BioPhama Updates: shows when companies are scheduled to meet with FDA concerning on-going trial and testing results for drugs.
BPC AUGUST 05 UPDATE
16 Upcoming PDUFA dates and Advisory Committee Meetings for August/September; Week in Review ~ August 4, 2017
Weekly watchlist
As we reach the halfway point of earnings season, it has become more than apparent that despite relatively positive earnings most reporting companies have seen a drop in their share prices. The downtrend was also evident with biotech net outflows hitting $612m for the week ended August 2 as noted by Brad Loncar, the worst week since January 2017.
The coming week will see earnings releases from most of the companies yet to report, with eyes then switching to key catalysts slated for the rest of 3Q. Before we look over such catalysts let’s review five key events from the week that was.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced a delay to its original PDUFA date of August 10, 2017 following a request from the FDA of more information about its proposed post-marketing trial for HEPLISAV-B vaccine for Hepatitis B. The request follows feedback received from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) which voted 12 to 1 supporting approval. The new PDUFA date is November 10, 2017.
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) shares plunged to close the week down 36% to $20.60 following a fall in second quarter earnings and a 75% cut in its dividend. Revenue from its generics was below consensus while it also lowered its EPS forecast to $4.30-$4.50 from $4.90-$5.30, as the company struggled to deal with lower prices for its generic drugs.
Janssen Biotech, Inc. announced that the Arthritis Advisory Committee of FDA did not recommend approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults. The panel voted 12-1 opposing the safety profile of sirukumab.
Spark Therapeutics (NASDAQ:ONCE) shares closed the week up 8% to $76.96 following its announcement earlier in the week of promising initial data from its Phase 1/2 trial of SPK-8011, for patients with hemophilia A. The data showed the gene therapy candidate stabilized Factor VIII activity levels at 14% and 11% of normal in two patients. Shares initially closed up 20% before retracing gains following news of a $350m public offering.
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc.(NASDAQ:AGIO) announced that the FDA approved IDHIFA (enasidenib) for the treatment of adult patients with relapsed or refractory with an IDH2 mutation. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and an IDH2 mutation. Approval was granted under priority review one month earlier than the assigned PDUFA date. Agios shares closed the week up 9% to $61.46.
16 upcoming August and September PDUFA dates and Advisory Committee Meetings:
DRUG STAGE CATALYST
ADMS
ADS-5102
Levodopa-Induced Dyskinesia
PDUFA PDUFA date August 24, 2017.
AMGN
ABP 215
Biosimilar candidate to Avastin (bevacizumab)
PDUFA BsUFA (PDUFA) date September 14, 2017.
AZN
Lynparza - SOLO 2
Second-line ovarian cancer
PDUFA priority review Data presented March 14, 2017 showed significant PFS benefit. PDUFA date under priority review 3Q 2017. Estimate September 28, 2017 assuming 6-month review.
BMY
Opdivo (CM-040)
Previously Treated Hepatocellular Carcinoma
PDUFA priority review PDUFA date under priority review September 24, 2017.
GSK
Shingrix
Shingles
PDUFA BLA filing announced October 24, 2016. PDUFA estimate October 24, 2017. Advisory Committee Meeting September 13, 2017.
IPCI
Rexista
Pain relief
PDUFA PDUFA date September 25, 2017. Advisory Committee Meeting July 26, 2017 voted 22-1 against recommending approval.
JNJ
Sirukumab
Rheumatoid arthritis
PDUFA BLA filing announced September 23, 2016. PDUFA estimate September 23, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
KMDA
KamRAB
Prophylaxis of rabies disease
PDUFA PDUFA date August 29, 2017.
MRK
Keytruda
Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma
PDUFA priority review PDUFA date under priority review Sept. 22, 2017.
MYL
MYL-1401O - trastuzumab biosimilar
Trastuzumab biosimilar
PDUFA PDUFA date September 3, 2017. Advisory Committee Meeting July 13, 2017 voted 16-0 recommending approval.
NEOS
NT-0201
Attention deficit hyperactivity disorder (ADHD)
PDUFA PDUFA date September 15, 2017.
PFE
Sutent (Sunitinib)
Renal cell carcinoma (RCC)
PDUFA priority review PDUFA date January 2018. Specific date not released. BPC estimate late January. Advisory Committee Meeting September 19, 2017.
NVO
Victoza (liraglutide)
Type 2 diabetes
PDUFA FDA Advisory Committee voted 17-2 vote from that Victoza provides substantial evidence of cardiovascular risk reduction. PDUFA date. sNDA filing announced October 25, 2017 - 10 month timeline would render a PDUFA date of on or about August 25, 2017.
NVS
CTL019
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
PDUFA priority review PDUFA date under priority review announced March 29, 2017. No date given. Assume 6-month review - September 29, 2017. Advisory Committee Meeting July 12, 2017 voted 10-0 recommending approval.
PFE
Inotuzumab Ozogamicin
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
PDUFA priority review Priority review announced February 21, 2016. Estimate PDUFA date August 21, 2017 at latest. Possibly earlier as NDA acceptance was announced following 3-day weekend.
PTCT
Translarna
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
PDUFA Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017.
VRX
Latanoprostene bunod
Open angle glaucoma (OAG) or ocular hypertension (OHT)
CRL CRL issued August 7, 2017.
