KMDA Slips On AAT Therapy Concerns, ETRM Gains Weight, LJPC On Watch

(RTTNews) - Today's Daily Dose brings you news about Kamada's proposed phase III trial for inhaled Alpha-1 Antitrypsin (AAT) therapy; cost-effectiveness of EnteroMedics' vBloc therapy for obesity; Bristol-Myers and Daiichi Sankyo's partnership; Nasdaq's warning for Biostar Pharma; La Jolla's and Roche's upcoming regulatory catalysts, and approval of Tandem Diabetes' sensor-augmented insulin pump.

Read on...

Biostar Pharmaceuticals Inc. (BSPM) has been notified of not being in compliance with Nasdaq for continued listing since it has not filed its Quarterly Report on Form 10-Q for the fiscal year ended June 30, 2017.

The Company is required within 60 calendar days of the Nasdaq notification to submit a plan of compliance with the foregoing continued listing deficiency. If the Company's plan is approved by the Nasdaq staff, the Company may be eligible for a listing exception of up to 180 calendar days (or until February 12, 2018) to regain compliance.

BSPM closed Monday's trading at $1.43, up 2.88%.

Bristol-Myers Squibb Co. (BMY) and Daiichi Sankyo Co. Ltd. are teaming up to evaluate the combination of Bristol-Myers' immunotherapy Opdivo and Daiichi Sankyo's investigational DS-8201 in HER2-expressing metastatic breast and urothelial (bladder) cancers.

A phase Ib study evaluating the combination of Opdivo and DS-8201 in patients with HER2-expressing breast cancer who are refractory to standard therapies or for which no standard therapy is available is expected to begin enrollment in first quarter of 2018 in the US and Europe.

As per the agreement terms, Daiichi Sankyo will be the sponsor conducting the trial.

BMY closed Monday's trading at $58.58, up 0.36%.

Coherus BioSciences Inc.'s (CHRS) first of three ongoing pharmacokinetic bioequivalence studies of CHS-1420, a proposed biosimilar candidate to AbbVie's Humira has shown positive results.

Humira is approved for multiple inflammatory diseases.

According to the Company, the study met the criteria for clinical PK/BE on all prospectively defined endpoints.

Two biosimilar versions of Humira have been approved by the FDA - Amgen's Amjevita in September 2016 and Boehringer Ingelheim's Cyltezo as recently as last week.

CHRS closed Monday's trading at $14.25, up 0.71%.

C. R. Bard Inc.'s (BCR) LUTONIX 035 Drug Coated Balloon PTA Catheter has received FDA approval for a new indication - this time, for the treatment of patients with dysfunctional AV fistulae.

LUTONIX 035 DCB Catheter is already approved for the treatment of superficial femoral artery (SFA) and popliteal artery disease.

The proposed merger of C. R. Bard with Becton, Dickinson and Co. (BDX) was approved by Bard shareholders early in the month. The transaction, subject to other conditions, is expected to close in the fourth calendar quarter of 2017.

EnteroMedics Inc.'s (ETRM) vBloc therapy for Class II and III obese patients with diabetes and Class III obese patients without diabetes is likely to be a cost-effective alternative to conventional weight loss therapy, according to a study.

The study also suggests that vagal nerve blocking represents good value for the money from the perspective of a U.S. payer.

The Company's vBloc vagal blocking therapy was approved by the FDA in 2015 for the treatment of obese adults with a Body Mass Index (BMI) of 40 and 45 kg/m2, or BMI between 35 and 39.9 kg/m2, and with a weight-related health condition, such as high cholesterol levels, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years. This therapy is delivered through the Maestro System.

ETRM closed Monday's trading at $1.94, up 1.57%. In after-hours, the stock gained another 7.73% to $2.09.

La Jolla Pharmaceutical Co.'s (LJPC) New Drug Application for LJPC-501 for the treatment of hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy has been accepted for priority review - with a decision expected by February 28, 2018.

LJPC closed Monday's trading at $32.79, up 10.33%.

Shares of Kamada Ltd. (KMDA) were down over 5% in extended trading on Monday after a filing with the SEC showed that the FDA continues to have concerns and questions about the safety and efficacy of the Company's investigational inhaled Alpha-1 Antitrypsin (AAT) therapy.

On July 18, 2017, the Company had submitted to the FDA for review a proposed pivotal phase III protocol for its proprietary inhaled AAT therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

Now that the FDA has raised some concerns, the Company will need to receive authorization from the regulatory agency in order to proceed with the clinical development of Inhaled AAT in the United States, including its proposed phase III trial.

KMDA closed Monday's trading at $4.40, down 3.30%. In after-hours, the stock was down another 5.68% to $4.15.

A supplemental Biologics License Application for Gazyva submitted to the FDA by Roche's Genentech, seeking approval in treating people with previously untreated follicular lymphoma, has been accepted for priority review - with a decision date set for December 23, 2017.

Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin's lymphoma, is incurable and characterized by cycles of remission and relapse.

RHHBY.OB closed Monday's trading at $31.65, up 0.16%.

Shares of Tandem Diabetes Care Inc. (TNDM) rose over 44% on Monday, following the FDA approval and launch of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM integration. It is approved for ages 6 and older.

The device is the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger.

TNDM closed Monday's trading at $1.01, up 44.24%.

VBI Vaccines Inc. (VBIV) (VBV.TO) expects to initiate enrollment in a multi-center Phase I/2a clinical study of VBI-1901 in patients with recurrent Glioblastoma in the second half of 2017.

The Company will be presenting new preclinical data for VBI-1901 on August 30, 2017.

VBIV closed Monday's trading at $3.57, up 4.39%.