On July 27, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that the Company will release its second quarter 2018 financial results on Thursday, August 2, 2018, before the U.S. financial markets open (Press release, Curis, JUL 27, 2018, View Source [SID1234527930]). The Company’s management will also host a conference call on the same day at 8:30 a.m. EDT.

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To access the live conference call, please dial (888) 346-6389 from the United States or 1 (412) 317-5252 from other locations, shortly before 8:30 a.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On July 27, 2018 MannKind Corporation (Nasdaq: MNKD) reported that it will host a conference call to discuss the 2018 second quarter and year-to-date financial results and other corporate developments at 5:00 PM (Eastern Time) on Thursday, August 2, 2018 (Press release, Mannkind, JUL 27, 2018, View Source [SID1234527931]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna, Chief Financial Officer, Steven Binder, Chief Commercial Officer, Patrick McCauley and Chief Medical Officer, David Kendall.

To view and listen to the earnings call webcast live via the Internet, visit the Company’s website at www.mannkindcorp.com and click on the "Q2 2018 MannKind Earnings Conference Call" link in the Webcasts section of News & Events. To participate in the live call by telephone, please dial (800) 239-9838 toll-free or (323) 794-2551 toll/international and use the conference passcode: 5195402.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 5195402. A replay will also be available on MannKind’s website for 14 days.

On July 27, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the second quarter ending June 30, 2018 on Thursday, August 2, 2018, before the U.S. financial markets open (Press release, Alnylam, JUL 27, 2018, http://investors.alnylam.com/news-releases/news-release-details/alnylam-webcast-conference-call-discussing-second-quarter-2018 [SID1234527936]).

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Management will provide an update on the Company and discuss second quarter 2018 results as well as expectations for the future via conference call on Thursday, August 2, 2018 at 8:30 am ET. To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 1365915. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international) and refer to conference ID 1365915.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

On July 27, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of UDENYCA (formerly CHS-1701), a pegfilgrastim (Neulasta1) biosimilar candidate (Press release, Coherus Biosciences, JUL 27, 2018, View Source [SID1234531701]). UDENYCA has the opportunity to become one of the first pegfilgrastim biosimilars to gain Marketing Authorization in Europe.

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"The positive opinion issued by the CHMP today is a significant milestone for Coherus, as it validates both our UDENYCA biosimilarity package as well as our development platform as a whole," said Denny Lanfear, President and CEO of Coherus BioSciences. "We believe UDENYCA will represent an important option for patients, providers and payers seeking alternatives for the treatment and prevention of febrile neutropenia due to cytotoxic chemotherapy in Europe."

UDENYCA’s marketing authorization application to EMA is supported by analytical similarity data, a 3-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamics (PD) study in healthy subjects, as well as a robust immunogenicity package including a dedicated immunogenicity study in over 300 subjects.

"UDENYCA is clinically differentiated with positive PK/PD and immunogenicity studies in over 600 healthy subjects," said Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences. "We have worked in a harmonized fashion with the EU and U.S. regulatory authorities, and continue to work with the FDA toward our expected November action date."

The European Commission decision on the approval for UDENYCA is expected in October. UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date expected on or before November 3, 2018.

1 Neulasta is a registered trademark of Amgen Inc.

About UDENYCA
UDENYCA, formerly CHS-1701, is a biosimilar candidate to pegfilgrastim, a growth-colony-stimulating-factor (G-CSF) designed to decrease the chance of infection as manifested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017. UDENYCA drug substance manufacturing is located in Boulder, Colorado.

On July 27, 2018 Shanghai HaiHe Biopharma Co., Ltd. ("HaiHe Biopharma") and DAEHWA Pharmaceutical Co., Ltd. ("DAEHWA Pharma") reported, RMX3001, co-developed by both companies, has been granted the clinical trial approval (CTA) for gastric cancer by China National Drug Administration (CNDA) (Press release, Daehwa Pharmaceutical, JUL 27, 2018, View Source [SID1234593982]). At the same time, IND filing for breast cancer phase III multi-regional clinical trial (MRCT) was also accepted by CNDA.

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Dr. Ruiping Dong, CEO of HaiHe Biopharma, commented,
"We are very pleased that RMX3001 project has been granted CTA by CNDA in only 4 months. This approval is undoubtedly good news for Chinese cancer patients. We will immediately advance clinical trials for gastric cancer. As the world’s first successfully developed oral paclitaxel, RMX3001 was developed under a unique and innovative oral formulation process. It needs no premedication before treatment, and is convenient to use with less adverse reactions such as peripheral neuropathy, contributes to high patient compliance. We look forward to the launch of RMX3001 as soon as possible to benefit cancer patients."

Mr. Eun-Seok Kim, President and CEO of DAEHWA Pharma, commented,
"With the support and assistance of friends from HaiHe Pharma, RMX3001 (DHP1007/ Liporaxel) project co-developed by both companies has progressed faster than expected, having obtained CTA for gastric cancer, and IND filing for breast cancer phase III MRCT accepted by CNDA. We are eagerly looking forward to the early initiations of clinical trials in China, and we hope that both companies will work together closely to write a new history of Chinese and global anticancer drugs."

About RMX3001
Paclitaxel is one of the most widely used drug for chemotherapy. There are huge market needs in China, with Paclitaxel usage by 220,000 patients of gastric cancer, breast cancer, ovary cancer and lung cancer alone. Currently used Paclitaxel products are all injectable with a lot of side effects and is inconvenience to use. Therefore, the development of oral paclitaxel formulations has always been a hot area in industry.

RMX3001 is originally developed by DAEHWA Pharma based on its innovative lipid self-emulsifying drug delivery technology. The product, with brand name Liporaxel, was successfully approved for launch for the treatment of gastric cancer by Korean Drug Administration (MFDS) on September 9, 2016. To date, Liporaxel is the world’s first successfully developed and approved oral paclitaxel. HaiHe Biopharma licensed in the rights of China mainland, Taiwan, Hong Kong and Thailand from DAEHWA Pharma in September 2017. HaiHe Biopharma actively advanced the IND filing process in China, with IND submission for gastric cancer in March 2018, and CTA granted in July 2018. It took only 4 months for CNDA review.