Author Archive

Additional trials required for EGLT. ACOR acquires Phase 3 Parkinson’s candidate + LCPN MDGN MNOV updates

Sep 24, 2014 No Comments

Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced that it will acquire Civitas Therapeutics, a privately-held biopharmaceutical company, for $525 million in cash. Acorda will obtain worldwide rights to CVT-301, for OFF episodes of Parkinson’s disease (PD).  The Phase 3 trial is expected to commence in early 2015. Egalet Corporation (Nasdaq: EGLT) (Egalet) announced that they will need […]

Read more

LPCN Phase 3 data due Wednesday. ATOS Breast Aspirator NOT cleared + OPK TTNP ZSPH updates

Sep 23, 2014 No Comments

Lipocine Inc. (Nasdaq:LPCN) announced that they will host a conference call on Wednesday September 24, 2014 at 8:45 a.m. Eastern time to discuss top-line results from its Study of Oral Androgen Replacement (“SOAR”) pivotal Phase 3 clinical trial. A press release will be released prior to the call. Atossa Genetics Inc. (NASDAQ: ATOS) announced that […]

Read more

AVNR offering. THLD trial to continue through to completion + TKMR DVAX AUXL updates

Sep 22, 2014 No Comments

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that it is offering to sell $200 million of its common stock in an underwritten public offering. Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) has reviewed the merger proposal from Endo International plc and has unanimously determined it is not a superior proposal under the terms of its existing merger agreement with QLT […]

Read more

ADHD Phase 3 data due in about 2 weeks. LTPN offering + updates for HTBX ARGS

Sep 20, 2014 No Comments

Alcobra Ltd. (Nasdaq:ADHD) announced that data from their Phase 3 trial of Metadoxine Extended Release (MDX) in adult Attention Deficit Hyperactivity Disorder (ADHD) patients are due in about two weeks. Argos Therapeutics, Inc. (Nasdaq:ARGS) noted that they are on target to complete enrolment in their pivotal Phase 3 ADAPT trial of AGS-003 for the treatment of metastatic renal cell […]

Read more

FLXN FX006 placed on clinical hold. ONTY offering + updates NVAX VVUS AUXL ISIS OXGN

Sep 18, 2014 No Comments

Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced that the FDA informed the company that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2b clinical trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. The FDA has indicated that the clinical hold is due to a single occurrence of an […]

Read more

ENDO offers to acquire AUXL. NKTR FDA Approval + OGXI AGRX updates

Sep 17, 2014 No Comments

Nektar Therapeutics (NASDAQ:NKTR) announced that their partner AstraZeneca announced that the FDA approved MOVANTIK (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced that patient enrollment has been completed in the Phase 3 AFFINITY […]

Read more

AVNR meets endpoint in AVP-923 trial. SLXP Approval. OPXA offering. TGTX finalises SPA agreement + AMRN

Sep 16, 2014 No Comments

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that it met the primary endpoint in a Phase 2 trial of AVP-923 for the treatment of agitation in patients with Alzheimer’s disease. Treatment with AVP-923 was associated with significantly reduced agitation as measured by the primary endpoint, the agitation/aggression domain score of the neuropsychiatric inventory (NPI) compared to […]

Read more

HALO FDA Approval. NPSP positive Adcom vote. AMRN SPA appeal denied + ASTM ONTY GNCA

Sep 14, 2014 No Comments

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara for the long-term treatment of Hypoparathyroidism. The PDUFA date is October 24, 2014. Halozyme Therapeutics, Inc., (NASDAQ: HALO) and Baxter International Inc. (NYSE: BAX) announced that the FDA approved HYQVIA for the treatment of adult patients […]

Read more

OREX MDVN FDA Approval. Updates for PTCT ENTA CLVS.

Sep 11, 2014 No Comments

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (NASDAQ: OREX) announced that the FDA has approved Contrave for the treatment of obesity. They plan to launch Contrave in the fall of 2014. Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. announced that the FDA approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic […]

Read more

EVOK Phase 3 data due ahead of schedule + updates for PTN EVOK GALE

Sep 10, 2014 No Comments

Evoke Pharma, Inc. (Nasdaq:EVOK) announced that it has completed enrollment of its Phase 3 trial of EVK-001 for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Top-line data are due later in 2014, rather than in mid-2015 as was noted in previous guidance. Palatin Technologies, Inc. (NYSE MKT: PTN) provided […]

Read more

TSRO OPK submit rolapitant NDA. HPTX terminates DiaPep277 trial + VTL update

Sep 09, 2014 No Comments

OPKO Health, Inc. (NYSE:OPK) announced that TESARO, Inc. (Nasdaq:TSRO) has submitted a New Drug Application (NDA) to the FDA for oral rolapitant, for the prevention of chemotherapy-induced nausea and vomiting (CINV). Vital Therapies, Inc. (Nasdaq:VTL) provided an update on their VTI-208 clinical trial  in alcohol induced liver decompensation noting that preliminary results are expected in 1H 2015. Hyperion […]

Read more