Author Archive

Offering news for EPZM HALO ABIO

Feb 04, 2014 No Comments

Epizyme, Inc. (NASDAQ: EPZM) announced that it has commenced an underwritten public offering of 3,000,000 new shares. Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that it has commenced an underwritten public offering of $100,000,000 of shares of its common stock. ARCA biopharma, Inc. (Nasdaq: ABIO) also announced that it intends to offer and sell common stock and warrants in […]

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VNDA FDA Approval. IMGN Phase 3 data release update. RGDO and MELA private placements + CYTR prices offering

Feb 02, 2014 No Comments

Vanda Pharmaceuticals Inc.(VANDA) (NASDAQ: VNDA) announced that the FDA has approved HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).  HETLIOZ is the first FDA approved medication for Non-24. Regado Biosciences, Inc. (Nasdaq: RGDO) announced that it will sell $20 million of its common stock in a private placement. They also noted that the second interim analysis of REGULATE-PCI […]

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AVNR files NDA. AVEO discontinues BATON trial. CORT date due 2Q. CYTR offering. SLXP PDUFA set + AERI GERN

Jan 31, 2014 No Comments

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that they have submitted a New Drug Application (NDA) to the FDA for AVP-825, for the acute treatment of migraine. AVEO Oncology (NASDAQ: AVEO $1.67)  announced that AVEO and Astellas Pharma Inc. have jointly decided to discontinue the BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer Phase 2 trial due to insufficient enrollment. Aerie Pharmaceuticals, Inc. (NASDAQ:AERI $17.91) announced dosing […]

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KBIO fails Phase 2 asthma trial. Offering news from GERN PBYI and TSRO

Jan 30, 2014 No Comments

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO $4.65) announced that their Phase 2 trial of KB003, in patients with severe asthma, did not meet its primary clinical endpoint. Geron Corporation (Nasdaq: GERN $4.33) announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Puma Biotechnology Inc (NYSE:PBYI $125.19) noted in a […]

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NYMX trial updates. TSRO ALIM IDIX raising cash + CTIC news

Jan 29, 2014 No Comments

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update noting that patient participation in the NX02-0017 pivotal Phase 3 benign prostatic hyperplasia (BPH) study is completed. Patient participation in the second pivotal trial, NX02-0018, will be completed in 2Q 2014. Unblinding and data analyses of the two pivotal studies will commence in 2Q 2014 with top line results […]

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HRTX NDA filing delay. KOOL ASTM to raise cash + GERN news

Jan 28, 2014 No Comments

Heron Therapeutics, Inc. (NASDAQ: HRTX $11.50 – formerly APPA) announced that their resubmission of the new drug application (NDA) for Sustol, for chemotherapy-induced nausea and vomiting (CINV), will be delayed by approximately one quarter. Previous guidance had Heron resubmitting their NDA this quarter. However, this has been delayed until 2Q 2014. The delay is due […]

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BDSI ENDP Phase 3 endpoint met. PGNX ATOS TXNP DSCI to raise cash. EXEL XNPT price offerings. APPA NASDAQ uplist + CYTR

Jan 24, 2014 No Comments

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) filed a $150m shelf and also noted that it has entered into a sales agreement where up to $50m of common stock may be issued and sold under a sales agreement with Cantor Fitzgerald & Co. Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) announced that it intends to offer shares of its common stock in an […]

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AMAG issued CRL. EXEL EBS offerings + NKTR KERX offering details

Jan 23, 2014 No Comments

AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced that the FDA issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. Emergent BioSolutions Inc. (NYSE: EBS) announced that it intends to offer $200 million aggregate principal amount of Convertible Senior Notes due 2021. Exelixis, Inc.(Nasdaq: EXEL) announced that it plans to […]

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AMAG PDUFA update due TODAY. FDA rejects AMRN SPA appeal. NKTR KERX offerings + VVUS BLRX AUXL news

Jan 22, 2014 No Comments

Amarin Corporation plc (Nasdaq:AMRN $1.73) announced that the FDA rejected their appeal to reinstate the ANCHOR Special Protocol Assessment (SPA) agreement. They plan to appeal the decision. Amarin do not expect an approval decision of their pending ANCHOR supplemental new drug application (sNDA) while the appeal is pending. Nektar Therapeutics (Nasdaq: NKTR $13.51) announced that it has commenced an underwritten public […]

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Further delays for AMRN. CLSN RNN offerings. Updates for ZIOP and GERN

Jan 15, 2014 No Comments

Amarin Corporation plc (Nasdaq:AMRN $2.40) announced that the FDA notified the company that a determination on Amarin’s request for reconsideration of the October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement will be delayed.No definitive date has been given for the FDA response planned response. Celsion Corporation  (NASDAQ:CLSN $4.00)  announced they will issue approximately $15 million of […]

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CHTP wins at Adcom + updates for MEIP MNOV BMRN CYTR NKTR CTIC NYMX

Jan 15, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $2.30) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic […]

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