On July 9, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug Conjugate (PDC) product candidate, for the treatment of Ewing’s sarcoma, a rare pediatric cancer (Press release, Cellectar Biosciences, JUL 9, 2018, View Source [SID1234527614]).

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"Ewing’s sarcoma is the second most common bone malignancy among children and adolescents and there are limited treatment options for patients who relapse or become refractive to therapy," said John Friend, M.D., chief medical officer of Cellectar. "The ODD for Ewing’s sarcoma represents another important milestone for our CLR 131 pediatric program as we work to bring new options to patients suffering from rare cancers."

The FDA grants orphan drug designation to therapies targeted at conditions that affect fewer than 200,000 people in the United States. The designation provides seven-year market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. In 2018 the FDA also granted CLR 131 orphan drug and rare pediatric disease designations for the treatment of neuroblastoma and rhabdomyosarcoma.

Cellectar is currently initiating a Phase 1 clinical study evaluating CLR 131 for the potential treatment of pediatric patients with Ewing’s sarcoma, rhabdomyosarcoma, osteosarcoma, neuroblastoma, high grade glioma and lymphomas. Cellectar has received clearance from the FDA to proceed with an accelerated Phase 1 trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CLR 131 in pediatric patients with these cancer types. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03478462.

About Ewing’s Sarcoma

Ewing’s sarcoma is the second most common bone malignancy among children and adolescents. According to a study published in the Journal of Hematology/Oncology, the incidence is about 3 cases per 1 million per year in children younger than age 20. Despite the favorable prognosis, an American Cancer Society study showed that approximately 30-40% of patients develop metastases or local recurrence, and the long-term survival rate for refractory or recurrent disease is only 22-24%. The relapsed and refractory statistics underscore the need for new treatment options.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

On July 9, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company will host webcasts and conference calls of its annual stockholders meeting and to discuss its second-quarter 2018 financial results (Press release, Exact Sciences, JUL 9, 2018, View Source [SID1234527615]).

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Date: Thursday, July 26, 2018

Time: 11 a.m. ET, 10 a.m. CT

Webcast: The live webcast can be accessed at www.exactsciences.com

Telephone: Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 7198945

The company plans to release its second-quarter 2018 financial results after the close of the U.S. financial markets on Aug. 1, 2018. Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

Second-Quarter 2018 Webcast & Conference Call Details

Date: Wednesday, Aug. 1, 2018

Time: 5 p.m. ET, 4 p.m. CT

Webcast: The live webcast can be accessed at www.exactsciences.com

Telephone: Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 4260268

An archive of the webcasts will be available at www.exactsciences.com. A replay of the annual meeting and second-quarter conference calls will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The annual meeting replay can be accessed with the code 7198945. The access code for the second-quarter call replay is 4260268. The webcasts, conference calls and replays are open to all interested parties.

On June 9, 2018 Horizon Pharma plc (Nasdaq: HZNP) reported that its second-quarter financial results will be released on Wednesday, August 8, 2018 (Press release, Horizon Pharma, JUL 9, 2018, View Source [SID1234527617]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

On July 9, 2018 HedgePath Pharmaceuticals, Inc. (OTCQB:HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, reported that on July 5, 2018, it closed on a second tranche of funding from its majority stockholder, Mayne Pharma, as part of a securities purchase agreement executed in January 2018 (Press release, HedgePath Pharmaceuticals, JUL 9, 2018, View Source [SID1234528441]).

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The $1.6 million in new funding will support HPPI’s ongoing efforts with the U.S. Food and Drug Administration (FDA) toward the anticipated filing of a new drug application (NDA) with the FDA later in 2018 for its SUBA BCCNS clinical and regulatory program.

As with the initial funding tranche that closed in January 2018, HPPI issued shares of Series B preferred stock and warrants to purchase common stock to Mayne Pharma in the current funding. After giving effect to this most recent funding, Mayne Pharma owns 53.6% of HPPI’s outstanding common stock and beneficially owns 59.1% of HPPI’s voting securities (including shares of common stock, and shares of common stock underlying the Series B preferred stock and all warrants to purchase common stock held by Mayne Pharma).

