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OTIC Data Music To Ears, Apellis IPO Opens Today, CAPR High On HOPE

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Today's Daily Dose brings you news about OTIC's Ménière's disease trial results; the IPO of Apellis; AEZS' upcoming milestone; Fibrogen's corporate update; CAPR's progress n HOPE program and CDTX's near-term catalyst.

Read on...

Aeterna Zentaris Inc. (AEZS) (AEZS.TO) is continuing its focus on the preparation for the FDA approval of Macrilen by December 30, 2017. If approved, Macrilen will be the only FDA-approved drug for assessing adult growth hormone deficiency in the United States.

The Company has reported a wider loss and lower revenue in the third quarter of 2017.

AEZS closed Wednesday's trading at $1.90, up 0.53%.

Shares of Apellis Pharmaceuticals Inc. are expected to begin trading on the NASDAQ Global Select Market under the ticker symbol "APLS" on Thursday, November 9, at a public offering price of $14.00 each.

The offering is expected to close on November 13, 2017, subject to customary closing conditions.

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system.

In August of this year, the Company had reported that its phase II clinical trial of APL-2 in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) met its primary endpoint.

Capricor Therapeutics Inc. (CAPR) is busy with preparations to launch the HOPE-2 clinical trial of CAP-1002 for the treatment of Duchenne muscular dystrophy.

The HOPE-2 Trial is being planned as phase II study that will evaluate repeat dosing of IV CAP-1002 in boys and young men with DMD.

The Company is slated to present 12-month results from Phase I/II HOPE clinical trial of CAP-1002 in DMD on November 15, 2017. The Company announced positive 6-month results from the HOPE trial in April of this year.

CAPR closed Wednesday's trading at $2.32, up 16%.

Cidara Therapeutics Inc. (CDTX) expects top-line data from its phase II clinical trial of Rezafungin in candidemia and invasive candidiasis in the first quarter of 2018.

Pending final results from the STRIVE trial, and subject to feedback from European regulators, the Company plans to conduct a single phase III clinical trial in approximately 150 patients in mid-2018, with top line data expected in mid-2020.

CDTX closed Wednesday's trading at $7.95, down 1.85%.

FibroGen Inc. (FGEN) has a couple of events to watch out for in the coming months.

The Company expects to define a registrational strategy for Pamrevlumab for Idiopathic Pulmonary Fibrosis in the first half of 2018. Positive results from phase 2b study of Pamrevlumab in patients with idiopathic pulmonary fibrosis were announced in September of this year.

The New drug application filing for Roxadustat for anemia in Chronic Kidney Disease in the U.S. is targeted for 2018. Positive top line results from the first completed Japan Roxadustat phase III Chronic Kidney Disease trial, for the treatment of anemia in peritoneal dialysis patients were reported last month.

The Company is planning to start phase III U.S. clinical trial of Roxadustat for anemia in Myelodysplastic Syndromes (MDS) in the fourth quarter of 2017.

The NDA for Roxadustat for anemia associated with CKD in dialysis-dependent and non-dialysis-dependent patients is under review in China.

A phase 2/3 clinical study of Roxadustat for anemia in Myelodysplastic Syndromes in China is planned for initiation in the fourth quarter of 2017/first quarter of 2018 timeframe.

FGEN closed Wednesday's trading at $54.05, up 0.28%.

Shares of Otonomy Inc. (OTIC) soared more than 100% in extended trading on Wednesday after the Company announced that the second of two phase III clinical trials of OTIVIDEX in patients with Ménière's disease, dubbed AVERTS-2, achieved its primary efficacy endpoint.

Ménière's disease is a disorder of the inner ear characterized by acute episodes of vertigo, fluctuations in hearing, tinnitus and aural fullness. The underlying cause of Ménière's disease is unknown and there are currently no FDA-approved drug treatments. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), approximately 615,000 individuals have been diagnosed with Ménière's disease in the United States.

The AVERTS-2 was a four month, placebo-controlled trial of OTIVIDEX in patients with unilateral Ménière's disease conducted in Europe. The trial has achieved the primary endpoint of count of definitive vertigo days.

The OTIVIDEX group demonstrated a 6.2 day reduction in the mean reported number of definitive vertigo days (DVD) from baseline to Month 3 with a 2.5 day mean difference between OTIVIDEX and placebo. There was a 68% reduction in vertigo frequency from baseline to Month 3 in the OTIVIDEX group vs. 40% for placebo, added the Company.

On August 30, 2017, the Company had announced that the first phase III trial of OTIVIDEX in patients with Ménière's disease, conducted in the U.S., dubbed AVERTS-1, failed to achieve the primary endpoint. The news sent the stock plunging to $3.58 from $20 that day.

At that time, Otonomy had also said that it was immediately suspending the AVERTS-2 trial, which was then underway, due to poor data from the AVERTS-1 trial. It is that trial that has now produced positive results.

Commenting on the developments, David Weber, president and CEO said, "We will complete analysis of this trial and prepare for discussions with the FDA which we expect to occur during the first quarter of 2018. We will also further assess the AVERTS-1 trial to identify factors that might explain the different outcome in that trial and inform the design of our clinical program to support an NDA filing."

OTIC closed Wednesday's trading at $2.80, down 1.75%. In after-hours, the stock was up 101.79% to $5.45.

by RTT Staff Writer

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