MDCO Tastes Bitter, PRTO Awaits Phase 3 Data In Dec., It's Time To Cherish IONS

(RTTNews) - Agile Therapeutics Inc. (AGRX) phase III study of its investigational once-weekly transdermal contraceptive patch, Twirla, dubbed SECURE, is progressing well - with all subject visits having been completed.

The company expects to report top-line data from the SECURE study in early January 2017.

AGRX closed Monday's trading at $7.53, up 4.87%.

Achaogen Inc. (AKAO) has two important events to watch out for in the coming months. The company has completed patient enrollment in its phase III registration clinical trial of Plazomicin, dubbed EPIC, and supportive phase III clinical trial of Plazomicin, known as CARE. Topline results from both the trials are expected to be reported by the end of this year - earlier than previously planned.

AKAO closed Monday's trading at $4.24, up 6.27%.

Cocrystal Pharma Inc.'s (COCP.OB) phase Ia/Ib study of CC-31244 for the treatment of chronic hepatitis C virus infection has yielded positive results.

The study evaluated CC-31244's safety/tolerability and pharmacokinetics, including food effect and antiviral activity in two groups - say Group A (single ascending doses, and multiple doses in healthy volunteers), and Group B (multiple doses in HCV infected individuals).

According to the trial results, once daily 400 mg dosing arm demonstrated that CC-31244 had a substantial and durable antiviral effect with an average HCV RNA viral load decline from baseline of 3 log orders by 48 hours after dosing. The average viral load at 6 days post last dose remained on average 1.9 log orders below baseline. In addition, no viral breakthrough was observed during the treatment period. No serious adverse event was reported, added the company.

COCP.OB closed Monday's trading at $0.49, up 4.26%.

DBV Technologies (DBVT) has completed enrollment in phase II part of the Phase I/II study of Viaskin Milk for the treatment of patients with IgE-mediated cow's milk protein allergy.

The study, dubbed MILES, is evaluating the efficacy and safety of Viaskin Milk in desensitizing children two to 17 years of age suffering from cow's milk protein allergy, or CMPA.

DBVT closed Monday's trading at $35.66, up 2.86%.

Shares of Ionis Pharmaceuticals Inc. (IONS) jumped more than 18%, following positive results from a phase III study of SPINRAZA in later-onset (consistent with Type 2) spinal muscular atrophy.

An interim analysis of the study, dubbed CHERISH, revealed that children receiving SPINRAZA experienced a highly statistically significant improvement in motor function compared to those who did not receive treatment. SPINRAZA demonstrated a favorable safety profile in the study.

SPINRAZA, developed in partnership with Biogen Inc. (BIIB), is under priority review by the FDA as a potential treatment for infantile-onset (most likely to develop Type 1) SMA. The drug candidate is also under review by the European Medicines Agency.

IONS closed Monday's trading at $32.12, up 18.39%.

Shares of The Medicines Co. (MDCO) were down over 6% in extended trading on Monday after the company announced that it is discontinuing the clinical development program for MDCO-216, its investigational cholesterol efflux promoter.

The decision to halt the development of MDCO-216 was based on the top-line efficacy data of a proof-of-concept study, which measured MDCO-216's effect on atherosclerotic plaque burden and its impact on cholesterol efflux. The study, dubbed MILANO-PILOT, provided insufficient basis for further investment on MDCO-216.

The company does not expect to incur any charge associated with the discontinuation of the MDCO-216 development program.

MDCO closed Monday's trading at $32.52, up 1.66%. In after-hours, the stock was down 6.52% to $30.40.

Portola Pharmaceuticals Inc. (PTLA) is all set to resubmit its Biologics License Application for AndexXa, which is designed to reverse the anticoagulant effect in patients treated with oral or injectable Factor Xa inhibitors, in the second quarter of 2017.

The FDA had turned down Portola's AndexXa BLA in August of this year, requesting additional information primarily related to manufacturing.

PTLA closed Monday's trading at $18.65, up 5.67%.

It's time to keep an eye on Proteon Therapeutics Inc. (PRTO) as it has an important catalyst coming its way.

The company is all set to report topline data from its phase III clinical study of Vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis next month (December 2016).

The trial, dubbed PATENCY-1, is the first of two phase 3 clinical studies of Vonapanitase.

PRTO closed Monday's trading at $8.45, up 6.29%.

Zogenix Inc. (ZGNX) expects top-line results from its two phase III safety and efficacy clinical trials of ZX008 in Dravet Syndrome in the second-quarter of 2017. The company is on track to file for potential regulatory submissions by year-end 2017.

ZGNX closed Monday's trading at $8.55, up 3.01%.