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Panbela Announces Issuance of key U.S. Patent; Patent is for Claims of a Novel Process for the Production of SBP-101

On August 9, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported an Issue Notification for patent US 11,098,005 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL" (Press release, Panbela Therapeutics, AUG 9, 2021, View Source [SID1234586104]). This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process for the production of our lead investigational product SBP-101, reduces the number of synthetic steps for its production from seventeen to six, and provides patent coverage to 2039.

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Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Panbela Therapeutics, commented, "We’re excited to receive this U.S. patent issuance, a landmark event for the company. This patent, covering a shorter synthesis of SBP-101, provides many benefits including: 1) the ability to manufacture product with a reduced lead time 2) quicker access to drug supply facilitating expansion into additional indications and 3) enables a scalable, efficient and cost-effective manufacturing process for future commercialization. We applaud the dedicated efforts of our valued long-term partner Syngene International Ltd. in helping us achieve this important goal."

Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International said, "We congratulate Panbela for this milestone achievement. Our partnership with them dates back to 2013 and since then we have collaborated on multiple projects. In this case, streamlining the production process of an investigational product is a core expertise in our Development Services division. If the drug is approved, a simpler production process means that commercialization will be easier and the drug will reach patients more quickly."

Dr. Simpson added, "This process developed utilizes a pharmaceutical starting material that is widely available, assuring the company of drug supply moving forward. The Company expects to continue innovation and patent portfolio building as it develops its clinical programs".

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Biofrontera reports preliminary revenue for the month of July 2021

On August 9, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the month of July 2021 (Press release, Biofrontera, AUG 9, 2021, View Source [SID1234586103]).

The Company’s preliminary, unaudited revenue from product sales in July 2021 amounted to approximately EUR 1,570 thousand, compared to EUR 1,523 thousand in July 2020, an increase of 3%.

Preliminary revenues from product sales in the US were around EUR 1,026 thousand compared to EUR 795 thousand in July 2020, an increase of 29%. In Germany, revenues from product sales amounted to approximately EUR 357 thousand, compared to EUR 572 thousand in July 2020, a decrease of 38%. In this context, the relatively high comparative sales in July 2020 in Germany resulted from catch-up effects due to the weak previous months caused by the pandemic. In the rest of Europe, the Company generated product sales of around EUR 187 thousand, compared to EUR 156 thousand in July 2020, a plus of 20%.

Due to the pandemic, the monthly and year-to-date sales development is also compared with sales in 2019 for increased transparency. As such, an increase of 9% in July 2021 for total product sales was achieved in all markets compared to July 2019. In the USA, product sales increased by about 15% compared to July 2019. In July 2021, sales were up by around 6% in Germany while sales revenue in the remaining European markets decreased by approximately 11% compared to July 2019.

Compared to 2019, product sales in all markets were down by around 3% compared to sales in the period January to July 2021. Year-to-date sales in 2021 increased by around 23% in Germany and by 22% in the rest of the European market compared to the same period in 2019. Revenue in the US market was down 13%, mainly due to weak sales in January, February, and the first half of March this year due to the pandemic, as well as the lack of or lower sales of Aktipak and Xepi compared to the period January to July 2019.

NAVROGEN CLOSES $3.0M SEED FINANCING TO ADVANCE ITS PRECLINICAL PIPELINE TARGETING HUMORAL IMMUNOSUPPRESSED CANCERS AND IMMUNE-RELATED DISORDERS

On August 9, 2021 Navrogen, Inc., a privately held preclinical biotechnology company, reported that it has raised $3.0M from an equity financing to support its Humoral Immuno-Oncology (HIO) discovery platform and preclinical therapeutic pipeline activities (Press release, Navrogen, AUG 9, 2021, View Source [SID1234586102]). HIO is a process by which tumors produce factors that suppress a patient’s humoral immune response against malignant tissues. The major use of proceeds will focus on advancing the company’s lead HIO-refractory, anti-mesothelin NAV-001 antibody drug conjugate program and its NK cell activator platforms that specifically address HIO suppressed cancers and immune-mediated diseases. The financing was led by Tellus BioVentures along with existing investors. As part of the financing, Lonnie Moulder, Managing Member of Tellus, and Allan Bedwick, will join the Navrogen Board of Directors.

