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AKRX Slumps On Court Ruling, OMER Reports IgA Data, INSM On Watch

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The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Akorn Inc. (AKRX)

Lost 58.71% to close Monday's (Oct.1) trading at $5.36.

News: Delaware Chancery Court has upheld German healthcare group Fresenius Kabi AG's decision to terminate the $4.3 billion deal to buy generic-drug maker Akorn.

Fresenius Kabi had inked an agreement to acquire Akorn for US$34 per share, equivalent to a total acquisition price US$4.3 billion, plus approximately US$450 million of net debt, last April. The acquisition was supposed to close in early 2018. But in February of this year, Akorn came under scrutiny for possible violations of FDA data integrity rules.

On February 26, 2018, Fresenius started conducting an independent investigation, using external experts, into alleged breaches of FDA data integrity requirements relating to product development at Akorn. In April of this year, the German pharmaceutical firm terminated its agreement to acquire Akorn.

Now, with the Delaware Chancery Court ruling in favor of Fresenius Kabi, Akorn has decided the appeal the Court ruling.

2. AVROBIO Inc. (AVRO)

Lost 51.55% to close Monday's trading at $25.13.

AVROBIO is a phase II clinical stage gene therapy company focused on developing gene therapies to treat rare diseases.

Pipeline:
-- AVR-RD-01 for the treatment of Fabry disease, currently under an investigator-sponsored Phase 1 clinical trial and company-sponsored Phase 2 clinical trial.
-- AVR-RD-02 for the treatment of Gaucher disease for which Phase 1/2 clinical trials are planned.
-- AVR-RD-03 for the treatment of Pompe disease, under preclinical testing.
-- AVR-RD-04 for the treatment of cystinosis for which Phase 1/2 clinical trials are planned.

Recent events:

-- The Company went public on the Nasdaq Global Select Market on June 21, 2018, offering its shares at a price of $19.00 each.
-- On October 1, the Company announced clinical data and patient updates from the investigator-sponsored phase I study and the AVROBIO-sponsored phase II clinical trial of AVR-RD-01 meant for Fabry disease.

According to the Company, the first two patients in Phase 1 study continue to demonstrate AGA enzyme activity above the diagnostic range for classic Fabry disease 18 months and six months after receiving AVR-RD-01, respectively. Patient 1 is no longer receiving enzyme replacement therapy.

Enrollment continues in Phase 2 clinical trial and first patient's 3-month results demonstrate AGA enzyme activity from AVR-RD-01 gene therapy in ERT-naïve patient, noted the Company.

-- The Company has received no objection to its clinical trial application from Health Canada for a Phase 1/2 clinical trial of AVR-RD-02, its gene therapy for Gaucher disease.

The phase 1/2 clinical trial of AVR-RD-02 in patients with Gaucher disease is expected to be initiated in 2019.

3. RXi Pharmaceuticals Corporation (RXII)

Lost 49.57% to close Monday's trading at $0.59.

News: The Company has offered to sell 21.43 million units to the public at a price of $0.70 per unit.

Each unit contains one share of common stock (or common stock equivalent) and one warrant to purchase one share of common stock. This offering is expected to close on or about October 3, 2018, subject to customary closing conditions.

4. Omeros Corporation (OMER)

Lost 42.81% to close Monday's trading at $13.96.

News: The Company announced positive data from its ongoing phase II clinical trial of OMS721 in patients with immunoglobulin A (IgA) nephropathy, a progressively worsening kidney disease.

However, investors were not happy as the data from nine evaluable patients showed that the median reduction in proteinuria following the initial 12-week course of treatment was 18.4 percent for the OMS721 and 18.0 percent for the placebo group.

5. Insmed Incorporated (INSM)

Lost 22.16% to close Monday's trading at $15.74.

News: The Company has been granted accelerated approval for ARIKAYCE (amikacin liposome inhalation suspension).

ARIKAYCE becomes the first and only therapy specifically indicated for the treatment of Mycobacterium Avium Complex Lung Disease in adult patients with limited or no alternative treatment options.

However, the drug's label sports a Boxed Warning regarding the increased risk of respiratory conditions including hypersensitivity pneumonitis (inflamed lungs), bronchospasm (tightening of the airway), exacerbation of underlying lung disease and hemoptysis (spitting up blood) that have led to hospitalizations in some cases.

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