ADMS Adamas Pharmaceuticals Inc.

2.56
-0.16  -6%
Previous Close 2.72
Open 2.75
52 Week Low 1.9
52 Week High 7.78
Market Cap $72,085,005
Shares 28,158,205
Float 23,385,689
Enterprise Value $98,428,317
Volume 402,430
Av. Daily Volume 496,375
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Upcoming Catalysts

Drug Stage Catalyst Date
GOCOVRI (ADS-5102)
Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
GOCOVRI (amantadine)
Multiple sclerosis (MS)
Phase 3
Phase 3
Phase 3 data met primary endpoint at one of two doses. Secondary endpoint in walking impairment not met. Second trial will not be initiated as a result of data - December 17, 2019. Findings were confirmed June 17, 2020.
ADS-4101
Partial onset seizures in patents with epilepsy
Phase 1b
Phase 1b
Further development deferred - noted May 9, 2019.
GOCOVRI (amantadine)
Dyskinesia patients with Parkinson's disease
Phase 3
Phase 3
Phase 3 open-label data released April 19, 2018.
Namzaric
Moderate to severe dementia of the Alzheimer's type.
Approved
Approved
Approved December, 24 2014.

Latest News

  1. EMERYVILLE, Calif., June 17, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the completion of its evaluation of ADS-5102 in multiple sclerosis patients with walking impairment (MSW).

    A comprehensive analysis of the INROADS Phase 3 data validated the top line results announced in December 2019 and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity. Further engagement with the U.S. Food and Drug…

    EMERYVILLE, Calif., June 17, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the completion of its evaluation of ADS-5102 in multiple sclerosis patients with walking impairment (MSW).

    A comprehensive analysis of the INROADS Phase 3 data validated the top line results announced in December 2019 and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity. Further engagement with the U.S. Food and Drug Administration (FDA) to fully understand a potential path to submission confirmed the need for an additional pivotal Phase 3 confirmatory study. Based on these findings, Adamas reconfirms it will not initiate further Phase 3 development in MSW.

    "As a patient focused company this was a difficult decision, and I want to thank the patients, healthcare professionals, and employees who contributed to this development program. There remains a significant unmet need for this population and we are committed to completing the open-label study and publishing our data to benefit the MS community," said Neil F. McFarlane, CEO. "We remain focused on maximizing the opportunity for GOCOVRI to benefit Parkinson's disease patients, which includes our recently filed sNDA for a label revision to include OFF episodes. Moving forward we believe we have sufficient capital to execute our near-term strategy and deliver long-term value for shareholders."

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About ADS-5102

    Adamas evaluated ADS-5102 in the INROADS Phase 3 clinical study for multiple sclerosis patients with walking impairment. ADS-5102 was previously approved by the FDA under the trade name GOCOVRI®. GOCOVRI is not FDA-approved for the treatment of multiple sclerosis patients with walking impairment.

    About INROADS

    The INROADS study was a 12-week, three-arm, multi-center, randomized, double-blind, placebo-controlled study with a 4-week placebo-run in designed to evaluate the efficacy and safety of ADS-5102 for the treatment of walking impairment in multiple sclerosis. The study enrolled 594 patients with walking impairment in the US and Canada and randomized 560 patients in a 1:1:1 fashion to receive 274 mg ADS-5102 (N=185), 137 mg ADS-5102 (N=187), or placebo (N=186). The primary endpoint was the proportion of responders (at least 20% improvement in Timed 25-Foot Walk from baseline) at Week 12.

    Key secondary endpoints include the mean change in the Timed 25-Foot Walk, the Timed Up and Go, and the 2-Minute Walk at 12-week post-treatment at both the 274 mg and 137 mg dose.

    Baseline characteristics were similar across all treatment arms. The mean time since diagnosis of MS was 15.9 years, median Expanded Disability Status Scale at screening was 6.0, and mean timed 25-foot walk at baseline was between 11.5 to 12.4 seconds. Prior dalfampridine use was reported in 52.5% of patients and prior amantadine use was reported in 12.9% of patients.

    Results from the study showed that patients taking 274 mg ADS-5102 had a statistically significant improvement in response rate of 21.1% compared to 11.3% taking placebo (p=0.01). Response was defined as at least a 20% improvement in walking speed from baseline to 12 weeks post-treatment, as measured by the Timed 25 Foot Walk. Additionally, the response rate for patients taking a lower dose of 137 mg ADS-5102 was 17.6% (p=0.08). ADS-5102 did not demonstrate a significant effect on the secondary walking measures at either dose.

