On May 14, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the first quarter of 2025. Following the completion of the sale of INBRX-101 by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the current year (Press release, Inhibrx, MAY 14, 2025, View Source [SID1234653096]). Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company’s financial statements are the historical financial statements of the Former Parent.

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Upcoming Milestones

INBRX-109
Data from the registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma are expected during the third quarter of 2025; and
Initial data on the colorectal cancer expansion cohort are anticipated in the third quarter of 2025 with interim data from the Ewing sarcoma expansion cohort expected in the second half of 2025.
INBRX-106
Initial Phase 2 data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA (pembrolizumab) are expected during the fourth quarter of 2025; and
Interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer are expected during the fourth quarter of 2025.
Financial Results

Cash and Cash Equivalents. As of March 31, 2025, Inhibrx had cash and cash equivalents of $216.5 million, compared to $152.6 million as of December 31, 2024. The Company’s cash balance increased following the receipt of $100.0 million in gross principal in January 2025 under a loan and security agreement (the "2025 Loan Agreement") entered into with Oxford Finance LLC ("Oxford").
R&D Expense. Research and development expenses were $36.9 million during the first quarter of 2025, compared to $63.9 million during the first quarter of 2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial expenses and contract manufacturing expenses following the spin-off of our INBRX-101 program in the second quarter of 2024.
G&A Expense. General and administrative expenses were $6.0 million during the first quarter of 2025, compared to $10.0 million during the first quarter of 2024. The decrease in general and administrative expenses was primarily due to:
a decrease in non-cash stock option expense as a result of fewer stock options outstanding in the current period under the Company’s new 2024 Omnibus Incentive Plan following the termination of its prior plan in connection with the spin-off;
a decrease in professional service expenses in the current period as a result of higher legal and accounting services in the prior period to support the spin-off transaction and the conclusion of legal proceedings.
Other Income (Expense). Other expense was $0.4 million during the first quarter of 2025, compared to other expense of $4.9 million during the first quarter of 2024. Other expense consists of interest expense incurred on the Company’s outstanding third-party debt during each period, offset in part by interest income earned on the Company’s sweep and money market account balances. The Company incurred less interest expense during the first quarter of 2025 as compared to the first quarter of 2024 due to a lower principal balance under its 2025 Loan Agreement as compared to its prior borrowings with Oxford which were extinguished as a result of the spin-off transaction.
Net Loss. Net loss was $43.3 million during the first quarter of 2025, or $2.80 per share, basic and diluted, compared to a net loss of $78.7 million during the first quarter of 2024, or $5.77 per share, basic and diluted.

On May 14, 2025 AbbVie (NYSE: ABBV) and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, reported a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology (Press release, AbbVie, MAY 14, 2025, View Source [SID1234653095]).

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siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates the expression of genes. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.

The strategic collaboration will leverage ADARx’s RNA discovery expertise and proprietary siRNA technology, which has the potential to enable sustained and precise mRNA silencing. AbbVie will contribute its expertise in antibody engineering, antibody drug conjugates (ADCs) and tissue delivery approaches as appropriate, to augment ADARx’s discovery efforts.

"siRNA is a promising genetic medicine approach for silencing disease-causing genes, but challenges still remain in targeting and delivering siRNA effectively," said Jonathon Sedgwick, Ph.D., senior vice president and global head, discovery research, AbbVie. "We are very pleased to collaborate with ADARx, leveraging their proprietary RNA technology alongside our antibody, ADC, and therapeutic area research and development expertise to bring siRNA forward as a potential novel therapeutic modality alongside our other established approaches. Together, we’re committed to developing innovative solutions for difficult-to-treat diseases across neuroscience, immunology and oncology."

"This collaboration with AbbVie further validates the differentiated RNA technology that we have developed at ADARx and has the potential to unlock tremendous clinical and commercial potential across multiple disease areas. AbbVie’s research and development expertise combined with its global commercial reach make them the ideal strategic collaborator to accelerate these programs for the potential benefit of patients worldwide," said Zhen Li, Ph.D., co-founder, president and chief executive officer of ADARx. "In addition to this strategic collaboration with AbbVie, ADARx continues to advance a deep pipeline of wholly-owned clinical-stage programs that span complement-mediated, cardiovascular and thrombotic diseases and various preclinical discovery programs including in obesity and neurodegeneration."

Under the terms of the agreement, ADARx will receive a $335 million upfront payment and will be eligible to receive several billion dollars in additional contingent payments including option-related fees and milestone payments, as well as tiered royalties.

On May 14, 2025 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that preclinical data will be presented on its lead program, RGT-61159, at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress, which will be held from June 12-15, 2025, in Milan, Italy (Press release, Rgenta Therapeutics, MAY 14, 2025, View Source [SID1234653094]).