"We are pleased to have Tellus BioVentures lead this round of funding as we take steps to further validate and advance our pipeline agents towards clinical development," stated Nicholas Nicolaides, Ph.D., Chief Executive Officer at Navrogen. "With Tellus, we gain additional access to professionals with deep biopharmaceutical operational and drug development experience that coupled with our extensive internal expertise will strengthen the pursuit of our value-creating objectives to deliver innovative medicines to patients with HIO-positive cancers and other immune-related disorders."

Lonnie Moulder, Managing Member of Tellus BioVentures, added, "We are thrilled to support Navrogen and its accomplished founding team in their efforts to achieve their platform and pipeline goals. Navrogen has discovered a unique translational approach for developing a new class of compounds to address immune-mediated diseases, including various cancer types".

Eagle Pharmaceuticals Reports Second Quarter 2021 Results

On August 9, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and six months ended June 30, 2021 (Press release, Eagle Pharmaceuticals, AUG 9, 2021, View Source [SID1234586080]).

Business and Recent Highlights:

Entered into a licensing agreement for the U.S. commercial rights to Landiolol, a leading hospital emergency use product in Europe and Japan. Landiolol is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia ("SVT"), including atrial fibrillation and atrial flutter.
Advanced vasopressin program and continue to expect a commercial launch prior to year-end:
Responded to the Complete Response Letter ("CRL") for its Abbreviated New Drug Application ("ANDA") for vasopressin received from FDA in February 2021;
FDA maintained Priority Review for the Company’s ANDA for vasopressin and assigned a GDUFA date of December 15, 2021;
Patent trial against Endo Par Innovation Company, LLC took place on July 7, 2021; Court ruling expected around mid-September.
Approval of TREAKISYM (bendamustine) ready-to-dilute ("RTD") formulation, in combination with rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") received from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. This represents a meaningful extension of Eagle’s bendamustine franchise and is expected to significantly increase the market opportunity for bendamustine;
Filing of TREAKISYM rapid infusion ("RI") (50ml) liquid formulation with the PMDA in Japan. Eagle expects RTD, and RI, if approved, formulations to generate approximately $20-$25 million of combined royalty and milestone revenue;
Appointed former FDA Official and Public Health Expert Dr. Luciana Borio to its Board of Directors; and
Continue to pursue additional in-licensing and acquisition opportunities to broaden Eagle’s pipeline and revenue streams.
Financial Highlights

Second Quarter 2021

Total revenue for Q2 2021 was $48.1 million, compared to $41.9 million in Q2 2020, primarily reflecting higher product sales of BELRAPZO and RYANODEX, partially offset by lower product sales of BENDEKA.

Q2 2021 net income was $3.6 million, or $0.28 per basic and $0.27 per diluted share, compared to net loss of $0.3 million, or ($0.02) per basic and diluted share in Q2 2020.
Q2 2021 adjusted non-GAAP net income was $12.4 million, or $0.95 per basic and $0.93 per diluted share, compared to adjusted non-GAAP net income of $8.0 million, or $0.59 per basic and $0.57 per diluted share, in Q2 2020.
Cash and cash equivalents were $108.7 million, net accounts receivable was $52.7 million, and debt was $30 million as of June 30, 2021.
"We had a strong and productive quarter on multiple fronts and have laid the foundation for important growth drivers going forward. We made good progress with vasopressin during the quarter and continue to believe that we will be able to launch that important product before year-end. We are just months away from our February 2022 PEMFEXY launch, which allows us an initial period of exclusivity in a billion-dollar market. With the potential for an additional royalty and milestone revenue stream of $20-$25 million from the expanding TREAKISYM franchise in Japan, next year could be a record earnings year for Eagle," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"The licensing agreement for Landiolol represents Eagle’s first new chemical entity and is a true catalyst in reshaping our company as we evolve from a specialty pharmaceutical company into a mainstream pharmaceutical company, with a vibrant pipeline of products. Landiolol solidifies our hospital and critical care product portfolio, and we plan to leverage our current sales force with little additional infrastructure costs to promote the product. We are also pursuing other such opportunities to build value for the company and look forward to providing updates," concluded Tarriff.

