On May 9, 2019 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, MAY 9, 2019, View Source [SID1234536062]).

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"Harpoon has continued to progress in 2019, both in the clinic and in its development as a company. We are pleased to now have two T cell engagers in the clinic, with dosing of the first patient with our second product candidate HPN536 in April. We continue to develop additional candidates, with IND submissions expected this year and next," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We believe TriTACs provide unique benefits in the exciting field of T cell engagers and we look forward to achieving a number of development milestones in 2019 across the TriTAC platform, including presentation of a maturing HPN424 dataset by the end of this year at a medical conference."

First Quarter 2019 Business Highlights and Other Recent Developments

In February, Harpoon successfully completed its initial public offering, raising net proceeds of approximately $71 million.

In March, Harpoon designated its fourth Tri-specific T cell Activating Construct (TriTAC) in development, HPN328, for the treatment of small cell lung cancer (SCLC). HPN328 targets delta-like 3 (DLL3), a protein highly expressed in a majority of SCLC tumors, but not in normal tissue. This selective expression makes DLL3 an attractive drug target for T cell engagers. Harpoon is currently conducting IND-enabling studies and expects to initiate a Phase 1 clinical trial of HPN328 in 2020.

In April, Harpoon dosed the first patient with HPN536, a mesothelin-targeting T cell engager, in a Phase 1/2a clinical trial for ovarian and other mesothelin-expressing solid tumors. This represents the second TriTAC that Harpoon has brought into the clinic. The study consists of two phases, an initial dose escalation phase of approximately 20 ovarian cancer patients followed by an expansion phase of up to three additional parallel cohorts of 20 patients each with ovarian, pancreatic and mesothelioma cancer. The study is designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN536. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT03872206.

Anticipated Milestones

Harpoon plans to have three TriTAC product candidates in the clinic by the end of 2019, with a fourth expected in 2020. All of Harpoon’s anticipated milestones for 2019 remain on track, as follows:

HPN424 – present additional Phase 1 data in the second half of 2019 at a medical conference

HPN536 – initiated Phase 1/2a trial in April 2019

HPN217 – initiate Phase 1 trial in the second half of 2019

HPN328 – initiate Phase 1 trial in 2020

First Quarter Financial Results

Harpoon Therapeutics ended the first quarter of 2019 with $147.6 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $71 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.

Net loss for the first quarter ended March 31, 2019 was $13.6 million compared to $4.9 million for the first quarter ended March 31, 2018.

Revenue for the first quarter of 2019 was $1.1 million compared to $1.6 million for the first quarter of 2018. The decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to our license agreement with Werewolf Therapeutics, Inc. During both periods, revenue primarily consisted of the amortized portion of the deferred $17.0 million upfront payment received in October 2017 under our collaboration agreement with AbbVie.

Research and development expense for the first quarter of 2019 was $9.4 million compared to $5.5 million for the first quarter of 2018. The increase primarily arose from clinical development expenses and an increase in personnel-related expenses, including conducting preclinical studies, continuation of the first clinical trial for lead product candidate, HPN424, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expense for the first quarter of 2019 was $5.8 million compared to $1.0 million for the first quarter of 2018. The increase was primarily due to an increase in legal fees, consulting and accounting services related to our 2018 year-end audit, and an increase in headcount.

On May 9, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the first quarter of 2019 and recent operational highlights (Press release, Atara Biotherapeutics, MAY 9, 2019, View Source [SID1234536061]).

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"We have made important progress advancing our T-cell immunotherapy programs across our three major value drivers: tab-cel, multiple sclerosis and next-generation CAR T," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Discussions with EMA and FDA to align on a tab-cel global regulatory strategy for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease are progressing, with outcomes of these discussions expected in the first half of 2019. We are also looking forward to upcoming clinical milestones for our off-the-shelf, allogeneic ATA188 Phase 1 program in progressive multiple sclerosis with initial safety and efficacy results expected this year. In addition, recent clinical results presented by our MSK collaborators reaffirm mesothelin as a promising target for patients with advanced mesothelioma and establish an important proof-of-concept advance for CAR T immunotherapy in solid tumors."

