Author Archive

Offering news for ACAD CYCC RMTI VVUS + updates for GILD SYN

May 16, 2013 No Comments

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) announced that it is offering to sell shares of its common stock in an underwritten offering. VIVUS, Inc. (Nasdaq:VVUS) announced that it intends to offer $200 million aggregate principal amount of convertible senior unsecured notes due May 1, 2020. Rockwell Medical, Inc. (Nasdaq:RMTI) priced its underwritten public offering of 11,475,410 shares at a […]

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AFFY CEO contract terminated. ACAD RMTI offerings. SGEN PDUFA date set + TTPH LGND PTN PRMD KBIO GENT updates

May 15, 2013 No Comments

Affymax, Inc. (NASDAQ:AFFY) announced in a filing that the contract of its CEO, John Orwin, has been terminated. This follows a company-wide restructuring plan by The Brenner Group, Inc, a restructuring firm assigned by Affymax. Rockwell Medical, Inc. (Nasdaq:RMTI) announced it intends to offer shares in an underwritten public offering. ACADIA Pharmaceuticals Inc. (ACAD) also  announced it intends to offer shares […]

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Pipeline updates for SUPN KYTH MACK TGTX CCXI. BIOD files ATM. GHDX shelf.

May 14, 2013 No Comments

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) maintained guidance that they expect a final approval decision for Trokendi XR from the FDA in 3Q 2013. In addition, it intends to meet with the FDA by the end of the year regarding a Phase 3 trial of SPN 81o for Impulsive Aggression in ADHD. The company is also planning on initiating a Phase 2b […]

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Pipeline profiles of two recent IPOs – RCPT and GWPH

May 11, 2013 No Comments

Receptos, Inc. (Nasdaq:RCPT) – Pipeline profile RPC1063 – Phase 2 top-line data anticipated in mid-2014 from its Phase 2/3 trial (called RADIANCE)  for Relapsing Multiple Sclerosis (RMS). A Special Protocol Assessment (SPA) has been obtained for the Phase 3 portion and for the second pivotal Phase 3 RMS trial. RPC1063 – Phase 2 top-line data for the treatment of Ulcerative Colitis (UC) expected in […]

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THRX FDA Approval. DRRX PTIE Remoxy resubmission mid-2015 at earliest + BOTA LXRX LLY SLXP OMER updates

May 10, 2013 No Comments

DURECT Corporation(Nasdaq: DRRX) and Pain Therapeutics, Inc. (Nasdaq:PTIE) announced that Pfizer provided an update on the complete response letter received in 2011 for Remoxy for patients with chronic pain. Pfizer advised in the filing that, “if we elect to continue development of Remoxy,we would not expect to submit a response to the “complete response” letter before mid-2015.” […]

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Pipeline updates for OPK VNDA SNSS SRPT NKTR INSV VICL PBYI ANAC SPPI NPSP IMUC ZGNX + OMER offering

May 10, 2013 No Comments

OPKO Health, Inc. (NYSE: OPK) noted that Phase 3 data of CTAP 101 Capsules for the treatment of Secondary Hyperparathyroidism (SHPT) are due mid-2014, while Phase 3 data from its licensee trial (TESARO, Inc.) of rolapitant for the prevention of chemotherapy induced nausea and vomiting, are expected during 2H 2013. Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA) maintained guidance […]

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Pipeline updates for CNDO OREX BIOD RMTI ALIOF ACRX CYTR SGMO + ISIS offering

May 09, 2013 No Comments

Coronado Biosciences, Inc. (NASDAQ: CNDO) said that it expects data from its Phase 2 trials of Trichuris suis ova suspension (TSO) in patients with Crohn’s disease, during 2H 2013. Orexigen Therapeutics, Inc. (Nasdaq: OREX) maintained guidance that it expects to conduct the interim analysis from the Light Study and resubmit the Contrave NDA in 2013.  However, as the company stated […]

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Pipeline updates for ACHN BCRX BLRX CLVS RIGL INSM TRGT CBST INFI AEZS SCMP SGEN FURX EXEL FLML TSRX KERX ZIOP ISIS

May 08, 2013 No Comments

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) provided an update noting that interim RVR results from its Phase 2 ACH-3102 trials for the treatment of genotype 1 HCV are due in 3Q 2013 (-007 trial), followed by SVR results during 4Q 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it plans to initiate a Phase 2 trial of BCX4161 in patients with hereditary angioedema, later in 2013 […]

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News for ARRY ISIS ALNY ENTA CELG CYTR

May 07, 2013 No Comments

Array BioPharma Inc. (NASDAQ: ARRY) announced that it will initiate a Phase 3 trial called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer) of MEK162 compared to standard chemotherapy, in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013. Isis Pharmaceuticals, Inc.(NASDAQ: ISIS) announced the initiation of a Phase 1b/2a trial of ISIS-STAT3Rx in patients with advanced […]

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Negative Adcom votes for DCTH and AVEO. ARNA withdraws MAA + pipeline updates for ACOR RPRX DCTH AGN INCY ECYT NBIX OGXI NBY CLDX

May 03, 2013 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that it will be withdrawing the BELVIQ Marketing Authorization Application (MAA) for obesity in the European Union. Acorda Therapeutics, Inc. (Nasdaq: ACOR) noted that it remains on track to submit its NDA for Diazepam Nasal Spray in 2013. Repros Therapeutics Inc.(Nasdaq:RPRX) announced that it has completed enrolment in its second pivotal trial of (ZA-302) […]

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ALIM PSDV PDUFA date set. CHTP NDA update + updates for SHPG GSK PCYC VPHM ETRM JNJ OGXI

May 02, 2013 No Comments

Alimera Sciences, Inc. (NASDAQ: ALIM) and partner pSivida Corp. (NASDAQ:PSDV) announced that they have been assigned a PDUFA date of October 17, 2013 for the resubmission of its NDA for ILUVIEN for treatment of chronic diabetic macular edema (DME). Chelsea Therapeutics International (Nasdaq:CHTP) reported they intend on resubmitting its Northera New Drug Application, late in 2Q or early 3Q 2013, with […]

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