We have an exciting week on tap, with two FDA AdComs. We are also awaiting twp PDUFA dates which occur next week, lets take a look:
NGSX / ASTX - Both of these companies have panels this week, which is interesting as both are up for sNDAs. This means the drug is already approved, but they are seeking approval for a different indication. The FDA normally releases its 'notes' two days in advance. Recently though they have been releasing documents a bit early, providing quite the trading opportunity for those who watch the FDA's website for updates.
BPAX - BPAX has a PDUFA next week for its Bio-T-Gel. This approval means very little for the company and any spike in share price will likely be short lived. As I have said in the past, any spike in share price in BPAX due to approval will quickly fade and it may be an easy shorting opportunity.
CORT - The most interesting PDUFA date we have in a while is CORT, which is scheduled for NEXT Friday (2/17). CORT has traded poorly recently and the price targets range from $1 on a CRL to $8 on FDA approval. This is one to watch, and will make options trading very interesting.
2-3-12 Catalyst Summary: ALXA, GTHP, IDRA, NBIX, ORMP, CLDX, ADXS, IDIX, SCMP, TLON, and THLD
CTIC
Cell Therapeutics
Price: $1.07
Market Cap: $206
CTIC has (ClinicalTrials.gov ID NCT01321541) with results expected in the 4th quarter of 2012 for PHASE 3 trial in patients with B-cell Non-Hodgkin Lymphoma (NHL), in JANUARY 2012 withdrew NDA seeking approval for relapsed or refractory NHL and plans to resubmit in 2012. CHMP (EMA) opinion expected in mid-FEBRUARY 2012 for EU approval decision.
DND.TO
Cipher Pharma (CPHMF.PK)
Price: $1.04
Market Cap: $25
DND.TO has a PDUFA decision goal date of 5/29/12 under six-month Class 2 review seeking approval for novel formulation of acne drug isotretinoin. They are partnered with Ranbaxy in US. During the 2nd quarter of 2011 completed pivotal PHASE 3 safety trial under SPA to support amended NDA filing. Health Canada decision expected during the 1st quarter of 2013.
ZIOP
Ziopharm Oncology
Price: $5.58
Market Cap: $382
In JANUARY 2012, ZIOP announced independent data monitoring committee unanimously recommended pivotal PHASE 3 trial continue as planned for front-line treatment of metastatic soft tissue sarcoma. They expect to complete enrollment by end 1st quarter of 2012 with primary outcome of progression-free survival (PFS) data expected the 2nd half of 2012, and expects to begin PHASE 3 trial for small cell lung cancer (SCLC) the 2nd half of 2012.
ISTA
ISTA Pharma
Price: $8.10
Market Cap: $336
ISTA expects to file NDA during the 1st half of 2012. They are seeking FDA approval for treatment of post-operative inflammation and reduction of eye pain following cataract removal surgery. VRX unsolicited bid for $7.50 a share cash buyout withdrawn on 1/30/12 due to lack of progress on negotiations.
NPSP
NPS Pharma
Price: $7.67
Market Cap: $660
On 1/31/12, NPSP reported FDA accepted NDA seeking approval as once-daily subcutaneous treatment for short bowel syndrome. They expect a reply within 14 days (2/14/12) for FDA to issue PDUFA decision goal date. Their EU partner Nycomed submitted MAA to EMA in MAR 2011 with expected decision during the 1st quarter of 2012.
ACRX
AcelRx Pharma
Price: $3.22
Market Cap: $63
ACRX expects to dose first patient in first of three planned pivotal PHASE 3 trials (vs. placebo after abdominal and orthopedic surgeries and vs. IV morphine in post-operative patients) by late 1st quarter of 2012-early 2nd quarter of 2012 after software validation completed. It is being developed as patient-controlled analgesia (pain relief) system following surgery.
ARRY
Array BioPharma
Price: $2.97
Market Cap: $173
ARRY has ongoing PHASE 2 trial for treatment of chronic pain in patients with osteoarthritis being compared to OxyContin and placebo for moderate to severe pain in approximately 150 patients that require pain treatment beyond continuing NSAID (e.g. ibuprofen or naproxen) use. They expect to report top-line results during the 1st half of 2012.
DSCO
Discovery Labs
Price: $2.60
Market Cap: $64
In SEPTEMBER 2011, FDA accepted NDA resubmission as six-month Class 2 review with PDUFA decision goal date of 3/6/12. They are seeking approval to prevent respiratory distress syndrome in premature infants, in FEBRUARY 2012 registered AFECTAIR (ventilator connector to deliver aerosol drugs) with FDA (510k exempt) and expect EU clearance for this device the 2nd half of 2012.
DVAX
Dynavax
Price: $4.05
Market Cap: $605
In FEBRUARY 2012, DVAX announced results of pre-BLA meeting with FDA and plans to submit initial BLA by mid-MAY 2012 seeking approval to vaccinate healthy adults age 18-70 against hepatitis B infection. They plan to file sBLA for patients with chronic kidney disease after initial BLA is approved.