Atara continues to progress tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD), with enrollment proceeding slower than anticipated. The Company is in discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development of tab‑cel and Atara’s intention is to align on a global regulatory strategy for patients with EBV+ PTLD. Atara now plans to submit a tab‑cel EU conditional marketing authorization (CMA) application based on initial Phase 3 results in 2020. To ensure the integrity of the ongoing, open-label tab-cel Phase 3 study, the Company anticipates disclosing initial top-line EBV+ PTLD results following acceptance of the EMA CMA application.

"Global regulators recognize the critical need of new therapies to treat patients with EBV+ PTLD," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "We look forward to our continued discussions with the FDA under Breakthrough Therapy Designation and EMA based on the Priority Medicines (PRIME) regulatory pathway to bring tab‑cel to patients with this often life-threating disease as expeditiously as possible."

The Company is also advancing an off-the-shelf, allogeneic ATA188 Phase 1 study in patients with progressive multiple sclerosis (MS). Initial safety results for this study are expected to be presented at the 5th Congress of the European Academy of Neurology (EAN) in June 2019. Additional safety and efficacy results from this study are expected to be presented at a scientific congress in the second half of 2019.

Atara’s collaborators at Memorial Sloan Kettering Cancer Center (MSK) reported positive Phase 1 clinical results for their mesothelin-targeted CAR T immunotherapy for patients with solid tumors at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. Efficacy and safety results were presented for patients with malignant pleural mesothelioma who may also have received pembrolizumab and lymphodepleting chemotherapy. Following administration of a novel mesothelin-targeted CAR T, MSK investigators observed a 72% response rate in a subset of these patients. Atara expects additional results from this study to be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Based on these encouraging results, Atara and MSK are advancing development of a next-generation, mesothelin-targeted CAR T immunotherapy using a novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies, with an IND expected in 2020.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
In the United States and Australia, 32 sites are available for enrollment, with additional sites expected to open in the United States and other geographies.
2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Expect presentations highlighting tab-cel and next-generation CAR T immunotherapy technology to be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting to be held May 31 to June 4 in Chicago.
Oral Presentation: Regional delivery of mesothelin-targeted CAR T cells for pleural cancers: Safety and preliminary efficacy in combination with anti-PD-1 agent. Abstract 2511, S406, Tuesday, June 4, 2019, 8:36 a.m. – 8:48 a.m. CDT.
Poster Presentation: Correlation of circulating EBV-targeted cytotoxic T lymphocyte precursors (EBV-CTLp) and clinical response following tabelecleucel (tab-cel) infusion in patients with EBV-driven disease. Abstract 2532, Hall A, Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. CDT.
Poster Presentation: Tabelecleucel in combination with pembrolizumab (Pembro) in platinum-pretreated, recurrent/metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma (EBV+ NPC). Abstract TPS6092, Hall A, Saturday, June 1, 2019, 1:15 p.m. – 4:15 p.m. CDT.
ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Atara expects to present initial safety results from this study during at the 5th Congress of the European Academy of Neurology (EAN) to be held June 29 to July 2 in Oslo, Norway.
Additional safety and efficacy results from this study are expected to be presented at a scientific congress in the second half of 2019.
Expect to initiate a randomized study of autologous ATA190 in progressive MS patients during the second half of 2019.
Next-Generation CAR T

Positive Phase 1 clinical results for MSK’s mesothelin-targeted CAR T immunotherapy were recently presented by our MSK collaborators at the AACR (Free AACR Whitepaper) Annual Meeting 2019.
Encouraging safety results and anti-tumor responses observed in combination with a PD-1 checkpoint inhibitor, support Atara’s plans to progress development of a next-generation, mesothelin-targeted CAR T immunotherapy using MSK’s novel 1XX CAR signaling domain and PD-1 DNR checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.
Atara plans to prioritize mesothelin CAR T development and anticipates that this program will be the first CAR T program to enter the clinic, with an IND expected in 2020.
Additional results from ongoing MSK investigator-sponsored mesothelin-targeted CAR T studies are expected to be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
Corporate

