On May 9, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2019 (Press release, Cytokinetics, MAY 9, 2019, View Source [SID1234536034]). Net loss for the first quarter was $29.4 million, or $0.54 per share, compared to net loss for the first quarter of 2018 of $30.3 million, or $0.56 per share. Cash, cash equivalents and investments totaled $176.6 million at March 31, 2019.

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"We are pleased with the progress made across our pipeline of muscle-directed investigational medicines during the first quarter of 2019," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Recently, we shared encouraging data from FORTITUDE-ALS demonstrating consistency of effect for doses, endpoints and timepoints in patients treated with reldesemtiv and we believe the results may support progression to further clinical trials toward potential registration. We also passed through the first planned interim analysis of GALACTIC-HF and opened enrollment in METEORIC-HF while we also independently continued the conduct of the Phase 1 study of CK-274 and prepared for potential progression to Phase 2. Our strategy to advance multiple drug candidates, under our collaborations and independently, continues to generate upside potential for patients and shareholders."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued conduct of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, following first planned interim analysis for futility. We expect screening in this event-driven trial to complete in the second quarter of 2019.

Opened METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil, to enrollment. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. We expect to continue enrollment of METEORIC-HF throughout 2019.

John Teerlink, M.D., Professor of Clinical Medicine, University of California San Francisco and Director of Heart Failure, San Francisco Veterans Affairs Medical Center, presented additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) at the American College of Cardiology’s 68th Annual Scientific Session. The results of a post hoc subgroup analysis of the COSMIC-HF data showed that, between 32 patients with atrial fibrillation (AF) and 117 patients without AF, there were no statistically significant differences in the effects of treatment with omecamtiv mecarbil on cardiac function, including systolic ejection time and stroke volume, as well as ventricular volumes, heart rate, and NT-proBNP.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued conduct of the Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). We expect results from this study in the third quarter of 2019 and are preparing for potential progression of CK-274 to Phase 2 in the second half of 2019.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Results from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), were presented during a platform presentation at the American Academy of Neurology 71st Annual Meeting in Philadelphia on Sunday, May 5, 2019.

FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Similar analyses of ALSFRS-R and slope of the Muscle Strength Mega-Score yielded p values of 0.09 and 0.31, respectively. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, patients who received reldesemtiv in FORTITUDE-ALS declined less than patients who received placebo. The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints. The differences between reldesemtiv and placebo in SVC and ALSFRS-R total score observed after 12 weeks of treatment were still evident at follow-up, four weeks after the last dose of study drug.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA), under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Joined the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day, an international campaign elevating the public understanding of rare diseases.
Financials

Revenues for the first quarter of 2019 increased to $8.5 million from $5.3 million for the first quarter of 2018, primarily due to increased research and development revenues from our collaborations with Astellas and Amgen. License revenues in the first quarter of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscle atrophy completed in 2018.

Research and development expenses for the first quarter of 2019 increased to $23.5 million from $22.1 million for the first quarter of 2018, primarily due to increased spending related to the opening of METEORIC-HF and development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017. General and administrative expenses increased slightly to $9.4 million for the first quarter of 2019 from $9.3 million for the first quarter of 2018.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 4486595.

An archived replay of the webcast will be available via Cytokinetics’ website until May 16, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 4486595 from May 9, 2019 at 7:30 PM Eastern Time until May 16, 2019.

On May 9, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter of 2019 (Press release, Surface Oncology, MAY 9, 2019, View Source [SID1234536051]).

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"2019 is an important execution year for Surface and we are off to a fantastic start. During the first quarter, we continued to make strong progress on a number of fronts, including the expansion of both our executive team and scientific advisory board, as well as the advancement of our next wave of product programs, SRF617 and SRF388, towards initial clinical trials," said Jeff Goater, chief executive officer.

