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The Daily Biotech Pulse: Tilray Inks Cannabis Drink Pact, Double Delight For Merck, FDA Snub For Spectrum

Shanthi Rexaline

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 19)

  • Endocyte, Inc. (NASDAQ: ECYT)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 19)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • Accelerate Diagnostics Inc (NASDAQ: AXDX)
  • Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Aileron Therapeutics Inc (NASDAQ: ALRN)
  • Akebia Therapeutics Inc (NASDAQ: AKBA)
  • Akers Biosciences Inc (NASDAQ: AKER)
  • Albireo Pharma Inc (NASDAQ: ALBO)
  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR)
  • Alkermes Plc (NASDAQ: ALKS)
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD)
  • AnaptysBio Inc (NASDAQ: ANAB)
  • Anavex Life Sciences Corp (NASDAQ: AVXL)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
  • Applied DNA Sciences Inc (NASDAQ: APDN)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC)
  • Aptevo Therapeutics Inc (NASDAQ: APVO)
  • ASLAN PHARMACEUTICALS ADR REP 5 ORD (NASDAQ: ASLN)
  • aTyr Pharma Inc (NASDAQ: LIFE)
  • Avrobio Inc (NASDAQ: AVRO)
  • Bellicum Pharmaceuticals Inc (NASDAQ: BLCM)
  • BENITEC BIOPHAR/S ADR (NASDAQ: BNTC)
  • BioXcel Therapeutics Inc (NASDAQ: BTAI)
  • BIOLINERX LTD/S ADR (NASDAQ: BLRX)
  • Catalyst Biosciences Inc (NASDAQ: CBIO)
  • Celgene Corporation (NASDAQ: CELG)
  • Celsion Corporation (NASDAQ: CLSN)
  • Checkpoint Therapeutics Inc (NASDAQ: CKPT)
  • Chimerix Inc (NASDAQ: CMRX)
  • Cidara Therapeutics Inc (NASDAQ: CDTX)
  • Constellation Pharmaceuticals Inc (NASDAQ: CNST)
  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Dova Pharmaceuticals Inc (NASDAQ: DOVA)
  • Edap Tms SA (NASDAQ: EDAP)
  • Edge Therapeutics Inc (NASDAQ: EDGE)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)
  • Enzo Biochem, Inc. (NYSE: ENZ)
  • Epizyme Inc (NASDAQ: EPZM)
  • Eyegate Pharmaceuticals Inc (NASDAQ: EYEG)
  • Fennec Pharmaceuticals Inc (NASDAQ: FENC)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX)
  • Genocea Biosciences Inc (NASDAQ: GNCA)
  • Geron Corporation (NASDAQ: GERN)
  • Gilead Sciences, Inc. (NASDAQ: GILD)
  • GlycoMimetics Inc (NASDAQ: GLYC)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • ImmunoGen, Inc. (NASDAQ: IMGN)
  • Insmed Incorporated (NASDAQ: INSM)
  • Intellia Therapeutics Inc (NASDAQ: NTLA)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Jounce Therapeutics Inc (NASDAQ: JNCE)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Karyopharm Therapeutics Inc (NASDAQ: KPTI)
  • Laboratory Corp. of America Holdings (NYSE: LH)
  • La Jolla Pharmaceutical Company (NASDAQ: LJPC)
  • Leap Therapeutics Inc (NASDAQ: LPTX)
  • LeMaitre Vascular Inc (NASDAQ: LMAT)
  • Magenta Therapeutics Inc (NASDAQ: MGTA)
  • Marinus Pharmaceuticals Inc (NASDAQ: MRNS)
  • Melinta Therapeutics Inc (NASDAQ: MLNT)
  • Menlo Therapeutics Inc (NASDAQ: MNLO)
  • Midatech Pharma PLC-ADR (NASDAQ: MTP)
  • Mylan NV (NASDAQ: MYL)
  • Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)
  • Odonate Therapeutics Inc (NASDAQ: ODT)
  • OHR Pharmaceutical Inc (NASDAQ: OHRP)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • OptiNose Inc (NASDAQ: OPTN)
  • OraSure Technologies, Inc. (NASDAQ: OSUR)
  • Otonomy Inc (NASDAQ: OTIC)
  • Ovid Therapeutics Inc (NASDAQ: OVID)
  • PLx Pharma Inc (NASDAQ: PLXP)
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA)
  • Prana Biotechnology Limited (NASDAQ: PRAN)
  • Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX)
  • Prothena Corporation PLC (NASDAQ: PRTA)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Regulus Therapeutics Inc (NASDAQ: RGLS)
  • Reshape Lifesciences Inc (NASDAQ: RSLS)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
  • SAGE Therapeutics Inc (NASDAQ: SAGE)
  • Savara Inc (NASDAQ: SVRA)
  • Selecta Biosciences Inc (NASDAQ: SELB)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Sonoma Pharmaceuticals Inc (NASDAQ: SNOA)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN)
  • Sophiris Bio Inc (NASDAQ: SPHS)
  • Synlogic Inc (NASDAQ: SYBX)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Teva Pharmaceutical Industries Ltd (NYSE: TEVA)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX)
  • Titan Medical Inc. (NASDAQ: TMDI)
  • Trevena Inc (NASDAQ: TRVN)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • Verrica Pharmaceuticals Inc (NASDAQ: VRCA)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH)
  • Zosano Pharma Corp (NASDAQ: ZSAN)
  • Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE)

