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The Daily Biotech Pulse: IPOs, Puma's Breast Cancer Drug Gets Label Expansion, Buyout Offer For Organovo

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The Daily Biotech Pulse: IPOs, Puma's Breast Cancer Drug Gets Label Expansion, Buyout Offer For Organovo

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week lows on Oct. 2)

  • Dova Pharmaceuticals Inc (NASDAQ: DOVA)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 2)

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  • 10X Genomics Inc (NASDAQ: TXG)
  • ABIOMED, Inc. (NASDAQ: ABMD)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Adaptive Biotechnologies Corp (NASDAQ: ADPT)
  • Aduro BioTech Inc (NASDAQ: ADRO)
  • Albireo Pharma Inc (NASDAQ: ALBO)
  • Allena Pharmaceuticals Inc (NASDAQ: ALNA)
  • Alpine Immune Sciences Inc (NASDAQ: ALPN)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • AxoGen, Inc Common Stock (NASDAQ: AXGN)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)
  • BioTelemetry Inc (NASDAQ: BEAT)
  • bluebird bio Inc . (NASDAQ: BLUE)
  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • DelMar Pharmaceuticals Inc (NASDAQ: DMP)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)
  • Gemphire Therapeutics Inc (NASDAQ: GEMP)
  • IGM Biosciences Inc (NASDAQ: IGMS)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI)
  • Inovio Pharmaceuticals Inc (NASDAQ: INO)
  • Inflarx NV (NASDAQ: IFRX)
  • Karuna Therapeutics Inc (NASDAQ: KRTX)
  • Kalvista Pharmaceuticals Inc (NASDAQ: KALV)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
  • Neurometrix Inc (NASDAQ: NURO)
  • Neurotrope Inc (NASDAQ: NTRP)
  • Novus Therapeutics Inc (NASDAQ: NVUS)
  • NewLink Genetics Corp (NASDAQ: NLNK)
  • Obseva SA (NASDAQ: OBSV)
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)
  • PDL BioPharma Inc (NASDAQ: PDLI)
  • PDS Biotechnology Corp (NASDAQ: PDSB)
  • Plus Therapeutics Inc (NASDAQ: PSTV)
  • Precision BioSciences Inc (NASDAQ: DTIL)
  • Qiagen NV (NYSE: QGEN)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA) (IPOed on Oct. 2)
  • Savara Inc (NASDAQ: SVRA) (FDA rejected its BLA for Molgradex)
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Titan Pharmaceuticals, Inc. (NASDAQ: TTNP)
  • Tocagen Inc (NASDAQ: TOCA)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • TransMedics Group Inc (NASDAQ: TMDX)
  • Trinity Biotech plc (NASDAQ: TRIB)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • Verastem Inc (NASDAQ: VSTM)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Wave Life Sciences Ltd (NASDAQ: WVE)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)
  • Zosano Pharma Corp (NASDAQ: ZSAN)

Stocks In Focus

Puma Gets FDA Nod For Label Expansion For Its Breast Cancer Drug

Puma Biotechnology Inc (NASDAQ: PBYI) said the FDA has approved a labeling supplement for its Nerlynx for the extended adjuvant treatment of HER2-positive early stage breast cancer.

Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

The stock rallied 8.45% to $10.65 in after-hours trading.

Organovo Receives Buyout Proposal From Viscient

Organovo Holdings Inc (NASDAQ: ONVO) confirmed it has received a proposal from early-stage private company Viscient Biosciences for acquiring Organovo. Organovo's board had earlier in August determined that it would be in the best interest of the company's shareholders to evaluate strategic alternatives.

"Organovo intends to evaluate Viscient's proposal in due course, and is not asking its stockholders to take any action at this time," the company said.

The stock was seen rising 5.36% to 30 cents in pre-market trading.

Clinical Trial Readouts

Millendo Therapeutics Inc (NASDAQ: MLND) is scheduled to release Phase 2b progress report on livoletide in Prader-Willi syndrome at the Foundation for Prader-Willi Research, PWS Research Symposium being held in New Orleans, Los Angeles.

Jaguar Health Inc (NASDAQ: JAGX) and Roche Holdings AG Basel ADR (OTC: RHHBY)'s will release interim analysis of Phase 2 update for Mytesi in cancer-related diarrhea.

ID Week 2019 Presentations

ContraFect Corp (NASDAQ: CFRX) – Phase 2 data for CF-301 exebacase in serious infections caused by Staph aureus, including MRSA

Enanta Pharmaceuticals Inc (NASDAQ: ENTA) – New Phase 2a data for EDP-938 in respiratory syncytial virus

resTORbio, Inc. (NASDAQ: TORC) – Phase 2b data for RTB101 in respiratory tract infections

IPOs

ADC Therapeutics, which develops antibody therapies for cancer, said it has withdrawn its registration statement on Form F-1 with the SEC related to its proposed IPO of 8.164 million shares. The company cited adverse market conditions as the reason for the withdrawal.

Monopar Therapeutics also withdrew its proposed 4.44-million share IPO, citing market conditions.

Aprea Therapeutics said it has priced its upsized offering of 5.67 million shares at $15, the mid-point of the estimated price range of $14-$16. The shares of the biotech that develops targeted therapies for cancer will be listed on the Nasdaq under the ticker symbol APRE.

Frequency Therapeutics, which focuses on therapies for degenerative diseases, priced its downsized offering of 6 million shares at $14, the lower bound of the estimated price range of $14-$16. Shares will be begin trading on the Nasdaq under the ticker symbol "FREQ."

Viela Bio priced its 7.9-million share IPO at $19, the low end of the estimated price range of $19-$21. Shares of the company, which develops antibodies, will be listed on the Nasdaq under the ticker symbol "VIE."

Posted-In: Biotech Earnings News FDA IPOs Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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