MOH Opens Wallet, IMMU Fast Tracked, OVAS Continues To Deliver

(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY) has filed a Clinical Trial Application with the U.K. Medicines and Healthcare products Regulatory Agency to initiate a phase 1/2 clinical trial with ALN-AAT for the treatment of AAT deficiency-associated liver disease (alpha-1 liver disease).

Upon approval of the CTA filing, the company will initiate the phase 1/2 study in late 2015, with initial data expected to be reported in early 2016.

ALNY closed Friday's trading at $119.84, up 3.43%.

AbbVie's (ABBV) HUMIRA has received orphan drug designation from the FDA for the investigational treatment of moderate-to-severe hidradenitis suppurativa (Hurley Stage II and Hurley Stage III disease), a painful, chronic inflammatory skin disease.

AbbVie's supplemental Biologic License Application seeking FDA approval for the use of HUMIRA in patients with moderate-to-severe HS is currently under review with the regulatory agency.

ABBV closed Friday's trading at $65.99, up 0.03%.

Inotek Pharmaceuticals Corp. (ITEK) expects to initiate the first phase III trial with its ophthalmic product candidate Trabodenoson monotherapy, designed to lower intraocular pressure in the third quarter of 2015.

The company went public on February 18, 2015, priced at $6.00 per share.

ITEK closed Friday's trading at $5.80, down 1.02%.

Immunomedics Inc.'s (IMMU) drug candidate Sacituzumab Govitecan, which is under phase I/II testing, has been granted Fast Track designation by the FDA for yet another indication - this time, for the treatment of patients with metastatic non-small cell lung cancer who have failed two prior lines of therapy.

Sacituzumab Govitecan has also won FDA's Fast Track status for the therapy of patients with triple-negative breast or small-cell lung cancers. Sacituzumab govitecan has also been designated an orphan drug by FDA for the treatment of patients with small-cell lung or pancreatic cancers.

The company noted that in a mid-stage clinical study in patients with advanced metastatic solid cancers who had failed multiple prior therapies for their disease, Sacituzumab Govitecan has produced promising therapeutic results in patients with several different cancer types, including breast, lung, esophageal, colorectal, and urinary bladder cancers, with limited and tolerable side effects, noted the company.

IMMU closed Friday's trading 1.23% higher at $4.12.

Molina Healthcare Inc.'s (MOH) wholly owned subsidiary Molina Healthcare of Michigan, is acquiring certain assets of Medicaid and MIChild businesses of HealthPlus of Michigan and its subsidiary, HealthPlus Partners Inc., with the aim of expanding its health plan in the State of Michigan.

The transaction, which will be funded with available cash on hand, is expected to occur during the third quarter of 2015.

MOH touched a new high of $69.78 on Friday before closing the day's trading at $69.25, up 0.12%.

OvaScience's (OVAS) fertility treatment AUGMENT continues to demonstrate improved clinical pregnancy rates in women with poor prognoses, which showed at least a three-fold increase over their prior histories.

The AUGMENT treatment is designed to improve the health of a woman's existing eggs, and enhance the IVF procedure.

OVAS closed Friday's trading 5.50% higher at $29.17.

Pharmaxis'(PXS.AX) phase I anti-inflammatory drug candidate PXS4728A has been acquired by Boehringer Ingelheim, which intends to develop it for the treatment of the liver-related condition NASH and to prevent its consequences, in a deal with a total potential value in excess of $A750 million.

PXS.AX closed Friday's trading at A$0.26, up 57.58%

Paratek Pharmaceuticals Inc. (PRTK) is all set to initiate its first phase III clinical trial for Omadacycline in acute bacterial skin and skin structure infections in mid-2015 and a phase III study in community-acquired bacterial pneumonia later this year.

The company ended March 31, 2015 with cash of $92.5 million, and raised $70.7 million in aggregate proceeds from a public offering earlier this month.

Based on current assumptions, the company's cash and cash equivalents are expected to fund operations through mid-2017, expected to coincide with the availability of top-line data from the second of two planned phase 3 trials of Omadacycline in community-acquired bacterial pneumonia.

PRTK closed Friday's trading at $27.49, down 1.12%.