05.04.2018 06:33:03

CNAT Disappoints, EBIO To Report VISTA Data In May, PRTK To Face FDA In Oct.

(RTTNews) - Today's Daily Dose brings you news about disappointing phase II trial results of Conatus; follow-on offering of Cellectis; near-term catalysts of Eleven Biotherapeutics; Paratek's date with FDA, and Lilly's REACH-2 liver cancer trial results.

Read on...

Cellectis S.A. (CLLS) has offered to sell 5.65 million American Depositary Shares at a price of $31 each.

The underwriters have a 30-day option to purchase up to an additional 846,900 ADSs. The closing of the offering is expected to occur on April 10, 2018, subject to customary closing conditions.

The Company has two product candidates in clinical testing - UCART19 & UCART123.

UCART19 is under two phase I trials in acute lymphoblastic leukemia, dubbed CALM and PALL. The other drug candidate UCART123 is under two phase I trials - one in acute myeloid leukemia (AML) and the other in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

CLLS closed Wednesday's trading at $33.10, down 14.09%.

Shares of Conatus Pharmaceuticals Inc. (CNAT) slumped more than 33% in after-hours trading on Wednesday, as its exploratory IIb proof-of-concept clinical trial of Emricasan in post-orthotopic liver transplant (POLT) recipients, dubbed POLT-HCV-SVR, failed to meet its primary endpoint.

Although the trial missed the goal, the Emricasan treatment effect in the subgroup of patients where the histology endpoint is most relevant, patients with advanced fibrosis and early cirrhosis, supports further evaluation, noted the Company.

The other ongoing clinical trials with Emricasan are:

-- A phase IIb trial of Emricasan in reducing hepatic venous pressure gradient in patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension, dubbed ENCORE-PH. Top-line results from this trial are expected in the second half of 2018. -- A phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF. Top line results are expected in the first half of 2019. -- A phase IIb clinical trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF. Top-line results are expected in the second half of 2019.

CNAT closed Wednesday's trading at $6.01, up 2.65%. In after-hours, the stock was down 33.28% to $4.00.

Eleven Biotherapeutics Inc. (EBIO) has a couple of catalysts to keep an eye on in the coming months.

The Company is scheduled to present preclinical data from its deBouganin program at the 2018 American Association for Cancer Research (AACR) Annual Meeting on April 16, 2018.

The first, topline data from its phase III trial of Vicinium in patients with high grade non-muscle invasive bladder cancer, dubbed VISTA, are expected to be presented on May 21, 2018, at this year's American Urological Association Annual Meeting being held in San Francisco.

EBIO closed Wednesday's trading at $1.41, up 12.80%.

Eli Lilly and Co.'s (LLY) phase III study of CYRAMZA as a single agent in the second-line treatment of people with hepatocellular carcinoma, also known as liver cancer, has met the key goals.

The study, dubbed REACH-2, met its primary endpoint of overall survival (OS) as well as the secondary endpoint of progression-free survival (PFS), according to the Company.

CYRAMZA is already approved by the FDA for the treatment of advanced gastric cancer as a single agent and in combination with paclitaxel. The drug is also approved for metastatic non-small cell lung cancer in combination with docetaxel.

An ongoing phase III trial of CYRAMZA in advanced urothelial carcinoma has met its primary endpoint of PFS, and OS data are expected in the first half of 2018. Another ongoing Phase 3 study of CYRAMZA - in EGFR-positive non-small cell lung cancer - is ongoing, with an expected PFS data readout in late 2018.

CYRAMZA brought home sales of $758.3 million for Lilly in 2017 compared to $614.1 million in 2016.

LLY closed Wednesday's trading at $78.60, up 1.37%.

Paratek Pharmaceuticals Inc.'s (PRTK) New Drug Applications for oral and intravenous Omadacycline, proposed for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), have been accepted for Priority review by the FDA - with a decision expected in October 2018.

Omadacycline has previously been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of CABP and ABSSSI.

PRTK closed Wednesday's trading at $14.50, down 0.68%.

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Cellectis SA (spons. ADRs) 1,77 -4,84% Cellectis SA (spons. ADRs)
Eli Lilly 747,40 0,38% Eli Lilly