Skip to main content

Market Overview

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

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 (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


Related Articles (XBI + IBB)

View Comments and Join the Discussion!

Posted-In: Biotech M&A News FDA Trading Ideas Best of Benzinga

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at