CHTP FDA decision delayed until Tuesday. BMRN FDA Approval. STEM offering

Feb 16, 2014 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $4.73) announced that as a result of severe weather conditions leading to an office closure, the FDA today notified the company that the goal date for their NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014. BioMarin Pharmaceutical Inc. (Nasdaq:BMRN $75.81) announced that the FDA […]

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

Jan 15, 2014 No Comments by

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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PCYC FDA Approval. Offering priced for CHTP SNTA + updates for DSCI SGYP NKTR

Nov 13, 2013 No Comments by

Pharmacyclics, Inc. (NASDAQ: PCYC $123.82) announced that the FDA has approved IMBRUVICA (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Synta Pharmaceuticals Corp. (NASDAQ: SNTA $3.78) announced that it has priced an underwritten public offering of 14,000,000 shares at a price to the […]

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FDA says no to early NDA filing for SRPT + CHTP offering+ updates for APPA GTXI OREX SNSS SNTA SPPI ARIA PBYI CLSN KBIO ARIA PBYI OXGN BDSI SGYP ONTX MGNX

Nov 13, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it plans to offer shares of its common stock in an underwritten public offering. A.P. Pharma, Inc. (OTCBB: APPA.OB) said that their resubmission of the NDA for Sustol (formerly known as APF530) is targeted for 1Q 2014 GTx, Inc. (Nasdaq: GTXI) said that they expect to complete enrollment of their Phase […]

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CHTP PDUFA date set. RMTI meets endpoints + updates for TTNP ENDO BDSI ARIA THRX

Sep 05, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $3.09) announced that the FDA has accepted the New Drug Application (NDA) resubmission of NORTHERA, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is February 14, 2014. ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA $20.35)  announced enrollment of fifty percent of the patients planned in its randomized Phase 3 […]

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CHTP PDUFA delay. VNDA PDUFA date assigned. ANAC submits NDA + SNSS VRTX ARRY news

Jul 30, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the FDA has requested further information regarding the resubmitted New Drug Application (NDA) for NORTHERA (droxidopa). As a result the original PDUFA date will be extended from January 3, 2014, to a date to be confirmed later. The FDA noted deficiencies that relate to the formatting of certain submitted […]

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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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FDA upholds non approval PMA decision. CVM offering + CHTP THRX news

Dec 04, 2012 No Comments

Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today that the FDA has upheld its non-approvable decision for the Monovisc PMA. The company plans to schedule a meeting with the FDA to determine the next steps concerning the Monovisc product. CEL-SCI Corporation (NYSE MKT: CVM) said it will sell 35 million shares of its common stock at a price per […]

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Pipeline updates for SNTS BCRX ANAC VNDA ATRS AUXL ITMN ALIM NKTR CHTP VICL

Nov 08, 2012 No Comments

Vical Incorporated (Nasdaq:VICL) said that it has revised  its projection for reaching the target number of death events in its Phase 3 Allovectin melanoma trial, to mid-2013. The company also noted that Astellas is planning to initiate a multinational pivotal Phase 3 trial of TransVax in hematopoietic cell transplant (HCT) recipients and a Phase 2 trial of TransVax for solid organ […]

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CHTP advised to conduct additional trial. OSUR FDA Approval. NVO terminates PCRX agreement. MNOV October FDA meeting.PTN raises cash + SPPI

Jul 03, 2012 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) received advice from the FDA regarding further development of Northera (droxidopa) in the U.S. The FDA advised that the company conduct an additional trial to demonstrate that droxidopa has a significant and persistent effect’ on symptoms of neurogenic orthostatic hypotension. OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that the U.S. Food and Drug Administration […]

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EXEL files shelf. CHTP cost-saving measures. ALNY initiates Phase 2 trial for ATTR.

Jun 08, 2012 No Comments

EXELIXIS INC (NASDAQ: EXEL) filed a mixed shelf today on a Form S‑3ASR to register an unspecified amount of equity or debt securities. The shelf becomes effective automatically without the requirement of review by the SEC. Companies classed as “well known seasoned issuers” (“WKSI”) may file an automatic shelf registration (ASR), which allows it to not specify the dollar […]

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