    The most common adverse events (occurring in greater than 5% of any ADS-5102 treatment group) were: peripheral edema, dry mouth, fall, constipation, UTI, and insomnia. 20.5% of patients discontinued study drug due to adverse events in the 274 mg group, compared to 6.4% in the 137 mg group, and 3.8% in the placebo group. The reported adverse events associated with ADS-5102 in this study were dose-dependent and consistent with the known safety profile of amantadine.

    About walking impairment in multiple sclerosis

    Multiple sclerosis (MS) is a chronic neurological autoimmune disease that is often disabling with unpredictable symptoms. Among the MS patients in the US, nearly 270,000 have walking impairment, which is present throughout the day. Walking impairment in MS remains an area of high unmet need, as there is only one approved product on the market for this indication.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption "Risk Factors." Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    Media:

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528



    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



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  2. EMERYVILLE, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that its supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy has been accepted for review by the U.S. Food and Drug Administration (FDA). The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021. 

    GOCOVRI (amantadine) extended release capsules is approved to treat dyskinesia in PD patients treated with levodopa-based therapy, with or without other dopaminergic medications…

    EMERYVILLE, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that its supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy has been accepted for review by the U.S. Food and Drug Administration (FDA). The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021. 

    GOCOVRI (amantadine) extended release capsules is approved to treat dyskinesia in PD patients treated with levodopa-based therapy, with or without other dopaminergic medications. In the sNDA, Adamas has proposed a revision to the indication statement to include GOCOVRI as an appropriate therapy for the treatment of OFF episodes in PD patients receiving levodopa. The clinical evidence supporting GOCOVRI's effect on OFF time was demonstrated in two large pivotal Phase 3 trials and is currently included in the GOCOVRI prescribing information.

    "We are pleased the FDA has accepted our sNDA for review. If approved, the indication would reflect the full spectrum of GOCOVRI's therapeutic benefit in PD motor complications and better support physicians to identify appropriate treatments for their patients," said Neil F. McFarlane, Chief Executive Officer. "Many PD medications necessitate a trade-off between reducing OFF time and exacerbating levodopa-induced dyskinesia. GOCOVRI is the first medication clinically proven to reduce both."

    About GOCOVRI®
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.
    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Parkinson's disease, dyskinesia and OFF
    Parkinson's disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About Adamas
    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements
    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption "Risk Factors." Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    Media
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528
     
    Investors
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505
     

     

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  3. EMERYVILLE, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the William Blair Growth Stock Conference on Wednesday, June 10 at 9:20 a.m. Central Time (7:20 a.m. Pacific Time).

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals,

    EMERYVILLE, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the William Blair Growth Stock Conference on Wednesday, June 10 at 9:20 a.m. Central Time (7:20 a.m. Pacific Time).

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com

    Contact:
    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

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    View Full Article Hide Full Article
  4. EMERYVILLE, Calif., May 13, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has been issued a new patent (no. 10,646,456) by the United States Patent and Trademark Office (USPTO) that covers GOCOVRI® (amantadine) extended release capsules. The new patent covers a method of reducing ‘OFF' time and increasing ‘good ON' time (ON time without troublesome dyskinesia) in people with Parkinson's disease (PD) being treated with levodopa.  GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without…

    EMERYVILLE, Calif., May 13, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has been issued a new patent (no. 10,646,456) by the United States Patent and Trademark Office (USPTO) that covers GOCOVRI® (amantadine) extended release capsules. The new patent covers a method of reducing ‘OFF' time and increasing ‘good ON' time (ON time without troublesome dyskinesia) in people with Parkinson's disease (PD) being treated with levodopa.  GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Data from two pivotal, placebo-controlled phase 3 clinical studies showed that GOCOVRI reduced dyskinesia, as well as a secondary benefit in reduction of OFF time, leading to an increase in good ON time.

    This is the second patent to be issued for GOCOVRI that covers reduction in OFF time and will expire in 2034. Adamas' portfolio of patents for GOCOVRI now includes 15 U.S. patents, across three separate patent families that will expire from 2025 to 2034. This latest addition is listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

    About GOCOVRI®
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Parkinson's Disease, Dyskinesia and OFF
    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements
    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7 2020, particularly under the caption "Risk Factors." Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528


     
    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505


     

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  5. EMERYVILLE, Calif., May 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted five new employees the option to purchase an aggregate of 66,000 shares of the company's common stock, at a per share exercise price of $3.46, the closing trading price on May 7, and restricted stock units to acquire 33,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new…

    EMERYVILLE, Calif., May 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted five new employees the option to purchase an aggregate of 66,000 shares of the company's common stock, at a per share exercise price of $3.46, the closing trading price on May 7, and restricted stock units to acquire 33,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

     

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