On January 13, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) and Incyte Corporation (NASDAQ: INCY) reported that the companies have entered into a collaboration and license agreement to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab (MOR208) globally (Press release, MorphoSys, JAN 13, 2020, View Source [SID1234553049]). Tafasitamab is an Fc-engineered antibody against CD19 currently in clinical development for the treatment of B cell malignancies. MorphoSys and Incyte will co-commercialize tafasitamab in the U.S., while Incyte has exclusive commercialization rights outside of the U.S.

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"The global partnership with Incyte is an important step towards unlocking the full potential of tafasitamab and achieving our goal of rapidly bringing tafasitamab to patients inside and outside of the U.S.," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "The combination of our strong antibody and drug development expertise partnered with Incyte’s well-established hematology-oncology experience and their commercial operations in key territories has the potential to significantly broaden the tafasitamab opportunity. We are pleased to work with Incyte to jointly improve the lives of patients suffering from DLBCL and other devastating diseases."

"Bringing together Incyte’s expertise and MorphoSys’ commitment to innovation will allow us to make tafasitamab widely available to patients with cancer, upon approval," said Hervé Hoppenot, CEO of Incyte. "We look forward to collaborating closely with the team at MorphoSys and adding tafasitamab to our portfolio of oncology candidates as part of our committment to bringing new, advanced treatment options to patients and the clinical community around the world."

Under the terms of the agreement, MorphoSys will receive an upfront payment of $750 million and, in addition, Incyte will make an equity investment into MorphoSys of $150 million in new American Depositary Shares (ADS) of MorphoSys at a premium to the share price at signing of the agreement. Depending on the achievement of certain developmental, regulatory and commercial milestones, MorphoSys will be eligible to receive milestone payments amounting to up to $1.1 billion. MorphoSys will also receive tiered royalties on ex-U.S. net sales of tafasitamab in a mid-teens to mid-twenties percentage range of net sales.

In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, with MorphoSys leading the commercialization strategy and booking all revenues from sales of tafasitamab. Incyte and MorphoSys will be jointly responsible for commercialization activities in the U.S. and will share profits and losses on a 50:50 basis. Outside the U.S., Incyte will have exclusive commercialization rights, and will lead the commercialization strategy and book all revenues from sales of tafasitamab, paying MorphoSys royalties on ex-U.S. net sales.

Furthermore, the companies will share development costs associated with global and U.S.-specific trials at a rate of 55% (Incyte) to 45% (MorphoSys); Incyte will cover 100% of the future development costs for trials that are specific to ex-U.S. countries.

Both parties have agreed to co-develop tafasitamab broadly in relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL), frontline DLBCL as well as additional indications beyond DLBCL, such as follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia (CLL). Incyte will be responsible for initiating a combination study of its investigational PI3K-delta inhibitor parsaclisib and tafasitamab in r/r B cell malignancies. Further, Incyte will be responsible for leading any potential registration-enabling studies in CLL and a phase 3 trial in r/r FL/MZL. MorphoSys will continue to be responsible for its currently ongoing clinical trials of tafasitamab in non-Hodgkin lymphoma (NHL), CLL, r/r DLBCL and frontline DLBCL. The parties will share responsibility in starting additional global trials, and Incyte intends to pursue development in additional territories including Japan and China.

MorphoSys recently submitted a Biologics License Application (BLA) for tafasitamab, in combination with lenalidomide, to the U.S. Food and Drug Administration (FDA) for the treatment of r/r DLBCL; the FDA decision regarding a potential approval is expected by mid-2020. The submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in r/r DLBCL is planned for mid-2020.

The agreement between MorphoSys and Incyte, including the equity investment, is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act as well as by the German and Austrian antitrust authorities, and will become effective as soon as these conditions have been met.

MorphoSys and Incyte will host a joint conference call on January 13, 2020 at 7:00am PST/ 4:00pm CET.

Dial-in numbers for the conference call on Monday, January 13, 2020 at 7:00am PST; 3:00pm GMT; 10:00am EST; 04:00pm CET:

For Germany: +49 69 201 744 220
For the U.K.: +44 203 009 2470
For the U.S.: +1 877 423 0830

Participant PIN: 55656540#

Please dial in 10 minutes before the beginning of the conference.

A live webcast will be made available at www.morphosys.com and at investor.incyte.com.

About Tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. Re-MIND, the real-world data lenalidomide alone matched control cohort met its primary endpoint in October 2019, demonstrating clinical superiority of the tafasitamab/lenalidomide combination compared to lenalidomide alone. The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On January 12, 2020 Ambrx Inc., a clinical-stage biopharmaceutical company focused on the development of next generation biologics using an expanded genetic code and Sino Biopharmaceutical Limited (1177.HK), a leading Chinese pharmaceutical company with a large number of medical products covering multiple therapeutic areas, reported a joint collaboration to develop two products enabled by Ambrx’s unique non-natural amino acid incorporation technology platforms (Press release, Ambrx, JAN 12, 2020, View Source [SID1234553077]).

