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)
XOMA Corp (NASDAQ: XOMA)
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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