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

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Shanthi Rexaline
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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 (NASDAQ: AIMT)

  • Allergan plc (NYSE: AGN)

  • Applied Genetic Technologies Corp (NASDAQ: AGTC)

  • Aprea Therapeutics Inc (NASDAQ: APRE)

  • Arvinas Inc (NASDAQ: ARVN)

  • Ascendis Pharma A/S (NASDAQ: ASND)

  • Audentes Therapeutics Inc (NASDAQ: BOLD)

  • Aurinia Pharmaceuticals Inc (NASDAQ: AUPH)

  • Avenue Therapeutics Inc (NASDAQ: ATXI)

  • Axsome Therapeutics Inc (NASDAQ: AXSM)

  • Cassava Sciences Inc (NASDAQ: SAVA)

  • Clearside Biomedical Inc (NASDAQ: CLSD)

  • Cue Biopharma Inc (NASDAQ: CUE

  • Dermira Inc (NASDAQ: DERM)

  • DURECT Corporation (NASDAQ: DRRX)

  • Eiger Biopharmaceuticals Inc (NASDAQ: EIGR)

  • Esperion Therapeutics Inc (NASDAQ: ESPR)

  • Exagen Inc (NASDAQ: XGN)

  • Fortress Biotech (NASDAQ: FBIO)

  • Fulcrum Therapeutics Inc (NASDAQ: FULC)

  • Global Blood Therapeutics Inc (NASDAQ: GBT)

  • Horizon Therapeutics PLC (NASDAQ: HZNP)

  • IGM Biosciences Inc (NASDAQ: IGMS)

  • Immunomedics, Inc. (NASDAQ: IMMU) (announced resubmission of BLA for sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer)

  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)

  • Jounce Therapeutics Inc (NASDAQ: JNCE)

  • Karyopharm Therapeutics Inc (NASDAQ: KPTI)

  • Kodiak Sciences Inc (NASDAQ: KOD)

  • Mirati Therapeutics Inc (NASDAQ: MRTX)

  • Molecular Templates Inc (NASDAQ: MTEM)

  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)

  • Myokardia Inc (NASDAQ: MYOK)

  • NeoGenomics, Inc. (NASDAQ: NEO)

  • NewLink Genetics Corp (NASDAQ: NLNK)

  • Novan Inc (NASDAQ: NOVN)

  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)

  • Ovid Therapeutics Inc (NASDAQ: OVID)

  • Oyster Point Pharma Inc (NASDAQ: OYST)

  • Phathom Pharmaceuticals Inc (NASDAQ: PHAT)

  • Profound Medical Corp (NASDAQ: PROF)

  • Recro Pharma Inc (NASDAQ: REPH)

  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)

  • Synthorx Inc (NASDAQ: THOR)

  • TG Therapeutics Inc (NASDAQ: TGTX)


  • Zimmer Biomet Holdings Inc (NYSE: ZBH)

Down In The Dumps

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

  • Akorn, Inc. (NASDAQ: AKRX)

  • Ekso Bionics Holdings Inc (NASDAQ: EKSO)

  • MediciNova, Inc. (NASDAQ: MNOV)

  • Stealth BioTherapeutics Corp (NASDAQ: MITO)

  • Ritter Pharmaceuticals Inc (NASDAQ: RTTR)

  • Spectrum Pharmaceuticals, Inc. (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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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