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)
- VIVUS, Inc. (NASDAQ: VVUS)
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.
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.
See more from Benzinga
- The Daily Biotech Pulse: Abeona Fires CEO, Loxo Passes FDA Muster, Bristol-Myers Flunks Lung Cancer Trial
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