Second Quarter 2021 Financial Results

Total revenue for the three months ended June 30, 2021 was $48.1 million, compared to $41.9 million for the three months ended June 30, 2020.

Q2 2021 BELRAPZO product sales were $7.6 million, compared to $4.1 million in Q2 2020.

Q2 2021 RYANODEX product sales were $7.9 million, compared to $4.7 million in Q2 2020.

Royalty revenue was $28.5 million in the second quarter of 2021, compared to $27.6 million in the second quarter of 2020. BENDEKA royalties were $27.8 million in the second quarter of 2021, compared to $27.5 million in the second quarter of 2020. A summary of total revenue is outlined below:

Gross Margin was 78% during the second quarter of 2021, as compared to 69% in the second quarter of 2020. The increase in gross margin for the second quarter of 2021 was driven by revenue mix.

R&D expense was $9.9 million for the second quarter of 2021, compared to $7.1 million in the second quarter of 2020. The increase is largely attributable to development cost for vasopressin of $1.5 million, RYANODEX related projects of $0.8 million and PEMFEXY of $0.6 million, partially offset by $0.5 million decrease in development activity related to fulvestrant. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter of 2021 was $9.2 million.

SG&A expenses in the second quarter of 2021 totaled $16.6 million compared to $18.0 million in the second quarter of 2020. The decrease is primarily related to lower stock compensation expense and marketing spend. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2021 SG&A expense was $12.4 million.

Net income for the second quarter of 2021 was $3.6 million, or $0.28 per basic and $0.27 per diluted share, compared to net loss of $0.3 million, or ($0.02) per basic and diluted share, in the second quarter of 2020, due to the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2021 was $12.4 million, or $0.95 per basic and $0.93 per diluted share, compared to adjusted non-GAAP net income of $8.0 million or $0.59 per basic and $0.57 per diluted share in the second quarter of 2020. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2021 Expense Guidance

R&D spend in 2021, on a non-GAAP basis, is expected to be $34-$38 million, as compared to $27.8 million in 2020.
SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of June 30, 2021, the Company had $108.7 million in cash and cash equivalents plus $52.7 million in net accounts receivable. The Company had $30 million in outstanding debt. Therefore, as of June 30, 2021, the Company had net cash plus receivables of $131.4 million.

In the second quarter of 2021, the Company purchased $2.9 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through June 30, 2021, the Company has repurchased $211.2 million of its common stock.

Conference Call

As previously announced, Eagle management will host its second quarter 2021 conference call as follows:

www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 888-562-2815 (US) or 402-220-7352 (International) and entering conference call ID EGRXQ221. The webcast will be archived for 30 days at the aforementioned URL.

Epizyme Reports Second Quarter 2021 Financial Results and Provides Business Update

On August 9, 2021 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported its second quarter 2021 financial results and provided a business update (Press release, Epizyme, AUG 9, 2021, View Source [SID1234586079]).

"TAZVERIK has significant potential as a backbone of therapy in both epithelioid sarcoma and follicular lymphoma based on real-world evidence and physician feedback. With that in mind, the challenging launch environment and evolving expectations of the future commercial landscape have led us to revise our commercial strategy and operating plans, prioritizing company resources on our most important value-driving activities," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "Most significantly, we have taken steps to realign our current commercial organization, reducing traditional sales roles and creating new field roles to achieve better access to thought leaders and large community oncology practices. These, and other changes across our business, are designed to reduce our cash burn and allow us to maintain sufficient operating capital to achieve important milestones."

"As we implement these changes, we continue to execute across the business. During the second quarter we launched EZH2Now, a sponsored program to improve access to EZH2 mutation testing; received FDA clearance of our IND for EZM-0414, our novel SETD2 inhibitor, which we anticipate advancing into clinical development later this year; and advanced the ongoing clinical trials of TAZVERIK, all of which remain on track with previous guidance. In addition, this morning we announced a strategic partnership with HutchMed to bring TAZVERIK to patients in China and expand the development of tazemetostat in new combinations. These important accomplishments bring diversity to our pipeline while advancing TAZVERIK’s potential."

