=Progenics (PGNX) falls on missed study endpoint

Progenics Pharmaceuticals Inc. (PGNX) shares fell in the extended session Wednesday after the cancer drug company said one of its imaging agents was not sensitive enough to detect prostate cancer in a clinical study. Progenics shares fell 19% after hours, following a 1.6% decline to close the regular session at $7.30. The company said a late-stage clinical trial found its so-called "1404" imaging agent needed to positively detect prostate cancer with a 60% or more sensitivity but did so with a 47% to 51% range. The imaging agent, however, was able to detect the absence of prostate cancer correctly with a specificity of 71% to 75% compared with the study target of 60% or more.

This week's biggest % winners & losers : March 19 - 23, 18 (wk 13)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: GERN (5.64 +67.36%), ARNA (41.88 +32.91%), HRTX (28.2 +31.16%), OMER (14.09 +26.71%), AKAO (12.88 +12%)
• Materials: KLDX (2.35 +63.19%), NG (4.61 +12.99%), NGD (2.55 +10.87%), GFI (4.1 +9.92%)
• Industrials: DXPE (39.29 +21.53%), RUN (8.43 +10.05%)
• Consumer Discretionary: GES (20.36 +36.74%), LE (21.45 +32.82%), NWY (3.50 +2.35%)
• Energy: CRC (17.24 +15.78%), SN (3.31 +12.59%), AAV (3.2 +10.34%)
• Telecommunication Services: NIHD (2.2 +20.22%)

This week's top 20 % losers

• Healthcare: ALDR (11.25 -20.49%), MACK (8.29 -19.83%), OTIC (4.05 -19.8%), ENDP (5.86 -16.41%), EXAS (4.12 -16.07%), PGNX (7.54  -10.66%)
• Materials: GSM (11.09 -31.15%), CENX (16.67 -20%), CMC (20.39 -17.21%), EGO (0.9 -15.89%),
• Industrials: RRTS (3.25 -21.5%), MLHR (30.7 -18.68%)
• Consumer Discretionary: GPRO (4.58 -17.33%), EVC (4.35 -15.53%)
• Information Technology: CARB (27.75 -16.92%), BDC (64.55 -16.35%), MTSI (17.72 -16.22%)
• Energy: DM (16.25 -24.77%)
• Telecommunication Services: IDT (10.08 -15.37%)

Progenics Pharma (PGNX) : FDA extends review of the New Drug Application for AZEDRA

Progenics Pharma announces that they have received notification from the FDA that the Agency will extend its review of the New Drug Application for AZEDRA (iobenguane I 131) by three months to July 30, 2018

** charts before announcement **

  

** charts after announcement **

  

=Progenics Pharma (PGNX) : results from AZEDRA phase 2 study

Progenics Pharm announces study results that show treatment with AZEDRA produced clinically meaningful and durable responses across multiple study endpoints, including radiographic tumor response, tumor biomarker response, and overall survival

Co states, "A meaningful proportion of patients treated in this study with AZEDRA achieved a sustained reduction of antihypertensive medications which was correlated with favorable tumor responses, including radiographic tumor responses, tumor biomarker response, and overall survival. The clinical response and antitumor effects observed in this heavily pre-treated study population, along with the acceptable adverse event profile from this trial, provide a strong rationale for the potential use of AZEDRA."

• The study met the primary endpoint, with 17 (25%) of the 68 evaluable patients experiencing a 50% or greater reduction of all antihypertensive medication for at least 6 months.
• Treatment with AZEDRA produced favorable data for a key secondary endpoint, the proportion of study patients with overall tumor response as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
• Median survival time as of March 10, 2017 was 36.7 months (95% CI 29.9 -- 49.1) from first AZEDRA therapeutic dosing in the overall study population, and 48.73 months among patients who received two therapeutic doses, compared to 17.42 months among patients who received only one therapeutic dose.

=Progenics Pharma (PGNX) reported earnings on Wed 9 Aug 2017 (b/o)

Progenics Pharma misses by $0.03, misses on revs

• Reports Q2 (Jun) loss of $0.24 per share, $0.03 worse than the Capital IQ Consensus of ($0.21); revenues fell 67.3% year/year to $2.77 mln vs the $3.34 mln Capital IQ Consensus. 
• AZEDRA NDA Expected to be Submitted August 2017: Progenics expects to complete the rolling submission of the NDA for AZEDRA in patients with malignant and/or recurrent pheochromocytoma to the FDA in August 2017.

=Progenics Pharm (PGNX) reported earnings on Thur 4 May 2017 (b/o)

Progenics Pharm misses by $0.04, misses on revs :

• Reports Q1 (Mar) loss of $0.23 per share, $0.04 worse than the Capital IQ Consensus of ($0.19); revenues fell 4.0% year/year to $2.4 mln vs the $4.5 mln Capital IQ Consensus.
• Phase 3 Study of 1404 Remains On-Track; Phase 2 Data Published in the Journal of Nuclear Medicine. Progenics continues to enroll patients in a Phase 3 study of 1404. The trial is designed to evaluate the specificity of the imaging agent in identifying patients without clinically significant prostate cancer as well as its sensitivity to identify patients with clinically significant disease, and will include approximately 450 patients. Progenics still expects to complete enrollment by the end of 2017.