Atara’s Board of Directors is conducting a search for a new Chief Executive Officer following Dr. Ciechanover’s transition plan announced in January. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2019 totaled $237.5 million, which the Company believes will be sufficient to fund planned operations to mid-2020.
The Company reported net losses of $66.3 million, or $1.44 per share, for the first quarter of 2019 as compared to $41.4 million, or $1.05 per share, for the same period in 2018.
Total operating expenses include total non-cash expenses of $13.9 million for the first quarter of 2019 as compared to $7.3 million for the same period in 2018.
Research and development expenses were $48.7 million for the first quarter of 2019 as compared to $28.5 million for the same period in 2018. The increase in the first quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
clinical study, manufacturing and outside service costs related to tab-cel and the Phase 1 clinical study of off-the-shelf, allogeneic ATA188;
higher employee-related and overhead costs from increased headcount and operations, and
an increase in facilities and information technology expenses that are allocated to our research and development function.
Research and development expenses include $6.1 million of non-cash stock-based compensation expense for the first quarter of 2019 as compared to $2.9 million for the same period in 2018.
General and administrative expenses were $19.2 million for the first quarter of 2019 as compared to $14.0 million for the same period in 2018. The increase in the first quarter of 2019 was primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $6.2 million of non-cash stock-based compensation expense for the first quarter of 2019 as compared to $4.1 million for the same period in 2018.
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 8:30 a.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 1956289. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

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On May 9, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ended March 31, 2019 (Press release, Quanterix, MAY 9, 2019, View Source [SID1234536058]).

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"We’ve made strong progress over the past quarter, which now marks our sixth consecutive quarter since the IPO of accelerated growth. In addition, we are achieving important goals in neurology and now oncology with the launch of our new SP-X Imaging and Detection System" said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix. "There is mounting evidence supporting our Simoa technology’s potential to transform virtually every category of medicine. The extreme precision and sensitivity of our expanding portfolio of instruments and platforms is fueling new insights on drug targets, disease progression biomarkers and new opportunities for patient stratification for clinical trials, transforming traditional approaches to drug development and precision medicine."

First Quarter 2019 Financial Highlights

Key financial results for the first quarter are shown below:

·Q1 revenue of $12.3M versus prior year Q1 of $7.5M, an increase of 64%.

·Q1 instrument revenue of $3.4M versus prior year Q1 of $2.0M, an increase of 70%.

·Q1 consumables revenue was $6.1M versus prior year Q1 of $2.7M, an increase of 124%.

· Q1 Service and Other revenue totaled $2.8M versus prior year Q1 of $2.5M, an increase of 11%.

·Q1 gross margin was 48.7%, a 650 basis point improvement over the 42.2% in Q1 2018.

First Quarter 2019 Business Highlights

·Extended its footprint in oncology with the accelerated launch of its Simoa SP-X Imaging and Detection System, 10-Plex Simoa CorPlex Cytokine Panel, and broad menu of additional multiplex panels to further revolutionize cancer research, immunotherapy monitoring, and drug development.

·Expanded its leadership team with the hiring of Amol Chaubal as Chief Financial Officer (CFO), formerly the CFO of Global Operations at Smith & Nephew and North America CFO – Novartis Vaccines & Diagnostics, bringing with him more than 20 years of experience in diagnostics, pharmaceutical services and medical devices.

· Increased citations in peer-reviewed publications of scientific research further validating Simoa’s capabilities in oncology and neurology with several groundbreaking studies, including a seminal study in Nature, which used Simoa to show that the biomarker LIF can be a reliable marker to help monitor the progression of pancreatic cancer. This was widely covered for its potential to help diagnose the disease more quickly and efficiently, and was proposed as a promising new target to assist in drug development. Another study using Simoa was published in Nature showing that elevated Nf-L levels were present in blood 16 years before the diagnosis of Alzheimer’s disease, demonstrating promise as part of an earlier diagnostic work-up. In total, Quanterix increased its number of third-party, peer-reviewed publications by 61, its strongest quarter ever, to a total of more than 500.

·Presented at the 37th Annual J.P. Morgan Healthcare Conference for the third year in a row, detailing Quanterix’ significant growth in its first year since becoming a public company.

