FDA Nod For PBYI, ANIK Sees 23-26% Revenue Growth, CBAY Abuzz, RPRX Plunges

(RTTNews) - Today's Daily Dose brings you news about Anika's preliminary second quarter revenue; Asterias' progress in SCiStar trial; CymaBay's encouraging results from PBC trial; EDAP's Focal One update; Ligand's expanded license relationship with Amgen; Paratek's encouraging results from OASIS-2 study; FDA approval of Puma's breast cancer drug and Repros' disappointment over the clinical program of oral Proellex.

Read on...

Anika Therapeutics Inc. (ANIK) expects revenue growth for the second quarter of 2017 to be in the range of 23% to 26% year-over-year. The expected revenue includes $5 million milestone payment from U.S. commercial sales of MONOVISC, announced on Monday. The Company reported revenue of $26.6 million in Q2, 2016.

Anika is scheduled to report its second quarter 2017 financial results on July 26, 2017.

In a SEC filing dated July 13, 2017, Anika has revealed that it will pay a gross amount of $350 thousand to Stephen Mascioli for all alleged damages and attorneys' fees. Stephen Mascioli was appointed to the role of Chief Medical Officer at Anika in April 2016, and according to reports, he left the Company in January 2017. The nature of allegations has not been disclosed.

ANIK closed Monday's trading at $46.47, up 0.76%.

Asterias Biotherapeutics Inc. (AST) has completed enrollment and dosing of AIS-A 20 million cell cohort in its ongoing phase 1/2a clinical trial of AST-OPC1 for acute spinal cord injury, dubbed SCiStar.

In this cohort, five patients with AIS-A grade spinal cord injury were administered 20 million AST-OPC1 cells. The 20 million AST-OPC1 cell dose is the highest to be investigated in the SCiStar clinical trial. The company expects to report top-line six-month results from this cohort in January 2018.

AST closed Monday's trading at $3.50, unchanged from the previous trading day's close.

Shares of CymaBay Therapeutics Inc. (CBAY) were down more than 6% in extended trading on Monday, following its proposed public offering of common stock.

The Company has agreed to sell 10 million shares of its common stock, subject to market and other conditions, in an underwritten public offering.

In other news, the Company reported positive interim results from its ongoing low-dose phase II study of Seladelpar in patients with primary biliary cholangitis, or PBC, a life-threatening and life-limiting chronic cholestatic liver disease.

To know more about CBAY, read our premium stock report posted on June 21, 2017. The stock was trading around $5.11 then. CBAY touched a new 52-week high of $7.77 on Monday, before closing the day's trading at $5.98, up 5.84%. In after-hours, the stock fell 6.35% to $5.60.

EDAP TMS SA (EDAP) has withdrawn its 510(k) application seeking FDA clearance for its next generation HIFU device: the Focal One, which is currently under regulatory review, in order to include new and additional clinical data. (HIFU stands for high-intensity focused ultrasound).

The 510(k) application for Focal One was submitted last April.

Marc Oczachowski, Chief Executive Officer of EDAP noted, ""In our effort to continue to continue making our HIFU technology and devices available in the U.S., we will also submit a 510(k) filing to the FDA for the clearance of our Ablatherm Fusion device in the near future, enabling American patients to benefit from the latest innovations in prostate tissue ablation with HIFU."

EDAP closed Monday's trading at $3.44, up 4.56%.

Ligand Pharmaceuticals Inc. (LGND) has expanded its license relationship with Amgen Inc. (AMGN) on AMG 330 by granting rights to use its Captisol technology in the formulation of AMG 330.

Ligand's Captisol patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Amgen's AMG 330 is under phase I trial for the treatment of acute myeloid leukemia.

The prior research agreement between the two companies allowed Amgen to evaluate AMG 330 with Captisol in preclinical and early clinical studies. Under the new commercial license agreement, Amgen receives exclusive worldwide rights to combine Captisol with AMG 330 for use in humans for a wide variety of therapeutic indications.

Ligand is entitled to receive an upfront payment, potential milestone payments, royalties and revenue from future sales of AMG 330 formulated using Captisol.

LGND closed Monday's trading at $116.75, down 1.60%.

Shares of Paratek Pharmaceuticals Inc. (PRTK) rose more than 5% in after-hours on Monday, following positive top-line results from a phase III study comparing its once-daily, oral investigational antibiotic, Omadacycline, to twice-daily FDA-approved oral linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI).

In the pivotal study, dubbed OASIS-2, Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority compared to linezolid, 48 to 72 hours after the first dose of study drug.

OASIS-2 represents the third positive phase III registration study of Omadacycline.

PRTK closed Monday's trading at $24.95, up 3.74%. In after-hours, the stock was up another 5.41% to $26.30.

The FDA has approved Puma Biotechnology Inc.'s (PBYI) Neratinib, formerly known as PB272, for the extended adjuvant treatment of HER2-positive early stage breast cancer.

An FDA panel had voted 12-4 recommending approval of Neratinib in May of this year. Neratinib, which will be marketed as NERLYNX, is expected to become commercially available in September 2017.

This drug becomes the first anti-HER2 treatment to be FDA-approved as extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant Herceptin-based therapy.

Neratinib is also under review in the European Union, and a decision is expected this quarter (Q3, 2017).

PBYI closed Monday's trading at $86.10, down 3.85%. In after-hours, the stock was up 7.43% to $92.50.

Shares of Repros Therapeutics Inc. (RPRX) plunged more than 33% on Monday, after the Company announced that the clinical program of oral Proellex for the treatment of uterine fibroids and endometriosis will continue to remain on partial clinical hold.

The FDA had imposed a full clinical hold on oral Proellex studies in August 2009 due to safety reasons. Later, in October 2012, the FDA reclassified the full clinical hold to a partial clinical hold to allow the Company to conduct a Phase 2 study of low dose oral Proellex in the treatment of endometriosis.

Repros is assessing Uterine Fibroid and Endometriosis development program with vaginal drug delivery treatment.

RPRX closed Monday's trading at $0.38, down 33.49%.

Spark Therapeutics' (ONCE) Biologics License Application for Voretigene neparvovec, an investigational, potential one-time gene therapy candidate for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease has been accepted for priority review by the FDA.

The investigational gene therapy has the proposed trade name LUXTURNA. The FDA's decision on LUXTURNA is expected by January 12, 2018.

ONCE closed Monday's trading at $60.65, up 2.17%.