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

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. ECYT

Down In The Dumps

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

• Abeona Therapeutics Inc ABEO
• Accelerate Diagnostics Inc AXDX
• Achillion Pharmaceuticals, Inc. ACHN
• Acorda Therapeutics Inc ACOR
• Adamas Pharmaceuticals Inc ADMS
• Aileron Therapeutics Inc ALRN
• Akebia Therapeutics Inc AKBA
• Akers Biosciences Inc AKER
• Albireo Pharma Inc ALBO
• Alder Biopharmaceuticals Inc ALDR
• Alkermes Plc ALKS
• Amicus Therapeutics, Inc. FOLD
• AnaptysBio Inc ANAB
• Anavex Life Sciences Corp AVXL
• ANI Pharmaceuticals Inc Common Stock ANIP
• Applied DNA Sciences Inc APDN
• Applied Genetic Technologies Corp AGTC
• Aptevo Therapeutics Inc APVO
• ASLAN PHARMACEUTICALS ADR REP 5 ORD ASLN
• aTyr Pharma Inc LIFE
• Avrobio Inc AVRO
• Bellicum Pharmaceuticals Inc BLCM
• BENITEC BIOPHAR/S ADR BNTC
• BioXcel Therapeutics Inc BTAI
• BIOLINERX LTD/S ADR BLRX
• Catalyst Biosciences Inc CBIO
• Celgene Corporation CELG
• Celsion Corporation CLSN
• Checkpoint Therapeutics Inc CKPT
• Chimerix Inc CMRX
• Cidara Therapeutics Inc CDTX
• Constellation Pharmaceuticals Inc CNST
• Corvus Pharmaceuticals Inc CRVS
• Cyclacel Pharmaceuticals Inc CYCC
• Diffusion Pharmaceuticals Inc DFFN
• Dova Pharmaceuticals Inc DOVA
• Edap Tms SA EDAP
• Edge Therapeutics Inc EDGE
• Endologix, Inc. ELGX
• Entasis Therapeutics Holdings Inc ETTX
• Enzo Biochem, Inc. ENZ
• Epizyme Inc EPZM
• Eyegate Pharmaceuticals Inc EYEG
• Fennec Pharmaceuticals Inc FENC
• Five Prime Therapeutics Inc FPRX
• Genocea Biosciences Inc GNCA
• Geron Corporation GERN
• Gilead Sciences, Inc. GILD
• GlycoMimetics Inc GLYC
• Halozyme Therapeutics, Inc. HALO
• ImmunoGen, Inc. IMGN
• Insmed Incorporated INSM
• Intellia Therapeutics Inc NTLA
• Jaguar Health Inc JAGX
• Jounce Therapeutics Inc JNCE
• Kala Pharmaceuticals Inc KALA
• Karyopharm Therapeutics Inc KPTI
• Laboratory Corp. of America Holdings LH
• La Jolla Pharmaceutical Company LJPC
• Leap Therapeutics Inc LPTX
• LeMaitre Vascular Inc LMAT
• Magenta Therapeutics Inc MGTA
• Marinus Pharmaceuticals Inc MRNS
• Melinta Therapeutics Inc MLNT
• Menlo Therapeutics Inc MNLO
• Midatech Pharma PLC-ADR MTP
• Mylan NV MYL
• Nabriva Therapeutics PLC – ADR NBRV
• Odonate Therapeutics Inc ODT
• OHR Pharmaceutical Inc OHRP
• OncoSec Medical Inc ONCS
• OptiNose Inc OPTN
• OraSure Technologies, Inc. OSUR
• Otonomy Inc OTIC
• Ovid Therapeutics Inc OVID
• PLx Pharma Inc PLXP
• Portola Pharmaceuticals Inc PTLA
• Prana Biotechnology Limited PRAN
• Progenics Pharmaceuticals, Inc. PGNX
• Prothena Corporation PLC PRTA
• Psychemedics Corp. PMD
• Regulus Therapeutics Inc RGLS
• Reshape Lifesciences Inc RSLS
• Revance Therapeutics Inc RVNC
• Rigel Pharmaceuticals, Inc. RIGL
• SAGE Therapeutics Inc SAGE
• Savara Inc SVRA
• Selecta Biosciences Inc SELB
• Sienna Biopharmaceuticals Inc SNNA
• Sonoma Pharmaceuticals Inc SNOA
• Supernus Pharmaceuticals Inc SUPN
• Sophiris Bio Inc SPHS
• Synlogic Inc SYBX
• Syndax Pharmaceuticals Inc SNDX
• T2 Biosystems Inc TTOO
• Taro Pharmaceutical Industries Ltd. TARO
• Tetraphase Pharmaceuticals Inc TTPH
• Teva Pharmaceutical Industries Ltd TEVA
• TG Therapeutics Inc common stock TGTX
• Titan Medical Inc. TMDI
• Trevena Inc TRVN
• Unum Therapeutics Inc UMRX
• Verrica Pharmaceuticals Inc VRCA
• Zimmer Biomet Holdings Inc ZBH
• Zosano Pharma Corp ZSAN
• Zynerba Pharmaceuticals Inc 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 TLRY and Anheuser Busch Inbev NV 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. 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 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 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 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 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 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 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 JAZZ awaits FDA verdict on JZP-110, which is being evaluated for treating excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.