BioPharm Update,,,I HATE DVAX! They continually screw over investors.
Also, really bad week in Biotechs as shown:
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
Also, really bad week in Biotechs as shown:
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
'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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