OTIC Hits Right Notes, GEMP To Report Data This Month, Busy Year Ahead For RVNC

(RTTNews) - Seeking to rein in expenses and align itself around immuno-oncology business, Dynavax Technologies Corp. (DVAX) has reduced its global workforce by 38 percent.

Last November, the company refused to approve the company's HEPLISAV-B for immunization of adults 18 years and older against hepatitis B infection. Dynavax continues to believe that HEPLISAV-B is an approvable product and plans to submit its response to the FDA's outstanding questions shortly.

Meanwhile, the company has suspended manufacturing for HEPLISAV-B to increase its financial strength.

DVAX closed Thursday's trading at $4.20, down 4.55%.

Gemphire Therapeutics Inc. (GEMP) is all set to announce interim results from COBALT-1, a phase 2b trial designed to investigate Gemcabene in the treatment of homozygous familial hypercholesterolemia, during the week of January 30, 2017.

A phase 2b study of Gemcabene in hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy, known as ROYAL-1, is underway, and patient enrollment in the trial is expected to be completed this month. Top line data from ROYAL-1 trial is anticipated in the third quarter of 2017.

GEMP closed Thursday's trading at $8.34, up 4.25%.

Halozyme Therapeutics Inc.'s (HALO) phase II study of investigational agent PEGPH20 in advanced pancreas cancer has met key goals.

A combined analysis of Stages 1 and 2 of the phase II trial showed a statistically significant increase in progression-free survival in patients treated with PEGPH20 plus ABRAXANE and Gemcitabine when compared to patients receiving ABRAXANE and Gemcitabine alone.

An analysis of Stage 2 of the study showed a 91 percent improvement in median PFS in the PEGPH20 arm over the control arm - i.e., 8.6 months in the PEGPH20 arm and 4.5 months in the control arm.

HALO closed Thursday's trading at $12.61, up 17.96%.

Lipocine Inc. (LPCN) has initiated a dosing flexibility study for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males with hypogonadism.

The first patient of the dosing flexibility study is expected to be enrolled this quarter - with top-line results projected in the second quarter of 2017.

The dosing validation ("DV") study for LPCN 1021 is also underway, and top-line results from the DV study are anticipated in the second quarter of 2017.

LPCN closed Thursday's trading at $3.76, down 2.34%.

Shares of Momenta Pharmaceuticals Inc. (MNTA) were up over 5% in extended trading on Thursday, following an exclusive research collaboration and worldwide license agreement with CSL Limited.

The agreement focuses on the development and commercialization of Fc multimer proteins, including Momenta's M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic in 2017.

Momenta will receive a $50 million upfront license fee and up to $550 million in potential milestone payments from CSL. The transaction is expected to close in the first quarter of 2017.

MNTA closed Thursday's trading at $15.50, down 1.43%. In after-hours, the stock was up 5.84% to $16.41.

Neurocrine Biosciences Inc.'s (NBIX) New Drug Application for INGREZZA for the treatment of tardive dyskinesia will not be reviewed by the FDA panel which was originally scheduled for February 16, 2017.

INGREZZA is under priority review, and the regulatory agency's decision will be known on April 11, 2017.

NBIX closed Thursday's trading at $41.38, up 0.24%. In after-hours, the stock gained 6.40% to $44.03.

Shares of OncoGenex Pharmaceuticals Inc. (OGXI) surged over 55% in after-hours trading on Thursday, following a reverse merger with Achieve Life Science, Inc., a privately held specialty pharmaceutical company.

OncoGenex will acquire Achieve in an all-stock transaction. Upon completion of the proposed merger, Achieve's equity holders are expected to own 75% of the combined company's outstanding shares and current stockholders of OncoGenex are expected to own the remaining 25% of the combined company's outstanding shares. Following completion of the merger, OncoGenex Pharmaceuticals, Inc. will be renamed Achieve Life Sciences, Inc.

The proposed merger is expected to close by mid-2017.

OGXI closed Thursday's trading at $0.58, up 6.19%. In after-hours, the stock was up another 55.17% to $0.90.

Otonomy Inc.'s (OTIC) phase III trial of OTIPRIO in patients with acute otitis externa has met the primary endpoint.

In a pivotal phase III clinical trial in patients with acute otitis externa (AOE), also known as swimmer's ear, OTIPRIO met the primary endpoint by showing a statistically significant increase in clinical cure rate compared to sham (no treatment) at Day 8.

OTIPRIO is already approved for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery.

Otonomy expects to submit a supplemental New Drug Application with the FDA, seeking approval of OTIPRIO for acute otitis externa, in the first half of 2017.

OTIC closed Thursday's trading at $17.95, up 10.80%.

Revance Therapeutics Inc. (RVNC) expects to report results from three clinical trials of DaxibotulinumtoxinA for Injection, also known as RT002, this year.

A phase III program of RT002 for treatment of frown lines is underway - with pivotal results scheduled for 4Q 2017.

A phase II trial of RT002 for treatment of Cervical Dystonia is ongoing, and topline results are anticipated in the first half of this year.

A phase II trial of RT002 for treatment of Plantar Fasciitis is ongoing and results from this study are expected in the second half of 2017.

The plantar fascia is the foot's shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can result in plantar fasciitis, characterized by inflammation accompanied by sharp, constant pain in the heel that can become highly debilitating.

RVNC closed Thursday's trading at $23.80, up 5.08%.

Roche (RHHBY.OB) has received FDA clearance for its Anti-Müllerian assay for the clinical assessment of ovarian reserve.

This 18-Minute Anti-Müllerian Hormone Test is the first approved fully automated AMH test available in the U.S. to doctors looking to help women who are planning to become pregnant or struggling with infertility, the company said.

The Anti-Müllerian Hormone is produced by granulosa cells which envelop and support the eggs inside the ovary to help them grow. However, this hormone decreases with age until becoming undetectable before menopause.

In other news, the company announced the FDA approval of Lucentis for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.

RHHBY.OB closed Thursday's trading at $29.92, up 2.36%.

Following the court ruling that Sanofi (SNY) and Regeneron's (REGN) cholesterol drug Praluent infringes the patents on rival drug Repatha, produced by Amgen (AMGN), the aggrieved parties have decided to appeal the decision. The patents on Repatha are estimated to expire in 2029.

The Court ruling prevents marketing, selling or manufacturing of Praluent in the U.S. during the term of two Amgen patents. The imposition of the ban on Praluent has been delayed by 30 days to allow Sanofi and Regeneron to file a motion for a stay on the ruling.

Praluent, approved in July 2015 had global net sales of $38 million in Q3, 2016. Repatha, approved in August 2015, had global net sales of $40 million in the above same period.

REGN closed Thursday's trading at $380.92, down 0.57%.

Stemline Therapeutics Inc. (STML) has reached an agreement with the FDA on the expedited registration pathway to full approval of SL-401 in blastic plasmacytoid dendritic cell neoplasm, or BPDCN.

SL-401 is currently under a phase II trial, and is expected to reach full enrollment this quarter. Stemline intends to file a BLA in 2H17, which is anticipated to undergo an expedited review given SL-401's Breakthrough Therapy Designation. If successful, Stemline projects a commercial launch of SL-401 in 2018.

STML closed Thursday's trading at $11.35, down 4.62%.

Synthetic Biologics Inc.'s (SYN) phase 2b clinical trial for SYN-004 for C. difficile infection has met the primary endpoint.

According to the trial results, patients receiving SYN-004 achieved a 71.4% relative risk reduction in C. difficile infection rate compared to patients receiving placebo.

SYN closed Thursday's trading at $0.89, up 1.47%.