AGTC Slumps After-hrs, NBIX Fails To Strike GOLD, IDRA To Report Data On Dec.14

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Today's Daily Dose brings you news about disappointing trial results of Applied Genetic Technologies; near-term catalyst of Idera; stock offering of Marinus; disappointing Tourette syndrome trial results of Neurocrine Biosciences; bankruptcy proceedings of Synergy Pharma; Complete Response Letter for Mallinckrodt's pain drug, and promising data from Zynerba's phase II Fragile X Syndrome trial.

Read on...

Shares of Applied Genetic Technologies Corp. (AGTC) slumped more than 38% in extended trading on Wednesday, following disappointing topline interim six-month data from its phase I/II clinical trial of rAAV2tYF-CB-hRS1, an investigational AAV-based gene therapy, for X-linked retinoschisis due to mutations in the RS1 gene.

X-linked retinoschisis (XLRS) is a genetic condition affecting boys and men, and its main symptom is reduced vision that cannot be improved with glasses. (Source: NORD).

Although the results from the XLRS study support general safety and tolerability of AGTC's gene delivery platform, they do not demonstrate signs of clinical activity at interim six-month time point.

The Company has also terminated its collaboration with Biogen, which will become effective on March 8, 2019, and will regain full rights to the XLRS and X-linked retinitis pigmentosa (XLRP) programs and the three other partnered discovery programs.

AGTC closed Wednesday's trading at $6.56, up 7.36%. In after-hours, the stock plunged 38.72% to $4.02.

Idera Pharmaceuticals Inc. (IDRA) will be providing an update on clinical data from the ongoing phase II trial, dubbed ILLUMINATE-204, which is evaluating the combination of intratumoral Tilsotolimod and Yervoy for unresectable or metastatic melanoma following failure of anti-PD-1 inhibitor treatment on Friday, December 14, 2018.

IDRA closed Wednesday's trading at $6.68, down 1.18%.

Marinus Pharmaceuticals Inc. (MRNS) has offered to sell 12 million shares of common stock to the public at a price of $3.75 each.

The offering is expected to close on or about December 17, 2018, and the total gross proceeds from the offering are expected to be $45.0 million.

The underwriters participating in the offering have a 30-day option to purchase up to an additional 1.8 million shares of common stock.

On December 10, the Company announced positive results from its phase II clinical trials evaluating Ganaxolone intravenous, dubbed Magnolia Study, and Ganaxolone oral, known as Amaryllis Study, in women with postpartum depression. The news sent the stock as much as 16% to $6 that day.

A pivotal phase III clinical trial evaluating the use of oral Ganaxolone in children and young adults with CDKL5 Deficiency Disorder, dubbed Marigold, is underway.

MRNS closed Wednesday's trading at $4.21, down 17.45%.

Shares of Neurocrine Biosciences Inc. (NBIX) fell nearly 14% on Wednesday, following the failure of its phase IIb study of Valbenazine to meet the primary endpoint in pediatric patients with Tourette syndrome.

The study, dubbed T-Force GOLD, did not meet the primary endpoint of change from baseline of the Yale Global Tic Severity Scale (YGTSS) Total Tic Score at week 12. The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity and interference.

Tourette syndrome is a neurological disorder that consists of rapid, non-rhythmic stereotyped motor and vocal tics.

NBIX closed Wednesday's trading at $73.83, down 13.91%.

Synergy Pharmaceuticals Inc. (SGYP) slumped more than 52% on Wednesday, following initiation of voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of New York.

The Company has inked an agreement with Bausch Health Companies Inc., through which Bausch Health would acquire substantially all of Synergy's assets, including all rights to TRULANCE, dolcanatide and related intellectual property, for approximately $200 million in cash, subject to certain adjustments at closing, plus the assumption of certain liabilities related to the assets to be acquired.

SGYP closed Wednesday's trading at $0.16, down 52.80%.

SpecGx LLC, a subsidiary of Mallinckrodt plc (MNK), has failed to secure FDA approval for its abuse-deterrent, immediate-release reformulation of Roxicodone.

The Company had sought approval of Roxicodone (oxycodone hydrochloride) tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

MNK closed Wednesday's trading at $20.85, down 0.43%.

Tocagen Inc. (TOCA) has offered to sell 3 million shares of its common stock to the public at a price of $10.00 per share. The gross proceeds from the offering are expected to be approximately $30.0 million.

The offering is expected to close on or about December 17, 2018, subject to customary closing conditions.

In addition, the underwriters have been granted a 30-day option to purchase up to an additional 450,000 shares of Tocagen's common stock at the public offering price, less the underwriting discounts and commission.


The Company's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma, dubbed Toca 5.

Near-term Catalyst:

The second interim analysis of the Toca 5 study is expected to be conducted in the first half of 2019.

TOCA closed Wednesday's trading at $11.23, down 12.40%. In after-hours, the stock fell another 5.08% to $10.66.

Shares of Zynerba Pharmaceuticals Inc. (ZYNE) were up over 9% in after-hours trading on Wednesday, after the Company reported new 12-month open label phase II clinical data describing the long term impact of ZYN002 on emotional and behavioral symptoms of Fragile X Syndrome.

In the phase II trial of ZYN002 in children and adolescents with Fragile X Syndrome, dubbed FAB-C, patients experienced a 77% improvement in aberrant behaviors associated with social avoidance compared to baseline after 1 year of ZYN002 treatment.

A pivotal trial of ZYN002 in Fragile X Syndrome, dubbed CONNECT-FX, is underway, with topline results expected in the second half of 2019.

ZYNE closed Wednesday's trading at $4.70, up 0.86%. In after-hours, the stock was up 9.57% to $5.15.

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