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The Daily Biotech Pulse: Further Delay in Roche's Spark Acquisition, FDA Nod For Regeneron, Solid Biosciences Sinks On Earnings

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 May 13)

  • BioSig Technologies Inc (NASDAQ: BSGM)
  • Milestone Pharmaceuticals Inc (NASDAQ: MIST) (IPOed on May 9)
  • Silk Road Medical Inc (NASDAQ: SILK)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 13)

  • Alkermes Plc (NASDAQ: ALKS)
  • Amgen, Inc. (NASDAQ: AMGN)
  • Arbutus Biopharma Corp (NASDAQ: ABUS)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • Auris Medical Holding Ltd (NASDAQ: EARS) (announced pricing of its common stock and warrant offering)
  • BioNano Genomics Inc (NASDAQ: BNGO)
  • BRAINSWAY LTD/S ADR (NASDAQ: BWAY)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • DelMar Pharmaceuticals Inc (NASDAQ: DMPI)
  • Emergent Biosolutions Inc (NYSE: EBS)
  • Evoke Pharma Inc (NASDAQ: EVOK)
  • •Fennec Pharmaceuticals Inc (NASDAQ: FENC)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
  • Harvard Bioscience, Inc. (NASDAQ: HBIO)
  • Heat Biologics Inc (NASDAQ: HTBX)
  • Insys Therapeutics Inc (NASDAQ: INSY) ( warned of a potential bankruptcy filing)
  • Melinta Therapeutics Inc (NASDAQ: MLNT)
  • Mylan NV (NASDAQ: MYL) (named in a lawsuit for alleged price manipulation and anti-competitive practices)
  • NovaBay Pharmaceuticals, Inc. (NYSE: NBY)
  • Novavax, Inc. (NASDAQ: NVAX)
  • Nuvectra Corp (NASDAQ: NVTR)
  • Opko Health Inc. (NASDAQ: OPK)
  • Osmotica Pharmaceuticals PLC (NASDAQ: OSMT)
  • Outlook Therapeutics Inc (NASDAQ: OTLK)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Sensus Healthcare Inc (NASDAQ: SRTS)
  • Seres Therapeutics Inc (NASDAQ: MCRB)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Teva Pharmaceutical Industries Ltd (NYSE: TEVA)(named as one of the pharma companies involved in drug price manipulation)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • Transenterix Inc (NYSE: TRXC)
  • United Therapeutics Corporation (NASDAQ: UTHR)
  • Xenetic Biosciences Inc (NASDAQ: XBIO) (reacted to its first-quarter results)

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

Stock In Focus Roche, Spark To Delay Premerger Notification Filing By Two Weeks

Roche Holdings AG Basel ADR (OTC: RHHBY) and Spark Therapeutics Inc (NASDAQ: ONCE) said they intend to refile their respective premerger notification and report forms in connection with the pending acquisition of the latter by the former, on May 23 compared to the earlier notified date of May 9. The companies said the delay in refiling is to allow the government additional time to complete its review.

Following the refiling, the waiting period will expire at 11:59 pm ET on or about June 7, although the period could be shortened if the government allows early termination of the waiting period, the companies said.

FDA Greenlights Label Expansion For Regeneron's Eylea

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) said the FDA approved its sBLA for its Eylea injection to treat all stages of diabetic retinopathy. The VEGF inhibitor is now approved for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Earnings

Solid Biosciences Inc (NASDAQ: SLDB) reported a first-quarter loss of 85 cents per share, wider than the 54 cents reported for the year-ago period and the consensus loss estimate of 63 cents per share.

View more earnings on IBB

As of March 31, the company had cash, cash equivalents and available-for-sale securities worth $20.6 million compared to $15.9 million at the end of the first quarter of 2019.

The stock fell 5.65 percent to $8.35 in after-hours trading.

On The Radar Clinical Trial Readouts

Myovant Sciences Ltd (NYSE: MYOV) is scheduled to release topline Phase 3 data from a study dubbed Liberty 1 that evaluated its Relugolix for menstrual bleeding associated with uterine fibroids.

Earnings

Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL) (before the market open)
ImmuCell Corporation (NASDAQ: ICCC) (before the market open)
Eyenovia Inc (NASDAQ: EYEN) (before the market open)
Onconova Therapeutics Inc (NASDAQ: ONTX) (before the market open)
Matinas BioPharma Holdings Inc (NYSE: MTNB) (before the market open)
Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (before the market open)
Aptinyx Inc (NASDAQ: APTX) (before the market open)
Dare Bioscience Inc (NASDAQ: DARE) (after the close)
Cesca Therapeutics Inc (NASDAQ: KOOL) (after the close)
Curis, Inc. (NASDAQ: CRIS) (after the close)
Zosano Pharma Corp (NASDAQ: ZSAN) (after the close)
Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the close)
Vermillion, Inc. (NASDAQ: VRML) (after the close)
OpGen Inc (NASDAQ: OPGN) (after the close)
TRACON Pharmaceuticals Inc (NASDAQ: TCON) (after the close)
InspireMD Inc (NYSE: NSPR)
OncoCyte Corp (NYSE: OCX)

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