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

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 ALC
• BioSig Technologies Inc BSGM

Down In The Dumps

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

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

Stock In Focus

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

Novartis AG NVS announced an agreement with Takeda Pharmaceutical Co Ltd 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 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 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 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 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 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.

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

After the Close

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