Archive for September, 2011

September 21, 2011

Sep 21, 2011 No Comments by

Some short and long term potential catalysts as of September 21 2011 (share prices as at the close of trading Wednesday, September 21, 2011). 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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SNTS plans December NDA filing for ulcerative colitis + NBIX SPPI news

Sep 20, 2011 No Comments by

Santarus, Inc. (NASDAQ: SNTS) announced that its NDA of Budesonide MMX for induction of remission of ulcerative colitis is now planned for December 2011. Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced after hours yesterday that it has initiated a second Phase II clinical trial of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The data derived […]

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Clinical trial updates for KERX INHX AEN

Sep 19, 2011 No Comments by

Inhibitex, Inc. (Nasdaq: INHX), announced today that it has recently commenced dosing in a 90-patient randomized, placebo controlled, treatment guided, Phase 2 clinical trial to evaluate the safety, tolerability and antiviral activity of INX-189 in combination with pegylated interferon and ribavirin in chronic HCV-infected genotype 2 and 3 treatment naïve patients. Keryx Biopharmaceuticals (Nasdaq: KERX) […]

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VVUS and TSPT to refile NDAs over next two months. EPCT delist + DVAX TSRX ZGNX

Sep 16, 2011 No Comments

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and Nasdaq: EPCT) yesterday announced that its common stock will begin trading on the OTCQX effective September 19, 2011. EpiCept will simultaneously delist its stock from the Nasdaq Capital Market but maintain its primary listing on the Nasdaq OMX Stockholm Exchange. By doing so it avoids having to reverse […]

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GSK CRIS file NDA for BCC. BPAX to file 4Q 2012. ONTY FOLD initiate trials

Sep 12, 2011 No Comments

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) said today that it expects to file its NDA of Libigel for female sexual dysfunction (FSD) during 4Q 2012. Oncothyreon Inc. (Nasdaq: ONTY) today announced enrollment of the first patient in a Phase 2 trial of PX-866 in patients with recurrent or metastatic castration-resistant prostate cancer. Curis, Inc. (NASDAQ: CRIS) […]

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YMI pipeline update. OPTR positive CHMP opinion. IMMU clinical hold + RGRX CYCC

Sep 09, 2011 No Comments

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea (CDAD). RegeneRx Biopharmaceuticals, Inc. (OTC […]

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MYRX halts Phase 2b Azixa. PPHM pipeline update + SCMP

Sep 09, 2011 No Comments

Myrexis, Inc. (Nasdaq:MYRX) said after hours yesterday that it has suspended any further development of Azixa in order to reallocate resources towards advancing lead candidates from earlier stage programs through pre-clinical and clinical development. It concluded that completing the ongoing Azixa Phase 2b clinical trial would require a disproportionate investment of time and resources relative […]

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RPTP offering. NGSX files sNDA. EXEL data soon + PPHM ALKS

Sep 08, 2011 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP), today announced the pricing of its previously announced underwritten public offering of 10m shares of its common stock at a price to the public of $4 per share for net proceeds of approximately $37,250,000. NeurogesX, Inc. (Nasdaq:NGSX), today announced it submitted a supplemental new drug application (sNDA) to the FDA seeking […]

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DSCO responds to CRL. PARD Nasdaq extension + DRRX ADLR

Sep 06, 2011 No Comments

DURECT Corporation (Nasdaq: DRRX) announced today the dosing of the last patient in the U.S. pivotal Phase 3 clinical study for POSIDUR known as BESST (Bupivacaine Effectiveness and Safety in SABER trial). POSIDUR is a post-operative pain relief depot that utilizes its patented SABER(TM) technology to deliver bupivacaine to provide up to three days of […]

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NURO reverse split. PPHM raise cash. VVUS PDUFA date + TSRX SUPG

Sep 02, 2011 No Comments

NeuroMetrix, Inc. (Nasdaq: NURO), announced after hours yesterday a one-for-six reverse stock split of its common stock, effective immediately. Shares now trade under the symbol NUROD. This is in line with my article last month predicting a late August or early September reverse split. Expect EPCT to be the next to announce a reverse split, […]

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OXGN restructuring. DCTH Ph2 colorectal data + RPRX XOMA

Sep 01, 2011 No Comments

OXiGENE, Inc. (Nasdaq:OXGN) announced today that its Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC) is not feasible. Future development decisions concerning ZYBRESTAT in patients with ATC will be made following a review of all options by management and its board of directors. It is also concluding its Phase 2 […]

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