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BPC AUGUST 05 UPDATE
16 Upcoming PDUFA dates and Advisory Committee Meetings for August/September; Week in Review ~ August 4, 2017
Weekly watchlist
As we reach the halfway point of earnings season, it has become more than apparent that despite relatively positive earnings most reporting companies have seen a drop in their share prices. The downtrend was also evident with biotech net outflows hitting $612m for the week ended August 2 as noted by Brad Loncar, the worst week since January 2017.
The coming week will see earnings releases from most of the companies yet to report, with eyes then switching to key catalysts slated for the rest of 3Q. Before we look over such catalysts let’s review five key events from the week that was.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced a delay to its original PDUFA date of August 10, 2017 following a request from the FDA of more information about its proposed post-marketing trial for HEPLISAV-B vaccine for Hepatitis B. The request follows feedback received from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) which voted 12 to 1 supporting approval. The new PDUFA date is November 10, 2017.
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) shares plunged to close the week down 36% to $20.60 following a fall in second quarter earnings and a 75% cut in its dividend. Revenue from its generics was below consensus while it also lowered its EPS forecast to $4.30-$4.50 from $4.90-$5.30, as the company struggled to deal with lower prices for its generic drugs.
Janssen Biotech, Inc. announced that the Arthritis Advisory Committee of FDA did not recommend approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults. The panel voted 12-1 opposing the safety profile of sirukumab.
Spark Therapeutics (NASDAQ:ONCE) shares closed the week up 8% to $76.96 following its announcement earlier in the week of promising initial data from its Phase 1/2 trial of SPK-8011, for patients with hemophilia A. The data showed the gene therapy candidate stabilized Factor VIII activity levels at 14% and 11% of normal in two patients. Shares initially closed up 20% before retracing gains following news of a $350m public offering.
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc.(NASDAQ:AGIO) announced that the FDA approved IDHIFA (enasidenib) for the treatment of adult patients with relapsed or refractory with an IDH2 mutation. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and an IDH2 mutation. Approval was granted under priority review one month earlier than the assigned PDUFA date. Agios shares closed the week up 9% to $61.46.
16 upcoming August and September PDUFA dates and Advisory Committee Meetings:
DRUG STAGE CATALYST
ADMS
ADS-5102
Levodopa-Induced Dyskinesia
PDUFA PDUFA date August 24, 2017.
AMGN
ABP 215
Biosimilar candidate to Avastin (bevacizumab)
PDUFA BsUFA (PDUFA) date September 14, 2017.
AZN
Lynparza - SOLO 2
Second-line ovarian cancer
PDUFA priority review Data presented March 14, 2017 showed significant PFS benefit. PDUFA date under priority review 3Q 2017. Estimate September 28, 2017 assuming 6-month review.
BMY
Opdivo (CM-040)
Previously Treated Hepatocellular Carcinoma
PDUFA priority review PDUFA date under priority review September 24, 2017.
GSK
Shingrix
Shingles
PDUFA BLA filing announced October 24, 2016. PDUFA estimate October 24, 2017. Advisory Committee Meeting September 13, 2017.
IPCI
Rexista
Pain relief
PDUFA PDUFA date September 25, 2017. Advisory Committee Meeting July 26, 2017 voted 22-1 against recommending approval.
JNJ
Sirukumab
Rheumatoid arthritis
PDUFA BLA filing announced September 23, 2016. PDUFA estimate September 23, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
KMDA
KamRAB
Prophylaxis of rabies disease
PDUFA PDUFA date August 29, 2017.
MRK
Keytruda
Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma
PDUFA priority review PDUFA date under priority review Sept. 22, 2017.
MYL
MYL-1401O - trastuzumab biosimilar
Trastuzumab biosimilar
PDUFA PDUFA date September 3, 2017. Advisory Committee Meeting July 13, 2017 voted 16-0 recommending approval.
NEOS
NT-0201
Attention deficit hyperactivity disorder (ADHD)
PDUFA PDUFA date September 15, 2017.
PFE
Sutent (Sunitinib)
Renal cell carcinoma (RCC)
PDUFA priority review PDUFA date January 2018. Specific date not released. BPC estimate late January. Advisory Committee Meeting September 19, 2017.
NVO
Victoza (liraglutide)
Type 2 diabetes
PDUFA FDA Advisory Committee voted 17-2 vote from that Victoza provides substantial evidence of cardiovascular risk reduction. PDUFA date. sNDA filing announced October 25, 2017 - 10 month timeline would render a PDUFA date of on or about August 25, 2017.
NVS
CTL019
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
PDUFA priority review PDUFA date under priority review announced March 29, 2017. No date given. Assume 6-month review - September 29, 2017. Advisory Committee Meeting July 12, 2017 voted 10-0 recommending approval.
PFE
Inotuzumab Ozogamicin
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
PDUFA priority review Priority review announced February 21, 2016. Estimate PDUFA date August 21, 2017 at latest. Possibly earlier as NDA acceptance was announced following 3-day weekend.
PTCT
Translarna
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
PDUFA Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017.
VRX
Latanoprostene bunod
Open angle glaucoma (OAG) or ocular hypertension (OHT)
CRL CRL issued August 7, 2017.
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