The Daily Biotech Pulse: Flexion Receives FDA Nod For Zilretta Label Expansion, Astellas Goes Shopping

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 Dec. 26.)

  • Aimmune Therapeutics Inc AIMT
  • Allergan plc AGN
  • Applied Genetic Technologies Corp AGTC
  • Aprea Therapeutics Inc APRE
  • Arvinas Inc ARVN
  • Ascendis Pharma A/S ASND
  • Audentes Therapeutics Inc BOLD
  • Aurinia Pharmaceuticals Inc AUPH
  • Avenue Therapeutics Inc ATXI
  • Axsome Therapeutics Inc AXSM
  • Cassava Sciences Inc SAVA
  • Clearside Biomedical Inc CLSD
  • Cue Biopharma Inc (NASDAQ: CUE
  • Dermira Inc DERM
  • DURECT Corporation DRRX
  • Eiger Biopharmaceuticals Inc EIGR
  • Esperion Therapeutics Inc ESPR
  • Exagen Inc XGN
  • Fortress Biotech FBIO
  • Fulcrum Therapeutics Inc FULC
  • Global Blood Therapeutics Inc GBT
  • Horizon Therapeutics PLC HZNP
  • IGM Biosciences Inc IGMS
  • Immunomedics, Inc. IMMU (announced resubmission of BLA for sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer)
  • Ironwood Pharmaceuticals, Inc. IRWD
  • Jounce Therapeutics Inc JNCE
  • Karyopharm Therapeutics Inc KPTI
  • Kodiak Sciences Inc KOD
  • Mirati Therapeutics Inc MRTX
  • Molecular Templates Inc MTEM
  • Momenta Pharmaceuticals, Inc. MNTA
  • Myokardia Inc MYOK
  • NeoGenomics, Inc. NEO
  • NewLink Genetics Corp NLNK
  • Novan Inc NOVN
  • Oncolytics Biotech, Inc. ONCY
  • Ovid Therapeutics Inc OVID
  • Oyster Point Pharma Inc OYST
  • Phathom Pharmaceuticals Inc PHAT
  • Profound Medical Corp PROF
  • Recro Pharma Inc REPH
  • SpringWorks Therapeutics Inc SWTX
  • Synthorx Inc THOR
  • TG Therapeutics Inc TGTX
  • XOMA Corp XOMA
  • Zimmer Biomet Holdings Inc ZBH

Down In The Dumps

(Biotech stocks that hit 52-week lows on Dec. 26.)

  • Akorn, Inc. AKRX
  • Ekso Bionics Holdings Inc EKSO
  • MediciNova, Inc. MNOV
  • Stealth BioTherapeutics Corp MITO
  • Ritter Pharmaceuticals Inc RTTR
  • Spectrum Pharmaceuticals, Inc. SPPI (announced negative Phase 2 data for investigational drug to treat non-small cell lung cancer patients with a particular mutation)
  • Spring Bank Pharmaceuticals Inc SBPH (announced halting of a mid-phase study of hepatitis B virus therapy due to liver injury)

Stocks In Focus

Flexion's Zilretta Granted Label Expansion For Osteoarthritis Knee Pain

Flexion Therapeutics Inc FLXN said the FDA approved its sNDA for a label expansion for Zilretta in osteoarthritis knee pain.

"ZILRETTA is an invaluable non-opioid option for managing chronic OA knee pain, and it is encouraging to see a new product label that better informs clinical decision making," Dr. John Richmond, a clinician, said in a statement. 

Originally, the FDA had set a PDUFA action date of Oct. 14, which was extended by three months.

The stock was trading 24.85% higher at $23.94 in Friday's premarket session. 

Astellas Buys Immuno-Oncology Company Xyphos For Up To $665M

Japanese pharma company Astellas Pharma Inc. ALPMY announced the acquisition of privately held Xyphos Biosciences, which will give the former access to the latter's proprietary ACCEL tech platform, as well as immuno-oncology talent to help develop new ways to mobilize, target and control immune cells.

"The innovative technology in development at Xyphos fits perfectly in advancing our immuno-oncology strategy to create and deliver value for patients," Astellas CEO Kenji Yasukawa said in a statement. 

"Combining this technology with our capabilities in cell therapy that we have been working on so far, we can create next-generation high-function cells and maximize the value of our technology."

With the $120 million paid by Astellas at the time of closing and the potential future development milestone payments, the deal is valued at up to $665 million.

Related Links:

10 Biotech M&A Targets Under The Scanner For 2020

A Perspective On Biopharma's Record M&A Run In 2019

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