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Benzinga's Daily Biotech Pulse: Epidiolex, Roche's Influenza Drug Gets Priority Review Status, Xeris Jumps On Positive Trial Results

Benzinga's Daily Biotech Pulse: Epidiolex, Roche's Influenza Drug Gets Priority Review Status, Xeris Jumps On Positive Trial Results

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 June 25)

  • Quest Diagnostics Inc (NYSE: DGX)(Barclays upgraded shares to Overweight)
  • Regenxbio Inc (NASDAQ: RGNX)
  • Surface Oncology (Inc NASDAQ: SURF)

Down In The Dumps

(Stocks hitting 52-week lows on June 25)

  • Agenus Inc (NASDAQ: AGEN)
  • Avadel Pharmaceuticals PLC (ADR) (NASDAQ: AVDL)
  • Cellectar Biosciences Inc (NASDAQ: CLRB)
  • Curis, Inc. (NASDAQ: CRIS)
  • Erytech Pharma SA (ADR) (NASDAQ: ERYP)(announced decision to cease development of its eryaspase in acute lymphoblastic leukemia, but plans to focus development efforts for the potential treatment of select solid tumor indications)
  • Eyenovia Inc (NASDAQ: EYEN)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)
  • Magenta Therapeutics Inc (NASDAQ: MGTA)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK)(on failed trial results for its pancreatic cancer treatment candidate MM-141, chemically isitiratumab)
  • Oncolytics Biotech, Inc. (USA) (NASDAQ: ONCY)
  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)
  • Tocagen Inc (NASDAQ: TOCA)
  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)

Stocks In Focus

GW Pharma's Epidiolex Becomes First Cannabis-Based FDA-Approved Drug

The FDA approved GW Pharmaceuticals PLC-ADR (NASDAQ: GWPH)'s Epidiolex for the treatment of epilepsy, specifically for people who suffer with Lennox-Gastaut and Dravet syndromes.

Roche's Genentech Unit's Influenza Treatment Gets Priority Review Status

Roche Holdings AG Basel ADR (OTC: RHHBY)'s Genentech unit said the FDA accepted the NDA for its influenza treatment candidate baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older, and also granted the application priority review status.

The PDUFA data has been set for Dec. 24, 2018.

Xeris Releases Positive Results For Glucagon Rescue Pen

At the American Diabetes Association's 78th Scientific Sessions, Xeris Pharmaceuticals Inc (NASDAQ: XERS) presented positive results for two of its Phase 3 clinical trials that evaluated its ready-to-use, room-temperature stable liquid glucagon rescue pen for treating severe hypoglycemia in adults and children with type 1 diabetes as compared to the currently marketed Glucagon Emergency Kit.

The company also generated positive data from an additional Phase 3 crossover study of the Xeris rescue pen among adults with type 1 diabetes.

The stock soared 18.06 percent to $22.55 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, Clinical Trials And IPOs

Heron Announces & Prices Common Stock Offering

Heron Therapeutics Inc (NASDAQ: HRTX) priced its common stock offering of $200 million worth of shares. The company expects to close the offering on or before June 28.

Exelixis Added to S&P MidCap 400 Index

Standard & Poor's announced that Exelixis, Inc. (NASDAQ: EXEL) will replace Copart, Inc. (NASDAQ: CPRT) in the S&P MidCap 400 Index, effective July 2.

The stock gained 5.73 percent to $20.66 in after-hours trading.

Arqule Joins Russell 2000 Index

ArQule, Inc. (NASDAQ: ARQL) said its stock has been added to the Russell 2000 Index, effective June 22.

The stock rose 3.14 percent to $5.2499 in after-hours trading.

Aerpio to Offer Shares, Up-list to Nasdaq

Aerpio Pharmaceuticals Inc (OTC: ARPO) said it plans to sell $40 million of its shares in an IPO. Additionally, the company said its stock has been approved for uplisting on the Nasdaq, subject to the pricing of the proposed offering.

On The Radar

FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee are set to give their decision on the NDA for remoxy, oxycodone extended-release capsules, submitted by Pain Therapeutics, Inc. (NASDAQ: PTIE) and DURECT Corporation (NASDAQ: DRRX).

FDA Tidbits

FDA Commissioner Scott Gottlieb released a statement outlining the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.

Posted-In: Biotech News Offerings FDA Top Stories Trading Ideas Best of Benzinga


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