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The Daily Biotech Pulse: NewLink Genetics Licenses Ovarian Cancer Dug, Correvio Awaits FDA Verdict

Shanthi Rexaline

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 Dec. 23)

  • 10X Genomics Inc (NASDAQ: TXG)(reacted to a ruling regarding patent infringement)

  • Acasti Pharma Inc (NASDAQ: ACST)

  • Aimmune Therapeutics Inc (NASDAQ: AIMT)

  • Aptose Biosciences Inc (NASDAQ: APTO)

  • Aurinia Pharmaceuticals Inc (NASDAQ: AUPH)

  • BIO-TECHNE Corp (NASDAQ: TECH)

  • BridgeBio Pharma Inc (NASDAQ: BBIO)

  • Cassava Sciences Inc (NASDAQ: SAVA)

  • Cortexyme Inc (NASDAQ: CRTX)

  • DURECT Corporation (NASDAQ: DRRX)

  • Esperion Therapeutics Inc (NASDAQ: ESPR)

  • Exagen Inc (NASDAQ: XGN)

  • Forty Seven Inc (NASDAQ: FTSV)

  • Fulcrum Therapeutics Inc (NASDAQ: FULC)

  • Global Blood Therapeutics Inc (NASDAQ: GBT)

  • Horizon Therapeutics PLC (NASDAQ: HZNP)

  • IGM Biosciences Inc (NASDAQ: IGMS)

  • Intra-Cellular Therapies Inc (NASDAQ: ITCI)( announced FDA nod for schizophrenia drug)

  • Iovance Biotherapeutics Inc (NASDAQ: IOVA)

  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)

  • IVERIC bio Inc (NASDAQ: ISEE)

  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)

  • Karyopharm Therapeutics Inc (NASDAQ: KPTI)(announced Xpovio regulatory submission for the treatment of diffuse large B-cell lymphoma)

  • Mirati Therapeutics Inc (NASDAQ: MRTX)

  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)

  • Myokardia Inc (NASDAQ: MYOK)

  • NeoGenomics, Inc. (NASDAQ: NEO)

  • Neoleukin Therapeutics Inc (NASDAQ: NLTX)

  • Nevro Corp (NYSE: NVRO)

  • Novartis AG (NYSE: NVS)

  • NuVasive, Inc. (NASDAQ: NUVA)

  • Ovid Therapeutics Inc (NASDAQ: OVID)

  • Oyster Point Pharma Inc (NASDAQ: OYST)(reacted to its announcement concerning addition to the Russell 2000, Russell 3000 and Russell MicroCap Indexes)

  • Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX)(announced positive results for its late-stage prostate cancer drug trials)

  • Reata Pharmaceuticals Inc (NASDAQ: RETA)

  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)

  • TG Therapeutics Inc (NASDAQ: TGTX)(announced a $50 million registered direct public offering to a single institutional investor)

  • Veru Inc (NASDAQ: VERU)

  • XOMA Corp (NASDAQ: XOMA)

  • Zimmer Biomet Holdings Inc (NYSE: ZBH)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 23)

  • Akorn, Inc. (NASDAQ: AKRX)

  • Aridis Pharmaceuticals Inc (NASDAQ: ARDS)

  • Ekso Bionics Holdings Inc (NASDAQ: EKSO)

  • KemPharm Inc (NASDAQ: KMPH)

  • Outlook Therapeutics Inc (NASDAQ: OTLK) (announced warrant amendment and restructuring of senior secured notes)

  • Sellas Life Sciences Group Inc (NASDAQ: SLS)

  • Sophiris Bio Inc (NASDAQ: SPHS)

Stocks In Focus NewLink Genetics Out-Licenses Ovarian Cancer Drug

NewLink Genetics Corp (NASDAQ: NLNK) said it has entered into an exclusive worldwide license agreement with Ellipses Pharma for developing and commercializing NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin. NLG207 showed encouraging Phase 2 results in refractory ovarian cancer, the company added.

The agreement also grants Ellipses rights to develop and commercialize CRLX-301, a nanoparticle formulation of docetaxel that has completed a Phase 1a study.

NewLink is eligible to receive potential future royalty payments or a share of any future economics related to NLG207.

The stock rallied 12.82% to $2.20 in after-hours trading.

See Also: 8 Biotech Stocks Morgan Stanley Recommends For 2020

Otonomy Pops On Analyst Action

Otonomy Inc (NASDAQ: OTIC) shares advanced after Oppenheimer initiated coverage of the shares of the company with an Outperform rating and $8 price target.

The stock gained 9.13% to $2.75 in after-hours trading.

Codexis Licenses Diagnostic Enzyme to Roche

Codexis, Inc. (NASDAQ: CDXS), a protein engineering company, said it has entered into license agreement with Roche Holdings AG Basel ADR (OTC: RHHBY) for supplying the latter Its EvoT4 DNA ligase high-performance molecular diagnostic enzyme.

Codexis said Roche will incorporate the enzyme developed using the former's CodeEvolver protein engineering platform into its next-gen sequencing library preparation kits and other sequencing products.

Codexis stock moved up 5.72% to $17.92 in after-hours trading.

Gilead Grants Eisai Japanese License of Rheumatoid Arthritis Drug

Gilead Sciences, Inc. (NASDAQ: GILD) and Eisai Co., Ltd (OTC: ESALF) entered into an agreement for distribution and co-promotion of filgotinib in Japan, pending regulatory approval for the treatment of rheumatoid arthritis.

Filgotinib is an oral selective JAK1 inhibitor Gilead is co-developing with GALAPAGOS NV/S ADR (NASDAQ: GLPG).

Teligent Says FDA Hands Out CRL For Partner's ANDA

Teligent Inc (NASDAQ: TLGT) said its development partner has received a CRL from the FDA for the ANDA for its first complex drug indicated for an orphan disease population. The FDA has sought further information and raw data to support the application.

Acasti To Delay Results of Late-Stage Study Of Drug To Treat Elevated Level Of Triglycerides

Acasti said it is postponing the release of top-line results for the TRILOGY 1 pivotal Phase 3 study of CaPre to January 2020, citing an unexpected delay in data processing and transfer from the central testing laboratory to the statistical consultants for independent and external validation.

CaPre, a highly purified omega-3 phospholipid concentrate derived from krill oil, is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis.

On The Radar PDUFA Date

The FDA is set to rule on Correvio Pharma Corp (NASDAQ: CORV)'s NDA for Brinavess, or vernakalant HCl in intravenous formulation, an antiarrhythmic drug that is being evaluated for the rapid onset atrial fibrillation to sinus rhythm for non-surgery patients. The PDUFA action date is planned for Tuesday. A FDA panel, which met Dec. 10, voted against approval of the drug.

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