Recent Corporate Highlights:

Addition of F. Steven Hodi, M.D., Dana Farber Cancer Institute, to our Scientific Advisory Board. Dr. Hodi is a clinical pioneer in the field of cancer immunotherapy and his groundbreaking work in melanoma with checkpoint inhibitors led to the first wave of cancer immunotherapy drug approvals.

Appointment of Wendy Dwyer as chief business officer. Ms. Dwyer brings over 20 years of transactional experience, including prior business development leadership roles at AstraZeneca, Ipsen Biosciences and Endo Pharmaceuticals.

The Novartis-sponsored phase 1 trial of NZV930 (CD73) continues to progress, now enrolling patients in seven countries.

IND filings for both SRF617 (CD39) and SRF388 (IL-27) remain on track for Q4 of 2019.

Surface Oncology scientists co-authored the paper, "IL-27 and TCR Stimulation Promote T Cell Expression of Multiple Inhibitory Receptors," which was published in ImmunoHorizons.
Financial Results:

As of March 31, 2019, cash, cash equivalents and marketable securities were $140.2 million, compared to $158.8 million on December 31, 2018.

Research and development (R&D) expenses were $14.3 million for the first quarter ended March 31, 2019, compared to $11.1 million for the same period in 2018. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.6 million in stock-based compensation expense for the first quarter of 2019.

General and administrative (G&A) expenses were $5.1 million for the first quarter ended March 31, 2019, compared to $3.4 million for the same period in 2018. The increase in G&A expenses is primarily due to increased personnel costs and professional fees associated with the growth of the company and operating as a public company. G&A expenses included $0.8 million in stock-based compensation expense for the first quarter of 2019.

For the first quarter ended March 31, 2019, net loss was $4.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.15. Net income was $31.2 million for the same period in 2018 or diluted net income per share attributable to common stockholders of $1.05. Income from the first quarter of 2018 was driven by milestones from our partnership with Novartis.

Financial Outlook:

Based upon its current operating plan, Surface continues to have a projected cash runway through 2021.

On May 9, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways, reported its financial results for the first quarter ended March 31, 2019. As of March 31, 2019, cash equivalents and investments totaled $117.0 million (Press release, Calithera Biosciences, MAY 9, 2019, View Source [SID1234536068]).

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"This year we expect to achieve multiple, key milestones in our clinical development program and several data readouts, including top-line results of the ENTRATA trial mid-year, and with our partner Incyte, data from the INCB001158 program in the second half of the year," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "In the first quarter, we’ve also made great strides in our earlier stage programs, moving our cystic fibrosis program into the clinic and presenting preclinical data on our CD73 inhibitor, which is poised to enter the clinic by year end."

First Quarter 2019 and Recent Highlights

Completed enrollment of the Phase 2 renal cell carcinoma ENTRATA trial. The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report top-line results including key efficacy and safety data in mid-2019.

Initiated Phase 1/2 clinical trial of telaglenastat (CB-839) in combination with talazoparib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s PARP inhibitor talazoparib in patients with solid tumors. Calithera expects to initiate an additional trial of the combination of telaglenastat plus the CDK4/6 inhibitor palbociclib in patients with KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer in the second quarter of 2019.

Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. The first-in-human Phase 1 trial initiated in February 2019 will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers.

Presented preclinical data for CB-708 at AACR (Free AACR Whitepaper) Annual Meeting 2019. The preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrate that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single-agent activity in syngeneic mouse tumor models. In the pre-clinical studies presented, CB-708 was well-tolerated and shows enhanced anti-tumor activity in combination with checkpoint inhibitors as well as chemotherapy. Calithera anticipates that CB-708 will enter clinical trials in 2019.

Selected First Quarter 2019 Financial Results

Cash, cash equivalents and investments totaled $117.0 million at March 31, 2019.

Research and development expenses were $20.2 million for the three months ended March 31, 2019, compared with $15.5 million for the same period in the prior year. The increase of $4.7 million was primarily due to a $2.3 million increase in the telaglenastat program, including our Phase 2 CANTATA trial, an increase of $1.1 million in the INCB001158 program, an increase of $1.0 million in the CB-280 program, as well as investment in early stage research.

