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ARGS Hit By Double Whammy, GWPH's Epidiolex Nears Approval, FDA Nod For AZN

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Today's Daily Dose brings you news about Rigel Pharma's stock offering; FDA panel support for GW Pharma's New Drug Application for Epidiolex; FDA approval of expanded use of AstraZeneca's TAGRISSO and Argos' decision to pull the plug on its ADAPT phase III trial.

Read on…

Shares of Argos Therapeutics Inc. (ARGS) slumped over 68% on Thursday, following the Company's decision to terminate its phase III trial, dubbed ADAPT, evaluating Rocapuldencel-T in combination with Sutent/standard-of-care for the treatment of metastatic renal cell carcinoma.

Last February, an Independent Data Monitoring Committee, based on its planned interim data analysis, had recommended that the study be discontinued as it was unlikely to meet the endpoints. However, the Company continued to keep the ADAPT trial open while it conducted data review.

Based upon review of the data, now, the Company also does not believe that it would achieve the endpoints if the trial were to be continued.

Argos also noted that it does not expect to regain compliance with the $2.5 million minimum shareholders' equity requirement for continued listing on the Nasdaq Capital Market by the April 24, 2018 deadline. As a result, the Company's common stock may be delisted from the Nasdaq Capital Market, and trading may be suspended effective at the open of business on April 23, 2018.

Based on a review of the status of its internal programs, resources and capabilities, Argos is planning to explore a wide range of strategic alternatives.

ARGS closed Thursday's trading at $0.33, down 68.84%. In after-hours, the stock fell another 5.97% to $0.31.

AstraZeneca plc's (AZN) supplemental New Drug Application for the use of TAGRISSO in 1st-line EGFR-mutated Non-Small Cell Lung Cancer has been approved by the FDA.

In the U.S., Tagrisso is already approved for the 2nd-line treatment of patients with metastatic EGFRm NSCLC, whose disease has progressed on or after a 1st-line EGFR-TKI therapy and who have developed the secondary T790M mutation, as detected by an FDA-approved test. In 2017, Tagrisso was granted Breakthrough Therapy and Priority Review designations by the FDA in the 1st-line treatment setting.

The drug is approved for first-line use in patients with metastatic EGFRm NSCLC in Brazil also.

Tagrisso is under regulatory review in the European Union and Japan for use in the 1st-line treatment setting with regulatory decisions anticipated in the second half of 2018.

The drug brought home annual sales of $955 million in 2017, up 126% over 2016.

AZN closed Thursday's trading at $35.40, down 1.61%.

An FDA panel has unanimously recommended supporting the approval of GW Pharmaceuticals plc's (GWPH) New Drug Application for Epidiolex.

Epidiolex is the Company's proprietary oral solution of pure plant-derived cannabidiol, or CBD. It is proposed for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) are rare, severe forms of epilepsy with onset in early childhood and poor long-term prognoses.

The FDA's final decision on Epidiolex is expected by June 27, 2018. If approved, Epidiolex would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).

Analysts expect Epidiolex to bring in excess of $1 billion in annual peak sales.

GWPH closed Thursday's trading at $134.09, up 0.52%. In after-hours, the stock was up $136.04, up 1.45%.

Rigel Pharmaceuticals Inc. (RIGL) has offered to sell 16 million shares of its common stock at a price of $3.90 each. The gross proceeds to the Company from this offering are expected to be $62.4 million.

The offering is expected to close on or about April 24, 2018, subject to the satisfaction of customary closing conditions.

Rigel has granted the underwriters a 30-day option to purchase up to an aggregate of 2,400,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions.

On April 17, 2018, the Company secured FDA approval for Tavalisse, an oral drug, for chronic immune thrombocytopenia (ITP) in adult patients.

The Company plans to launch Tavalisse in the United States in late May 2018. Analysts expect Tavalisse to rake in peak sales of $360 million.

Amgen's Nplate and GlaxoSmithKline/Ligand Pharma's Promacta are the other two FDA-approved drugs for ITP.

RIGL closed Thursday's trading at $4.06, up 4.64%.

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