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The Daily Biotech Pulse: Puma Aces Late-Stage Trial, Chinese Cheer For FibroGen, J&J $5B Buyback Plan

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 17)

  • Endocyte, Inc. (NASDAQ: ECYT)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 17)

  • Accelerate Diagnostics Inc (NASDAQ: AXDX)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Aileron Therapeutics Inc (NASDAQ: ALRN)
  • Applied DNA Sciences Inc (NASDAQ: APDN)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC)
  • Aptevo Therapeutics Inc (NASDAQ: APVO)
  • Aquestive Therapeutics Inc (NASDAQ: AQST)
  • Aravive Inc (NASDAQ: ARAV)
  • Ardelyx Inc (NASDAQ: ARDX)
  • Assertio Therapeutics Inc (NASDAQ: ASRT)
  • aTyr Pharma Inc (NASDAQ: LIFE)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL)
  • AzurRx BioPharma Inc (NASDAQ: AZRX)
  • Bioblast Pharma Ltd (NASDAQ: ORPN)
  • Biocept Inc (NASDAQ: BIOC)
  • BioXcel Therapeutics Inc (NASDAQ: BTAI)
  • BIOLASE Inc (NASDAQ: BIOL)
  • BIOLINERX LTD/S ADR (NASDAQ: BLRX)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • Chimerix Inc (NASDAQ: CMRX)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)
  • CytRx Corporation (NASDAQ: CYTR)
  • Dare Bioscience Inc (NASDAQ: DARE)
  • Dova Pharmaceuticals Inc (NASDAQ: DOVA)
  • DURECT Corporation (NASDAQ: DRRX)
  • Edge Therapeutics Inc (NASDAQ: EDGE)
  • Evogene Ltd (NASDAQ: EVGN)
  • Enzo Biochem, Inc. (NYSE: ENZ)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Forward Pharma A/S (NASDAQ: FWP)
  • Geron Corporation (NASDAQ: GERN)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)
  • Intellia Therapeutics Inc (NASDAQ: NTLA)
  • Intra-Cellular Therapies Inc (NASDAQ: ITCI)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
  • Mylan NV (NASDAQ: MYL)
  • Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)
  • Nantkwest Inc (NASDAQ: NK)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Neovasc Inc (NASDAQ: NVCN)
  • Neurometrix Inc (NASDAQ: NURO)
  • Novan Inc (NASDAQ: NOVN)
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)
  • Oncomed Pharmaceuticals Inc (NASDAQ: OMED)
  • Onconova Therapeutics Inc (NASDAQ: ONTX)
  • Ophthotech Corp (NASDAQ: OPHT)
  • Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP)
  • Paratek Pharmaceuticals Inc (NASDAQ: PRTK)
  • PLx Pharma Inc (NASDAQ: PLXP)
  • Precipio Inc (NASDAQ: PRPO)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Reshape Lifesciences Inc (NASDAQ: RSLS)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Ritter Pharmaceuticals Inc (NASDAQ: RTTR)
  • Rockwell Medical Inc (NASDAQ: RMTI)
  • SCYNEXIS Inc (NASDAQ: SCYX)
  • Selecta Biosciences Inc (NASDAQ: SELB)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Sierra Oncology Inc (NASDAQ: SRRA)
  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)
  • Sophiris Bio Inc (NASDAQ: SPHS)
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
  • Spero Therapeutics Inc (NASDAQ: SPRO)
  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • The Medicines Company (NASDAQ: MDCO)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Trinity Biotech plc (NASDAQ: TRIB)
  • TrovaGene Inc (NASDAQ: TROV)
  • Urovant Sciences Ltd (NASDAQ: UROV)
  • Vermillion, Inc. (NASDAQ: VRML)
  • Verrica Pharmaceuticals Inc (NASDAQ: VRCA)
  • Vital Therapies Inc (NASDAQ: VTL)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Voyager Therapeutics Inc (NASDAQ: VYGR)
  • Wright Medical Group NV (NASDAQ: WMGI)
  • Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE)

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

Stocks In Focus FibroGen Gets Chinese Approval For Drug to Treat Anemia Caused By Chronic Kidney Disease

FibroGen Inc (NASDAQ: FGEN) said its China unit has received marketing authorization from the National Medical Products Administration for Roxadustat, a hypoxia-inducible factor propyl hydroxylase inhibitor for treating patients with anemia caused by chronic kidney disease, who are dialysis dependent.