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Presentation Details:

Title: RGT-61159, a Potent and Selective Small Molecule MYB RNA Inhibitor, Showed Significant Anti-Tumor Activity as Monotherapy or in Combination with Standards of Care in Several Leukemia Disease Models Harboring AML Most Common Genetic Lesions.
Presenting Author: Patricia Soulard
Session title: Poster Session 2
Session date and time: Saturday, June 14 (18:30 – 19:30 CEST)
Abstract #: PS1424

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of the oncogenic MYB protein and potential cell death of the cancer cells that overexpress the MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemia (AML), T-cell acute lymphoblastic leukemia (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer. Rgenta is evaluating RGT-61159 in an ongoing multi-center, open-label Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is designed to evaluate safety, tolerability, pharmacokinetics, target engagement, and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

On May 14, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported updated, positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) in an abstract accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress taking place June 12-15 in Milan, Italy, and virtually (Press release, Enliven Therapeutics, MAY 14, 2025, View Source [SID1234653093]). Updated data will be presented during an oral presentation at the conference on Friday, June 13, at 5 p.m. CEST/11 a.m. ET. Enliven management will host a webcast and conference call to discuss the data on Friday, June 13, at 7:30 p.m. CEST/1:30 p.m. ET.

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ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with CML. Data presented at EHA (Free EHA Whitepaper) will be from the ongoing ENABLE Phase 1a/1b clinical trial, which enrolled patients with CML that have failed, are intolerant to, or are not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377).

"We are strongly encouraged by the consistent efficacy, safety and tolerability data from the ongoing ENABLE trial in heavily pretreated patients with CML," said Helen Collins, M.D., Chief Medical Officer of Enliven. "These data continue to demonstrate the potential for ELVN-001 to achieve a best-in-class profile compared to the available active-site TKIs. We look forward to providing additional updates at the EHA (Free EHA Whitepaper) Congress in June."

Abstract Highlights

Patient Demographics

As of the cutoff date of January 21, 2025, 74 patients have been enrolled in the ongoing Phase 1 trial across dose levels from 10-160 mg daily and the vast majority of patients (82%) remain on study with a median treatment duration of ~26 weeks.
Patients enrolled continue to be heavily pretreated, with 66% having received three or more prior tyrosine kinase inhibitors (TKIs), including ponatinib (45%) and asciminib (57%).
Updated Efficacy

Of the enrolled patients, 36 with typical transcripts and without T315I mutations were evaluable for molecular response by 24 weeks.
16 of 36 (44%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 7 of 27 (26%) achieving and 9 of 9 (100%) maintaining MMR.
Of those resistant to their last TKI, 10 of 25 (40%) were in MMR by 24 weeks.
Of those previously treated with asciminib or ponatinib, 9 of 25 (36%) were in MMR by 24 weeks, including one with a known asciminib resistance mutation (A337T).
All patients who achieved or maintained MMR were still in MMR at the time of data cutoff.
These data continued to compare favorably to precedent Phase 1 MMRs for approved BCR::ABL1 TKIs, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.
Updated Safety

ELVN-001 remains well-tolerated across all doses, consistent with its selective kinase profile.
Dose interruptions and reductions occurred in less than 10% and less than 5% of patients, respectively.
The maximum tolerated dose was not reached.
Details of the oral presentation are as follows:
Title: ENABLE: A Phase 1a/1b Study of ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with previously treated CML
Presenter: Andreas Hochhaus, M.D.
Session Title: s425 Novel approaches of CML treatment
Location: Coral 2
Abstract Number: S165
Presentation Date/Time: June 13, 5 p.m. CEST / 11 a.m. ET

The abstract is available on the EHA (Free EHA Whitepaper) website. Following the presentation, a copy will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.

Webcast and Conference Call Information
Enliven will host a conference call with management on June 13, 2025, at 7:30 p.m. CEST/1:30 p.m. ET. To access the call, please dial +1 (800) 803-6955 (domestic) or (240) 220-9050 (international), and reference participant ID 631-128-259 at least 10 minutes prior to the start time and ask to be joined to the Enliven call. Accompanying slides and a link to the webcast will be available in the Investors section of the Enliven website at View Source To participate in the live event, please register using this link. An archived webcast will be available following the event.

About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/1b development and is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.

About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active site inhibitor, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

On May 14, 2025 AbbVie (NYSE: ABBV) reported that EMRELIS (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy (Press release, AbbVie, MAY 14, 2025, View Source [SID1234653092]). High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.2,3

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This indication is approved based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population. ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent ‘payload’ directly to the biomarker-expressing cell.

Approximately 85% of lung cancers are classified as NSCLC4,5 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world.1 The c-Met protein is found to be overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients and is associated with poor prognosis.2,6-12 Approximately half of these patients have high c-Met overexpression, defined as ≥ 50% of tumor cells with strong (3+) staining by immunohistochemistry (IHC) test.2

"We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes," said Jonathan Goldman, MD, professor of medicine, director of thoracic oncology clinical trials, UCLA. "People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and EMRELIS is a first-in-class ADC that can address a critical unmet need for this patient population."

