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BCRX At Its Zenith, CRON Walks The Walk, TSRO To Report Data In Nov.

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Today's Daily Dose brings you news about BioCryst Pharma's ZENITH-1 study results; Cronos' partnership with Ginkgo Bioworks; Opiant's progress in Bulimia Nervosa study; OPKO Health's ongoing additional trials with RAYALDEE and TESARO's anticipated milestones.

Read on...

Shares of BioCryst Pharmaceuticals Inc. (BCRX) were up more than 6% on Tuesday, following positive initial results from a proof-of-concept phase II clinical trial of oral liquid formulation of BCX7353 for treatment of acute hereditary angioedema (HAE) attacks.

The trial, dubbed ZENITH-1, showed that a single 750 mg oral dose of BCX7353 was well tolerated and superior to placebo against the majority of efficacy endpoints evaluated in HAE patients suffering an acute attack.

BCRX closed Tuesday's trading at $7.59, up 6.01%.

Shares of Cronos Group Inc. (CRON) (CRON.TO) were up more than 12% on Tuesday, following a landmark partnership with Ginkgo Bioworks Inc. to produce wide range of cannabinoids, including THC, CBD and a variety of other lesser known and rarer products.

Cronos Group will fund certain R&D and foundry expenses expected to be approximately US$22 million, subject to the achievement of certain milestones. As part of the deal, Cronos Group will also issue up to approximately 14.7 million common shares in total, in accordance with certain milestones, all of which were well detailed.

On August 21, the Company had announced its initial supply agreements for retail distribution, both government-operated and private, across Canada for the upcoming launch of the cannabis recreational market in October 2018.

Cronos lost more than 28% of its share value on August 30, and closed that day's trading at $9.12 after Short seller Citron Research in a report titled "Cronos:The Dark Side of The Cannabis Space", alleged that "Cronos management appears to have been deceiving the investing public by purposely not disclosing the size of its distribution agreements with provinces - unlike every other major cannabis player".

CRON closed Tuesday's trading at $11.15, up 12.85%.

EyeGate Pharmaceuticals Inc. (EYEG) has randomized the first three patients in its study evaluating the ability of its Ocular Bandage Gel (OBG) to reduce corneal staining - a sign of ocular surface damage - in patients with punctate epitheliopathies (PE) due to pathologies such as dry eye.

Randomization occurs if a patient meets specific clinical criteria after a two-week qualification period and can then enter the treatment phase of the study. To date, EyeGate has enrolled 34 subjects in the qualification stage and continues to enroll as 30 subjects are required to qualify for the treatment stage.

Another ongoing OBG study which is for patients that have large corneal defects due to photorefractive keratectomy (PRK) surgery is currently greater than 80% enrolled.
The top-line data on both studies are expected to be announced in the fourth quarter of 2018.

In other news, the Company announced that its phase III study evaluating the safety and efficacy of EGP-437 delivered through the EyeGate II Drug Delivery System in patients with non-infectious anterior segment uveitis did not demonstrate non-inferiority to the prednisolone acetate ophthalmic solution control group.

EYEG closed Tuesday's trading at $0.48, down 14.29%.

NeuroMetrix Inc. (NURO) will be introducing Quell 2.0: the next generation, wearable pain relief technology at PAINWeek 2018 today.

The new Quell 2.0 device is smarter, more powerful and 50% smaller, and the Quell app has been totally redesigned to make it easier to use, noted the Company.

Consumers will be able to purchase the Quell 2.0 system at QuellRelief.com starting September 5th.

NURO closed Tuesday's trading at $1.32, up 2.33%.

Opiant Pharmaceuticals Inc. (OPNT) has completed patient enrollment in its Phase 2 clinical trial of OPTN001, a naloxone nasal spray, for the treatment of Bulimia Nervosa.

The Company expects to report top-line data from this trial in the first quarter of 2019.

Bulimia Nervosa is a serious and potentially life-threatening eating disorder affecting mainly females, and is characterized by binge eating followed by purging, fasting, and other strategies to prevent weight gain.

OPNT closed Tuesday's trading at $22.19, up 1.19%.

OPKO Health Inc. (OPK) has initiated a Phase 2 clinical trial to study the safety and efficacy of RAYALDEE as a new treatment for secondary hyperparathyroidism (SHPT) in adults with vitamin D insufficiency and stage 5 chronic kidney disease (CKD) requiring hemodialysis.

The trial will be conducted at multiple dialysis centers in the U.S. in two sequential cohorts.

The first cohort of approximately 44 patients will be treated for 26 weeks in a randomized, open-label fashion with either RAYALDEE or placebo to identify the appropriate dosing to be studied in the second cohort. Data readout for this first cohort is expected in 2019.

RAYALDEE is approved in the U.S. to treat secondary hyperparathyroidism in adults with stage 3 or 4 CKD and vitamin D insufficiency. It is not yet approved for patients with stage 5 CKD on dialysis therapy. OPKO Health launched RAYALDEE in the U.S. in November 2016.

OPK closed Tuesday's trading at $5.86, down 1.01%.

Sol-Gel Technologies Ltd. (SLGL) has completed an End-of-Phase II meeting with the FDA for its topical drug candidate TWIN in the treatment of acne vulgaris.

Accordingly, the pivotal Phase III clinical trials for TWIN are expected to commence in the fourth quarter of 2018, with top-line data anticipated in 2019.

SLGL closed Tuesday's trading at $6.44, up 2.38%.

TESARO Inc. (TSRO) has initiated the second stage of the JASPER study that is designed to assess clinical benefit of ZEJULA in combination with an anti-PD-1 antibody in first-line non-small cell lung cancer (NSCLC) patients.

JASPER is a Phase 2, open-label, single arm trial designed to evaluate the safety and efficacy of ZEJULA in combination with an anti-PD-1 antibody for the treatment of first-line NSCLC.

In stage 1 of the study, patients received a starting dose of 200 milligrams of ZEJULA once per day and 200 milligrams Q3 weeks of an anti-PD-1 antibody.

ZEJULA is approved in the U.S. and Europe for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

In the second stage of the trial, 36 additional patients will be enrolled and treated with ZEJULA in combination with TSR-042, an anti-PD-1 antibody.

Near-term Catalysts:

-- Additional data from a phase 1 dose escalation and cohort expansion study of TSR-042 in patients with advanced solid tumors, dubbed GARNET, to be submitted to European Society for Medical Oncology (ESMO) in October and Society for Immunotherapy of Cancer (SITC) in November.
-- Initial data from a Phase 1 trial of TSR-022 in combination with TSR-042 in patients with advanced solid tumors to be submitted to SITC (November).
-- Phase 1 dose-escalation trial data of TSR-033, dubbed CITRINO, to be submitted to SITC (November).
-- Initial data from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor in patients with non-small cell lung cancer to be available in 2H 2018.

TSRO closed Tuesday's trading at $33.12, up 2.06%.

Zymeworks Inc. (ZYME) (ZYME.TO) is all set to receive a milestone payment of US$2.0 million for Eli Lilly and Co.'s (LLY) submission of an IND application for a bispecific antibody enabled by Zymeworks' proprietary Azymetric platform.

Under its two licensing and collaboration agreements with Lilly, Zymeworks has granted Lilly worldwide licenses to research, develop and commercialize multiple bispecific therapeutics directed towards Lilly's targets.

Zymeworks has received an upfront licensing payment and multiple research milestone payments under these agreements, in addition to historical equity investments made by Lilly in Zymeworks. The Company is also entitled to receive further development and commercial milestone payments and tiered royalties on global product sales.

ZYME closed Tuesday's trading at $13.49, down 3.99%.

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