The Daily Biotech Pulse: PhaseBio Leaps On Trial Results, Pacira Set To Join SmallCap 600 Index, Positive Readout For Amgen's Blood Cancer Drug

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 Sept. 24)

  • Bioanalytical Systems, Inc. BASI
  • Celgene Corporation CELG
  • Natera Inc NTRA
  • Sanofi SA SNY
  • ZEALAND PHARMA/S ADR ZEAL(announced positive results for the pediatric Phase 3 trial of dasiglucagon for severe hypoglycemia in diabetes)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 24)

  • Aduro BioTech Inc ADRO
  • Advaxis, Inc. ADXS
  • AEterna Zentaris Inc. AEZS
  • Akcea Therapeutics Inc AKCA
  • AnaptysBio Inc ANAB
  • China SXT Pharmaceuticals Inc SXTC
  • Citius Pharmaceuticals Inc CTXR
  • Catalyst Biosciences Inc CBIO
  • Cellectis SA CLLS
  • Clovis Oncology Inc CLVS
  • Crinetics Pharmaceuticals Inc CRNX
  • Eloxx Pharmaceuticals Inc ELOX
  • Endologix, Inc. ELGX
  • Erytech Pharma SA ERYP
  • Five Prime Therapeutics Inc FPRX
  • Fulcrum Therapeutics Inc (NASDAQ: FULC
  • Innoviva Inc INVA
  • Kalvista Pharmaceuticals Inc KALV
  • Mersana Therapeutics Inc MRSN
  • Myovant Sciences Ltd MYOV
  • Neon Therapeutics Inc NTGN
  • Onconova Therapeutics Inc ONTX
  • ProQR Therapeutics NV PRQR
  • Sarepta Therapeutics Inc SRPT
  • Satsuma Pharmaceuticals Inc STSA (priced its IPO on Sept. 13)
  • Seelos Therapeutics Inc SEEL
  • Sienna Biopharmaceuticals Inc SNNA
  • Sophiris Bio Inc SPHS
  • Tocagen Inc TOCA
  • Titan Pharmaceuticals, Inc. TTNP
  • Urogen Pharma Ltd URGN
  • Vaxart Inc VXRT
  • Viking Therapeutics Inc VKTX
  • Viveve Medical Inc VIVE
  • Wright Medical Group NV WMGI
  • Xenetic Biosciences Inc XBIO
  • Zosano Pharma Corp ZSAN

Stocks In Focus

PhaseBio Successfully Completes Phase 2a Study Of Antiplatelet Activity Reversal Agent

PhaseBio Pharmaceuticals Inc PHAS said the Phase 2a trial of PB2452, a recombinant, human, monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of AstraZeneca plc AZN's Ticagrelor, has been completed.

The company noted that PB2452 achieved immediate and sustained reversal of ticagrelor in older (ages 50-64) and elderly (ages 65-80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin.

"Our defined regulatory path for PB2452 remains on track as we prepare to advance the program into a Phase 2b trial in the fourth quarter of this year and a pivotal Phase 3 trial in the first quarter of 2020," the company said.

The stock rallied 17.65% to $4.60 in after-hours trading. 

Pacira To Be Added To S&P SmallCap 600 Index

Pacira Biosciences Inc PCRX said it will replace Shutterfly, Inc. SFLY in the S&P SmallCap 600 Index, effective before the market Sept. 30. Shutterfly is being acquired by Apollo Global Management, with the transaction expected to close Wednesday, pending final conditions.
Pacira gained 9.53% to $41.50 in after-hours trading.

Urogen Updates On Clinical Pipeline Following Investor Day

Issuing a clinical update in the wake of its Investor Day, Urogen Pharma Ltd URGN said it's looking to advance its UGN-201, a TLR 7/8 agonist for high-grade bladder cancer, into clinic in 2020.

UGN-101, one of the company's two lead product candidates, being evaluated in patients with low-grade upper tract urothelial cancer showed complete response rate of 59% in a Phase 3 trial dubbed OLYMPUS. The company said it's on track to make a rolling NDA submission in the fourth quarter, with a potential approval and launch in the first half of 2020.

Following an interim analysis of data from a Phase 2a trial of UGN-102 in patients with intermediate risk low-grade non-muscle invasive bladder cancer, which showed a 63% complete response rate, the company said it expects to initiate a pivotal Phase 3 trial in 2020.

Amgen's Blood Cancer Drug Found Effective In Pediatric Patients

Amgen, Inc. AMGN announced positive results for the Phase 3 trial that evaluated its Blincyto compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia at first relapse. Following a prespecified interim analysis, the company said the primary endpoint of event-free survival was met.

The company terminated the enrolment, in line with the Independent Data Monitoring Committee recommendation following the positive data.

On The Radar

Clinical Trial Readout

Rhythm Pharmaceuticals Inc RYTM is due to give an update on Phase 2 data for setmelanotide, which is being evaluated for a basket of rare melanocortin-4 receptor, pathway-driven disorders, including POMC heterozygous deficiency obesity, Alstrom syndrome, POMC epigenetic disorders.

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