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The Daily Biotech Pulse: Novartis Goes Shopping, Mixed Trial Results For Provention Bio, 4 Stocks To Debut

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 8)

  • Alcon AG (NYSE: ALC)
  • BioSig Technologies Inc (NASDAQ: BSGM)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 8)

  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Aquestive Therapeutics Inc (NASDAQ: AQST)(reacted to first-quarter results)
  • Arbutus Biopharma Corp (NASDAQ: ABUS)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • ITAMAR MED LTD/S ADR (NASDAQ: ITMR)
  • Opko Health Inc. (NASDAQ: OPK)(reacted to Q1 results)
  • Osmotica Pharmaceuticals PLC (NASDAQ: OSMT)
  • Retrophin Inc (NASDAQ: RTRX)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Sensus Healthcare Inc (NASDAQ: SRTS)

Stock In Focus Novartis to Buy Dry Eye Disease Drug From Takeda For $3.4B

Novartis AG (NYSE: NVS) announced an agreement with Takeda Pharmaceutical Co Ltd (NYSE: TAK) to acquire the assets associated with Xildra, chemically lifitefgrast ophthalmic solution, 5 percent worldwide for a $3.4 billion payment upfront and potential milestone payments up to $1.9 billion. Xildra is the only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease.
The company expects the transaction to close in the second half of 2019. The deal, according to Novartis, will bolster its front-of-the-eye portfolio and ophthalmic leadership.

Provention Bio's Ulcerative Colitis Drug Produces Mixed Results In Early-stage Trial

Provention Bio Inc (NASDAQ: PRVB) announced topline results from the Phase 1b study dubbed PULSE study evaluating PRV-300 in patients with active, moderate-to-severe ulcerative colitis, which showed mixed results. The pipeline asset met the primary safety and efficacy endpoint over the 12-week study period and also demonstrated TLR3 target engagement and proof-of-mechanism.

However, the company said improvements in secondary and exploratory clinical, endoscopic, histologic and other UC-related efficacy endpoints were not observed, suggesting the improvements observed are downstream or circumstantial effects that do not contribute significantly to causal pathology.

The stock slipped 5.64 percent to $3.85 in after-hours trading.

Ampliphi Shareholders Ratify Merger With C3J Therapeutics

Ampliphi Biosciences Corp (NYSE: APHB) said shareholders voted to approve its business combination with C3J Therapeutics at a special meeting of AmpliPhi Biosciences stockholders. The combined company is to be named as Armata Pharma, with the shares of the combined company expected to begin trading on the NYSE under the ticker symbol ARMP.

The stock declined 16.79 percent to 33.2 cents in pre-market trading.

Avid Bioservices' CEO Quits

Avid Bioservices Inc (NASDAQ: CDMO) announced the appointment of Richard Hancock as its interim president and CEO, effective immediately, following the resignation of Roger Lias as CEO as well as from the board.

The stock declined 3.37 percent to $4.30 in after-hours trading.

Intercept Pharma to Offer Shares & Notes

Intercept Pharmaceuticals Inc (NASDAQ: ICPT) commenced an underwritten public offering to sell up to $200 million worth of shares. The company also intends to offer up to $200 million aggregate principal amount of convertible senior notes due 2026.

The stock fell 5.09 percent to $83.11 in after-hours trading.

Earnings

CareDx Inc (NASDAQ: CDNA) unexpectedly swung to a profit of 5 cents per share in its first quarter compared to a loss of 14 cents per share. Revenues also exceeded estimates. The company raised its 2019 revenue guidance.

The stock rallied 14.75 percent to $33.45 in after-hours trading.

View more earnings on IBB

Shockwave Medical Inc (NASDAQ: SWAV)'s first-quarter revenues exceeded expectations. The net loss per share narrowed from $5.63 to $1.37. The 2019 revenue guidance was also above the consensus.

The stock advanced 8.98 percent to $46.70 in after-hours trading.

Revance reported first-quarter revenues trailed expectations but the net loss was narrower than expected.

The stock slipped 8.12 percent to $11.65 in after-hours trading.

On The Radar Clinical Trial Readouts

Catabasis Pharmaceuticals Inc (NASDAQ: CATB) is due to present Phase 3 data for its Edasalonexent in Duchenne muscular dystrophy at the American Association of Neurology 2019 annual meeting.

IPOs

Axcella said it has priced it 3.57 million IPO at $20, the low end of the estimated price range of $20-$22. The biotech company developing therapies and food to treat metabolic dysregulation in the liver is to list its shares on the Nasdaq under the ticker symbol AXLA.

