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FDA Snubs LPCN Again, NVTA Boosts Revenue Outlook, New Lease Of Life For VTVT

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Today's Daily Dose brings you news about Aquinox's licensing agreement for Rosiptor; Asterias' progress in SCiStar study; Arcus' upcoming milestones; Catalyst Pharma's near-term catalysts; Invitae's solid financial results for 1Q, FDA rejection of Lipocine's oral testosterone product candidate TLANDO for the second time; TRACON's clinical trial catalysts to keep an eye on, and vTvT's post-hoc analyses of its STEADFAST study.

Read on…

Aquinox Pharmaceuticals Inc. (AQXP) and Astellas Pharma Inc. have entered into an exclusive licensing agreement for Rosiptor.

Rosiptor is Aquinox's lead drug candidate, a first-in-class, once-daily oral treatment currently in phase III clinical development for interstitial cystitis/bladder pain syndrome (IC/BPS) in North America and Europe.

Under the Agreement, Astellas will have the exclusive right to research, develop, and commercialize Rosiptor for all human diseases and conditions in Japan and additional countries in the Asia-Pacific region, including major markets such as South Korea, Australia, Taiwan, Indonesia, and Malaysia, but excluding China and India.

Aquinox stands to receive an upfront payment of $25 million from Astellas, and may also receive up to an additional $60 million in development milestone payments and $70 million in commercial milestone payments, as well as royalties on any future sales of Rosiptor within the licensed territory.

AQXP closed Wednesday's trading at $12.56, down 4.20%.

Arcus Biosciences Inc. (RCUS) has a couple of events to watch out for in the coming months.

The Company has initiated the submission of regulatory filings for three Phase 1/1b trials to evaluate AB928 in combination with AB122 or chemotherapy in selected tumor types. The trials will be conducted in both Australia and the U.S., and data will be presented in the first half of 2019.

A phase 1 double-blinded, placebo-controlled trial of AB928 in healthy volunteers is underway, with final results from this trial, including pharmacodynamic data for the 200 mg QD dosing cohort, expected to be released in mid-2018.

Dosing of a third cohort in the ongoing Phase 1 dose-escalation trial of AB122 in cancer patients in Australia has been initiated. The Company plans to present clinical activity data, among others, from this trial in the second half of 2018.

RCUS closed Wednesday's trading at $16.84, up 6.18%.

Asterias Biotherapeutics Inc. (AST) is making continued progress in its spinal cord injury clinical program.

The Company's lead product candidate is AST-OPC1, which is under a phase 1/2a study in acute spinal cord injury, dubbed SCiStar.

The following AST-OPC1 data readouts are expected later this year:

-- Six-month update for the entire SCiStar study, including Cohort 5, late in the second quarter or early third quarter of 2018.
-- 12-month update for Cohorts 3 and 4 in the third quarter of 2018.
-- 24-month update for Cohort 2 in the third or fourth quarter of 2018.
-- 12-month update for the entire SCiStar study, including Cohort 5, late in the fourth quarter of 2018 or early in the first quarter of 2019.

AST closed Wednesday's trading at $1.30, up 4.00%.

Catalyst Pharmaceuticals Inc. (CPRX) has been delivering on its key objectives for 2018, and has a couple of events lined up for the coming months.

The Company has resubmitted its NDA for Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), and expects the FDA's decision regarding the acceptance of the NDA in the second quarter of 2018. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.

Enrollment the phase III trial of Firdapse in congenital myasthenic syndromes is expected to be completed in the second half of this year. Top-line results from this study are expected in the first quarter of 2019.

CPRX closed Wednesday's trading at $2.80, up 2.19%.

Invitae Corporation (NVTA) has reported solid results for the first quarter ended March 31, 2018, and has boosted its revenue outlook for the year.

Invitae is a genetics company whose mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people.

Net loss for the recent first quarter widened to $36.12 million or $0.66 per share from $28.35 million or $0.64 per share in the year-ago quarter. Total revenue in Q1, 2018, soared to $27 million from $9.7 million in the year-earlier quarter.

Additionally, the company has boosted its 2018 revenue outlook to more than $130 million from its prior guidance of at least $120 million. The Company had reported revenue of $68.2 million in 2017.

NVTA closed Wednesday's trading at $5.92, up 5.71%.

Shares of Lipocine Inc. (LPCN) plunged more than 35% on Wednesday, with the FDA refusing to approve the Company's oral testosterone product candidate TLANDO, yet again.

TLANDO, formerly known as LPCN 1021, is a twice-a-day oral testosterone product candidate that is designed to help restore normal testosterone levels in hypogonadal men.

The FDA has identified four deficiencies related to TLANDO this time, which led to its rejection.

This is TLANDO's second go-around with the FDA.

The regulatory agency had turned down the oral testosterone product candidate in June 2016, citing deficiencies related to the dosing algorithm for the proposed label.

LPCN closed Wednesday's trading at $1.14, down 35.96%. In after-hours, the stock fell another 1.75% to $1.12.

Ra Pharmaceuticals Inc. (RARX) has provided an update on recent corporate and clinical developments.

The Company's lead product candidate is RA101495 SC, with a potential for treating paroxysmal nocturnal hemoglobinuria (PNH), generalized myasthenia gravis (gMG), atypical hemolytic uremic syndrome (aHUS), and lupus nephritis (LN).

Enrollment in a phase II clinical trial of RA101495 SC in gMG has been completed, with data expected in the first half of 2019.

A phase III clinical trial of RA101495 SC in PNH is expected to be initiated in the second half of this year.

A phase 1b clinical trial evaluating RA101495 SC in patients with renal impairment is ongoing. To date, eleven patients have been dosed in the study, and study results are expected mid-2018.

RARX closed Wednesday's trading at $5.99, up 1.01%.

TRACON Pharmaceuticals (TCON) has a couple of near-term catalysts to keep an eye on.

-- Completion of the dose escalation portion of a phase 1/2 trial of TRC253 in patients with prostate cancer is expected in mid-2018.
-- Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected in the second half of 2018.
-- Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018.
-- Presentation of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in the second half of 2018.

TCON closed Wednesday's trading at $2.50, up 4.17%.

Shares of vTv Therapeutics Inc. (VTVT) rose more than 20% in after-hours on Wednesday, following new observations in post-hoc analyses of the data from Part A of its STEADFAST study, which is a phase III trial of investigational medication Azeliragon in people with mild Alzheimer's disease.

According to the post-hoc analyses, Azeliragon demonstrated a statistically significant benefit in a subgroup of mild Alzheimer's patients in Part A of the STEADFAST Study.

On April 9, 2018, the Company announced disappointing results from Part A of STEADFAST study, and had revealed its decision to discontinue clinical studies involving Azeliragon, including the open-label extension study and Part B of the STEADFAST study.

Now, following new observations, the Company will submit a revised Statistical Analysis Plan (SAP) to the FDA for the Part B Study that pre-specifies a target population for the primary study analysis. The Part B top line efficacy results based on 12 month data is expected in June 2018.

VTVT closed Wednesday's trading at $1.71, down 1.16%. In after-hours, the stock was up 20.47% to $2.06.

by RTTNews Staff Writer

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