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

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. ECYT

Down In The Dumps

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

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

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

PhaseBio Appoints Pharma Industry Veteran to Board

PhaseBio Pharmaceuticals Inc PHAS said it has appointed former Pfizer Inc. 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 EYPT and Rubius Therapeutics Inc 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 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 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 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. 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 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.