Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech stocks hitting 52-week highs on Nov. 20)
Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)(announced FDA approval for its Givlaari for treating adults with acute hepatic porphyria)
Amgen, Inc. (NASDAQ: AMGN) (announced elimination of 172 more jobs)
Antares Pharma Inc (NASDAQ: ATRS)
Aravive Inc (NASDAQ: ARAV)(reacted to positive data on ovarian cancer drug candidate)
Arvinas Inc (NASDAQ: ARVN)
Axsome Therapeutics Inc (NASDAQ: AXSM)
Beigene Ltd (NASDAQ: BGNE)
BIO-TECHNE Corp (NASDAQ: TECH)
Bio-Rad Laboratories, Inc. Class A (NYSE: BIO)
BridgeBio Pharma Inc (NASDAQ: BBIO)
Cue Biopharma Inc (NASDAQ: CUE)
DexCom, Inc. (NASDAQ: DXCM)
Epizyme Inc (NASDAQ: EPZM)
Galera Therapeutics Inc (NASDAQ: GRTX)(IPOed Nov. 7)
Gossamer Bio Inc (NASDAQ: GOSS)
Halozyme Therapeutics, Inc. (NASDAQ: HALO)
Horizon Therapeutics PLC (NASDAQ: HZNP)
Incyte Corporation (NASDAQ: INCY)
Insulet Corporation (NASDAQ: PODD)
Karyopharm Therapeutics Inc (NASDAQ: KPTI)
Kodiak Sciences Inc (NASDAQ: KOD)
Nevro Corp (NYSE: NVRO)
OptiNose Inc (NASDAQ: OPTN)
Reata Pharmaceuticals Inc (NASDAQ: RETA)
ResMed Inc. (NYSE: RMD)
Seattle Genetics, Inc. (NASDAQ: SGEN)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
XBiotech Inc (NASDAQ: XBIT)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on Nov. 20)
Acorda Therapeutics Inc (NASDAQ: ACOR)
Aethlon Medical, Inc. (NASDAQ: AEMD)
Affimed NV (NASDAQ: AFMD)
ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
Capricor Therapeutics Inc (NASDAQ: CAPR)
Checkpoint Therapeutics Inc (NASDAQ: CKPT)(announced pricing of common stock offering)
ENDRA Life Sciences Inc (NASDAQ: NDRA)
Genprex Inc (NASDAQ: GNPX)(announced $1.26 million registered direct offering)
Guardion Health Sciences Inc (NASDAQ: GHSI)
Helius Medical Technologies Inc (NASDAQ: HSDT)
Idera Pharmaceuticals Inc (NASDAQ: IDRA)
Innovate Biopharmaceuticals Inc (NASDAQ: INNT)
Invivo Therapeutics Holdings Corp (NASDAQ: NVIV)
Jaguar Health Inc (NASDAQ: JAGX)
KemPharm Inc (NASDAQ: KMPH)
Midatech Pharma PLC-ADR (NASDAQ: MTP)
Mirum Pharmaceuticals Inc (NASDAQ: MIRM)
Novavax, Inc. (NASDAQ: NVAX)
Ocugen Inc (NASDAQ: OCGN)
Onconova Therapeutics Inc (NASDAQ: ONTX)
Phio Pharmaceuticals Corp (NASDAQ: PHIO)
Plus Therapeutics Inc (NASDAQ: PSTV)
Rexahn Pharmaceuticals, Inc. (NASDAQ: REXN)
Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
Seneca Biopharma Inc (NASDAQ: SNCA)
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP)
Unum Therapeutics Inc (NASDAQ: UMRX)
Vir Biotechnology Inc (NASDAQ: VIR) (reacted to its third-quarter results)
Viveve Medical Inc (NASDAQ: VIVE)
X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
Stocks In Focus Cellectis Wins Patent Challenge On Method Used In CRISPR-Cas9 Gene Editing
Cellectis SA (NASDAQ: CLLS) said the European Patent EP3004337, which was challenged in May 2018, was upheld by the European Patent Office. The patent pertains to a method of preparing T-cells for immunotherapy using the CRISPR-Cas9 system, and was initially granted to the company Aug. 2, 2017.
The stock rose 5.05% to $13.74 in after-hours trading.
Therapix Receives Delisting Notice From Nasdaq
Therapix Biosciences Ltd – ADR (NASDAQ: TRPX) has received a written notice of delisting from the Nasdaq, with the company found flouting the listing standards regarding shareholders' equity requirement. Consequently, the company's ADSs will be suspended from trading on the Nasdaq at the opening of trading Nov. 29. Therapix said it intends to appeal the decision.
The stock declined 10.10% to $1.35 in after-hours trading.
Hepion's Anti-fibrotic Agent Shows Efficacy In Animal Study
Hepion Pharmaceuticals Inc (NASDAQ: HEPA) said its CRV431, an anti-fibrotic agent, prevented the development of liver cirrhosis in highly aggressive preclinical model of liver disease. The results, according to the company, contributed preclinical efficacy data that complements its ongoing human clinical trials.
The stock skyrocketed 60.74% to $3.89 in after-hours trading.
Neon to Focus On T-Cell Therapies, Reduce Workforce By 24%
Neon Therapeutics Inc (NASDAQ: NTGN) announced a new strategic focus and a corporate restructuring, as it plans to focus its efforts on the on the advancement of both personal and precision neoantigen-targeted T cell therapy candidates. As part of restructuring, the company plans to reduce its workforce by 24% and cease taking on new additional spending commitments related to its cancer vaccine programs NEO-PV-01 and NEO-SV-01.
The company also said it plans to explore strategic alternatives.
The stock rallied 18.88% to $1.70 in after-hours trading.
Tonix To Submit Investigational New Drug Application For Alcohol Use Disorder Drug
Following a Type B pre-IND meeting with the FDA, Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) said it plans to submit an IND application for its TNX-102 SL, a potential treatment for alcohol use disorder. The will support a Phase 2 proof-of-concept study in the first quarter of 2020.
The stock rose 11.64% to $1.63 in after-hours trading.
Bristol-Myers Completes Celgene Buy
Bristol-Myers Squibb Co (NYSE: BMY) announced the completion of its proposed $74 billion acquisition of Celgene Corporation (NASDAQ: CELG), about 11 months after the deal was announced. Celgene now becomes a wholly-owned subsidiary of Bristol-Myers.
Bristol-Myers stock added 1.54% to $57.28 in after-hours trading.
Karuna Therapeutics Inc (NASDAQ: KRTX) shares found some strength after hours after Wedbush raised the price target for the shares from $38 to $134. Separately, the company said it has priced its previously announced 2.6 million follow-on offering at $96 per share.
The stock rose 3.95% to $113.25 in after-hours trading.
OptiNose said it and certain selling stockholders intend to offer its common stock in an underwritten public offering. The company said it plans to use the net proceeds for working capital and general corporate purposes.
The stock slipped 6.40% to $10.68 in after-hours trading.
Crispr Therapeutics AG (NASDAQ: CRSP) priced its previously-announced common stock offering at $64.50 per share. The company expects to raise gross proceeds of $274.1 million from the offering. The offering is expected to close on or about Nov. 25.
The stock fell 1.51% to $66.40 in after-hours trading.
Molecular Templates Inc (NASDAQ: MTEM) announced the commencement of an underwritten public offering of its common stock and newly-designated Series A convertible preferred stock. All the shares earmarked for the offering are sold by the company.
The stock moved down 3.26% to $8 in after-hours trading.
On The Radar Earnings
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