General and administrative expenses were $4.2 million for the three months ended March 31, 2019, compared with $3.5 million for the same period in the prior year. The increase of $0.7 million was related to higher personnel-related costs and professional services costs.

Net loss for the three months ended March 31, 2019 was $23.7 million, or $0.61 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 9 at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 1182244. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 9, 2019 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, reported the publication of Phase 1 results in the peer-reviewed journal Neurosurgery (Press release, Blaze Bioscience, MAY 9, 2019, View Source [SID1234536085]). The publication entitled "Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults with Newly Diagnosed or Recurrent Gliomas" by Patil et al is available online in Neurosurgery Now!.

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The publication reports data from 17 subjects in a single dose, dose-escalation, open-label clinical trial conducted at Cedars-Sinai Medical Center in Los Angeles and the NEWRO Foundation in Brisbane, Australia. The primary objective of the study was to evaluate the safety and tolerability of tozuleristide in adult subjects with glioma undergoing surgery. Tozuleristide was found to be well tolerated at all tested doses with no dose limiting toxicities observed. A maximum tolerated dose was not reached. Exploratory imaging studies were conducted with the FLUOBEAM800 (Fluoptics), Odyssey CLx (LI-COR Biosciences) and SIRIS (Teal Light Surgical) imaging devices. Fluorescence signal was detected in both high- and low-grade tumors and was visible from 3 hours to 27 hours post dosing.

"Tozuleristide fluorescence visualized with a high-resolution imaging system shows great promise as a tool to increase extent of resection for both high- and low-grade gliomas while preserving critical normal brain tissue. Improved resection is the single most important factor for improving survival and quality of life in brain tumor patients. Based on these encouraging results, further clinical trials are definitely warranted," said Dr. Adam Mamelak, MD, neurosurgeon at Cedars-Sinai and senior author on the publication.

"The positive data in adult glioma subjects has paved the way for our broader pediatric brain cancer clinical trials," said Dr. Dennis Miller, Blaze Bioscience SVP of Development. "The study also pointed out the need for improved imaging devices for brain cancer surgery applications which led to the development of the Canvas Imaging System being used in our ongoing pivotal study."

About BLZ-100 (tozuleristide)

BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared (NIR) range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells throughout surgery, potentially enabling more precise, complete resection of cancer while sparing normal adjacent tissue. BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated clinical proof of concept in brain, breast and skin cancers. Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. BLZ-100, an investigational agent, is being evaluated in a pivotal Phase 2/3 clinical study in pediatric central nervous system tumors. More details about ongoing trials are available at www.clinicaltrials.gov.

About the Canvas Imaging System

The Canvas Imaging System is an investigational medical device designed to provide high-sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas Imaging System was developed and is manufactured by Teal Light Surgical, Inc. (a wholly owned subsidiary of Blaze Bioscience, Inc.). The first Canvas Imaging System under development is adapted for use with surgical microscopes and detects both BLZ-100 and indocyanine green (ICG).

On May 9, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter of 2019 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2019, View Source [SID1234536134]).

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"The first quarter of 2019 saw critical execution across multiple programs. With respect to the global roxadustat anemia platform, we received positive topline results from analyses of pooled MACE and MACE+ data from our Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients. We and our partners continue to prepare for NDA submission to the FDA in the third quarter, with the EMA MAA submission to follow," said Thomas B. Neff, Chief Executive Officer. "In our anti-CTGF antibody program, we completed the analysis of the first year of treatment with pamrevlumab, our anti-CTGF antibody, for the 21 non-ambulatory subjects in a Phase 2 trial with favorable results in lung and cardiac functions and muscle strength from our administrative analysis suggesting promise for a new treatment option for DMD patients."

