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The Daily Biotech Pulse: IntelliPharmaCeutics Generic Antidepressant Gets FDA Nod, GW Pharma Earnings

Shanthi Rexaline

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

None of the biotech stocks hit 52-week highs Tuesday.

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 27)

  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)

  • Avanos Medical In (NYSE: AVNS)

  • Aptevo Therapeutics Inc (NASDAQ: APVO)

  • Aquestive Therapeutics Inc (NASDAQ: AQST)

  • Biocept Inc (NASDAQ: BIOC)

  • BioXcel Therapeutics Inc (NASDAQ: BTAI)

  • Cidara Therapeutics Inc (NASDAQ: CDTX)

  • Citius Pharmaceuticals Inc (NASDAQ: CTXR)

  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS)

  • Curis, Inc. (NASDAQ: CRIS)

  • Edge Therapeutics Inc (NASDAQ: EDGE)

  • IntelliPharmaCeutics Intl Inc (NASDAQ: IPCI)

  • Midatech Pharma PLC-ADR (NASDAQ: MTP)

  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)

  • Nantkwest Inc (NASDAQ: NK)

  • Ovid Therapeutics Inc (NASDAQ: OVID)

  • Precision Therapeutics Inc (NASDAQ: AIPT)

  • Reshape Lifesciences Inc (NASDAQ: RSLS)

  • Revance Therapeutics Inc (NASDAQ: RVNC)

  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)

  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNX)(announces 1-for-10 reverse stock split)

  • Unum Therapeutics Inc (NASDAQ: UMRX)

  • Verrica Pharmaceuticals Inc (NASDAQ: VRCA)


See Also: The Week Ahead In Biotech: ASH 2018, PDUFA Dates, Clinical Trials And Earnings

Stocks In Focus IntelliPharmaCeutics Secures FDA Approval For Generic Version of Wyeth's Antidepressant

IntelliPharmaCeutic said the FDA approved its ANDA for the generic version of venlafaxine hydrochloride, extended-release capsules of 37.5, 75 and 150mg strengths. The product is a generic equivalent of Pfizer Inc. (NYSE: PFE)-owned Wyeth's major depressive disorder, or MDD, medication Effexor XR.

The penny stock jumped 17.43 percent to $0.3995 in after-hours trading.

Galapagos' Osteoarthritis Drug Gets Fast Track Designation

GALAPAGOS NV/S ADR (NASDAQ: GLPG) said the FDA has granted Fast Track Designation for its osteoarthritis pipeline candidate GLPG1972/S201086. The designation vests the advantage of more frequent interactions with the FDA, and the drug in question is potentially eligible for priority review and rolling review of a NDA.

View more earnings on IBB

The stock rose 0.77 percent to $98.64 in after-hours trading.

GW Pharma Reports Wider Loss, Lower Revenues For Q3

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) reported Q3 revenues of $2.42 million, almost flat with the year-ago revenues of $2.45 million. The company's net loss per share widened from 18 cents per share to 23 cents per share.

Cash and cash equivalents at Sep. 30, 2018 were $354.9 million compared to $322.2 million as of Sep. 30, 2017

The stock fell 3.32 percent to $117.68 in after-hours trading.

Obseva Commences Late-stage Study of Drug Facilitating Fertility Treatment

Obseva SA (NASDAQ: OBSV) said it initiated the IMPLANT 4 Phase 3 clinical trial of its oral oxytocin receptor antagonist, nolasiban, used for improving rates of pregnancy and live birth in patients undergoing assisted reproduction technology, or in-vitro fertilization.

"With a successful IMPLANT 4 outcome, we are planning a MAA submission in Europe prior to the end of 2019, a key step in ObsEva's evolution into a commercial company with a unique and innovative product that may not only help patients, but has the potential to lower associated health care costs," the company said.

On The Radar Earnings

Ascendis Pharma A/S (NASDAQ: ASND) (after the close)


The FDA will also decide on Catalyst Pharmaceuticals Inc (NASDAQ: CPRX)'s NDA for Firdapse, its pipeline candidate for Lambert-Eaton myasthenic syndrome.

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