INCY FDA Approval + Updates for ADMA APRI CLDX EARS NERV

Dec 05, 2014 No Comments by

Latest updates to the Company Pipeline Database from December 3 and 4 2014. Refer to the FDA Calendar for upcoming catalysts Ticker Price Drug Indication Stage Link Text Updated ADMA 10.80 RI-002 Primary Immune Deficiency Diseases Phase 3 Phase 3 prelim data released December 2014 met endpoint. Final data due 1Q 2015. BLA filing planned for […]

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EXEL Phase 3 data due 2Q 2015 + upcoming catalyst dates for XNPT IRWD ACHN AQXP + LXRX XOMA updates

Nov 04, 2014 No Comments by

Exelixis, Inc. (NASDAQ:EXEL) provided an update noting that top-line results from their pivotal Phase 3 trial METEOR in metastatic renal cell carcinoma, are now anticipated in 2Q 2015. XenoPort, Inc. (Nasdaq: XNPT) provided an update noting that top-line data from their Phase 2 XP23829 trial as a potential treatment for patients with moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of […]

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Pipeline updates for OPK CLDX ANAC CNAT ACRX GEVA. Offering news for ACAD BLRX

Mar 04, 2014 No Comments by

Anacor Pharmaceuticals (NASDAQ:ANAC) announced that following an End-of-Phase 2 meeting with the FDA, a Phase 3 trial of AN2728 for the topical treatment of mild-to-moderate atopic dermatitis is scheduled to commence by the start of May 2014. Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced the initiation of a Phase 2 clinical trial of emricasan, in patients with nonalcoholic […]

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CLDX prices offering. ABIO to initiate GENETIC-AF next quarter. CERS completes PMA filing + IDRA news

Dec 04, 2013 No Comments

Celldex Therapeutics, Inc. (Nasdaq:CLDX $26.16) announced the pricing of an underwritten public offering of 7,000,000 shares of its common stock, offered at a price to the public of $24.50 per share for an aggregate offering of $171,500,000 of common stock. Idera Pharmaceuticals, Inc. (Nasdaq: IDRA $2.45) announced that enrollment is open for a Phase 1/2 clinical trial of IMO-8400 in patients with […]

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Updates for VNDA RIGL TRGT CYTR BLRX AVNR PBYI OXGN KYTH CLDX

Aug 07, 2013 No Comments

Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA$11.14) announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL $4.14) provided an update that it expects announce a decision about its future plans for fostamatanib in 3Q 2013, as well as Phase 2 data of R343 in allergic asthma. Phase […]

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Biotech news from MDCO CLDX and ARRY

Jul 03, 2013 No Comments

The Medicines Company (NASDAQ: MDCO) announced results for its Phase 3 SOLO II trial of oritavancin, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria. In SOLO II, all protocol-specified primary and secondary efficacy endpoints were met. The company anticipates submitting an NDA in 4Q 2013 and a European MAA […]

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Negative Adcom votes for DCTH and AVEO. ARNA withdraws MAA + pipeline updates for ACOR RPRX DCTH AGN INCY ECYT NBIX OGXI NBY CLDX

May 03, 2013 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that it will be withdrawing the BELVIQ Marketing Authorization Application (MAA) for obesity in the European Union. Acorda Therapeutics, Inc. (Nasdaq: ACOR) noted that it remains on track to submit its NDA for Diazepam Nasal Spray in 2013. Repros Therapeutics Inc.(Nasdaq:RPRX) announced that it has completed enrolment in its second pivotal trial of (ZA-302) […]

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Pipeline updates for CLDX and OGXI. PCYC offering + JNJ files canagliflozin MAA

Mar 08, 2013 No Comments

Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat adult patients with type 2 diabetes. Pharmacyclics, Inc. (NASDAQ: PCYC) announced that it has commenced an underwritten registered public offering of […]

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HEB issued CRL for Ampligen. IDIX discontinues IDX184 trial + CLDX offering

Feb 04, 2013 No Comments

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) announced that it will cease development of IDX184, in phase 2b testing for the treatment of hepatitis C virus (HCV) infection. IDX184 was placed on partial clinical hold in August 2014 due to cardiac adverse events seen in a competitor’s phase 2 clinical trial of BMS-986094. In February 2013, the FDA communicated that the IDX184 […]

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DCTH expects May Adcom meeting. EDIT – BLRX + Pipeline updates for ALNY CLVS INFI OREX FOLD ICPT

Jan 07, 2013 No Comments

BioLineRx (NASDAQ: BLRX) announced today that the results of the interim analysis of its Phase 2/3 CLARITY trial of BL-1020, for the treatment of schizophrenia, are expected during the week beginning March 18, 2013. EDIT: DMC will provide estimate of the total number of patients required in the study in order to achieve statistical significance in the Phase 2/3 data […]

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DCTH PDUFA date set. CRTX CRL. Pipeline updates for IDIX CLDX THLD KERX INCY ECYT RPTP SGEN ISIS PCRX PLX

Nov 04, 2012 No Comments

Delcath Systems, Inc. (NASDAQ: DCTH) announced a PDUFA date of June 15, 2013, for the resubmission of its New Drug Application (NDA) of its chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver. Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced that it received a Complete Response Letter (CRL) for […]

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