated in patients with aspirin sensitive

    asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including diclofenac, can cause serious skin adverse reactions which can

    be fatal. Discontinue CAMBIA at first appearance of skin rash or other signs of hypersensitivity.

    Medication Overuse Headache: Detoxification may be necessary.

    Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks

    gestation.

    Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

    ADVERSE REACTIONS

    The most common adverse events (≥1% and greater than placebo) in clinical trials with CAMBIA were

    nausea and dizziness.

    DRUG INTERACTIONS

    Drugs That Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Increased risk of serious

    bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs),

    and serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients for bleeding who are

    concomitantly taking CAMBIA with drugs that interfere with hemostasis. Concomitant use of CAMBIA and

    analgesic doses of aspirin is not generally recommended.

    ACE Inhibitors and ARBs: Concomitant use with CAMBIA in elderly, volume depleted, or those with renal

    impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of

    worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure

    diuretic efficacy including antihypertensive effects.

    Digoxin: Concomitant use with CAMBIA can increase serum concentration and prolong half-life of digoxin.

    Monitor serum digoxin levels.

    Inhibitors of Cytochrome P450 2C9: Diclofenac is metabolized predominantly by Cytochrome P-450

    CYP2C9. During concomitant use of CAMBIA and drugs that inhibit CYP2C9, an increase in the duration

    between CAMBIA doses for subsequent migraine attacks may be necessary.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure

    of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of CAMBIA in women who

    have difficulties conceiving.

    Please see full Prescribing Information on CAMBIA.com, including BOXED WARNING and MEDICATION GUIDE.

    To report SUSPECTED ADVERSE REACTIONS, contact Assertio Therapeutics, Inc.

    at 1-866-458-6389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    SPRIX IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Thrombotic Events

    Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

    SPRIX® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Bleeding, Ulceration, and Perforation

    NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    Use SPRIX at the lowest effective dosage for shortest duration consistent with 

    individual patient treatment goals.

    CONTRAINDICATIONS

    SPRIX is contraindicated in the following patients:

    • Known hypersensitivity to ketorolac or any components of the drug product.

    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

    Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.

    • In the setting of coronary artery bypass graft (CABG) surgery.

    • Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.

    • Use as a prophylactic analgesic before any major surgery.

    • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.

    • Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.

    • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis,

    incomplete hemostasis, or those for whom hemostasis is critical.

    • Concomitant use with probenecid or pentoxifylline.

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In

    addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver

    necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms

    of hepatotoxicity. Discontinue immediately if abnormal liver tests persist or worsen or if clinical

    signs and symptoms of liver disease develop.

    Hypertension: NSAIDs, including SPRIX, can lead to new onset or worsening of preexisting

    hypertension. Patients taking some antihypertensive medications may have impaired response to

    these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: Avoid use of SPRIX in patients with severe heart failure unless benefits

    are expected to outweigh risk of worsening heart failure. If SPRIX is used in patients with severe

    heart failure, monitor patients for signs of worsening heart failure.

    Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal

    papillary necrosis and other renal injury and may cause a dose-dependent reduction in

    prostaglandin formation, which may precipitate overt renal decompensation. Monitor renal

    function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

    Avoid use of SPRIX in patients with advanced renal disease unless benefits are expected to

    outweigh risk of worsening renal function.

    Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: SPRIX is contraindicated in patients with

    aspirin-sensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including SPRIX, can cause serious skin adverse reactions, which

    can be fatal. These serious events may occur without warning. Discontinue SPRIX at the first

    appearance of skin rash or any other sign of hypersensitivity.

    Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting

    at 30 weeks gestation.

    Hematologic Toxicity: Anemia has occurred in patients treated with NSAIDs. Monitor hemoglobin

    or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX in patients for

    whom hemostasis is critical.

    Limitations of Use: The total duration of use of SPRIX alone or sequentially with other forms of

    ketorolac is not to exceed 5 days. SPRIX should not be used concomitantly with other forms of

    ketorolac, aspirin, or other NSAIDs.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence ≥2%) in patients treated with SPRIX and

    occurring at a rate at least twice that with placebo include: nasal discomfort; rhinalgia; increased

    lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT

    and/or AST; hypertension; rhinitis.

    DRUG INTERACTIONS

    Drugs That Interfere With Hemostasis: increased risk of serious bleeding with use of anticoagulants,

    antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine

    reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated. Monitor patients

    for bleeding who are concomitantly taking SPRIX with drugs that interfere with hemostasis.

    ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), and Beta-Blockers: may diminish the

    antihypertensive effect of these drugs; monitor blood pressure.

    ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result

    in deterioration of renal function; monitor for signs of worsening renal function.

    Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics

    in some patients. During concomitant use of SPRIX with diuretics look for signs of worsening renal

    function and assure diuretic efficacy and antihypertensive effects.

    Digoxin: has been reported to increase the serum concentration and prolong the half-life of

    digoxin, monitor serum digoxin levels.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature

    closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30

    weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX in

    women who have difficulties conceiving.

    Please see full Prescribing Information on SPRIX.com, including BOXED WARNING

    and MEDICATION GUIDE.

    To report SUSPECTED ADVERSE REACTIONS, contact Assertio Therapeutics, Inc.

    at 866-458-6389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    About Cove

    Cove is a specialized healthcare company that offers personalized treatment solutions. Cove aims to empower patients by providing direct access to high-quality, affordable care, personalized to each customer and their specific needs. In addition to CAMBIA and SPRIX, Cove offers 20+ acute and preventative treatments. For more information, visit www.withcove.com.

    About Assertio Holdings

    Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in neurology, hospital, and pain and inflammation. Assertio has grown through business development including licensing, mergers, and acquisitions. To learn more about Assertio, visit www.assertiotx.com.

    Forward Looking Statements

    Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio. All statements other than historical facts may be forward-looking statements; words such as "anticipate," "believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may", "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio. These risks are more fully described in Assertio's public filings with the Securities and Exchange Commission, including Assertio's most recent annual report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and in other filings Assertio makes with the SEC from time to time. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law.

    Assertio Holdings Contact Information

    Max Nemmers

    Head, Investor Relations and Administration

     

    Cove Contact Information

    Caroline Hofmann

    General Manager, Cove

     

    Jasmine Jones

    Public Relations, Cove

     

     



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