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PTIE Soars 200%, RTRX On Track, All Eyes On EVFM, MCRB

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Today's Daily Dose brings you news about Acasti Pharma and AtriCure's stock offering; near-term catalyst of Entasis, Evofem Biosciences, Neon Therapeutics and Seres, and updated results from Sarepta's Phase 1/2a gene therapy clinical trial in DMD.

Read on...

Acasti Pharma Inc. (ACST) (ACST.V) intends to offer and sell its common shares in an underwritten public offering in the United States. The underwriters will be granted a 30-day option to purchase additional common shares sold in the offering, to cover over-allotments, if any.

Clinical Trials & Near-term Catalyst:

-- Enrollment in the Company's TRILOGY program is slated to be completed this year, with topline results to be reported before the end of 2019.

TRILOGY is a two-trial phase III clinical program designed to evaluate the safety and efficacy of lead drug candidate CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia.

ACST closed Wednesday's trading at $1.22, down 12.86%. In after-hours, the stock was down another 11.48% to $1.08.

AtriCure Inc. (ATRC) has commenced an underwritten public offering of 2.5 million shares of its common stock pursuant to its existing shelf registration statement.
The underwriters will be granted a 30-day option to purchase up to 375,000 additional shares of common stock.

Recent event:

-- On August 28, the Company completed enrollment of the full cohort of 153 patients in the CONVERGE IDE clinical trial.

The CONVERGE IDE trial is a landmark prospective, randomized trial underway in the United States comparing the Convergent approach to endocardial catheter ablation for patients with persistent or long-standing persistent atrial fibrillation patients.
The last patient follow-up is expected to be sometime in the third quarter of 2019, after which the company will submit final documentation to the Food and Drug Administration and seek a pre-market approval (PMA).

Near-term Catalyst:

-- The Company is scheduled to report third quarter 2018 financial results on November 11.

Preliminary and unaudited revenue for the third quarter of 2018 is expected to be approximately $49.9 million, reflecting growth of 18.5% over the third quarter of 2017.

ATRC closed Wednesday's trading at $33.69, up 0.09%.

On October 4, Entasis Therapeutics (ETTX) will be providing an overview of its drug candidate ETX2514SUL, which recently completed a phase II study for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis in adults.

A phase III clinical trial evaluating ETX2514SUL against carbapenem-resistant A. baumannii infections is expected to begin in the first quarter of 2019.

Entasis went public on The Nasdaq Global Market on September 26, 2018, offering its shares at a price of $15.00 each.

ETTX closed Wednesday's trading at $8.97, down 5.78%.

Evofem Biosciences Inc. (EVFM) will present an update on the methodology and status of two ongoing late stage clinical trials of its lead product candidate, Amphora, on October 15.

Amphora, the Company's lead product candidate, is a non-hormonal, surfactant-free bioadhesive vaginal gel.

A phase III clinical trial of Amphora for the prevention of pregnancy, dubbed AMP002, and a phase IIb clinical trial of Amphora for the prevention of urogenital Chlamydia trachomatis (CT) infection, dubbed AMPREVENCE, are underway.

EVFM closed Wednesday's trading at $4.00, up 1.01%.

Neon Therapeutics Inc. (NTGN) will be disclosing updated data from NT-001, its ongoing Phase 1b clinical trial evaluating NEO-PV-01 in the metastatic setting on October 22.

As previously announced, 52-week data from the trial is expected in the first half of 2019.

NTGN closed Wednesday's trading at $11.34, up 2.62%.

Pain Therapeutics Inc. (PTIE) will host a live conference call to provide a strategic update regarding its business, its science and its pipeline on October 4th at 10 AM Eastern time, 9 AM Central time.

PTIE closed Wednesday's trading at $2.90, up 200.55%.

Retrophin Inc. (RTRX) is scheduled to make presentations highlighting the design of the ongoing pivotal phase III FORT Study of fosmetpantotenate for the treatment of pantothenate kinase-associated neurodegeneration (PKAN), the patient and caregiver experience with PKAN, and the diagnostic pathway and clinical experience of patients with PKAN on October 6, October 16, and October 21.

The top-line data from the FORT Study remains on-track for second half of 2019.

Another phase III trial evaluating the safety and efficacy of Sparsentan in approximately 300 patients with focal segmental glomerulosclerosis (FSGS) aged 8 to 75 years is ongoing. Top-line data from the interim efficacy analysis are expected in the second half of 2020.

RTRX closed Wednesday's trading at $27.17, up 0.56%.

The updated results from Sarepta Therapeutics Inc.'s (SRPT) Phase 1/2a gene therapy clinical trial assessing AAVrh74.MHCK7.micro-Dystrophin in patients with Duchenne muscular dystrophy have been promising.

Duchenne muscular dystrophy is the result of mutation in the dystrophin gene, leading to the absence of a functional dystrophin protein.

The preliminary results from 3 patients in this trial were reported in June, and they were also encouraging.

In the gene therapy trial, all treated patients showed robust expression of transduced micro-dystrophin, which is properly localized to the muscle sarcolemma, as measured by immunohistochemistry, according to the Company.

Doug Ingram, Sarepta's president and chief executive officer, added, "The encouraging results that we previously saw and reinforced in the fourth patient strengthen our resolve to rapidly move to a confirming trial and, assuming successful, to bring this therapy to the Duchenne community around the world with a sense of urgency."

For the fourth patient, as measured by immunohistochemistry, the level of micro-dystrophin positive fibers was 96.2% and the mean intensity of the fibers was 160.0% compared to normal control. As measured by Western blot, patient 4 showed robust levels of micro-dystrophin, with a mean of 182.7% compared to normal utilizing Sarepta's method, or 222% compared to normal pursuant to Nationwide Children's quantification of Sarepta's method that adjusts for fat and fibrotic tissue.

SRPT closed Wednesday's trading at $147.38, up 3.48%. In after-hours, the stock was up another 2.46% to $151.00.

Seres Therapeutics Inc. (MCRB) will present new data for SER-109, a microbiome candidate in Phase 3 development, at the IDWeek 2018 conference being held from October 3-7 in San Francisco, CA.

The findings, highlighted in two presentations, provide support for SER-109 as a potential new treatment option for individuals suffering from recurrent C. difficile infection, according to the Company.

MCRB closed Wednesday's trading at $7.38, down 1.86%.

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