Recent Highlights

Commercial Execution: TAZVERIK generated net product revenue of $8.0 million in the second quarter of 2021 consisting of $4.8 million in commercial sales in Epithelioid Sarcoma (ES) and Follicular Lymphoma (FL) and $3.2 million related to the sale of commercial product to a third-party pharmaceutical company for use in its combination clinical trials. Although commercial sales were down from the first quarter 2021, total patient demand slightly increased by 3%, offset by higher demand for the Company’s patient assistance program during the quarter. The Company continued to expand adoption through the addition of new prescribing accounts, including among large community practices, in the second quarter of 2021.
Announced Collaboration with HutchMed in China: The commercial and development collaboration with HutchMed will extend TAZVERIK’s reach to China and allow for additional exploration of TAZVERIK in new combinations across multiple tumor types. Epizyme will receive an upfront payment of $25 million from HutchMed in the fourth quarter of 2021 as a result of the collaboration, with potential future development, regulatory and commercial milestone payments of up to an aggregate of $285 million over the life of the collaboration, in addition to royalties on TAZVERIK sales in Greater China.
EZH-302 Phase 1b/3 Confirmatory Study of TAZVERIK in Follicular Lymphoma: The combination of TAZVERIK with R2 (lenalidomide and rituximab) is being evaluated in a Phase 1b/3 confirmatory study in relapsed or refractory (R/R) FL patients. During the second quarter of 2021, Epizyme completed enrollment of all Phase 1b cohorts of the Phase 1b/3 trial. Of the 36 patients enrolled in this safety run-in, 17 patients are evaluable for efficacy to date based on the availability of tumor scans. All 17 patients have achieved an objective response to treatment, with six patients having a complete response and 11 patients having a partial response.
IND Clearance for Epizyme’s Novel SETD2 Inhibitor: Epizyme reported the clearance of its Investigational New Drug (IND) application from the FDA for its novel SETD2 inhibitor, EZM-0414. The Company expects to initiate a first-in-human clinical trial later this year. SETD2 inhibition has been shown to have clinical potential in multiple settings, including high risk t(4;14) multiple myeloma and in other B-cell malignancies such as Large-cell Lymphoma, as monotherapy and in combination with existing and emerging therapies including tazemetostat.
Launched EZH2 Now Testing Program: Epizyme launched the EZH2Now Testing Program on June 16, 2021, with Quest Diagnostics, the leading provider of diagnostic information services, to provide EZH2 mutation testing for patients with R/R FL. The Company expects this program will promote interest in, and access to, EZH2 single gene mutation testing. Epizyme created this program with Quest in response to market research conducted in the first quarter of 2021 that indicated approximately one-third of physicians surveyed did not have an easy way to test their patients for EZH2 mutation.
Additional Ongoing Clinical Trials of Tazemetostat in Follicular Lymphoma: EZH-1401, Epizyme’s Phase 2 trial evaluating TAZVERIK plus rituximab in R/R FL continues to move forward as planned and is actively enrolling. Patient enrollment also continues in the Lymphoma Study Association (LYSA) trial in front-line FL and Diffuse Large B-cell Lymphoma (DLBCL), as well as other investigator sponsored trials.
IND Clearance for Solid Tumor Basket Trial: Epizyme received clearance of its IND from the FDA for a solid tumor basket trial, EZH-1301, which will evaluate tazemetostat safety and efficacy across multiple solid tumors. With this approach, the Company plans to study multiple combinations with standard-of-care therapies and novel mechanisms of action to expand the potential of tazemetostat. Epizyme plans to initiate the study later this year.
EZH-1101 Phase 1b/2 Study of Tazemetostat in Prostate Cancer: Based on encouraging preliminary safety and activity data, Epizyme initiated enrollment in the Phase 2 efficacy portion of this study evaluating enzalutamide plus tazemetostat compared to enzalutamide alone earlier this year in metastatic castration resistant Prostate Cancer (mCRPC) patients. The Phase 2 portion of the study is now over one-third enrolled. Epizyme plans to present updated safety and efficacy data from the Phase 1b safety run-in as part of a poster presentation during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September.
Presented Preclinical and Clinical Data at EHA (Free EHA Whitepaper) and ASCO (Free ASCO Whitepaper) in June: Epizyme shared the discovery of a selective inhibitor of the SETD2 histone methyltransferase with potent in vitro and in vivo activity in a European Hematology Association (EHA) (Free EHA Whitepaper) 2021 oral presentation. The Company separately shared results of the Phase 1b Soft-tissue Sarcoma (STS) portion of its ongoing global randomized, double-blind, placebo-controlled study of tazemetostat plus doxorubicin as front-line therapy for advanced ES in an American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 poster presentation.
Operating Plan Refinement