The stock rallied 15.41 percent to $45 in after-hours trading.

Puma's Breast Cancer Drug Produces Positive Results In a Late-stage Trial

Puma Biotechnology Inc (NASDAQ: PBYI) released top-line results from a late-stage study of its lead drug candidate PB272 being evaluated for HER2-positive metastatic breast cancer patients who have failed two or more prior lines of HER2-directed treatments. The study showed that PB272, or neratinib, in combination with capecitabine lead to a statistically significant improvement in centrally confirmed progression free survival, one of the coprimary endpoints. Although for the other coprimary endpoint of overall survival, the combo therapy did not achieve statistical significance, it trended positively in favor of the combo.

"The study was to be considered positive if either of the co-primary endpoints was positive," the company said.

The stock gained 11.58 percent to $23.90 in after-hours trading.

Achillion First-gen Factor D inhibitor Aces Mid-stage Trial

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) reported positive interim Phase 2 trials of its first-gen oral factor D inhibitor ACH-4471, as well as pharmacokinetics and potency data for its next-gen factor D inhibitors ACH-5228 and ACH-5548.

ACH-4471 is being evaluated for two indications, namely C3 glomerulopathy, or C3G, and paroxysmal nocturnal hemoglobinuria, or PNH. C3G leads to decline in kidney function over time, while PNH is a rare acquired blood disorder resulting in lethal hemolysis.

The company said it plans to enroll 20 patients in its 6- and 12-month trials for C3G and present data at an End-of-Phase 2 meeting in Q4 2019.

View more earnings on XBI

The stock moved up 7.50 percent to $2.58 in after-hours trading.

PhaseBio Appoints Pharma Industry Veteran to Board

PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS) said it has appointed former Pfizer Inc. (NYSE: PFE) executive Edmund Harrigan to its board, effective Dec. 13.

The stock fell 1.06 percent to $3.75 in after-hours trading.

Eyepoint, Rubius To Join Nasdaq Biotech Index

Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) and Rubius Therapeutics Inc (NASDAQ: RUBY) announced separately they will be added to the Nasdaq Biotechnology Index, effective Dec. 24.

Johnson & Johnson to Buyback $5B Worth of Shares; Reaffirms FY19 Guidance

Johnson & Johnson (NYSE: JNJ), which has been roiled in controversy over small amounts of carcinogenic asbestos found in its baby powder, announced a $5 billion stock buyback program.

The company also reaffirmed its full-year 2018 sales and adjusted EPS guidance of $81 billion-$81.4 billion, and $8.13-$8.18, respectively, which is in line with the current consensus estimate.

OptimizeRx Announces 2.1M Common Stock Offering

OptimizeRx Corporation (NASDAQ: OPRX) announced a proposed underwritten public offering of 2.1 million shares of its common stock by a selling shareholder.

The stock retreated 5.60 percent to $10.95 in after-hours trading.

Champions Oncology

Champions Oncology Inc (NASDAQ: CSBR) reported Q2 revenues of $6.7 million, up 28.6 percent year-over-year, and non-GAAP EPS of 3 cents compared to break-even results a year ago. Analysts, on average, estimated EPS of 3 cents. The company reiterated its 2019 guidance of 20 percent revenue growth and sustained quarterly operational profitability.

The stock fell 2.05 percent to $9.35 in after-hours trading.

Ligand In-licenses Drug to Treat Rare Skin Disorder

Ligand Pharmaceuticals Inc. (NASDAQ: LGND) said it has acquired economic rights to PTX-022 from Palvella Therapeutics for $10 million. PTX-022 is a novel topical formulation of rapamycin currently in Phase 2/3 development for the treatment of pachyonychia congenita, a rare skin disorder.

Ligand said it will not incur any development and commercialization expenses, but will receive a tiered royalty on net sales in the mid-to-upper single digits as well as regulatory and financing milestones.

On The Radar PDUFA Dates

ADMA Biologics Inc (NASDAQ: ADMA) awaits approval for its Prior Approval Supplement, or PAS, filing for Bivigam, which is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency.

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