Author Archive

CLSN fails Phase 3 ThermoDox trial. Updates for SPPI ARQL VNDA CYTR

Feb 01, 2013 No Comments

Celsion Corporation (NASDAQ: CLSN) announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase 3 trial in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer. Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: ARQL)  announced that the first patient has been enrolled in the pivotal Phase […]

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CLSN Phase 3 data due Thursday. STML pipeline profile. Offering details for NLNK NAVB VTUS + ANX MDGN updates

Jan 30, 2013 No Comments

Celsion Corporation (NASDAQ: CLSN) today announced that it will host a conference call and webcast at 8:00 a.m. Eastern Time on Thursday, January 31, 2013 to present the top-line results from its pivotal Phase 3 HEAT Study with ThermoDox in combination with radiofrequency ablation (RFA) in patients with intermediate hepatocellular carcinoma (HCC) versus those patients receiving RFA alone. Stemline Therapeutics, Inc […]

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ISIS FDA Approval. ANAC meets endpoint but disappoints. Offering news for KERX VTUS NLNK

Jan 30, 2013 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) announced positive preliminary results from the first of two Phase 3 trials of tavaborole, for onychomycosis, a fungal infection of the nail and nail bed. 6.5% of patients treated with tavaborole met the primary endpoint of “complete cure” vs. 0.5% of patients treated with vehicle (p=0.001) at week 52. However, data disappointed traders […]

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ANAC data and new biotech IPO Tuesday. RPRX data delay.KERX postive data release. SPPI NDA due mid 2013 + BCRX news

Jan 28, 2013 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) will release preliminary results from the first of two Phase 3 studies of tavaborole for onychomycosis tomorrow, January 29, 2013 at approximately 7:00 a.m. ET. The announcement will be followed by a conference call at 8:00 a.m. ET to discuss the results. Stemline Therapeutics, Inc., (NASDAQ: STML) today announced the pricing of its initial public offering of […]

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FURX FDA Approval. THLD initiates Phase 3 pancreatic trial. IMGN pipeline update + ANTH

Jan 27, 2013 No Comments

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) said that Takeda Pharmaceutical Company Limited received approval from the FDA for three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. […]

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BIIB positive Phase 3 data. CBST pipeline update.ANTH offering + SGEN ARIA ACOR news

Jan 25, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced that it met the primary endpoint, the annualized relapse rate (ARR) at one year, for both the two-week and four-week doses in its Phase 3 pivotal clinical trial, ADVANCE, of peginterferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). It also mentioned that it met the secondary endpoints of risk of 12-week […]

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ARIA offering. VNDA NDA filing due mid 2013. ENMD initiated Phase 2 Soft Tissue Sarcoma

Jan 24, 2013 No Comments

ARIAD Pharmaceuticals, Inc.(NASDAQ: ARIA) announced that it has commenced an underwritten public offering of shares of its common stock. EntreMed, Inc. (ENMD) announced the initiation of a single-center Phase 2 trial of Oral ENMD-2076 in patients with Advanced/Metastatic Soft Tissue Sarcoma. Vanda Pharmaceuticals Inc.(NASDAQ: VNDA) announced positive results for the second Phase 3 study of […]

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ARNA EMA update. AGN to acquire MAPP. PGNX adds to pipeline. IPXL receives CRL + BDSI update

Jan 23, 2013 No Comments

Arena Pharmaceuticals (NASDAQ:ARNA) said in a filing today that it has received the Day 180 List of Outstanding Issues from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its Marketing Authorization Application (MAA) of BELVIQ (lorcaserin HCl) for obesity. The major concerns from the EMA include issues such as tumors in rats, valvulopathy and psychiatric events, […]

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AGN FDA Approval. ANAC enters into ATM equity agreement. TSRX offering details.

Jan 18, 2013 No Comments

Anacor Pharmaceuticals, Inc (NASDAQ: ANAC) announced that they have entered into an equity distribution agreement with Wedbush Securities Inc. where we may offer and sell shares of its common stock having an aggregate offering price of up to $25m from time to time through Wedbush. Allergan, Inc. (NYSE:AGN) announced today that the FDA has approved BOTOX (onabotulinumtoxinA) for the […]

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PATH receives FDA Approval. TSRX offering. AVEO prices offering

Jan 17, 2013 No Comments

NuPathe Inc. (NASDAQ: PATH) today announced that FDA approved Zecuity for the acute treatment of migraine with or without aura in adults. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN). The company now plans to focus on securing commercial partners and preparing for the launch of Zecuity expected in 4Q 2013. A conference […]

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HPTX PDUFA delay. QRXPY to refile NDA this quarter + updates for BIIB ELN EXEL AVEO

Jan 16, 2013 No Comments

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) said that the FDA has advised the company not to expect a final action by the PDUFA date of January 23, 2013. The FDA explained it is continuing to work on label and post-marketing requirements. This follows a previous three month extension. Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that they have submitted applications […]

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