ARIA
Ariad Pharma
Price: $15.07
Market Cap: $2,002
On 10/5/11, ARIA announced FDA accepted NDA for 10-month standard review seeking approval for treatment of metastatic soft tissue or bone sarcomas in patients with favorable response to chemo. Their partner is MRK filed for US and EU approval in 3rd quarter of 2011. The estimated FDA decision by 6/5/12 and EU decision during the 1st half of 2012 with FDA advisory panel meeting scheduled 3/20/12.
IDIX
Idenix Pharma
Price: $11.68
Market Cap: $1,123
In FEBRUARY 2012, IDIX FDA removed partial clinical hold allowing enrollment of 30 additional patients in ongoing PHASE 2B trial (ClinicalTrials.gov ID NCT01371604 with final results expected 2nd half of 2013 in combo with interferon and ribavirin) and start new PHASE 2B program (oral interferon-free combo regimens) in coming months for treatment of hepatitis C virus (HCV) infection.
SCMP
Sucampo Pharma
Price: $6.24
Market Cap: $261
In FEBRUARY 2012, SCMP reported PHASE 3 trial-met primary endpoint for Opioid-Induced Bowel Dysfunction (OBD) and plans to file sNDA during the 1st half of 2012. The expected Japan NDA and UK MHRA decisions are during the 1st half of 2012 and arbitration decision with US co-promotion partner Takeda expected during the 1st quarter of 2012.
TLON
Talon Therapeutics (formerly Hana Biosciences)
Price: $0.89
Market Cap: $19
On 9/27/11, TLON announced accelerated FDA review (based on PHASE 2 data) with PDUFA decision goal date of 5/13/12 under standard 10-month review. They are seeking approval for treatment of adults with Philadelphia Chromosome Negative ALL, FDA advisory panel meeting scheduled for 3/21/12.
THLD
Threshold Pharma
Price: $2.99
Market Cap: $147
In SEPTEMBER 2011, THLD announced start of pivotal PHASE 3 trial under SPA in patients with soft tissue sarcoma in combo with doxorubicin (ClinicalTrials.gov ID NCT01440088) with expected update on interim analysis around year-end 2012. In FEBRUARY 2012, licensed (global) to Merck KGaA for $25M upfront, up to $35M milestone paymentss in 2012 ($525M total) and 70% cost-sharing.
NGSX / ASTX - Both of these companies have panels this week, which is interesting as both are up for sNDAs. This means the drug is already approved, but they are seeking approval for a different indication. The FDA normally releases its 'notes' two days in advance. Recently though they have been releasing documents a bit early, providing quite the trading opportunity for those who watch the FDA's website for updates.
BPAX - BPAX has a PDUFA next week for its Bio-T-Gel. This approval means very little for the company and any spike in share price will likely be short lived. As I have said in the past, any spike in share price in BPAX due to approval will quickly fade and it may be an easy shorting opportunity.
CORT - The most interesting PDUFA date we have in a while is CORT, which is scheduled for NEXT Friday (2/17). CORT has traded poorly recently and the price targets range from $1 on a CRL to $8 on FDA approval. This is one to watch, and will make options trading very interesting.
2-3-12 Catalyst Summary: ALXA, GTHP, IDRA, NBIX, ORMP, CLDX, ADXS, IDIX, SCMP, TLON, and THLD
CTIC
Cell Therapeutics
Price: $1.07
Market Cap: $206
CTIC has (ClinicalTrials.gov ID NCT01321541) with results expected in the 4th quarter of 2012 for PHASE 3 trial in patients with B-cell Non-Hodgkin Lymphoma (NHL), in JANUARY 2012 withdrew NDA seeking approval for relapsed or refractory NHL and plans to resubmit in 2012. CHMP (EMA) opinion expected in mid-FEBRUARY 2012 for EU approval decision.
DND.TO
Cipher Pharma (CPHMF.PK)
Price: $1.04
Market Cap: $25
DND.TO has a PDUFA decision goal date of 5/29/12 under six-month Class 2 review seeking approval for novel formulation of acne drug isotretinoin. They are partnered with Ranbaxy in US. During the 2nd quarter of 2011 completed pivotal PHASE 3 safety trial under SPA to support amended NDA filing. Health Canada decision expected during the 1st quarter of 2013.
ZIOP
Ziopharm Oncology
Price: $5.58
Market Cap: $382
In JANUARY 2012, ZIOP announced independent data monitoring committee unanimously recommended pivotal PHASE 3 trial continue as planned for front-line treatment of metastatic soft tissue sarcoma. They expect to complete enrollment by end 1st quarter of 2012 with primary outcome of progression-free survival (PFS) data expected the 2nd half of 2012, and expects to begin PHASE 3 trial for small cell lung cancer (SCLC) the 2nd half of 2012.
