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 DOVA

Down In The Dumps

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

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

Stocks In Focus

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

Puma Biotechnology Inc 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 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 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 JAGX and Roche Holdings AG Basel ADR RHHBY's will release interim analysis of Phase 2 update for Mytesi in cancer-related diarrhea.

ID Week 2019 Presentations

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

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

resTORbio, Inc. 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."