· Presented and sponsored exhibits at critical industry conferences on the vital role of biomarkers to advance disease detection and therapeutics, including the 14th Annual Biomarkers Congress, Type 2 Immunity in Homeostasis and Disease, Molecular Med Tri-Con, 8th Global Reverse Phase Protein Array Workshop, the 14th International Conference on Alzheimer’s and Parkinson’s Diseases and American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference.

·Invited to speak at leading healthcare investor conferences including the 21st Annual Needham Growth Conference, the 8th Annual Leerink Partners Global Healthcare Conference, and the 39th Annual Cowen and Company Health Care Conference.

·Served as lead sponsor of the Boston, Mass. screening of "VINCIBLE The Documentary" — an inspiring true story that profiles the lives of several young adult cancer survivors who have lost their youth to the devastating disease.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 9, 2019, at 4:30 p.m., EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 8955828.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

On May 9, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2019 (Press release, Coherus Biosciences, MAY 9, 2019, View Source [SID1234536057]).

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First Quarter 2019 Company Highlights

UDENYCA (pegfilgrastim-cbqv) Launch Performance Consistent with Plan

Net product revenue for the first quarter of 2019 was $37.1 million following Coherus’ successful launch of UDENYCA in the U.S. marketplace on January 3, 2019.

Uptake of UDENYCA in 340B hospitals, non-340B hospitals and community oncology clinics is in line with the Company’s expectations.

UDENYCA launch performance validates its broad value proposition approach and the commercial strategy Coherus implemented. This comprehensive branded biosimilar approach leverages Coherus’ robust commercial infrastructure and its comprehensive support services program, Coherus Complete www.coheruscomplete.com.

The Company secured transitional pass-through status in 340B hospitals from CMS effective April 1, 2019, granted for a period of 36 months, incentivizing access to UDENYCA for Medicare patients.

The Company secured a $75 million credit financing with Healthcare Royalty Partners to accelerate the manufacturing and launch of UDENYCA.

Legal Developments

Coherus and Amgen settled the trade secret action brought by Amgen and Coherus continues to commercialize UDENYCA across all segments.

The Company announced a global settlement with AbbVie securing rights to commercialize its adalimumab biosimilar candidate, CHS-1420, affording a U.S. market entry date of December 15, 2023.

The Company announced the filing of a patent infringement suit against Amgen directed to Amgen’s Humira biosimilar formulation.

First Quarter 2019 Financial Results

Net product revenue for the first quarter of 2019 was $37.1 million. Cost of goods sold for the first quarter of 2019 was $2.2 million, resulting in a gross profit margin of 94 percent for the first quarter of 2019.

Research and development (R&D) expenses for the first quarter of 2019 were $18.8 million, as compared to $25.5 million for the same period in 2018. The decreases in R&D expenses were mainly due to the capitalization of UDENYCA manufacturing in the first quarter of 2019.

Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $32.7 million, as compared to $16.6 million for the same period in 2018. The increase in SG&A expenses in 2019, which was mainly attributable to the costs associated with commercializing UDENYCA in the U.S.

Total operating expenses decreased by $6.8 million from $60.5 million in the fourth quarter of 2019 to $53.7 million in the first quarter of 2019 primarily as a result of a reduction in UDENYCA manufacturing pre-approval activities.

Cash and cash equivalents and investments in marketable securities for the first quarter totaled $96.4 million as of March 31, 2019, as compared to $95.2 million as of March 31, 2018, and $72.4 million as of December 31, 2018.

Net loss attributable to the Company for the first quarter of 2019 was ($20.0) million, or ($0.29) per share, compared to a net loss of ($44.3) million, or ($0.74) per share, for the same period in 2018.

Guidance for the Next Nine Months from March 31, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)

Increase the breadth and depth of adoption across all market segments.

Secure reimbursement coverage among remaining national and regional payers.

CHS-1420, biosimilar candidate to Humira (adalimumab)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S.

CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)

Complete manufacturing technology transfer to support clinical development of CHS-3351.

Continue preclinical development of CHS-2020.

CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")

Initiate clinical phase program in NASH.

Conference Call Information

When: Thursday, May 9, 2019 starting at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (international)

Conference ID: 2969536

Webcast: View Source

You will be asked to register when you join the call. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.

Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.

Fatal sickle cell crises: Have occurred.

Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.

Adverse Reactions

Most common adverse reactions (³ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.