FLXN FX006 placed on clinical hold. ONTY offering + updates NVAX VVUS AUXL ISIS OXGN

Sep 18, 2014 No Comments by

Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced that the FDA informed the company that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2b clinical trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. The FDA has indicated that the clinical hold is due to a single occurrence of an […]

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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 by

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

May 16, 2013 No Comments by

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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ARIA MRK receive CRL. VVUS Qnexa MAA decision delayed. ABT NBIX initiate Phase 3 endometriosis. DYAX analysis of ecallantide due within 3 months + SGYP

Jun 06, 2012 No Comments

Merck (NYSE: MRK) announced that the FDA issued a complete response letter (CRL) regarding the New Drug Application (NDA) for ridaforolimus for patients with metastatic soft tissue or bone sarcoma. The letter stated that additional clinical trial would need to be conducted to further assess safety and efficacy. ARIAD Pharmaceuticals, Inc (Nasdaq: ARIA) has a license […]

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INSM clinical hold lifted. VVUS MAA decision due 2Q. Updates for ANX BCRX KERX PSDV SGEN TZYM PBTH

May 07, 2012 No Comments

Insmed Incorporated (Nasdaq CM: INSM) today announced the FDA lifted the clinical hold previously placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections. ADVENTRX Pharmaceuticals, Inc.(NYSE Amex: ANX) today said that its product ANX-188 is expected to be initiated in a Phase 3 trial in patients with sickle cell disease, later in 2012. VIVUS, Inc. (NASDAQ: VVUS) […]

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Upcoming FDA and clinical catalysts as of April 10 2012

Apr 10, 2012 No Comments

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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VVUS PDUFA date extended. SGYP Phase 2/3 data due 4Q. DARA offering + AFFY OPTR news

Apr 09, 2012 No Comments

VIVUS (Nasdaq:VVUS) was informed today of an extended PDUFA date for the review of the Qnexa New Drug Application (NDA) from April 17, to July 17, 2012. The three-month extension is to allow the FDA time to review the Qnexa Risk Evaluation and Mitigation Strategy (REMS) submitted by the company on April 4, 2012. Synergy Pharmaceuticals, Inc. […]

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MAPP receives CRL. ISTA buyout. RPTP NDA filing this week. APPA NDA mid-2012 + ASTX VVUS ARNA CLVS NBIX news

Mar 26, 2012 No Comments

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it received a Complete Response letter for LEVADEX. The FDA noted that the company will need to address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also noted that it had requested the company to provide information of […]

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Pipeline updates for KERX ZIOP ISIS SNTA + VVUS prices offering.

Mar 01, 2012 No Comments

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) gave a pipeline update noting that it intends to complete its Perifosine Phase 3 study in metastatic colorectal cancer in March 2012, and release top-line data release within several weeks thereafter.  It expects to complete its long-term Phase 3 study of Zerenex in 4Q 2012. ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) gave a pipeline update, […]

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VVUS offering and MAA update. Pipeline updates for BDSI POZN ARIA

Feb 29, 2012 No Comments

VIVUS,Inc. (Nasdaq:VVUS) announced it will offer 8.5m shares of its common stock in an underwritten public offering with an option to issue 1.275m additional shares of common stock to cover over-allotments, if any. It also noted that it received the 180-Day list of outstanding issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) for […]

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VVUS positive AdCom vote. Pipeline updates for SNTA AMLN DYAX + HZNP AVII news

Feb 23, 2012 No Comments

VIVUS, Inc. (NASDAQ: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted in favour by 20 to 2. The PDUFA date for Qnexa is April 17, 2012. Synta Pharmaceuticals Corp. (NASDAQ: SNTA) provided a pipeline update noting that it expects to complete enrolment […]

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