Cortexyme, which develops a novel therapy for Alzheimer's disease, priced its 4.412 million-share IPO at $17, at the midpoint of the estimated price range of $16-$18. The shares are to be listed on the Nasdaq under the ticker symbol CRTX.

Milestone Pharmaceuticals, a Phase 3 biotech developing therapies for heart rate conditions, said it has priced its upsized IPO of 5.5 million shares at $15 compared to the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol MIST.

NextCure priced its 5 million shares at $15, at the middle of the estimated price range of $14-$16. The shares of the cancer immunotherapy company will be listed on the Nasdaq under the ticker symbol NXTC.

Earnings Before the Market Open

Athenex Inc (NASDAQ: ATNX)
Elanco Animal Health Inc (NYSE: ELAN)
Aldeyra Therapeutics Inc (NASDAQ: ALDX)
Akebia Therapeutics Inc (NASDAQ: AKBA)
Albireo Pharma Inc (NASDAQ: ALBO)
Atara Biotherapeutics Inc (NASDAQ: ATRA)
Axsome Therapeutics Inc (NASDAQ: AXSM)
Amneal Pharmaceuticals Inc (NYSE: AMRX)
Agenus Inc (NASDAQ: AGEN)
Selecta Biosciences Inc (NASDAQ: SELB)
Karyopharm Therapeutics Inc (NASDAQ: KPTI)
Kala Pharmaceuticals Inc (NASDAQ: KALA)
Ionis Pharmaceuticals Inc (NASDAQ: IONS)
OptiNose Inc (NASDAQ: OPTN)
Reata Pharmaceuticals Inc (NASDAQ: RETA)
Immunomedics, Inc. (NASDAQ: IMMU)
Neos Therapeutics Inc (NASDAQ: NEOS)
Mersana Therapeutics Inc (NASDAQ: MRSN)
Obseva SA (NASDAQ: OBSV)
Urogen Pharma Ltd (NASDAQ: URGN)
Chimerix Inc (NASDAQ: CMRX)
Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)
Syneos Health Inc (NASDAQ: SYNH)
Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
Oxford Immunotec Global PLC (NASDAQ: OXFD)
Endo International PLC (NASDAQ: ENDP)

After the Close

Accelerate Diagnostics Inc (NASDAQ: AXDX)
Adamis Pharmaceuticals Corp (NASDAQ: ADMP)
• Adamas Pharma
Amphastar Pharmaceuticals Inc (NASDAQ: AMPH)
Acceleron Pharma Inc (NASDAQ: XLRN)
Calithera Biosciences Inc (NASDAQ: CALA)
BioTime, Inc. (NYSE: BTX)
Puma Biotechnology Inc (NASDAQ: PBYI)
Coherus Biosciences Inc (NASDAQ: CHRS)
Nevro Corp (NYSE: NVRO)
Corcept Therapeutics Incorporated (NASDAQ: CORT)
BioLife Solutions Inc (NASDAQ: BLFS)
PDL BioPharma Inc (NASDAQ: PDLI)
Kindred Biosciences Inc (NASDAQ: KIN)
Pfenex Inc (NYSE: PFNX)
Verastem Inc (NASDAQ: VSTM)
Rockwell Medical Inc (NASDAQ: RMTI)
ICU Medical, Incorporated (NASDAQ: ICUI)
Opiant Pharmaceuticals Inc (NASDAQ: OPNT)
Synlogic Inc (NASDAQ: SYBX)
Inovio Pharmaceuticals Inc (NASDAQ: INO)
Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
Natera Inc (NASDAQ: NTRA)
NovaBay Pharmaceuticals, Inc. (NYSE: NBY)
Transenterix Inc (NYSE: TRXC)
Xencor Inc (NASDAQ: XNCR)
Melinta Therapeutics Inc (NASDAQ: MLNT)
Viveve Medical Inc (NASDAQ: VIVE)
Osmotica Pharmaceuticals PLC (NASDAQ: OSMT)
Corvus Pharmaceuticals Inc (NASDAQ: CRVS)
CytomX Therapeutics Inc (NASDAQ: CTMX)
HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
Dicerna Pharmaceuticals Inc (NASDAQ: DRNA)
Chiasma Inc (NASDAQ: CHMA)
Myokardia Inc (NASDAQ: MYOK)
PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS)
• Sensus Healthcare
FibroGen Inc (NASDAQ: FGEN)
G1 Therapeutics Inc (NASDAQ: GTHX)
Guardant Health Inc (NASDAQ: GH)

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