"EMRELIS, AbbVie’s first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie. "Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors."

"Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working," said Upal Basu Roy, PhD, MPH, executive director of research, LUNGevity Foundation, a leading lung cancer nonprofit organization. "This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade."

The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study (NCT03539536), a study designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with high c-Met protein overexpression (n=84) who received EMRELIS demonstrated a 35% (95% CI: 24, 46) Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months (95% CI: 4.2, 12). The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium.2

In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.

EMRELIS is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites. Additional information on clinical trials for EMRELIS is available at www.clinicaltrials.gov.

The FDA has also approved the Roche VENTANA MET (SP44) RxDx Assay, the only IHC companion diagnostic that identifies patients eligible for treatment with EMRELIS. To determine c-Met protein biomarker status, patients can be tested on recent or archived tissue.

About the LUMINOSITY Trial
The LUMINOSITY trial (NCT03539536) is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for telisotuzumab vedotin-tllv monotherapy in the second-line or third-line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS).2

Patient Access and Support
AbbVie is committed to helping people access EMRELIS and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. Financial support might also include reimbursement for out-of-pocket costs related to IV administration. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides EMRELIS at no charge to those who qualify. More information can be found at www.AbbVie.com/PatientAccessSupport.

About EMRELIS
EMRELIS (telisotuzumab vedotin-tllv) is a first-in-class c-Met-directed antibody-drug conjugate (ADC) comprising of a c-Met-binding antibody, cleavable linker and the monomethyl auristatin E (MMAE) payload designed to target c-Met expressing cells.3 The c-Met protein is a receptor tyrosine kinase that can be overexpressed in NSCLC and is associated with poor prognosis.2, 6-12

EMRELIS (telisotuzumab vedotin-tllv) U.S. Uses and Important Safety Information3

What is EMRELIS?
EMRELIS is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC):

that has spread to areas near the lungs (locally advanced) or to other parts of the body (metastatic), and
whose tumors have high c-Met protein overexpression, and
who have received a prior treatment.
Your healthcare provider will perform a test to make sure EMRELIS is right for you.

It is not known if EMRELIS is safe and effective in children.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about EMRELIS?
EMRELIS can cause serious side effects, including:

Nerve problems in your hands or feet (peripheral neuropathy). Nerve problems are common during treatment with EMRELIS and can also be severe. Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including:

numbness
tingling
burning sensation

pain or discomfort
muscle weakness
difficulty walking
Lung problems. EMRELIS can cause lung problems that may be severe, life-threatening or that may lead to death. Tell your healthcare provider right away if you develop new or worsening lung symptoms, including:

cough
trouble breathing or shortness of
breath

fever
wheezing
Eye problems. Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including:

blurred vision
dry eyes
sensitivity to light

eye pain or swelling
eye redness
Infusion-related reactions. EMRELIS can cause infusion reactions that can be severe or life-threatening. Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including:

itching or rash
shortness of breath or wheezing
flushing
chest discomfort
fever

back pain
chills
headache
nausea or vomiting
feel like passing out
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with EMRELIS and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with EMRELIS if you have severe side effects.

Before receiving EMRELIS, tell your healthcare provider about all of your medical conditions, including if you:

have a history of nerve problems
have lung or breathing problems other than your lung cancer
have eye problems
have liver problems
are pregnant or plan to become pregnant. EMRELIS can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with EMRELIS.
You should use effective birth control (contraception) during treatment and for 2 months after your last dose of EMRELIS.
Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EMRELIS.
Males with female partners who are able to become pregnant:
You should use an effective birth control during treatment and for 4 months after taking the last dose of EMRELIS
are breastfeeding or plan to breastfeed. It is not known if EMRELIS passes into your breast milk. Do not breastfeed during treatment with EMRELIS and for 1 month after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines with EMRELIS may increase your risk of side effects.

How will I receive EMRELIS?

Your healthcare provider will give you EMRELIS into your vein through an intravenous (IV) line over 30 minutes.
EMRELIS is given 1 time every 2 weeks.
Your healthcare provider will decide how many infusions of EMRELIS you will receive.
What are the possible side effects of EMRELIS?
EMRELIS can cause serious side effects. See ‘What is the most important information I should know about EMRELIS?"

The most common side effects of EMRELIS include:

feeling tired
decreased appetite
swelling in the feet, ankles, legs, or hands
The most common severe abnormal laboratory tests results of EMRELIS include:

decreased white blood cell counts
increased blood sugar levels
increased blood liver enzyme levels
decreased blood phosphorus levels

decreased blood sodium levels
decreased red blood cell counts
decreased blood calcium levels
EMRELIS may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of EMRELIS.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

Please see the Full Prescribing Information and Medication Guide.