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

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

Down In The Dumps

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

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

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