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

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 ADAP
• Avanos Medical In AVNS
• Aptevo Therapeutics Inc APVO
• Aquestive Therapeutics Inc AQST
• Biocept Inc BIOC
• BioXcel Therapeutics Inc BTAI
• Cidara Therapeutics Inc CDTX
• Citius Pharmaceuticals Inc CTXR
• Corvus Pharmaceuticals Inc CRVS
• Curis, Inc. CRIS
• Edge Therapeutics Inc EDGE
• IntelliPharmaCeutics Intl Inc IPCI
• Midatech Pharma PLC-ADR MTP
• Momenta Pharmaceuticals, Inc. MNTA
• Nantkwest Inc NK
• Ovid Therapeutics Inc OVID
• Precision Therapeutics Inc AIPT
• Reshape Lifesciences Inc RSLS
• Revance Therapeutics Inc RVNC
• Sunesis Pharmaceuticals, Inc. SNSS
• Tonix Pharmaceuticals Holding Corp TNX(announces 1-for-10 reverse stock split)
• Unum Therapeutics Inc UMRX
• Verrica Pharmaceuticals Inc VRCA
• VIVUS, Inc. VVUS

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. 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 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.

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 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 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 ASND (after the close)

PDUFA Dates

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