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February 10, 2014
04:55 EDTALKS, ALKS, RGDO, RGDO, LXRX, LXRX, ZIOP, ZIOP, RNA, RNA, AUXL, AUXL, XON, XON, SIGA, SIGA, GALE, GALE, MSTX, MSTXBiotech Industry Organization to hold a conference
16h Annual BIO CEO & Investor Conference is being held in New York on February 10-11.
Check below for free stories on ALKS;GALE;SIGA;XON;AUXL;RNA;ZIOP;LXRX;RGDO;MSTX the last two weeks.
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August 1, 2014
10:00 EDTRNAOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Arista Networks (ANET) initiated with a Neutral at Citigroup... Casella Waste (CWST) initiated with a Hold at Stifel... CymaBay Therapeutics (CBAY) initiated with an Outperform at Cowen... Finish Line (FINL) initiated with a Buy at Jefferies... Flamel Technologies (FLML) initiated with an Outperform at Leerink... PTC Therapeutics (PTCT) initiated with an Outperform at Oppenheimer... Paramount Gold & Silver (PZG) initiated with a Buy at Noble Financial... Progressive Waste (BIN) initiated with a Hold at Stifel... Prosensa (RNA) initiated with an Outperform at Oppenheimer... Sangamo (SGMO) initiated with an Overweight at JPMorgan... Sarepta (SRPT) initiated with an Outperform at Oppenheimer... Sucampo (SCMP) initiated with a Buy at Roth Capital.
08:08 EDTALKSAlkermes pipeline programs remain on track, says Leerink
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06:55 EDTSIGASIGA Technologies to host business news update conference call
Conference call to be held on August 4 at 4:30 pm. Webcast Link
06:00 EDTALKSAlkermes remains a 'worthwhile investment,' says Mizuho
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July 31, 2014
16:39 EDTZIOPZiopharm, Solasia enter global license, collaboration agreement for darinaparsin
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16:24 EDTRNAProsensa initiated with an Outperform at Oppenheimer
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07:14 EDTALKSAlkermes cuts FY14 adjusted EPS view to 19c-32c, consensus 49c
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07:12 EDTALKSAlkermes reports Q2 adjusted EPS 11c, consensus 14c
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06:41 EDTAUXLAuxilium reports XIAFLEX milestone, triggers $10M payment
Auxilium Pharmaceuticals announced that the company will receive a $10M regulatory milestone payment from its partner Asahi Kasei Pharma Corporation. The payment is due because of the successful submission of a regulatory application to the Japanese Pharmaceutical and Medical Device Agency, or PMDA, for XIAFLEX for the treatment of Dupuytren's contracture, or DC. The review by PMDA is expected to be completed by mid-2015. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
July 30, 2014
13:54 EDTRNASarepta surges after FDA says will explore quick approval of DMD drugs
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09:04 EDTRNAFDA says 'willing to explore' accelerated approval for DMD drugs
In response to a White House petition urging the FDA to accelerate approval for safe, effective therapies for children with Duchenne, Janet Woodcock, Director, FDA Center for Drug Evaluation and Research, said in a response, "We are willing to explore the use of all potential pathways for the approval of drugs for Duchenne muscular dystrophy, including accelerated approval, as appropriate." She added, "We share your sense of urgency to make safe and effective drugs available for patients with Duchenne muscular dystrophy as soon as possible. That's why we're actively engaged with a number of drug companies focused on developing new drugs for Duchenne muscular dystrophy, including Sarepta Therapeutics, the company developing eteplirsen, an investigational new drug for Duchenne muscular dystrophy." Shares of Sarepta (SRPT) are trading up 5%, or 97c, to $21.30 in pre-market trading. Yesterday afternoon, Wall Street Journal reported that Sarepta is limiting the role its CEO Chris Garabedian is playing in talks with the FDA. Prosensa (RNA) is also developing a treatment for Duchenne muscular dystroph, or DMD. Reference Link
07:17 EDTALKSAlkermes announces initiation of ALKS 5461 FORWARD-5 clinical study
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July 29, 2014
08:32 EDTXONIntrexon enters into technology collaboration with animal health company
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July 28, 2014
06:35 EDTRNAProsensa upgraded to Buy from Neutral at Roth Capital
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July 22, 2014
15:46 EDTGALEGalena in-license of Zuplenz makes sense, says Piper Jaffray
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09:55 EDTGALEGalena 'stands little chance' of improving Zuplenz sales, TheStreet says
After Galena BioPharma entered into a license agreement with MonoSol Rx for Zuplenz, TheStreet's Adam Feuerstein predicted that the company "stands little chance of delivering higher sales of Zuplenz than its previous marketer," calling the drug one that "no one wants" and "something to promote while waiting for the phase III study of NeuVax in breast cancer to inevitably fail." Reference Link
07:21 EDTGALEGalena enters into licensing agreement with MonoSol Rx
MonoSol Rx announced that it has licensed Zuplenz to Galena Biopharma. Zuplenz is an oral soluble film, or OSF, for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting. The licensing agreement includes an undisclosed upfront payment from Galena, as well as double digit royalty payments from sales of Zuplenz. Zuplenz is the first oral soluble lingual film product approved by the FDA as a prescription medication, based on MonoSol Rx's proprietary PharmFilm technology.
07:15 EDTXON, ZIOPZiopharm announces expansion of oncology programs with Intrexon
Ziopharm (ZIOP) announced the expansion of synthetic immuno-oncology programs in conjunction with Intrexon (XON) to include chimeric antigen receptor T-cell, or CAR-T, therapy. Additionally the company has provided an update on its development efforts with the proprietary RheoSwitch Therapeutic System, or RTS, platform, an inducible regulator for expression of therapeutic molecules through administration of an oral activator ligand, as well as its clinical program with Ad-RTS-IL-12, a novel DNA-based therapeutic candidate for the controlled expression of IL-12. CAR-T cells represent an emerging, high value immunological therapy that can target and destroy cancer cells displaying "personalized" fingerprints, yet current approaches feature challenges associated with toxicity, off-target effects, and uneconomical manufacturing. Intrexon possesses the integrated technology platforms, molecular engineering, systems biology, and cell engineering capabilities required to overcome these challenges and fully realize the potential of CAR]T cell therapies. Most significantly, utilization of the RTS platform will facilitate exquisite regulation of one or more bioeffectors in CAR-T cells enabling physicians to control systemic effects of cell therapies with an appropriate dosing regimen of the oral activator ligand, and eventually bring about improved safety and efficacy of these and related therapeutic strategies. Further preclinical work is underway in this promising area of study, and ZIOPHARM and Intrexon expect to provide a progress update in the second half of 2014.

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