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Under the agreement, Ambrx received an upfront payment to create two innovative drug candidates, with Sino Biopharma then leading IND enabling activities for both China and the US. The parties will jointly develop the programs to world-class standards with Sino Biopharma commercializing the products within the greater China area and Ambrx commercializing the products rest-of-world. Ambrx is eligible to receive additional milestone payments for development, regulatory, and sales-based events, as well as tiered royalties on future sales.

"We are delighted to join forces with Ambrx, a leader in precision engineered biologics and breakthrough protein therapeutics, to develop two next generation cancer drugs" commented Stephen Hsin Tse, Executive Director of Sino Biopharma. "This collaboration helps fulfill our strong commitment to develop and commercialize innovative biological drugs for the China market."

The collaboration combines Ambrx’s clinically validated ReCODE and EuCODE platforms with Sino Biopharma’s strong resources and commitment to bring nextgeneration biologic drugs to market.

"Sino Biopharma is a large, unique and fast-growing powerhouse in the Chinese pharmaceutical industry, combining strong drug development expertise with substantial commercial resources and infrastructure. We are delighted to collaborate with Sino Biopharma as we continue to push the boundaries of next generation biologics with our proprietary technologies." said Feng Tian, Ph.D., President and CEO of Ambrx. "We are very excited about the future of these two novel first-in-class and best-in-class drug candidates and look forward to working with Sino Biopharma to unleash the therapeutic potential of those drug candidates."

On January 12, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address significant unmet medical needs, reported that it will provide an outlook for 2020 and review progress towards Vision 3×3, the company’s strategic roadmap through 2025 to achieve sustainable growth at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Ascendis Pharma, JAN 12, 2020, View Source [SID1234553048]).

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"2019 was a transformative year for Ascendis Pharma. For our endocrinology rare disease portfolio, we were successful in our first phase 3 trial for a TransCon product candidate, TransCon hGH, and we advanced two other programs globally into phase 2. In addition, we established oncology as our second therapeutic area with a highly-differentiated pipeline leveraging the TransCon technology," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "As groundbreaking as 2019 was for Ascendis, it was only the beginning of our path to build a leading fully-integrated global biopharma company. We are on track with our Vision 3×3 goals to deliver multiple sources of sustainable growth as we seek to make a meaningful difference in patients’ lives."

Pipeline Updates and 2020 Outlook

TransCon hGH: TransCon hGH is an investigational long-acting prodrug of human growth hormone (hGH) in phase 3 development as a once-weekly treatment for growth hormone deficiency (GHD). TransCon hGH releases unmodified somatropin and has demonstrated a statistically significant increase in height velocity compared to a daily hGH in the phase 3 heiGHt Trial:

Ascendis Pharma recently held two pre-BLA meetings with the U.S. Food and Drug Adminstration (FDA) to review its Chemistry, Manufacturing and Controls (CMC), and clinical/non-clinical packages for TransCon hGH as a potential treatment for pediatric GHD. The company is on track to file a Biologics License Application with the FDA in the second quarter. A Marketing Authorisation Application to the European Medicines Agency is planned to follow in the fourth quarter.
Long-term data presented from the ongoing enliGHten Trial (long-term extension) continued to demonstrate statistically superior growth of subjects treated with once-weekly TransCon hGH in the heiGHt Trial who continued into enliGHten, compared to those who started treatment with daily Genotropin and switched to TransCon hGH after one year. The adverse event profile of TransCon hGH, which was comparable to Genotropin in the phase 3 heiGHt Trial, was consistent across the phase 3 clinical trials.
The company plans to submit regulatory filings to initiate a global, phase 3 clinical trial in adult GHD during the first quarter, and to initiate a trial in pediatric GHD in Japan during the fourth quarter.

TransCon PTH: TransCon PTH is an investigational long-acting prodrug of parathyroid hormone (PTH) in development as a once-daily replacement therapy for hypoparathyroidism (HP) designed to replace PTH at physiologic levels for 24 hours each day and fully address all aspects of the disease:

Following completion of screening of subjects in the recently expanded phase 2 PaTH Forward Trial, Ascendis intends to enroll approximately 55 subjects in the trial. The company expects to report top-line results from the trial around the end of March 2020, with six-month data from the open-label extension phase expected in the third quarter.
Preliminary data presented from the first eight subjects who completed four weeks of follow-up in the open-label extension portion of the phase 2 PaTH Forward Trial reinforce the company’s target product profile for TransCon PTH as a promising new potential therapy for HP in the absence of standard of care.
The company plans to submit regulatory filings to initiate a global, phase 3 clinical trial in adults with HP during the fourth quarter.

