ALXA resubmits NDA. RGEN receives CRL. Mixed CHMP recommendations for NPSP and PLX+ ASTX news BIOD raises cash

Jun 22, 2012 No Comments by

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its ADASUVE New Drug Application (NDA), for treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The resubmission is in response to a Complete Response Letter (CRL) received in May 2012.  A PDUFA date will be announced in the coming weeks but is […]

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DVAX files BLA. RGEN Adcom meeting cancelled, CRL expected + ONXX ITMN CYTR CYTK THRX POZN news

Apr 27, 2012 No Comments by

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that it has filed a U.S. Biologics License Application (BLA) to the FDA for HEPLISAV, for hepatitis B virus in adults 18 through 70 years of age. The company intends to file a European Marketing Authorization Application (MAA) for HEPLISAV in 3Q 2012. Repligen Corporation (NASDAQ:RGEN) announced the FDA notified the company that […]

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Upcoming FDA and clinical catalysts as of April 10 2012

Apr 10, 2012 No Comments by

Some short and long term potential catalysts as of April 9, 2012 (share prices as at the close of trading Monday, April 9, 2012). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take […]

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RGEN Advisory Committee meeting date set. POZN NDA filing due 3Q. CLVS CYCC raise cash

Mar 23, 2012 No Comments

Repligen Corporation (NASDAQ:RGEN) – The Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the new drug application (NDA) 200-436, synthetic human secretin, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making in patients with known or suspected pancreatitis. POZEN Inc. (NASDAQ: POZN) announced […]

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AEGR and RGEN MAA filings. XOMA offering. ANTH ZLCS update

Mar 06, 2012 No Comments

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lomitapide to reduce cholesterol in patients with Homozygous Familial Hypercholesterolemia (HoFH). Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) said its Phase 2b PEARL-SC trial […]

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Merry Xmas – Summary of pharma events week ending 12/23/12

Dec 23, 2011 No Comments

A Merry Xmas to all readers of BioPharmCatalyst. Thank you all for your support over the past year and wish you all a relaxing break with friends and family! See individual posts made in the last week for more detail.   PDUFA/FDA RELATED EVENTS Santarus, Inc. (NASDAQ: SNTS) submitted its NDA for UCERIS for mild to […]

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Dec 21, 2011 No Comments

Repligen Corporation (NASDAQ: RGEN) said that it has submitted its NDA for SecreFlo (RG1068) for pancreatic imaging in patients with pancreatitis. A 6-month priority review was requested. Impax Pharmaceuticals (NASDAQ: IPXL) also announced the submission of its NDA for IPX066  for the treatment of idiopathic Parkinson’s disease (PD). Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) maintained previous guidance that it expects to […]

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RGEN NDA filing possibly delayed. CLSN raises cash + PLX MHAN

Jul 21, 2011 No Comments

Repligen Corporation (NASDAQ: RGEN) today it intends to file its NDA of RG1068 for MRI Imaging of the Pancreas LATER THIS YEAR. In a previous press release it noted that the NDA would be filed LATER THIS SUMMER. This subtle change in wording may suggest that it will not submit its NDA this summer, rather […]

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GTXI raises cash. ACHN HCV data due 4Q + PARD RGEN news

Jun 23, 2011 No Comments

GTx, Inc. (Nasdaq: GTXI) announced that it intends to sell 10m shares of its common stock in an underwritten public offering at $4.75 per share. Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) yesterday announced that it has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus […]

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RGEN NDA planned this summer + CORT and OREX news

Jun 01, 2011 No Comments

Orexigen Therapeutics, Inc. (Nasdaq: OREX), will announce a regulatory update on Friday, June 3, 2011 before the markets open regarding their obesity candidate Contrave. Coincidentally, they also have their shareholder meeting on June 2, where they will be voting to increase Authorised Shares from 100m to 300m. Corcept Therapeutics Incorporated (NASDAQ:CORT), today announced that it […]

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RGEN fails Phase 2b bipolar depression – ANTH files shelf. ZIOP + KERX

Mar 07, 2011 No Comments

Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) filed a mixed shelf of $75m. Keryx Biopharmaceuticals (Nasdaq: KERX) today announced that the final dataset from the Phase 3 short-term clinical trial of Zerenex (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis has been selected for oral presentation at the upcoming National Kidney […]

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