Recent Developments and Highlights

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and EU

In the pooled analyses of around 4,000 dialysis patients, the upper bound of the 95% confidence interval (CI) was below the pre-specified non-inferiority margin for the time to first MACE+ analyses. Based on the MACE safety analyses of this population, we believe there is no clinically meaningful difference in risk of MACE between roxadustat and epoetin alfa.

In the pooled analyses of about 1,500 incident dialysis patients roxadustat demonstrated superiority to epoetin alfa in the time to first MACE+ in this subpopulation. In the MACE analysis, there is a trend toward reduced risk for patients on roxadustat, compared to epoetin alfa.

In the non-dialysis pool of approximately 4,300 patients, non-inferiority was demonstrated for roxadustat compared to placebo in the time to first MACE+, based on the upper bound of the 95% CI being below the pre-specified non-inferiority margin. We believe there is no clinically meaningful difference in risk of MACE between roxadustat and placebo.

•

Multiple MACE and MACE+ analyses in non-dialysis from the roxadustat global Phase 3 program are being performed in intent-to-treat (ITT) analyses that demonstrated comparability of roxadustat to placebo. ITT is among the several statistical methods that we will discuss with the FDA. In these ITT analyses, roxadustat was comparable based on a commonly applied non-inferiority margin of 1.3.

Additional positive efficacy results from pooled analyses were observed in the areas of:

rate of kidney function decline, as measured by eGFR, as compared to placebo

quality of life, as measured by standard endpoints, as compared to placebo

efficacy in the presence of inflammation, as compared to epoetin alfa

FibroGen and AstraZeneca will begin discussions with the U.S. Food and Drug Administration (FDA) to prepare for regulatory submission of our New Drug Application (NDA), which is anticipated in September/October 2019, with the MAA for submission to the European Medicines Agency (EMA) to follow.

Roxadustat for Anemia in CKD in China

Completed clinical site inspections by the China Food and Drug Inspection division of the National Medical Products Administration (NMPA) for Phase 3 study evaluating roxadustat for treatment of anemia in non-dialysis-dependent CKD patients.

Anticipate NMPA approval decision on roxadustat for treatment of anemia in non-dialysis-dependent CKD mid-year 2019.

Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Completed enrollment of the open-label portion of our global multi-center Phase 3 study in transfusion-dependent, lower risk MDS patients.

Initiated patient dosing in the double-blind, placebo-controlled portion of this Phase 3 study.

Open-label portion of China Phase 2/3 MDS study is ongoing.

Pamrevlumab for Duchenne Muscular Dystrophy (DMD)

Received Orphan Drug Designation from the FDA for treatment of Duchenne muscular dystrophy.

Administrative analysis of the first year treatment in 21 non-ambulatory DMD patients shows favorable results in lung function, cardiac function, and muscle strength.

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

On track to initiate a randomized, double-blind, placebo-controlled Phase 3 clinical trial with a primary endpoint of change in forced vital capacity (FVC) from baseline in approximately 500 patients in Q2 2019.

Pamrevlumab for Pancreatic Cancer

On track to initiate a randomized, double-blind, placebo-controlled Phase 3 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as a neoadjuvant therapy versus placebo in combination with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer (LAPC) in approximately 260 patients in Q2 2019.

Corporate and Financial

Net loss for the first quarter of 2019 was $45.4 million, or $0.53 net loss per basic and diluted share, compared to a net loss of $41.4 million, or $0.53 net loss per basic and diluted share one year ago.

At March 31, 2019, FibroGen had $712.7 million in cash, restricted time deposits, cash equivalents, investments, and receivables, compared to $747.2 million at year-end 2018.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Thursday, May 9, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen first quarter 2019 financial results conference call, and use passcode 48545313. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 48545313#.

About Roxadustat

Roxadustat (FG-4592), discovered by FibroGen, is a first-in-class, orally administered small molecule currently approved in China for the treatment of anemia in CKD patients on dialysis. Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, has been granted Orphan Drug Designation (ODD) in each of these indications. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and for patients with locally advanced unresectable pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.