TransCon CNP: TransCon CNP is an investigational long-acting prodrug of CNP in development as a therapy for children with achondroplasia, the most common form of dwarfism, for which there is no FDA-approved treatment. TransCon CNP is designed to provide continuous exposure of CNP at safe, therapeutic levels via a single, weekly subcutaneous dose:

Ascendis is conducting the phase 2 ACcomplisH Trial of TransCon CNP in children (ages 2-10 years) with achondroplasia and plans to escalate sequential dose cohorts throughout 2020.
The company is expanding the TransCon CNP program in China through its strategic investment in VISEN Pharmaceuticals, with initiation of a second phase 2 trial in children with achondroplasia during the fourth quarter.

Oncology: Ascendis continues to advance a pipeline of multiple pre-clinical programs in oncology by applying both systemic and sustained localized TransCon technologies for clinically validated pathways:

Additional data from non-human primate studies demonstrated that a single dose of TransCon IL-2 b/g provided biased receptor binding and prolonged enhancement of lymphocyte counts, suggesting feasibility of every three week dosing and reduced risk of toxicity.
Ascendis Pharma’s innovative TransCon technology for sustained localized release intratumorally (IT) was accepted to participate in the FDA’s Emerging Technology Program. The program provides for enhanced interactions and dialogue with the FDA to discuss, identify and resolve potential technical and CMC regulatory questions related to the TransCon sustained IT programs prior to filing regulatory submissions.
The company plans to file an IND or equivalent for its first oncology program in 2020, furthering the goal to create best-in-class oncology therapeutics.
Presentation at J.P. Morgan Healthcare Conference on Monday, January 13

Live webcasts of the J.P. Morgan presentation and associated Question & Answer session will be available in the Investors and News section of the Ascendis Pharma website at:

View Source

The presentation will begin at 8:00 a.m. Pacific Time, followed by the Question & Answer session at 8:30 a.m. A webcast replay will also be available for 30 days.

The company’s corporate investor presentation and slides from the J.P. Morgan presentation are also available in the Investors and News section.

On January 12, 2020 Luminex Corporation (Nasdaq: LMNX) reported 2019 highlights and 2020 guidance (Press release, Luminex, JAN 12, 2020, View Source [SID1234553041]).

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All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").

Preliminary results, contained herein, are based on management’s initial analysis of operations for the quarter and year ended December 31, 2019 and are subject to further internal review and audit by the company’s external auditors.

Current Highlights

Total fourth quarter revenue of $90.4 million, an 11% increase over Q4 2018.
Total full year revenue of $334.6 million, up 6%; and up 19% without consideration of LabCorp revenue and including the effect of the Flow Cytometry acquisition.
Sample-to-answer full year revenue of $75.7 million, up more than 20% vs. 2018, including contracting 200 additional systems.
Licensed Technologies Group full year revenue was relatively unchanged from 2018, as expected; however, end user sales of our technology increased by 12% year over year.
Flow Cytometry full year revenue of $45 million, up 11% vs. 2018.
Anticipate being profitable in the fourth quarter of 2019.
Continued $0.09 per share dividend in the fourth quarter of 2019.
2020 Guidance

The company expects 2020 consolidated revenue to be between $352 and $362 million, up approximately 7% to the mid-point relative to 2019, which includes approximately 2 to 3 percent headwind attributable to the departure of certain remaining sales to LabCorp.

CEO Commentary

"2019 was a transition year for Luminex as we adjusted to the departure of certain sales to LabCorp and the integration of the Flow Cytometry acquisition," said Nachum "Homi" Shamir, President & CEO. "I am very pleased with the significant progress we are making. Luminex is now a more diversified company, with opportunities for strong organic growth, profitability, and cash flow, and exciting new platforms being launched across each of our major product lines. We are well positioned to achieve our mid-term target of $500 million of annual revenue in the next 4 to 5 years."

Luminex Presentation / Webcast at 38th Annual J.P. Morgan Healthcare Conference on January 14, 2020

Luminex President and CEO, Homi Shamir, will present at the 38th Annual J.P. Morgan Healthcare Conference to be held at The Westin St. Francis hotel in San Francisco, CA on Tuesday, January 14 at 12:00 p.m. Pacific Time. A live webcast of the Luminex presentation may be accessed at the company’s website at investor.luminexcorp.com. The presentation will be archived for six months on the website using the ‘replay’ link.

Fourth Quarter and Full Year 2019 Earnings Release on February 10, 2020

The company plans to report results for the fourth quarter and full year ended December 31, 2019 and provide details around the 2020 revenue guidance after the market close on Monday, February 10, 2020. Management will hold a conference call to discuss the operating highlights and financial results on that date, at 5:00 p.m. Eastern Time.

