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Benzinga's Daily Biotech Pulse: SIGA Rallies On FDA Panel Backing, Rigel And Gilead React To Earnings

Benzinga's Daily Biotech Pulse: SIGA Rallies On FDA Panel Backing, Rigel And Gilead React To Earnings

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on May 1)

  • AveXis Inc (NASDAQ: AVXS) (announced expiry of Anti-trust waiting period for its proposed acquisition by Novartis AG (ADR) (NYSE: NVS))
  • CareDx Inc (NASDAQ: CDNA)
  • Eleven Biotherapeutics Inc (NASDAQ: EBIO)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) (announced completion of common stock offering)
  • Inogen Inc (NASDAQ: INGN)(on beat-and-raise Q1)
  • Novocure Ltd (NASDAQ: NVCR)
  • Sophiris Bio Inc (NASDAQ: SPHS)

Down In The Dumps

(Stocks hitting 52-week lows on May 1)

  • Avadel Pharmaceuticals PLC (ADR) (NASDAQ: AVDL)
  • Cocrystal Pharma Inc (NASDAQ: COCP) (announced pricing of its common stock offering at $1.90 per share)
  • Forward Pharma A/S (NASDAQ: FWP) (reported a wider loss for its FY17 ended Dec. 31)
  • Incyte Corporation (NASDAQ: INCY) (announced below-consensus results for Q1)
  • Stellar Biotechnologies Inc (NASDAQ: SBOT)
  • Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP)
  • XBiotech Inc (NASDAQ: XBIT)

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates

Stocks In Focus

FDA Panel Backs SIGA's Pediatric Smallpox Treatment

SIGA Technologies, Inc. (NASDAQ: SIGA) announced that the FDA's Antimicrobial Drugs Advisory Committee voted 17-0 in favor of the NDA for is tecovitimat to treat smallpox caused by variola virus in adults and pediatric patients.

The stock rallied 11.37 percent to $6.56 in after hours, Tuesday.

Rigel Rallies On In-line Q1 Loss, Tavalisse Update

Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) reported a loss for its FQ1, which was in line with expectations., The company's Tavalisse for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia – a disorder, in which the immune system attacks and destroys the body's own platelets, was approved by the FDA on April 17.

The stock rallied after hours and was up more than 12 percent Wednesday morning.

Gilead Earnings Doesn't Soothe Investors

Gilead Sciences, Inc. (NASDAQ: GILD) said its Q1 non-GAAP earnings per share and revenues declined year-over-year. Both metrics trailed expectations. The stock fell 6 percent to $68.20.

Novartis Secures Second FDA Approval for Kymriah

Novartis announced it has received second approval for kymriah, its CAR-T therapy for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Kymriah is an immunocellular therapy meant to be a one-time treatment, manufactured individually for each patient using his own T cells.

On The Radar

The following companies report earnings on Wednesday:

  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Conatus Pharmaceuticals Inc (NASDAQ: CNAT)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Exelixis, Inc. (NASDAQ: EXEL)
  • Flex Pharma Inc (NASDAQ: FLKS)
  • Insmed Incorporated (NASDAQ: INSM)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Pacific Biosciences of California (NASDAQ: PACB)
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)

Other Events

FDA's Antimicrobial Drugs Advisory Committee is scheduled to deliberate on Achaogen Inc (NASDAQ: AKAO)'s plazomicin for complicated urinary tract infections and blood stream infections in adults. The stock was halted Wednesday morning.

FDA Tidbits

The FDA and FTC announced on Tuesday they would initiate action against companies, including manufacturers, distributors and retailers who sell e-liquids used in e-cigars, with labeling and advertising that mislead children into thinking they are juice boxes, candies or cookies.


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