AKRX, LXRX Get FDA Nod, KITE Flies Higher, SRPT Plunges On Dull Outlook

(RTTNews) - Akorn Inc. (AKRX) has received FDA approval for Mycophenolate Mofetil for Injection, USP, 500 mg/vial, a generic version of immunosuppressant CellCept.

Mycophenolate Mofetil is indicated for preventing organ rejection following kidney, liver, or heart transplants. According to IMS Health, sales of Mycophenolate Mofetil for Injection were approximately $43 million for the twelve months ended December 31, 2016.

Tuesday's approval is the first new product approval received out of Akorn's Decatur, Illinois manufacturing facility since the FDA re-inspection in December 2016, noted the company.

AKRX closed Tuesday's trading at $20.81, down 5.75%. In after-hours, the stock was up 4.52% to $21.75.

Dynavax Technologies Corp.'s (DVAX) resubmitted NDA for HEPLISAV-B, the company's vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older, has been accepted for review by the FDA.

The U.S. regulatory agency's decision on HEPLISAV-B will be known on August 10, 2017. This is HEPLISAV-B's third go-around with the FDA.

Last November, the FDA refused to approve HEPLISAV-B, seeking information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments.

In February 2013 too, the FDA had rejected HEPLISAV-B, and requested additional data before it could be approved.

DVAX closed Tuesday's trading at $4.50, up 2.27%.

Eagle Pharmaceuticals Inc.'s (EGRX) NDA for Pemetrexed Injection, 25 mg/mL, has been accepted for review by the FDA.

The NDA submitted under 505(b)(2) regulatory pathway seeks approval of Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma (in combination with cisplatin).

The FDA's decision is expected to be announced on October 30, 2017.

EGRX closed Tuesday's trading at $76.69, down 1.63%.

A primary analysis of Kite Pharma Inc.'s (KITE) pivotal phase II study of Axicabtagene ciloleucel (previously referred to as KTE-C19) in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma has demonstrated encouraging results.

The study, dubbed ZUMA-1, met the primary endpoint of objective response rate with 82%. At month 6, 41% of treated patients achieved a response, including 36 percent in Complete Response.

Last September, the company reported positive top line results from a pre-planned interim analysis of the ZUMA-1 trial.

Kite intends to complete its rolling submission of the Biologics License Application, seeking regulatory approval of Axicabtagene ciloleucel in aggressive NHL, by the end of the first quarter of 2017.

KITE touched a new 52-week high of $72.80 on Tuesday before closing the day's trading at $70.77, up 24.53%.

Shares of Lexicon Pharmaceuticals Inc. (LXRX) rose over 5% in extended trading on Tuesday, following FDA approval of its drug XERMELO.

XERMELO, generically known as telotristat ethyl, has been approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

Lexicon Pharma's XERMELO becomes the first and only oral treatment for carcinoid syndrome diarrhea in cancer patients with metastatic neuroendocrine tumors. The drug is now available by prescription and will be in select specialty pharmacies beginning March 6, 2017, says the company.

LXRX closed Tuesday's trading at $16.05, down 2.43%. In after-hours, the stock was up 5.36% to $16.90.

Shares of Sarepta Therapeutics Inc. (SRPT) plunged more than 14% in extended trading on Tuesday, following disappointing sales forecast of its Duchenne muscular dystrophy drug Exondys 51 for the year 2017.

In a conference call with analysts, hosted after the bell, Sandy Mahatme, the company's CFO forecast Q1, 2017 sales of Exondys 51 to range between $13 million and $15 million. The full-year 2017 sales of the drug are expected to be in excess of $80 million.

Analysts polled by Thomson Reuters expect the company to report revenue of $15.51 million in Q1, 2017 and $151.26 million in 2017.

SRPT closed Tuesday's trading at $31.11, down 4.89%. In after-hours, the stock was down 14.30% to $26.66.