On October 11, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has entered into an agreement to collaborate with the University of Bergen to expand research on inhibition of brain metastasis by Moleculin’s pre-clinical drug WP1066 and its unique ability to increase immune system response to cancer and suppression of tumor cell proliferation and survival (Press release, Moleculin, OCT 11, 2017, View Source [SID1234520848]).

“We’ve seen promising evidence that WP1066 has potent anticancer effects in animal tumor models due to its unique mode of action,” commented Walter Klemp, Chairman and CEO of Moleculin. “WP1066 is well known for its ability to block the expression of the key oncogenic transcription factors that promote tumor growth and suppress immune system responses. As such, we believe WP1066 has promising potential to stimulate patients’ natural immune response against tumors.”

Mr. Klemp continued: “We announced last month a separate collaboration with the University of Bergen in Norway on WP1122 for brain tumors. The WP1066 project will be led by Dr. Frits Alan Thorsen and may provide critical insight on WP1066, which we anticipate will be in clinical trials soon.”

The Company previously announced that Moleculin is working with MD Anderson in their effort to move forward with a physician sponsored IND (Investigational New Drug) application to study WP1066 in patients with glioblastoma and melanoma that has metastasized to the brain. That IND has been on hold pending responses to requests from the FDA. If the FDA allows the IND to proceed based on the responses provided, Moleculin anticipates this clinical trial could be ready to begin by the end of this year.

On October 11, 2017 Janssen Biotech, Inc. reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC) (Press release, Johnson & Johnson, OCT 11, 2017, View Source [SID1234520847]). Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.

This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy (ADT).1 Men with non-metastatic CRPC with a rapidly rising PSA are at high risk for developing metastatic disease.2,3 The primary endpoint of this study was metastasis free survival (MFS).1 MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.4 The SPARTAN study results will be presented at a future medical meeting.

“The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course. We have demonstrated that treating patients before the disease has metastasized improves outcomes,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen. “We are thrilled to have completed our submission of the SPARTAN data to the FDA and we look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”

Prostate cancer is the most common cancer among American men, other than skin cancer.5 According to the American Cancer Society, more than 161,000 men are estimated to be diagnosed with prostate cancer in 2017.5 Patients with non-metastatic prostate cancer receiving ADT will eventually become resistant to ADT, developing castration-resistant prostate cancer (CRPC). Data has estimated 10% to 20% of patients diagnosed with prostate cancer may develop CRPC within approximately 5 years.6

Non-metastatic castration-resistant prostate cancer refers to patients with CRPC who lack detectable distant metastatic disease.7,8 These individuals have a rising PSA, testosterone level below 50 ng/dl and bone scan and CT scans that show no evidence of spread to bones or visceral organs.9 Men with rapidly rising PSA have a high unmet medical need, as these patients are at high risk for developing metastatic disease.10

About Apalutamide (ARN-509)
Apalutamide is an investigational, next generation oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.

On October 11, 2017 Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, reported that it will release 2017 third quarter financial results on Thursday, October 26, 2017, prior to market open. In conjunction with the earnings release, the company will host a conference call at 8:30 a.m. ET (Press release, Integra LifeSciences, OCT 11, 2017, View Source [SID1234520895]).

Peter J. Arduini, president and chief executive officer, and Glenn G. Coleman, chief financial officer and corporate vice-president of International, will review 2017 third quarter results during the call.

The live call is accessible by dialing (323) 794-2551 and using the passcode 6660907. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.

A replay of the call will be available for five days via telephone stating at approximately 12:00 p.m. ET on Thursday, October 26, 2017. The replay is available by dialing (719) 457-0820 and using the passcode 6660907.

On October 11, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported preliminary total revenue of approximately $25.9 million to $26.9 million for the third quarter, including product and service revenue of approximately $16.9 million and collaboration revenue of $9.0 million to $10.0 million (Press release, NanoString Technologies, OCT 11, 2017, View Source [SID1234520896]). This unaudited estimate, based on management’s preliminary financial analysis, is lower than the company’s previous guidance for product and service revenue of $19.5 million to $21.5 million for the third quarter of 2017.

“We are in the process of transforming our business, by strengthening our commercial channel to drive growth on an increasing scale, while setting the stage for the launch of multiple innovative products currently in development,” said Brad Gray, president and chief executive officer of NanoString Technologies. “While we are disappointed that softness in our instrument and consumable sales drove a shortfall in our product and service revenue in the third quarter, we believe that initiatives underway will strengthen the value proposition of our products and enhance the growth of the business over time.”

The Company will release detailed operating results for third quarter of 2017 after the close of trading on Thursday, November 2, 2017. Company management will host a conference call beginning at 4:30pm ET to discuss those results, and provide updated 2017 financial guidance and a business update.

Individuals interested in listening to the conference call may do so by dialing (888) 793-9492 for domestic callers, or (734) 385-2643 for international callers. Please reference Conference ID: 88331168. To listen to a live webcast, please visit the investor relations section of the company’s website at: www.nanostring.com.

A replay of the call will be available beginning November 2, 2017 at 7:30pm ET through midnight on November 9, 2017. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 88331168. The webcast will also be available on the Company’s website for one year following the completion of the call.

On October 11, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its third quarter 2017 financial and operating results on Wednesday, November 8, 2017, before the U.S. financial markets open (Press release, Regeneron, OCT 11, 2017, View Source [SID1234520897]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Events and Presentations’ page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.