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PCRX Slumps On FDA Panel Feedback, DOVA Hits Record High, AGIO Up 38% YTD


Today's Daily Dose brings you news about the regulatory catalysts for Akcea; public offering of Amicus' shares; priority review of Agios' Ivosidenib NDA; FDA panel's feedback on the expanded indication for Pacira's EXPAREL, and United Therapeutics' patent litigation with Actavis.

Read on…

Akcea Therapeutics Inc.'s (AKCA) new drug application for Volanesorsen will be reviewed by an advisory committee on May 10, 2018, before the FDA announces its decision on the drug.

The Company is seeking approval of Volanesorsen for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS), which is characterized by the buildup of fats in the body due to a deficiency in the enzyme lipoprotein lipase.

The FDA's final decision on Volanesorsen is expected on August 30, 2018.

AKCA closed Thursday's trading at $23.22, up 0.96%.

Amicus Therapeutics (FOLD) has offered to sell 19.35 million shares of its common stock to the public at a price of $15.50 per share. The gross proceeds from the offering to Amicus are expected to be $300 million.

The offering is expected to close on February 21, 2018, subject to customary closing conditions.

The underwriters have a 30-day option to purchase up to an additional 2.90 million shares of the Company's common stock.

Upcoming Event:

-- The Company is slated to report Q4 and full year 2017 financial results on Feb.27, 2018.

Near-term Catalysts:

-- The NDA for Migalastat (Galafold) for Fabry disease was submitted to the FDA last month. The FDA acceptance of the NDA is expected this quarter (Q1, 2018).
-- Migalastat is under regulatory review in Japan, and a decision is expected in the first half of 2018.

FOLD closed Thursday's trading at $15.83, up 0.96%. In after-hours, the stock was up 1.14% to $16.01.

Agios Pharmaceuticals Inc.'s (AGIO) New Drug Application for Ivosidenib was been granted Priority Review by the FDA, with a decision expected on August 21, 2018.

Ivosidenib is proposed for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.

The Company intends to submit a Marketing Authorization Application for Ivosidenib to the European Medicines Agency in the fourth quarter of 2018.

The other activities lined up for this year include:

Initiate two global pivotal trials for AG-348 in pyruvate kinase (PK) deficiency in the first half of 2018.

-- ACTIVATE-T: A single arm trial of approximately 20 regularly transfused patients is expected to initiate in the first quarter of 2018.
-- ACTIVATE: A placebo-controlled trial of approximately 80 patients who do not receive regular transfusions is expected to initiate in the second quarter of 2018.

Initiate a global registry, known as PEAK, for adult and pediatric patients with PK deficiency in the first quarter of 2018.

Initiate a Phase 2 proof of concept trial of AG-348 in thalassemia in the fourth quarter of 2018.

AGIO closed Thursday's trading at $78.79, up 1.05%.

Dova Pharmaceuticals Inc. (DOVA) touched an all-time high of $35 in intraday trading on Thursday.

The Company's New Drug Application for Avatrombopag, proposed for the treatment of thrombocytopenia in patients with chronic liver disease, is under FDA review, with a decision expected on May 21, 2018.

Dova is expected to initiate a phase III clinical trial of Avatrombopag for the treatment of chemotherapy-induced thrombocytopenia in the second quarter of 2018.

DOVA closed Thursday's trading at $33.90, up 6.00%.

Shares of Pacira Pharmaceuticals Inc. (PCRX) slumped 14% in after-hours on Thursday as the FDA panel members were not able to reach an unanimous decision on the efficacy and safety of the use of EXPAREL as a nerve block to produce regional analgesia.

While four committee members voted to recommend FDA approval of the EXPAREL sNDA, 6 members voted against the proposed new indication.

EXPAREL is currently indicated for infiltration into the surgical site to produce postsurgical analgesia.

The FDA's final decision date is set for April 6, 2018.

In extended trading on Thursday, PCRX was down 14.13% to $31.00.

United Therapeutics Corp. (UTHR) has settled its patent litigation with Actavis Laboratories FL, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), relating to Orenitram Extended-Release Tablets.

Orenitram, developed by United Therapeutics, is a prescription medicine to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of lungs.

In February 2016, Actavis filed an Abbreviated New Drug Application, seeking FDA approval to market a generic version of Orenitram even before the drug's patents expire. United Therapeutics had sued Actavis, alleging patent infringement, in June of that year.

Now that a settlement has been reached, Actavis has a license to manufacture and commercialize the generic version of Orenitram in the United States beginning on June 15, 2027, although Actavis may be permitted to enter the market earlier under certain circumstances.

However, Actavis is not permitted to manufacture a generic version of any other United Therapeutics' product, such as Tyvaso Inhalation Solution or Remodulin Injection.

UTHR closed Thursday's trading at $136.11, down 0.59%.

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