Northwest Bio Heading North, PRTK To Report Data In June, FLML Gets FDA Nod

(RTTNews) - Shares of BIND Therapeutics Inc. (BIND) plunged over 73% on Monday, after the company announced that it has elected to file a voluntary petition under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware.

BIND plunged 73.77% to $0.38.

Cerulean Pharma Inc. (CERU) has a couple of catalysts lined up for the second half of this year.

The company expects top-line data from its phase II study of CRLX101 in combination with Avastin in relapsed renal cell carcinoma in the third quarter 2016.

Additional interim data from investigator-sponsored trials with CRLX101 in combination with Avastin in relapsed ovarian cancer and CRLX101 in combination with chemoradiotherapy in locally advanced rectal cancer are expected to be reported during the second half of 2016.

CERU closed Monday's trading at $3.10, down 5.49%. In after hours, the stock was down 1.61% to $3.05.

Shares of Flamel Technologies (FLML) were up over 7% on Monday, following FDA approval of Akovaz, a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.

The NDA was filed under Unapproved Marketed Drug. Drugs that are currently marketed as yet still "unapproved" products", but with well-established medical efficacy are known as Unapproved Marketed Drug.

Flamel expects to launch Akovaz during the third quarter 2016 in a strength of 50 mg/mL.

Including Akovaz, the company has FDA approvals for three Unapproved Marketed Drugs (UMD) in the U.S. - the other two being Bloxiverz and Vazculep, which are marketed by the company.

Bloxiverz is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Vazculep is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

FLML closed Monday's trading at $12.32, up 7.50%.

Kite Pharma Inc.'s (KITE) lead product candidate, KTE-C19 has been granted orphan drug designation by the FDA in five additional indications namely, for the treatment of primary mediastinal B cell lymphoma, mantle cell lymphoma, follicular lymphoma, acute lymphoblastic leukemia and chronic lymphocytic leukemia. The U.S. regulatory agency had earlier granted orphan drug status for KTE-C19 for the treatment of diffuse large B cell lymphoma (DLBCL).

KTE-C19 is under a phase I/II study for the treatment of aggressive, refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL), and under three additional pivotal multi-center studies for the treatment of relapsed/refractory mantle cell lymphoma (MCL), adult relapsed/refractory acute lymphoblastic leukemia (ALL), and pediatric relapsed/refractory ALL.

KITE closed Monday's trading at $47.80, up 3.28%.

Northwest Biotherapeutics (NWBO) has reported promising updated data from the ongoing follow-up of patients in the phase I portion of the phase I/II trial evaluating its investigational product DCVax-Direct for all types of inoperable solid tumors.

According to the company, to date, 20 of the 40 patients have exceeded 12 months overall survival, 13 of the 40 patients exceed 18 months OS, at least 10 of those 13 patients (with 2 of the 13 currently unknown) are still alive at OS times up to 29 months to date, with the majority having exceeded 20 months.

The company said that it is hoping to resolve the partial clinical hold on its phase III trial of DCVax-L for newly diagnosed Glioblastome multiforme brain cancer, imposed last August, in regard to new screening of patients, soon.

Northwest Bio also revealed that it has been notified that its certain stock issuances to contract manufacturing organization Cognate Bioservices did not comply with Nasdaq rules. The company added that it intends to take the appropriate steps to address the issues raised by the Nasdaq Staff as quickly as possible.

NWBO closed Monday's trading at $1.34, down 4.29%. In after-hours, the stock was up 29% to $1.73.

Paratek Pharmaceuticals Inc. (PRTK) has completed enrollment in its phase III registration study of Omadacycline in the treatment of acute bacterial skin and skin structure infections, and expects to report top-line data as early as the end of this June.

The enrollment in the company's phase III study of Omadacycline for the treatment of community-acquired bacterial pneumonia is currently ahead of initial projections. Paratek now expects reporting top-line data from this study as early as the third quarter of 2017.

The company has just initiated a phase Ib study of Omadacycline in patients with Urinary Tract Infections (UTI).

PRTK closed Monday's trading at $13.62, unchanged from the previous day's close.

Trevena Inc. (TRVN) is all set to start a phase III program of Oliceridine, which includes two pivotal efficacy trials evaluating moderate-to-severe acute pain, dubbed APOLLO-1 and APOLLO-2, this quarter.

The APOLLO-1 study will evaluate pain for 48 hours following bunionectomy, and the APOLLO-2 study will evaluate pain for 24 hours following abdominoplasty.

The company expects to report top-line data from the studies in the first quarter of 2017, and if all goes well as planned, may file an NDA for Oliceridine in the second half of 2017.

TRVN closed Monday's trading at $7.63, down 2.05%.

Xencor Inc. (XNCR) expects full results from a phase Ia trial of XmAb7195 for the treatment of severe asthma and allergic diseases this quarter. A phase I trial with a subcutaneous formulation of XmAb7195 is expected to be initiated this year.

Another compound in the pipeline is XmAb5871, which is under a phase II study for the treatment of IgG4-Related Disease (IgG4-RD) and a phase II study for the treatment of systemic lupus erythematosus (SLE).

The initial data from IgG4-RD phase II trial is expected in 1H 2017 while data from the SLE phase II trial IS expected in 2018.

XNCR closed Monday's trading at $12.33, up 0.65%.