On April 24, 2019 Precision BioSciences (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported its participation in several preclinical presentations and a Genome Editing Workshop presentation at the 22nd Annual Meeting of the American Society of Gene & Cell Therapy ("ASGCT") to be held in Washington, DC, April 29 – May 2, 2019 (Press release, Precision Biosciences, APR 24, 2019, View Source [SID1234535377]).

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Precision BioSciences Presentations:

Title: Genome Editing Workshop Presentation; Precision BioSciences Chief Scientific Officer Derek Jantz, Ph.D., will speak during the Corporate Review I session.

Session: 1:00-2:00 PM ET, Sunday, April 28 – Jefferson East

Title: A Gene Editing Approach to Eliminate Hepatitis B Virus In Vivo with an ARCUS Meganuclease Evolved to Prevent Off Target Cutting

Session: 5:00-6:00 PM ET, Tuesday, April 30 – Board no. 75

Title: Therapeutic Efficacy of ARCUS Meganuclease Gene Editing for Autosomal Dominant Retinitis Pigmentosa

Session: 10:15-10:30 AM ET, Thursday, May 2 – Jefferson

Presentations from Precision Collaborators:

Title: Gene Editing Approach to Disrupt Hydroxyacid Oxidase 1 for the Treatment of Primary Hyperoxaluria Type 1

Session: 10:30-10:45 AM, ET, Thursday, May 2 – Heights Courtyard 3

Title: Reduction of Transthyretin Expression by AAV Gene Delivery of a Novel Endonuclease in Mice

Session: 11:00-11:15 AM, ET, Thursday, May 2 – Heights Courtyard 3

Abstracts are available on the ASGCT (Free ASGCT Whitepaper) meeting website.

On April 24, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its first quarter 2019 financial results on Wednesday, May 8, 2019 (Press release, BioCryst Pharmaceuticals, APR 24, 2019, View Source [SID1234535360]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1777029. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 1777029.

On April 24, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported it will host its first quarter 2019 conference call and webcast at 4:30 PM ET on Wednesday, May 8, 2019, to discuss its first quarter financial results and provide an update of its clinical development activities (Press release, NewLink Genetics, APR 24, 2019, View Source [SID1234535378]). There will also be a question and answer session following the prepared remarks.

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Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode: 8457627.

On April 24, 2019 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") reported that it has submitted a supplemental application of KHK7580 (evocalcet)*1 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy*2 to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Kyowa Hakko Kirin, APR 24, 2019, View Source [SID1234535342]).

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This application is based on the interim result (24 weeks) of the phase 3 study that evaluates the efficacy of KHK7580 for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. The primary endpoint is the percentage of subjects whose corrected serum calcium level is maintain ≤ 10.3 mg/dL for 2 weeks in the evaluation period in a time frame up to 24 weeks. The primary endpoint was met with a 77.8% result, which exceeds the threshold set in the protocol.

KHK7580 was also granted Orphan Drug Designation for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy by the MHLW on March 4, 2019.

"We are delighted to submit the supplemental application for evocalcet," said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. "As it was granted Orphan Drug Designation by the MHLW, we believe that evocalcet has the potentials to provide more efficient treatment for hypercalcemia patients with parathyroid carcinoma and primary hyperparathyroidism."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*1 About KHK7580 (evocalcet)
KHK7580 is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia in March 2008. On March 2018, Kyowa Hakko Kirin received approval of KHK7580 for secondary hyperparathyroidism in maintenance dialysis patients and later on May 2018, the product was launched in Japan market, named Orkedia Tablets.

*2 About Hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism under inability parathyroidectomy or relapse after parathyroidectomy
Parathyroid carcinoma and primary hyperparathyroidism (PHPT) are diseases in which serum calcium levels elevates due to over autonomous secretion of parathyroid hormone (PTH) from tumors of the parathyroid gland. Parathyroidectomy (PTx) is the only reliable method to treat parathyroid carcinoma and PHPT. Control of hypercalcemia can prove challenging in cases of PHPT where PTx cannot be considered because of concomitant diseases or where PHPT recur after PTx and parathyroid carcinoma, although patients with such hypercalcemia are very rare. Hypercalcemia causes symptoms of fatigue, polyuria, thirst, and renal impairment and severe hypercalcemia can result in death due to a hypercalcemic crisis.

On April 24, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Punit Upadhyaya, Ph.D., Senior Scientist at Bicycle, will present at the 6th Annual Peptides Congress in London (Press release, Bicycle Therapeutics, APR 24, 2019, View Source [SID1234535361]). The presentation, entitled "Bicycles as T-cell Modulators: Activation of CD137 Using Multivalent and Tumour-targeted Bicycle Peptides," will take place on Thursday, April 25, at 12:00 BST.

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"Our T-cell targeting Bicycles are set apart from other biological approaches because they are fully synthetic and modular, which is designed to enable the rapid creation of molecules with unique drug-like properties," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "We’re looking forward to sharing research showcasing that our multivalent and tumour-targeted bispecific Bicycles robustly activate CD137 positive T-cells in in vivo disease models as well as in patient-derived material."