The Daily Biotech Pulse: PhaseBio To Buy Hypertension Asset, Stemline Falls On Q4 Pre-Announcement, FDA Panel To Review Nektar's Opioid Drug

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 on Jan. 13.)

  • Arvinas Inc ARVN
  • Baxter International Inc BAX (pre-announced a fourth-quarter sales beat)
  • Biondvax Pharmaceuticals Ltd – ADR BVXV
  • Bristol-Myers Squibb Co BMY
  • Collegium Pharmaceutical Inc COLL
  • ContraFect Corp CFRX
  • Eli Lilly And Co LLY (announced positive results for a study of its Tyvyt in combination with pemetrexed and platinum for the first-line treatment of lung cancer)
  • Fennec Pharmaceuticals Inc FENC
  • Fulcrum Therapeutics Inc FULC
  • Horizon Therapeutics PLC HZNP (raised peak U.S. annual sales expectations for key growth drivers)
  • Inspire Medical Systems Inc INSP
  • ITAMAR MED LTD/S ADR ITMR (announced preliminary fourth-quarter results and issued guidance for 2020)
  • LeMaitre Vascular Inc LMAT
  • Masimo Corporation MASI
  • Mesoblast limited MESO
  • Molecular Templates Inc MTEM
  • Nantkwest Inc NK (CEO said in an interview to Bloomberg its experimental cancer drug achieved a complete response in a patient with pancreatic cancer in an early stage trial)
  • NeoGenomics, Inc. NEO (announced acquisition of Human Longevity's oncology division)
  • Novo Nordisk A/S NVO
  • NuVasive, Inc. NUVA (pre-announced fourth-quarter results)
  • Oyster Point Pharma Inc OYST (announced a positive midstage readout for its lead candidate to treat dry eye disease)
  • PAVmed Inc PAVM (regained full compliance with Nasdaq's continued listing standards)
  • Repligen Corporation RGEN
  • ResMed Inc. RMD
  • Revance Therapeutics Inc RVNC
  • Veru Inc VERU (announced positive topline interim results from a Phase 2 study of zuclomiphene citrate for the treatment of androgen deprivation hormone therapy-induced hot flashes)
  • Viela Bio Inc VIE
  • West Pharmaceutical Services Inc. WST
  • Zoetis Inc ZTS

Down In The Dumps

(Biotech stocks that hit 52-week lows on Jan. 13.)

  • Acasti Pharma Inc ACST (announced a Phase 3 study evaluating its omega 3 phospholipid treatment for hypertriglyceridemia did not meet the primary endpoint)
  • Alterity Therapeutics Ltd ATHE
  • Anixa Biosciences Inc ANIX
  • Ekso Bionics Holdings Inc EKSO
  • Evolus Inc EOLS
  • Gossamer Bio Inc GOSS
  • Novan Inc NOVN
  • Salarius Pharmaceuticals Inc SLRX
  • Sellas Life Sciences Group Inc SLS
  • Therapix Biosciences Ltd – ADR TRPX
  • Xeris Pharmaceuticals Inc XERS

See also: The Week Ahead In Biotech: JPMorgan Healthcare Conference, FDA Panel Reviews Opioid Pain Drugs, I-Mab's IPO

Stocks In Focus

PhaseBio Agrees To Acquire Viamet's Pipeline Assets

PhaseBio Pharmaceuticals Inc PHAS said it has signed an agreement with Viamet Pharma and its subsidiary Selenity Pharma to buy all of the assets and intellectual property rights related to certain novel synthase inhibitors, including its lead candidate. PhaseBio said it intends to develop the asset as PB6440 for treatment-resistant hypertension.

Non-clinical IND-enabling studies are planed for 2020, which would be followed by an IND filing and a first-in-human study in early 2021.

Without disclosing specific financial terms of the deal, PhaseBio said it would make an upfront payment as well as development, approval and net sales milestones and tiered royalties on global net sales.

Last week, the stock rallied on securing a funding agreement for the development of its anticoagulant reversal agent PB2452.

The stock rallied 6.4% to $6.40 in after-hours trading.

Stemline Pre-Announces Q4, FY19 Revenue Shortfall On Soft Elzonris Sales

Stemline Therapeutics Inc STML announced preliminary results for 2019 and said it expects Elzonris net revenue of $43.2 million for the full year and $11.8 million for the fourth quarter.

Elzonris, a CD123-targeted therapy, was approved for treating blastic plasmacytoid dendritic cell neoplasm in December 2018.

Analysts, on average, are forecasting revenue of $15.06 million for the fourth quarter and $46.44 million for the full year.

The stock was down 17.39% at $7.79 in Tuesday's premarket session. 

Adaptimmune, Astellas Strike Oncology Stem Cell Therapy Partnership

Adaptimmune Therapeutics PLC – ADR ADAP shares, which skyrocketed 200% Monday on a positive data readout, could see more activity Tuesday after the company said it has signed a co-development and co-commercialization agreement with Astellas Pharma Inc. ALPMY for new stem-cell derived allogenic T-cell therapies for cancer. 

The agreement provides for the companies identifying three targets for co-development, leveraging Adaptimmune's target identification and validation capabilities for generating T-cell receptors or TCRs, chimeric antigen receptors and HLA-independent TCRs, while also using Astellas subsidiary Universal Cell's Universal Donor Cell and Gene Editing Platform.

Amgen To Collaborate With Guardant, Qiagen On Cancer Drug Diagnostic Tests

Amgen, Inc. AMGN announced strategic collaborations with diagnostic companies Guardant Health Inc GH and Qiagen NV QGEN to develop blood- and tissue-based companion diagnostics for its investigational cancer treatment AMG 510, a KRAS G12 inhibitor.

The companies will initially focus on companion diagnostic tests for non-small cell lung cancer, and subsequently on Amgen's other oncology clinical programs.

On The Radar

Adcom Meeting

A joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Nektar Therapeutics NKTR's NDA for oxycodegol, a NME full mu-opioid receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Related Link: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

Posted In: BiotechNewsGuidanceFDATrading Ideas

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