Pipeline updates for CYTR NBIX CEMP CERS QCOR KMDA CPRX ANTH

Oct 29, 2013 No Comments by

The following companies released pipeline updates with their 3Q financial results on Tuesday. Summary as follows: CytRx Corporation (NASDAQ: CYTR) $2.52 4Q13 – initiate a Phase 2 trial with aldoxorubicin in patients with relapsed glioblastoma. 4Q13 – initiate a Phase 2 trial of aldoxorubicin in treating AIDS-related Kaposi’s sarcoma. December 2013 – report top-line progression-free survival results […]

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CTIC Tosedostat placed on partial clinical hold. CYTK reverse split. CYTR aldoxorubicin data due 2H 2013 + PBMD ANTH updates

Jun 25, 2013 No Comments by

Cell Therapeutics, Inc. (NASDAQ:CTIC) was informed by the FDA that a partial clinical hold has been placed on Tosedostat, for the treatment of blood-related cancers. This follows the death of a patient from myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died. These data will […]

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FURX FDA Approval. THLD initiates Phase 3 pancreatic trial. IMGN pipeline update + ANTH

Jan 27, 2013 No Comments by

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) said that Takeda Pharmaceutical Company Limited received approval from the FDA for three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. […]

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BIIB positive Phase 3 data. CBST pipeline update.ANTH offering + SGEN ARIA ACOR news

Jan 25, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced that it met the primary endpoint, the annualized relapse rate (ARR) at one year, for both the two-week and four-week doses in its Phase 3 pivotal clinical trial, ADVANCE, of peginterferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). It also mentioned that it met the secondary endpoints of risk of 12-week […]

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TRGT fails Phase 2 ADHD. OXGN SPA agreement for Phase 3 ATC trial. ANTH plans Phase 3 lupus trial

Sep 18, 2012 2 Comments

Targacept, Inc. (NASDAQ: TRGT) today announced it failed its Phase 2 trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi). OXiGENE, Inc. (Nasdaq:OXGN) announced that it has come to agreement with the FDA on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid […]

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BPAX closes offering. PCYC $50m milestone. RGLS pending IPO. ANTH to vote to raise authorized shares

Aug 20, 2012 No Comments

BioPharmCatalyst is back with daily updates. BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced the closing of the sale of 2,359,932 shares of its common stock and warrants to purchase up to 1,179,966 additional shares for net proceeds of approximately $3.3 million. Pharmacyclics, Inc. (Nasdaq: PCYC) announced that the clinical trial, SPARK (MCL2001), of ibrutinib in patients with relapsed […]

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ONXX receives FDA Approval. SGEN and ASTX granted positive CHMP recommendations. ANTH and SOMX offering details + PSDV SGYP ARRY news

Jul 20, 2012 No Comments

Onyx Pharmaceuticals (Nasdaq: ONXX) today announced that it received accelerated approval from the FDA for Kyprolis (carfilzomib) for Injection, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Ligand […]

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FDA approves ARNA Belviq for obesity. ANTH fails Phase 2b trial. Pipeline updates for XOMA INSM INFI. EMA rejects Folotyn + SNSS news

Jun 28, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the FDA has approved BELVIQ  for the treatment of obesity. Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.  The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose […]

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ALXA issued CRL. SGYP offering. Pipeline updates for OGXI NGSX ANTH ZIOP THLD EXEL DRRX

May 04, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ADASUVE. In its press release the company said the CRL was issued due to medical device deficiencies and plans to meet with the FDA to resolve the issues. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) […]

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FURX issued CRL. PGNX PDUFA delay. INCY SPPI ANTH pipeline updates. TSPT offering + TRGT news

Apr 26, 2012 No Comments

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) said today that its partner Takeda Pharmaceutical Company Limited received a complete response letter (CRL) from the FDA for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone. The FDA has requested additional data. Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals (NASDAQ: PGNX)  announced that the FDA has extended the PDUFA date of their […]

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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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