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

Shanthi Rexaline

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

Down In The Dumps

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

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

Stocks In Focus Prevail's Dementia Gene Therapy Granted Orphan Drug Designation

Prevail Therapeutics Inc (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (OTC: RHHBY) and Spark Therapeutics Inc (NASDAQ: 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. (NYSE: PFE) and ASTELLAS PHARMA/ADR (OTC: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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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