The Daily Biotech Pulse: Roche Gets US Antitrust Clearance For Spark Purchase, An Orphan Drug Designation For Prevail, Dynavax Names CEO

The Daily Biotech Pulse: Roche Gets US Antitrust Clearance For Spark Purchase, An Orphan Drug Designation For Prevail, Dynavax Names CEO

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs Dec. 16.)

  • Acceleron Pharma Inc XLRN
  • Amarin Corporation plc AMRN (received FDA approval for label expansion for its fish oil pill)
  • Amgen, Inc. AMGN (Goldman Sachs added Amgen to its Americas Conviction List)
  • AstraZeneca plc AZN
  • Axsome Therapeutics Inc AXSM (announced positive Phase 3 readout for its AXS-05 in major depressive disorder)
  • BioNTech SE – ADR BNTX
  • Bio-Rad Laboratories, Inc. BIO
  • Boston Scientific Corporation BSX (received FDA nod for fully disposable duodenoscope)
  • Clearside Biomedical Inc CLSD
  • Cue Biopharma Inc CUE
  • Deciphera Pharmaceuticals Inc DCPH (announced NDA submission for ripretinib for treating patients with advanced gastrointestinal stromal tumors)
  • Eidos Therapeutics Inc EIDX
  • GlaxoSmithKline plc GSK
  • Globus Medical Inc GMED
  • Horizon Therapeutics PLC HZNP (announced positive Adcom verdict for its teprotumumab for treating thyroid eye disease)
  • IGM Biosciences Inc IGMS
  • Iovance Biotherapeutics Inc IOVA
  • Ironwood Pharmaceuticals, Inc. IRWD
  • Medtronic PLC MDT
  • Merck & Co., Inc. MRK
  • Mirati Therapeutics Inc MRTX
  • Mirum Pharmaceuticals Inc MIRM (announced successful completion of pre-NDA meeting with FDA for its maralixibat for the treatment of pruritus associated with Alagille syndrome)
  • Morphosys Ag MOR
  • Nantkwest Inc NK (reacted to data from Phase 1b trial evaluating its antibody-targeted NK cells combined with ImmunityBio's IL-15 superagonist N-803, chemotherapy, antigen virus and a PD-L1 checkpoint inhibitor in triple-negative breast cancer patients)
  • Neubase Therapeutics Inc NBSE
  • Novo Nordisk A/S NVO
  • NuVasive, Inc. NUVA
  • Principia Biopharma Inc PRNB
  • Ra Pharmaceuticals Inc RARX
  • ResMed Inc. RMD
  • Sanofi SA SNY
  • Soligenix, Inc. Common Stock SNGX
  • Varian Medical Systems, Inc. VAR
  • Veru Inc VERU
  • Zai Lab Ltd ZLAB

Down In The Dumps

(Biotech stocks that hit 52-week lows Dec. 16.)

  • AEterna Zentaris Inc. AEZS
  • Aethlon Medical, Inc. AEMD
  • Brickell Biotech Inc BBI
  • Capricor Therapeutics Inc CAPR
  • Cocrystal Pharma Inc COCP
  • Idera Pharmaceuticals Inc IDRA
  • Lipocine Inc LPCN
  • MEREO BIOPHARMA/ADR MREO
  • RA Medical Systems Inc RMED
  • Therapix Biosciences Ltd – ADR TRPX
  • Wave Life Sciences Ltd WVE (reacted to a failed Duchenne drug trial)

Stocks In Focus

Prevail's Dementia Gene Therapy Granted Orphan Drug Designation

Prevail Therapeutics Inc PRVL said the FDA has given Orphan Drug designation to its gene therapy candidate PR006 for the treatment of patients with frontemporal dementia with a GRN mutation.

ODD is granted to drugs or biologics intended to treat a rare disease condition or condition that affects fewer than 200,000 individuals in the U.S. The company said it plans to move PR006 into the clinics in the first half of 2020.

The stock was climbing 10.89% to $17 in Tuesday's premarket session. 

FDA Gives Agios's Bone Marrow Disorder Drug Breakthrough Therapy Designation

Agios Pharmaceuticals Inc AGIO said the FDA has granted Breakthrough Therapy Designation for Tibsovo for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with a susceptible IDH1 mutation as detected by an FDA-approved test.

The stock was up 4.55% at $48 in the premarket session. 

See also: After Amarin Snags Vascepa Label Expansion, Analyst Says Biopharma An Attractive M&A Target

Midatech Found In Violation Of Nasdaq Listing Standard

Midatech Pharma PLC-ADR MTP said it has received a written notification from the Nasdaq that it is not in compliance with the minimum bid price requirement to remain listed on the exchange. The company has a grace period of 180 days until June 8, 2020 to regain compliance.

The stock was up 1.58% at 60 cents.

Roche's Spark Buy Receives Antitrust Clearance

Roche Holdings AG Basel ADR RHHBY and Spark Therapeutics Inc ONCE said the FTC closed its investigation and granted unconditional clearance and termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the former's pending acquisition of the latter for $114.50 per share.

In a separate release, Roche said the tender offer for Spark expired at 5 p.m. Monday and that it expects the deal to close Tuesday.

Roche shares were down 0.1% at $38.57 in after-hours trading, while Spark shares were trading 0.8% higher at $114.48 in the premarket session. 

FDA Approves Expanded Label For Pfizer-Astellas Prostate Cancer Drug

Pfizer Inc. PFE and ASTELLAS PHARMA/ADR ALPMY said the FDA approved their sNDA for Xtandi for the treatment of patients with metastatic castration-sensitive prostate cancer. Xtandi has now been approved for three distinct types of advanced prostate cancer.

Acer Says Part B Portion Of ACER-001 Trial In Urea Cycle Disorders Fully Enrolled

Acer Therapeutics Inc ACER said it has completed full enrollment of the Part B portion of its pivotal trial that evaluates the bioavailability and bioequivalence of ACER-001 for treating urea cycle disorders.

"Successful completion of Part A and full enrollment of Part B mark important progress in the ongoing development of ACER-001," Chief Medical Officer William Andrews said in a statement. 

The company said it expects to complete Part B of the bioequivalence study in the first quarter of 2020, enroll and complete Part B of the Taste Assessment study, conduct some additional non-clinical work based on FDA feedback and monitor the product's long-term stability. 

If these efforts produce successful outcomes, Acer said it should be on track to submit an NDA in early 2021. 

The stock rose 3.48% to $3.87 in the premarket session. 

Dynavax Names Company Veteran As CEO

Dynavax Technologies Corporation DVAX announced the appointment of insider Ryan Spencer as its CEO effective Dec. 16. He has also been appointed to the board, the company said. 

Dynavax appointed David Novack as pesident and COO.

Offerings

Clovis Oncology Inc CLVS filed a prospectus with the SEC to offer up to $250 million worth of shares, preferred stock, warrants and debt securities.

The stock was slipping 9.17% to $11 in the premarket session. 

Aptose Biosciences Inc APTO said it has commenced an underwritten public offering of its common shares. All shares earmarked for the offering are to be sold by the company. The company said it intends to use the net proceeds to fund the clinical trials of CG-806 and APTO-253, to acquire additional clinical assets and for working capital and general corporate purposes.

The stock fell 1.8% to $4.35 in the premarket session. 

Related Link: The Week Ahead In Biotech: Avadel, Epizyme In Focus In A Quiet Week

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