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Stocks In Focus Tilray, AB Inbev Strike $100M Partnership For Cannabis Beverage

Tilray Inc (NASDAQ: TLRY) and Anheuser Busch Inbev NV (NYSE: BUD) announced a partnership in Canada to research on non-alcoholic beverages having tetrahydrocannabinol and cannabidiol. The partnership draws about $50 million investment from each company, with the total investment at $100 million.

"We are delighted to be joining forces with a world-leading beverage company, AB InBev, to research how to create enjoyable cannabis beverage products," Brendan Kennedy, CEO of Tilray said.

Tilray shares rallied 15.32 percent to $81.88 in after-hours trading.

Learn, connect or raise money at the leading event for connecting cannabis companies to investors.

FDA Approves Merck's Skin & Ovarian Cancer Drugs

Ahead of the Dec. 28 PDUFA date, the FDA approved Merck & Co., Inc. (NYSE: MRK)'s Keytruda for treating adult and pediatric patients with recurrent, locally advanced or metastatic Merkel cell carcinoma – a rare form of skin cancer.

The FDA also approved Merck-AstraZeneca plc (NYSE: AZN) combine's Lynparza as a first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.

Spectrum's Lung Cancer Drug Fails to Secure Breakthrough Therapy Designation

Spectrum Pharmaceuticals, Inc (NASDAQ: SPPI) said it failed to secure Breakthrough Therapy Designation, or BTD, for its poziotinib for treating metastatic non-small cell lung cancer in patients whose tumors have EGFR mutations. Therefore, the company said its development plan and timeline for a NDA filing based on the first cohort of the ZENITH20 trial remains unchanged, with enrolment to be completed in Q1'19 and top-line data to be announced in 2019.

A BTD would have expedited the review.

The stock plunged 34.39 percent to $6.85 in after-hours trading.

G1 Therapeutics Small Cell Lung Cancer Study Yields Mixed Results

G1 Therapeutics Inc (NASDAQ: GTHX) announced top-line results from a mid-stage trial that evaluated its Trilaciclib (in two doses) along with chemotherapy regimen Topotecan as second- and third-line treatment of small-cell lung cancer. The company said the study met both primary endpoints of reducing the duration and occurrence of Grade 4 neutropenia.

However, the number of people requiring granulocyte-colony stimulating factor usage and red blood cell transfusions was higher in the Trilaciclib arm relative to placebo.

"We plan to meet with U.S. and European regulatory authorities in 2019 to discuss the totality of trilaciclib data and pathways to approval," the company said.

The stock slumped 26.09 percent to $21.25 in after-hours trading.

Novartis Names New Oncology Head

Novartis AG (NYSE: NVS) announced the appointment of Susanne Schaffert, an insider, as the CEO of Novartis Oncology, effective Jan. 1, 2019 following the departure of Liz Barrett from the position.

The stock gained 1.53 percent to $85.74 in after-hours trading.

MannKind Prices Common Stock Offering

MannKind Corporation (NASDAQ: MNKD) said it has priced an underwritten public offering of 26.67 million shares of its common stock and warrants to buy up to an aggregate of another 26.67 million shares, at $1.50 per share. This would generate gross proceeds of $40 million.

The stock plunged 18.34 percent to $1.34 in after-hours trading.

Clearside Files NDA for Eye Inflammation Drug

Clearside Biomedical Inc (NASDAQ: CLSD) said it has submitted a NDA to the FDA for Xipere for the treatment of macular edema associated with uveitis.

The stock rallied 16.94 percent to $1.45 in after-hours trading.

On The Radar

Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) awaits FDA verdict on JZP-110, which is being evaluated for treating excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.

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