On January 12, 2020 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported an update on its business performance, including preliminary net product sales results for 2019, and key commercial and clinical development milestones for 2020 (Press release, Neurocrine Biosciences, JAN 12, 2020, View Source [SID1234553040]). Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, will discuss these updates as part of a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, Jan. 13 at 11:30 a.m. Pacific Time (2:30 p.m. Eastern Time).

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Preliminary Fourth Quarter and Full-Year 2019 INGREZZA (valbenazine) Net Product Sales and Financial Results (Unaudited)

Based on preliminary unaudited financial information, the Company expects INGREZZA net product sales for the three months and full-year ended December 31, 2019 to be approximately $238 million and $753 million, respectively, compared to $130 million and $410 million for the same periods in 2018. Preliminary analysis of INGREZZA net product sales and TRx for the fourth quarter 2019 compared to third quarter 2019 suggests:

– Continued strength in new patient additions
– End of fourth quarter days-on-hand channel inventory increased relative to the third quarter due to timing of quarter-end purchases resulting in an approximate $11 million benefit to net product sales. Given the increase to year-end channel inventory, the Company anticipates this may lead to a reduction to channel inventory in the first quarter of 2020.
– INGREZZA net product sales per prescription of $5,650 for the fourth quarter of 2019

Preliminary unaudited cash and marketable securities balance as of December 31, 2019 is $970 million.

"Our results reflect our team’s dedication to educating healthcare providers and patients about tardive dyskinesia as seen in the growing number of patients receiving treatment with INGREZZA. We still have a lot of work to do as a majority of people suffering from tardive dyskinesia remain undiagnosed and untreated," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2020, we aim to have three FDA-approved medicines in four indications and will remain focused on helping more tardive dyskinesia patients with INGREZZA, preparing for the anticipated approval of opicapone in the U.S., and advancing our growing pipeline, including three pivotal clinical trial programs. We are well positioned as we evolve towards becoming a leading global neuroscience-focused biopharmaceutical company."

2020 INGREZZA Net Product Sales Outlook

During the first quarter of 2020, the Company expects INGREZZA net product sales to be impacted as a result of payer-related seasonal dynamics, gross-to-net discount increases from payer and Medicare Part D rebates, and potential reduction in channel inventory. The Company does not intend to provide formal INGREZZA net product sales guidance for 2020 as the tardive dyskinesia market continues to evolve.

2020 Expected Milestones and Key Activities

INGREZZA (valbenazine) for Tardive Dyskinesia

– "Talk About TD" disease state awareness campaign
– Continued execution of post-marketing clinical studies, including RE-KINECT, the largest real-world study in patients with possible tardive dyskinesia
– Presentations at key scientific annual meetings, including American Academy of Neurology (AAN), American Psychiatric Association (APA), International Parkinson and Movement Disorder Society (MDS)
– Regulatory submissions for approval by Mitsubishi Tanabe in ASEAN territory

Valbenazine for Chorea in Huntington Disease

– Advance the current Phase III study recruitment and initiate open label portion of study during 1H 2020

Elagolix in Collaboration with AbbVie

– Prescription Drug User Fee Act (PDUFA) date in Q2 2020 of elagolix for uterine fibroids
– Continued launch of ORILISSA (elagolix) to treat moderate to severe pain associated with endometriosis by AbbVie

Opicapone for Parkinson’s Disease

– PDUFA date of April 26, 2020
– Preparation for commercial launch
– Presentations at key scientific annual meetings, including AAN, MDS

Crinecerfont (NBI-74788) for Congenital Adrenal Hyperplasia (CAH)

– Phase IIa data (adults) oral presentation in March at ENDO 2020
– Global registrational study initiation (adults) in mid-2020
– Advancement of pediatric plan including Phase IIa study

NBIb-1817 (VY-AADC) for Parkinson’s Disease

– Present 3yr follow up data from study PD-1101 at appropriate medical conference
– Implement amended protocol for RESTORE-1 registration trial by mid-year based upon feedback from the U.S. Food and Drug Administration (FDA)
– Initiate RESTORE-II registration trial in 2H 2020

NBI-921352 (XEN901) for Epilepsy

– File Investigational New Drug (IND) application with the FDA in mid-2020 in order to start a Phase II trial in SCN8A developmental and epileptic encephalopathy patients in 2H 2020

ACT-709478 for Epilepsy

– Upon IND application acceptance by the FDA, expected in mid-2020, the Company will have 30 days to exercise the option to license ACT-709478
– A Phase II study in a rare pediatric epilepsy is planned in 2H 2020

About INGREZZA (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso, and/or other body parts.

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine’s laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.

Important Safety Information

Contraindications
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

Warnings & Precautions
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism
INGREZZA may cause Parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.