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

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

Down In The Dumps

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

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

Stocks In Focus

Roche Extends Offer Period For Spark Buy Once Again

Roche Holdings AG Basel ADR RHHBY and Spark Therapeutics Inc 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 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 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 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.

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