Pipeline updates for ADHD ALXA ANAC ARQL CCXI CERU CLVS CTIC GWPH INFI MGNX PGNX PTLA RDUS SCMP TRLPF TTPH VNDA VSAR XNPT

May 07, 2015 No Comments by

Latest updates to the Company Pipeline Database for May 6 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADHD 5.53 MDX (Metadoxine Extended Release (MG01CI)) Fragile X Syndrome Phase 2b Phase 2b enrolment due to be completed 1Q 2015. Data due 2Q 2015 ADHD 5.53 MDX (Metadoxine Extended Release (MG01CI)) Adult […]

Daily News Read more

Updates for ACAD ANAC BIND BSTC CCXI CNAT CTIC CYTK EBIO EGLT FATE HRTX MRNS OCRX PLX PPHM SNTA SPPI TBPH TKAI TKMR XENE ZSPH

Mar 14, 2015 No Comments by

Latest updates to the Company Pipeline Database. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ACAD 34.45 Pimavanserin Parkinson’s disease psychosis (PDP) Phase 3 NDA filing of Pimavanserin for Parkinson’s disease psychosis (PDP) due 2H 2015 3/14/2015 ANAC 55.66 AN2728 Mild-to-moderate atopic dermatitis Phase 3 Phase 3 […]

Daily News Read more

SPPI PDUFA date set. KYTH Adcom approval. Setback for ACRX + updates for CTIC EDAP GLMD IMUC LGND SSH

Mar 10, 2015 No Comments by

Latest updates to the Company Pipeline Database. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ACRX 5.51 ARX-04 Moderate-to-severe acute pain Phase 3 Phase 3 planned 3/10/2015 ACRX 5.51 Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery CRL CRL Jul 26 2014. […]

Daily News Read more

Updates for ASPX ISIS CTIC MRNS + CPXX added to the database.

Feb 04, 2015 No Comments

Latest updates to the Company Pipeline Database for February 3, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ASPX 58.22 SD-809 Tardive Dyskinesia (TD) Phase 2/3 Phase 2b enrolment completed early Feb 2015. Topline data due mid 2015. Data from Phase 3 trial due 2016 2/4/2015 […]

Read more

Pipeline updates for BIND CTIC DERM + ALKS to initiate pivotal ALKS 3831 trial

Jan 08, 2015 No Comments

Latest updates to the Company Pipeline Database from January 7, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Text Updated ALKS 66.75 ALKS 3831 Schizophrenia Phase 2 Phase 2 data released Jan 2015.Met primary endpoint, equivalence to olanzapine. Pivotal trial planned for 2015 1/8/2015 BIND 5.15 BIND-014 Cancer – […]

Read more

CTIC and CEMP Phase 3 data due 1Q 2015 + pipeline updates for SNTA + CMRX offering

Oct 29, 2014 No Comments

CTI BioPharma Corp. (CTI) (NASDAQ: CTIC) provided an update, maintaining previous guidance that they continue to expect data from their PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis in 1Q 2015. Cempra, Inc. (Nasdaq:CEMP) also provided an update noting that data from their Phase 3 trial of oral solithromycin in adult patients with moderate […]

Read more

POZN resubmits NDA. Trial updates for CTIC OGXI THLD RARE

Jul 02, 2014 No Comments

POZEN Inc. (NASDAQ: POZN) announced that it has resubmitted the NDA for PA8140/PA32540 to the FDA. They expect to hear back from the FDA within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review […]

Read more

ADMP files NDA. INO reverse split update. CTIC name change. AKBA update.

May 30, 2014 No Comments

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced the submission of a 505(b)(2) New Drug Application (NDA) to the FDA for its epinephrine pre-filled single dose syringe (PFS) product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Akebia Therapeutics, Inc. (NASDAQ:AKBA) maintained guidance that Phase 2b data of AKB-6548, for the treatment of anemia related to chronic kidney disease (CKD) […]

Read more

NYMX trial updates. TSRO ALIM IDIX raising cash + CTIC news

Jan 29, 2014 No Comments

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update noting that patient participation in the NX02-0017 pivotal Phase 3 benign prostatic hyperplasia (BPH) study is completed. Patient participation in the second pivotal trial, NX02-0018, will be completed in 2Q 2014. Unblinding and data analyses of the two pivotal studies will commence in 2Q 2014 with top line results […]

Read more

CHTP wins at Adcom + updates for MEIP MNOV BMRN CYTR NKTR CTIC NYMX

Jan 15, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $2.30) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic […]

Read more

INSM Phase 3 data to be released Monday. CHMP approvals for HALO DNDN RPTP + CRL for JNJ

Jun 30, 2013 No Comments

Insmed Incorporated (NASDAQ: INSM) announced that it will report top-line results from its European and Canadian Phase 3 study of ARIKACE to treat cystic fibrosis patients with Pseudomonas aeruginosa lung infections on Monday, July 1, 2013 at 7:00 a.m. Eastern time. Cell Therapeutics, Inc. (NASDAQ: CTIC and MTA: CTIC) announced the resignation of Steven E. Benner, M.D., M.H.S., Senior Vice President, Chief Medical […]

Read more