CLSD Dims, SCPH Disappoints, ZEAL On Track, All Eyes On MRTX

(RTTNews) - Today's Daily Dose brings you news about Clearside's TYBEE trial results; Mirati's and Zealand Pharma's near-term catalyst; scPharmaceuticals' disappointment over its drug-device combination product approval; Trovagene's reverse stock split and Therapix's upcoming milestones.

Read on…

Shares of Clearside Biomedical Inc. (CLSD) dropped more than 32% on Thursday despite reporting positive, top-line results from its TYBEE trial.

The TYBEE trial is a phase II study, which evaluated suprachoroidal CLS-TA used with intravitreally administered EYLEA in patients with diabetic macular edema. In this trial, patients were randomized into either a combination arm to receive suprachoroidal CLS-TA together with intravitreal Eylea or a control arm to receive only intravitreal Eylea.

The trial met the primary outcome measure, which was a comparison of mean change from baseline in best corrected visual acuity between the two study arms. But here's the rub: patients in the combination arm gained an average of 12.3 *ETDRS letters compared to 13.5 ETDRS letters in the Elyea alone control arm.

ETDRS letters is a geometric progression in letter size from line to line, each line being of equal difficulty. (Source: Precision Vision).

Patients administered suprachoroidal CLS-TA together with intravitreal Eylea had a mean reduction from baseline of 208 microns in central subfield thickness ("CST") of the retina at six months, compared to a 177 micron mean reduction in the control arm. The reduction in central subfield thickness reflects better visual acuity outcomes.

CLSD plunged 32.19% to $9.86. In after-hours, the stock was up 1.93% to $10.05.

Mirati Therapeutics Inc. (MRTX) will be presenting new data from the ongoing Phase 1b clinical trial of single agent Sitravatinib in the treatment of patients with metastatic renal cell carcinoma (mRCC) who are refractory to anti-angiogenic therapy on June 2, 2018.

In that same Phase 1b trial of single agent Sitravatinib, enrollment continues in the cohorts of patients whose tumors harbor CBL, CHR4Q12 and RET genetic alterations in NSCLC and other tumor types.

MRTX closed Thursday's trading at $42.50, down 1.05%.

The FDA has notified scPharmaceuticals Inc. (SCPH) of certain deficiencies related to the New Drug Application for FUROSCIX Infusor 80 mg/10mL, a drug-device combination product.

The Company is seeking approval of Furoscix for the treatment of edema, or fluid overload, in patients with heart failure.

The original date of FDA decision on Furoscix NDA is June 23, 2018. The deficiencies identified by the FDA as part of its ongoing review have not been specified. The Company intends to work with the U.S. regulatory agency to understand the nature of the deficiencies once identified and resolve them as quickly as possible.

SCPH closed Thursday's trading at $9.94, down 30.10%. In after-hours, the stock was up 0.60% to $10.00.

Trovagene Inc. (TROV) is implementing a 1 for 12 reverse stock split, effective June 1, 2018, in order to bring the company into compliance with the minimum bid price requirement for maintaining its listing on the Nasdaq Capital Market.

The Company's common stock will begin trading on a split-adjusted basis when the markets open on June 4, 2018 under the existing trading symbol "TROV."

As a result of the reverse stock split, the number of outstanding common shares will be reduced from approximately 59.4 million shares to approximately 4.9 million shares.

TROV closed Thursday's trading at $0.24, down 0.41%.

Therapix Biosciences Ltd. (TRPX) has a couple of catalysts to watch out for in the coming months and next year.

A phase IIb, placebo-controlled 12-week clinical trial for THX-110 in Tourette Syndrome TS is expected to be initiated in Germany by the end of the third quarter. Top line results are expected in the first half of 2019.

A phase IIa, sponsor-initiated trial of THX-110 for the treatment of Obstructive Sleep Apnea is underway, with top-line results expected in the first half of 2019.

A pre-clinical study evaluating the effect of the THX-130 in a rodent model for cognitive impairment related to traumatic brain injury is ongoing - with results expected by the second half of this year.

TRPX closed Thursday's trading at $4.43, up 4.98%.

Vericel Corp. (VCEL) has offered to sell 5 million shares of its common stock to the public at a price of $13.00 per share.

The underwriters have a 30-day option to purchase up to an additional 750,000 shares of the Company's common stock. The gross proceeds to Vericel from this offering are expected to be $65 million.

The offering is expected to close on or about June 5, 2018.

VCEL closed Thursday's trading at $13.45, down 3.58%.

Zealand Pharma A/S (ZEAL) is all set to present new results from its phase II trial of Glepaglutide for the treatment of short bowel syndrome on June 3, 2018.

The trial was a 3-week proof-of-concept, double-blind, cross-over, dose-finding trial investigating the efficacy and safety of three different doses of Glepaglutide (0.1 mg, 1 mg and 10 mg per day).

Zealand remains on track for initiating the pivotal phase III trial of Glepaglutide in H2 2018. The 26-week trial will enroll approximately 130 patients with short bowel syndrome.

ZEAL closed Thursday's trading at $14.75, down 7.75%.