The Daily Biotech Pulse: Obseva Sinks On Adverse Clinical Readout, BioNano Surges On Saphyr Adoption, 2 IPOs

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. 6)

• Agile Therapeutics Inc AGRX(follow-on rally following positive Adcom verdict for Twirla)
• Constellation Pharmaceuticals Inc CNST(announced positive results from a Phase 2 trial of CPI-0610 in combination with Jakafi in myelofibrosis)
• Exagen Inc XGN
• INNATE PHARMA S/S ADR IPHA
• Momenta Pharmaceuticals, Inc. MNTA
• Repro-Med Systems, Inc. KRMD
• TFF Pharmaceuticals Inc TFFP
• Viela Bio Inc VIE (IPOed Oct. 3)
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 6)

• AcelRx Pharmaceuticals Inc ACRX
• Achieve Life Sciences Inc ACHV
• AVEO Pharmaceuticals, Inc. AVEO
• Biocept Inc BIOC
• bluebird bio Inc BLUE
• Cocrystal Pharma Inc COCP
• Corbus Pharmaceuticals Holdings Inc CRBP
• Cyclerion Therapeutics Inc CYCN
• Diffusion Pharmaceuticals Inc DFFN
• Exelixis, Inc. EXEL
• Helius Medical Technologies Inc HSDT
• Homology Medicines Inc FIXX
• Iterum Therapeutics PLC ITRM
• Midatech Pharma PLC-ADR MTP
• Morphic Holding Inc MORF
• Neuronetics Inc STIM
• Oyster Point Pharma Inc OYST (IPOed on Oct. 31)
• Rockwell Medical Inc RMTI
• Salarius Pharmaceuticals Inc SLRX
• Supernus Pharmaceuticals Inc SUPN( announced a negative clinical readout for ADHD drug and disappointing third-quarter results)
• Ultragenyx Pharmaceutical Inc RARE(reported wider-than-expected loss for the third quarter)
• Unum Therapeutics Inc UMRX

Stocks In Focus

Obseva's Drug To Boost Pregnancy Following Invitro Fertilization Fails In Late-Stage Study

Obseva SA OBSV said the results from the Phase 2 European confirmatory study of nolasiban in women undergoing embryo transfer following in-vitro fertilization did not meet the primary endpoint of an increase in ongoing pregnancy rate at 10 weeks.

Nosiblan is an oral oxycontin receptor antagonist licensed from Germany's MERCK KGAA/S ADR MKKGY. The company has decided to discontinue the current development of nolasiban for IVF and will explore potential repositioning of the product.

The company also reported third-quarter results showing a wider loss for the quarter.

Shares were declining 25.75% to $5.97 in pre-market trading.

InflaRx Reports Positive Results From Open-Label Extension Phase 2 Study Of Drug To Treat Skin Inflammation

Inflarx NV IFRX reported positive results for the open label extension part of the international Phase 2b study dubbed SHINE that is evaluating the safety and efficacy of IFX-1, an anti-human complement factor C5a monoclonal antibody, in patients with moderate to severe hidradenitis suppurativa, or HS. HS is a painful and debilitating chronic inflammatory skin disease with limited treatment options.

The shares are jumping 44.40% to $3.74 in pre-market trading.

Bionano's Saphyr System To Be Used By Novogene For Genome Imaging

BioNano Genomics Inc BNGO said Novogene has adopted the Saphyr system for genome imaging and incorporated it into the latter's genomic analysis technology services.

BioNano's Saphyr system automates the imaging of extremely long, high-molecular-weight DNA in its native state in proprietary NanoChannel arrays on the Saphyr Chip.

The stock jumped 54.62% to $1.39 in after-hours trading.

See Also: Analysts Remain Upbeat On GW Pharma's Optionality With Epidiolex

Coherus Acquires U.S. Rights To Lucentis Biosimilar

Coherus Biosciences Inc CHRS has acquired exclusive rights from Bioeq to commercialize the latter's Lucentis biosimilar in the U.S. Bioeq said it plans to file a BLA with the FDA for the biosimilar in the fourth quarter and launch the product in 2021.

Coherus will pay a mid-single digit million-dollar upfront payment as well as other regulatory and launch milestone payments, while both companies will share profits equally.

Lucentis is Roche Holdings AG Basel ADR's RHHBY Genentech unit's drug to treat wet age-related macular degeneration.

Separately, Coherus reported better-than-expected third-quarter results.

The stock gained 2.37% to $16.85 in after-hours trading.

Offerings

Evolus Inc EOLS said it has priced its secondary offering of 5.217 million shares at $13 per share. The company expects to get net proceeds of $63.5 million from the offering. The offering is expected to close Nov. 12.

The stock fell 5.36% to $13.25 in after-hours trading.

Sierra Oncology Inc SRRA said it intends to offer shares of Series A convertible preferred stock together with Series A warrants and Series B warrants, each to purchase shares of common stock, in an underwritten public offering. All the shares are to be offered by the company.

The company said it intends to use the net proceeds primarily to fund its Phase 3 trial of momelotinib.

The stock plunged 20.57% to 28 cents in after-hours trading.

Agios Pharmaceuticals Inc AGIO said it's planning a 7.5-million follow-on offering, with all shares earmarked for the offering to be sold by the company.

The stock declined 5.27% to $32 in after-hours trading.

Earnings

Vanda Pharmaceuticals Inc. VNDA reported third-quarter net product sales of $59.5 million compared to $49.1 million in the year-ago period. The earnings per share jumped to $1.84 from 13 cents, notably ahead of the 7-cent per share consensus estimate.

The stock jumped 19.86% to $15.75 in after-hours trading.