HPPI will be eligible to receive a third tranche of $1.0 million on the same terms if its NDA for SUBA BCCNS is accepted by FDA by the end of this year (or in January 2019 if the NDA is filed in December 2018 and accepted within 30 days of filing).

Nicholas J. Virca, HPPI’s President and Chief Executive Officer, stated "We are pleased to receive this additional capital, which takes our anticipated cash runway into the second quarter of 2019 and allows us to fully concentrate efforts on our SUBA BCCNS program. By way of update, on June 13, 2018, we filed a briefing package with FDA for our Phase 2(b) trial results in preparation for our face-to-face Type-C Meeting to occur with FDA on July 23, 2018. The July 23rd meeting is intended to provide us with further guidance regarding the regulatory pathway to potential approval of our SUBA-Itraconazole therapy for patients with BCCNS. We intend to provide updates when available through the remainder of the year as we proceed towards our anticipated NDA filing for SUBA BCCNS in 2018."

Readers are cautioned that no assurances can be given that the clinical study referenced herein will be found by FDA to be sufficient for an NDA filing, or if filed, that the NDA will be accepted and later approved by FDA.

About SUBA-Itraconazole

HPPI’s lead drug candidate, SUBA-Itraconazole, is a patent-protected formulation of itraconazole, an approved oral antifungal drug that has been in use for over 25 years. HPPI is the exclusive U.S. licensee (through Mayne Pharma, the majority stockholder of HPPI) of SUBA-Itraconazole for the treatment of cancer. Prior to research at Johns Hopkins University, itraconazole was not known to have any target in mammalian cells. Investigators at Johns Hopkins discovered that itraconazole inhibits the hedgehog pathway by binding to a surface receptor in the pathway called Smoothened. Unlike generic itraconazole, that has poor and unpredictable bioavailability, SUBA-Itraconazole can be dosed at half the level of the generic formulation due to its superior bioavailability, which exceeds 90%. As such, HPPI believes that generic itraconazole cannot be substituted for SUBA-Itraconazole.

About BCCNS

HPPI’s initial indication is for the orphan disease Basal Cell Carcinoma Nevus Syndrome, known as BCCNS. SUBA-Itraconazole has qualified under the FDA’s Orphan Drug Designation Program as a potential therapy for BCCNS.

There is no approved pharmaceutical therapy for this familial cancer syndrome. There are estimated to be 10,000 patients in the U.S. with BCCNS. This is an autosomal dominantly inherited defect in the hedgehog pathway that causes the pathway to be up-regulated, resulting in hundreds or even thousands of basal cell carcinomas developing over the lifetime of the affected patients. In many types of cancers, the hedgehog pathway is basically hijacked by the cancer cells to assist their growth and metastatic spread, but in the case of basal cell carcinomas, whether in this hereditary syndrome or in the much more common, sporadic basal cell carcinomas, the hedgehog pathway has a mutation that makes it the sole driver of the development of BCC tumors. Inhibition of the pathway, then, can inhibit the appearance of new tumors, shrink existing tumors, and even cause some tumors to disappear altogether.

Cautionary Note Regarding Forward Looking Statements

This press release and any statements of representatives and partners of HedgePath Pharmaceuticals, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the actual timing for, or actual results of, the Company’s clinical trial described herein, the Company’s meeting with FDA or the FDA’s review of any trial data or New Drug Application submitted by the Company to FDA as described herein) may differ significantly from those set forth or implied in the forward-looking statements (and may further differ from the Company’s previously announced interim study results). These forward-looking statements involve numerous risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

On July 9, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2018 financial and operating results on Thursday, August 2, 2018, before the U.S. financial markets open (Press release, Regeneron, JUL 9, 2018, View Source [SID1234527618]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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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 ‘Investors and Media’ 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.