ISTA
ISTA Pharma
Price: $8.10
Market Cap: $336
ISTA expects to file NDA during the 1st half of 2012. They are seeking FDA approval for treatment of post-operative inflammation and reduction of eye pain following cataract removal surgery. VRX unsolicited bid for $7.50 a share cash buyout withdrawn on 1/30/12 due to lack of progress on negotiations.
NPSP
NPS Pharma
Price: $7.67
Market Cap: $660
On 1/31/12, NPSP reported FDA accepted NDA seeking approval as once-daily subcutaneous treatment for short bowel syndrome. They expect a reply within 14 days (2/14/12) for FDA to issue PDUFA decision goal date. Their EU partner Nycomed submitted MAA to EMA in MAR 2011 with expected decision during the 1st quarter of 2012.
ACRX
AcelRx Pharma
Price: $3.22
Market Cap: $63
ACRX expects to dose first patient in first of three planned pivotal PHASE 3 trials (vs. placebo after abdominal and orthopedic surgeries and vs. IV morphine in post-operative patients) by late 1st quarter of 2012-early 2nd quarter of 2012 after software validation completed. It is being developed as patient-controlled analgesia (pain relief) system following surgery.
ARRY
Array BioPharma
Price: $2.97
Market Cap: $173
ARRY has ongoing PHASE 2 trial for treatment of chronic pain in patients with osteoarthritis being compared to OxyContin and placebo for moderate to severe pain in approximately 150 patients that require pain treatment beyond continuing NSAID (e.g. ibuprofen or naproxen) use. They expect to report top-line results during the 1st half of 2012.
DSCO
Discovery Labs
Price: $2.60
Market Cap: $64
In SEPTEMBER 2011, FDA accepted NDA resubmission as six-month Class 2 review with PDUFA decision goal date of 3/6/12. They are seeking approval to prevent respiratory distress syndrome in premature infants, in FEBRUARY 2012 registered AFECTAIR (ventilator connector to deliver aerosol drugs) with FDA (510k exempt) and expect EU clearance for this device the 2nd half of 2012.
DVAX
Dynavax
Price: $4.05
Market Cap: $605
In FEBRUARY 2012, DVAX announced results of pre-BLA meeting with FDA and plans to submit initial BLA by mid-MAY 2012 seeking approval to vaccinate healthy adults age 18-70 against hepatitis B infection. They plan to file sBLA for patients with chronic kidney disease after initial BLA is approved.
ARIA
Ariad Pharma
Price: $15.07
Market Cap: $2,002
On 10/5/11, ARIA announced FDA accepted NDA for 10-month standard review seeking approval for treatment of metastatic soft tissue or bone sarcomas in patients with favorable response to chemo. Their partner is MRK filed for US and EU approval in 3rd quarter of 2011. The estimated FDA decision by 6/5/12 and EU decision during the 1st half of 2012 with FDA advisory panel meeting scheduled 3/20/12.
IDIX
Idenix Pharma
Price: $11.68
Market Cap: $1,123
In FEBRUARY 2012, IDIX FDA removed partial clinical hold allowing enrollment of 30 additional patients in ongoing PHASE 2B trial (ClinicalTrials.gov ID NCT01371604 with final results expected 2nd half of 2013 in combo with interferon and ribavirin) and start new PHASE 2B program (oral interferon-free combo regimens) in coming months for treatment of hepatitis C virus (HCV) infection.
SCMP
Sucampo Pharma
Price: $6.24
Market Cap: $261
In FEBRUARY 2012, SCMP reported PHASE 3 trial-met primary endpoint for Opioid-Induced Bowel Dysfunction (OBD) and plans to file sNDA during the 1st half of 2012. The expected Japan NDA and UK MHRA decisions are during the 1st half of 2012 and arbitration decision with US co-promotion partner Takeda expected during the 1st quarter of 2012.
TLON
Talon Therapeutics (formerly Hana Biosciences)
Price: $0.89
Market Cap: $19
On 9/27/11, TLON announced accelerated FDA review (based on PHASE 2 data) with PDUFA decision goal date of 5/13/12 under standard 10-month review. They are seeking approval for treatment of adults with Philadelphia Chromosome Negative ALL, FDA advisory panel meeting scheduled for 3/21/12.
THLD
Threshold Pharma
Price: $2.99
Market Cap: $147
In SEPTEMBER 2011, THLD announced start of pivotal PHASE 3 trial under SPA in patients with soft tissue sarcoma in combo with doxorubicin (ClinicalTrials.gov ID NCT01440088) with expected update on interim analysis around year-end 2012. In FEBRUARY 2012, licensed (global) to Merck KGaA for $25M upfront, up to $35M milestone paymentss in 2012 ($525M total) and 70% cost-sharing.