DexCom, Inc.'s DXCM third-quarter revenues jumped 49% to $396.3 million. The company raised its full-year revenue as well margin guidance. The non-GAAP EPS jumped from 18 cents to 65 cents. Analysts had estimated EPS of 20 cents.

The stock rose 19.51% to $183 in after-hours trading.

TherapeuticsMD Inc TXMD said third-quarter net revenues climbed from $3.47 million in 2018 to $23.72 million in 2019. The loss per share narrowed from 16 cents to 13 cents. Analysts had estimated a wider loss of 19 cents per share.The company reaffirmed its 2019 guidance.

The stock gained 10.69% to $2.90 in after-hours trading.

Aerie Pharmaceuticals Inc AERI reported a narrowed adjusted net loss per share for the third quarter. The company reduced its full-year net revenue guidance.

The stock declined 18.98% to $19.30 in after-hours trading.

Puma Biotechnology Inc's PBYI third quarter revenues fell about 10% to $56.4 million and its net loss per share widened from 37 cents to 44 cents. Analysts had estimated a loss of 71 cents per share for the quarter.

The stock slipped 17.95% to $5.85 in after-hours trading.

Bellicum Pharmaceuticals Inc BLCM reported a decline in its third-quarter grant revenues from $292,000 in 2018 to $103,000 in 2019. The net loss per share widened to 68 cents to 55 cents. Analysts had estimated a loss of 53 cents per share for the quarter.

The stock moved down 10.16% to $1.15 in after-hours trading.

Nektar Therapeutics' NKTR third-quarter revenues climbed about 5% to $29.22 million and the loss per share remained unchanged at 56 cents, narrower than the consensus estimate for a loss of 73 cents.

The stock added 5.52% to $19.10 in after-hours trading.

OpGen Inc's OPGN third-quarter revenues rose 17.4% to $648,000 and the loss per share narrowed from $10.67 to $3.95.

The stock slipped 11.36% to $1.17 in after-hours trading.

On The Radar

Earnings

• Clovis Oncology Inc CLVS (before the market open)
• Athenex Inc ATNX (before the market open)
• Aldeyra Therapeutics Inc ALDX (before the market open)
• Atara Biotherapeutics Inc ATRA (before the market open)
• Autolus Therapeutics Ltd – ADR AUTL (before the market open)
• Aileron Therapeutics Inc ALRN (before the market open)
• Pacira Biosciences Inc PCRX (before the market open)
• Protalix Biotherapeutics Inc PLX (before the market open)
• Meridian Bioscience, Inc. VIVO (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• Lexicon Pharmaceuticals, Inc. LXRX (before the market open)
• Kala Pharmaceuticals Inc KALA (before the market open)
• Zoetis Inc ZTS (before the market open)
• Jounce Therapeutics Inc JNCE (before the market open)
• X4 Pharmaceuticals Inc XFOR (before the market open)
• Corbus Pharmaceuticals Holdings Inc CRBP (before the market open)
• Eyepoint Pharmaceuticals Inc EYPT (before the market open)
• GlycoMimetics Inc GLYC (before the market open)
• Catabasis Pharmaceuticals Inc CATB (before the market open)
• Concert Pharmaceuticals Inc CNCE (before the market open)
• Axsome Therapeutics Inc AXSM (before the market open)
• Viveve Medical Inc VIVE (after the market close)
• Sarepta Therapeutics Inc SRPT (after the market close)
• Pfenex Inc PFNX (after the market close)
• 10X Genomics Inc TXG (after the market close)
• Audentes Therapeutics Inc BOLD (after the market close)
• Adverum Biotechnologies Inc ADVM (after the market close)
• Adamas Pharmaceuticals Inc ADMS (after the market close)
• Aclaris Therapeutics Inc ACRS (after the market close)
• Arena Pharmaceuticals, Inc. ARNA (after the market close)
• Amphastar Pharmaceuticals Inc AMPH (after the market close)
• Pulse Biosciences Inc PLSE (after the market close)
• Navidea Biopharmaceuticals Inc NAVB (after the market close)
• Viveve Medical Inc VIVE (after the market close)
• ZIOPHARM Oncology Inc. ZIOP (after the market close)
• Shockwave Medical Inc SWAV (after the market close)
• Penumbra Inc PEN (after the market close)
• Syndax Pharmaceuticals Inc SNDX (after the market close)
• Sarepta Therapeutics Inc SRPT (after the market close)
• NovaBay Pharmaceuticals, Inc. NBY (after the market close)
• Spectrum Pharmaceuticals, Inc. SPPI (after the market close)
• Novavax, Inc. NVAX (after the market close)
• Zogenix, Inc. ZGNX (after the market close)
• Oncternal Therapeutics Inc ONCT (after the market close)
• Savara Inc SVRA (after the market close)
• Miragen Therapeutics Inc MGEN (after the market close)
• Pfenex Inc PFNX (after the market close)
• Dicerna Pharmaceuticals Inc DRNA (after the market close)
• Guardant Health Inc GH (after the market close)
• Flexion Therapeutics Inc FLXN (after the market close)
• Corcept Therapeutics Incorporated CORT (after the market close)
• Capricor Therapeutics Inc CAPR (after the market close)
• CytomX Therapeutics Inc CTMX (after the market close)
• Orthopediatrics Corp KIDS (after the market close)

IPO

Galera Therapeutics priced its 5-million share IPO at $12, below the estimated price range of $14-$16. The company's shares are to be listed on the Nasdaq under the ticker symbol "GRTX."

Gene testing company Centogene priced its IPO of 4 million shares at $14, the lower bound of the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol "CNTG."