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The Daily Biotech Pulse: Roche-Spark Deal Faces Further Delay, Bayer's Prostate Cancer Drug Passes FDA Muster

Shanthi Rexaline

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on July 30)

  • Acasti Pharma Inc (NASDAQ: ACST)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
  • Arcturus Therapeutics Ltd (NASDAQ: ARCT)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Insulet Corporation (NASDAQ: PODD)
  • Medpace Holdings Inc (NASDAQ: MEDP)(reported strong second-quarter results)
  • Novocure Ltd (NASDAQ: NVCR)
  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 30)

  • Alimera Sciences Inc (NASDAQ: ALIM)(reacted to second-quarter results)
  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • Aquestive Therapeutics Inc (NASDAQ: AQST)
  • Champions Oncology Inc (NASDAQ: CSBR)
  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Equillium Inc (NASDAQ: EQ)
  • Medtronic PLC (NYSE: MDT)
  • Obseva SA (NASDAQ: OBSV)
  • Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Trevi Therapeutics Inc (NASDAQ: TRVI)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH)

Stocks In Focus Roche Extends Offer Period For Spark Buy Once Again

Roche Holdings AG Basel ADR (OTC: RHHBY) and Spark Therapeutics Inc (NASDAQ: ONCE) announced Wednesday Roche has extended the offering period for its previously announced tender offer to buy all outstanding shares of Spark for $114.50 per share from the original deadline of 5 p.m. ET Wednesday, July 31 to 5 p.m. ET Tuesday, Sept. 2.

The companies attributed the delay to the additional time provided for the FTC and the U.K. Competition and Markets Authority to complete their previously disclosed reviews.

The companies said as of July 30, shares representing about 25.2% of Spark outstanding shares have been tendered.

The offer period has been extended multiple times in the past

Bayer's Castration-resistant Prostate Cancer Drug Approved

Bayer AG (OTC: BAYRY) said the FDA has approved its Nubeqa – an androgen receptor inhibitor – for treating patients with non-metastatic castration-resistant prostate cancer. Nubeqa is to be made available in oral tablets for adults. It's developed jointly by Bayer and Orion Corp.

Eyepoint Presents Positive Data For Micro-insert to Treat Eye Inflammation

Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) presented data supporting Yutiq 0.18mg three-year micro-insert for chronic, non-infectious uveitis, affecting the posterior segment of the eye.

The company presented the data in three oral sessions at the 37th Annual Scientific Meeting of the American Society of Retina Specialists in Chicago, Illinois

The stock shed 2.82% to $1.38 in after-hours trading.

Aclaris Reports Mixed Mid-stageTrial Result For Its Hair Loss Drug

Aclaris Therapeutics Inc (NASDAQ: ACRS) announced positive Phase 2 clinical trial data for ATI-501, an investigational oral Janus Kinase 1/3 inhibitor, in subjects with alopecia areata. Subjects treated with ATI-501 achieved statistically significant improvement over placebo in several measures of hair growth, including the primary endpoint and certain secondary endpoints of the trial.

View more earnings on IBB

However, the company said exploratory secondary endpoints were not statistically significant compared to placebo.

The stock declined 18.97% to $1.41 in after-hours trading.

Earnings

Amgen, Inc. (NASDAQ: AMGN)'s second-quarter non-GAAP EPS rose 4% to $3.97, exceeding the $3.59 consensus. Revenues fell 3% to $5.9 billion. The company issued in line 2019 guidance.

The stock climbed 1.98% to $179.95 in after-hours trading.

T2 Biosystems Inc ((NASDAQ: TTOO) reported a wider-than-expected loss of 35 cents per share. Revenues also trailed estimate. The company's 2019 guidance was below estimates.

The stock slumped 29.86% to $1.01 in after-hours trading.

BioTelemetry Inc (NASDAQ: BEAT) reported better-than-expected second-quarter results.

The stock rallied 9.45% to $49 in after-hours trading.

On The Radar Earnings

Amarin Corporation plc (NASDAQ: AMRN) (before the market open)
Strongbridge Biopharma plc (NASDAQ: SBBP) (before the market open)
United Therapeutics Corporation (NASDAQ: UTHR) (before the market open)
Nuvectra Corp (NASDAQ: NVTR) (after the market close)
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (after the market close)
Exelixis, Inc. (NASDAQ: EXEL) (after the market close)
DexCom, Inc. (NASDAQ: DXCM) (after the market close)
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the market close)
MacroGenics Inc (NASDAQ: MGNX) (after the market close)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the market close)
SurModics, Inc. (NASDAQ: SRDX) (after the market close)

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