Organizational Changes: In response to challenging market dynamics experienced over the course of the last twelve months since launching TAZVERIK, Epizyme will be making important changes to its operating plans that reduce the Company’s budgeted workforce and effect other cost reductions across the business. These changes include a refinement of Epizyme’s current field organization, aligned with a revised strategy for improved customer access and TAZVERIK adoption. The Company is creating new field roles meant to achieve better access to thought leaders and to large community accounts at the executive decision-maker level, while reducing the number of traditional sales roles. Epizyme is also shifting commercial resources to implement several digital approaches to reach both healthcare providers and patients directly. The new operating plan also achieves reductions in headcount and external spending across other areas of the business. The Company reduced its budgeted headcount by 20 percent. This includes 11 percent of current employees, resulting in estimated severance and termination costs of approximately $2.0 million. Epizyme expects to record these charges in the third quarter of 2021.
These changes are intended to allow the Company to better deliver on TAZVERIK adoption, and execute more effectively on the most important value-creating initiatives, continuing to advance the four pillars of its long-term growth strategy.

Revised Financial Guidance: Based on its refined commercial strategy and operating plan, including the cash it expects to generate from product sales and the $25 million upfront payments from its collaboration with HutchMed, Epizyme expects its current cash runway to extend into the fourth quarter of 2022. Additionally, the Company expects its non-GAAP adjusted operating expenses for 2021 to be between $220 and $230 million, down from previous guidance of $235 to $255 million.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $244.0 million as of June 30, 2021, as compared to $298.9 million as of March 31, 2021.
Revenue: Total revenue for the second quarter of 2021 was $13.0 million, compared to $2.5 million for the second quarter of 2020. Total revenue for the second quarter of 2021 consisted of $8.0 million of net product revenue, comprised of $4.8 million in commercial net sales of TAZVERIK and $3.2 million of TAZVERIK related to the sale of commercial product by one of the Company’s customers to a third-party pharmaceutical company for use in its clinical trials. The remaining $5.0 million was collaboration revenue related to Epizyme’s supply agreement with Eisai.
Operating Expenses: Total GAAP operating expenses were $71.2 million for the second quarter of 2021 compared to $60.0 million for the second quarter of 2020. Total non-GAAP adjusted operating expenses were $63.2 million for the second quarter of 2021 compared to $50.9 million for the second quarter of 2020.
R&D expenses: GAAP R&D expenses were $34.9 million for the second quarter of 2021 compared to $26.4 million for the second quarter of 2020. Non-GAAP adjusted R&D expenses were $32.7 million for the second quarter of 2021 compared to $23.4 million for the second quarter of 2020.
SG&A expenses: GAAP SG&A expenses were $33.9 million for the second quarter of 2021 compared to $32.7 million for the second quarter of 2020. Non-GAAP adjusted SG&A expenses were $29.1 million for the second quarter of 2021 compared to $27.1 million for the second quarter of 2020.
Net Loss (GAAP): Net loss attributable to common stockholders was $64.4 million, or $0.63 per share, for the second quarter of 2021, compared to $58.5 million, or $0.58 per share, for the second quarter of 2020.
A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.
Conference Call Information

Epizyme will host a conference call today, August 9, at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 3658407. A webcast, as well as supplemental slides to support the webcast, will be available in the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical and projected basis, non-GAAP adjusted R&D expenses on a historical basis and non-GAAP adjusted SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense and depreciation and amortization of intangibles. The company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to the company’s inability to predict with reasonable certainty the amount of future stock-based compensation expense.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com