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Discouraging results from a phase II study evaluating AbbVie’s (ABBV - Free Report) promising cancer candidate rovalpituzumab tesirine or Rova-T in third-line or later small cell lung cancer (“SCLC”) grabbed headlines this week. Other news included a purchase offer for J&J’s (JNJ - Free Report) diabetes device unit and successful study results announced by Heron Therapeutics (HRTX - Free Report) and Roche (RHHBY - Free Report) .
Recap of the Week’s Most Important Stories
AbbVie’s Rova-T Falls Short in Key Lung Cancer Study: AbbVie’s promising cancer candidate, rovalpituzumab tesirine or Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later small cell lung cancer (SCLC). AbbVie said it will not seek accelerated approval of Rova-T in the third-line setting after consulting with the FDA. Rova-T was added to AbbVie’s portfolio, following the $5.8 billion acquisition of Stemcentrx in June 2016. AbbVie had significant confidence in Rova-T’s potential. The failure of TRINITY has raised skepticism on Rova-T’s potential and has brought into question the viability of the Stemcentrx deal. (Read More: AbbVie Stock Falls on Weak Lung Cancer Study Outcome)
J&J Gets $2.1B Offer for LifeScan Unit: J&J said it has received a $2.1 billion binding offer from a private equity firm, Platinum Equity, for its LifeScan diabetes device unit. J&J has time until Jun 15 to accept the offer, failing which it will expire. J&J has been evaluating potential strategic options for its Diabetes Care units specifically, LifeScan, Animas Corporation, and Calibra Medical since early last year. (Read More: J&J Gets $2.1B Offer for LifeScan Diabetes Device Unit)
Pfizer Gets FDA’s Priority Review to Expand Label of Xtandi: Pfizer (PFE - Free Report) and its Japanese partner Astellas gained FDA’s priority review for a regulatory filing, which was looking to expand the label of its prostate cancer drug Xtandi to include an early-stage patient population. The regulatory applications to add the non-metastatic Castration-Resistant Prostate Cancer (“CRPC”) indication to the drug’s label were based on the results of the PROSPER study on Xtandi. With the FDA granting priority review, a decision is expected in July. (Read More: Pfizer’s Xtandi Label Expansion Filing Gets Priority Review).
Meanwhile, British company Reckitt Benckiser Group pulled out of the discussion with Pfizer to buy the latter’s Consumer Health segment. Last October, Pfizer had said that it was exploring strategic alternatives for its Consumer Healthcare segment including a partial or a full separation through a spin-off, sale or other transaction. A decision regarding the same is expected to be made this year and it may ultimately opt to retain the business. Glaxo also said it has withdrawn from the race to buy Pfizer’s unit.
Heron’s HTX-011 Succeeds in Phase III: Heron Therapeutics’ pipeline candidate, HTX-011 met the primary endpoint in two pivotal phase III studies, evaluating it in post-operative pain control, following bunionectomy and hernia repair, respectively. Top-line data from both the studies showed that treatment with HTX-011 led to statistically significant reductions in pain intensity and opoid use through 72 hours following surgery. The candidate was also superior to bupivacaine solution, which is the current standard-of care local anesthetic for postoperative pain control. (Read More: Heron's Pain Candidate Meets Endpoint in Pivotal Studies
Roche’s Tecentriq Succeeds in Lung Cancer Combo Study: Roche’s Tecentriq met the co-primary endpoint of progression-free survival in a phase III study, evaluating the PD-L1 inhibitor in combination with chemotherapy (carboplatin and Abraxane) for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC). Tecentriq is already marketed for the treatment of second-line metastatic NSCLC. Label expansion in the first line setting should boost the drug’s sales further. However, Roche awaits overall survival data and the study will continue.(Read More: Roche Tecentriq Phase III Combo Study Meets Primary Endpoint).
Novartis Tasigna Gets FDA Nod for Label Expansion: Novartis’s (NVS - Free Report) leukemia drug Tasigna was granted FDA approval for use in the pediatric (one year of age or older) population for the first- and the second-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Glaxo Begins New Combo Study on Benlysta: Glaxo (GSK - Free Report) has initiated a late-stage study - BLISS-BELIEVE - which will evaluate its systemic lupus erythematosus medicine Benlysta in combination with Roche’s Rituxan. Benlysta, in previous late-stage studies, has demonstrated its consistent efficacy in reducing disease activity in SLE. The aim of the new combination study is to achieve clinical remission in SLE patients apart from demonstrating low disease activity. (Read More: GlaxoSmithKline Initiates Phase III Combo Study on Benlysta
The NYSE ARCA Pharmaceutical Index declined 3.9% in the last five trading sessions.
Here is how the seven major stocks performed this week:
AstraZeneca (AZN - Free Report) was the only stock to record a gain (1.9%) in the last five trading sessions. While J&J declined 4.3%, Bristol-Myers (BMY - Free Report) was down 3.5%.
In the last six months, while AstraZeneca was the biggest gainer (4.2%), Merck (MRK - Free Report) was the biggest loser, declining 15.5%.
Watch out for regulatory and pipeline news from pharma stocks.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
Pharma Stock Roundup: ABBV's Rova-T Disappoints, J&J Unit Gets Buyout Offer
Discouraging results from a phase II study evaluating AbbVie’s (ABBV - Free Report) promising cancer candidate rovalpituzumab tesirine or Rova-T in third-line or later small cell lung cancer (“SCLC”) grabbed headlines this week. Other news included a purchase offer for J&J’s (JNJ - Free Report) diabetes device unit and successful study results announced by Heron Therapeutics (HRTX - Free Report) and Roche (RHHBY - Free Report) .
Recap of the Week’s Most Important Stories
AbbVie’s Rova-T Falls Short in Key Lung Cancer Study: AbbVie’s promising cancer candidate, rovalpituzumab tesirine or Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later small cell lung cancer (SCLC). AbbVie said it will not seek accelerated approval of Rova-T in the third-line setting after consulting with the FDA. Rova-T was added to AbbVie’s portfolio, following the $5.8 billion acquisition of Stemcentrx in June 2016. AbbVie had significant confidence in Rova-T’s potential. The failure of TRINITY has raised skepticism on Rova-T’s potential and has brought into question the viability of the Stemcentrx deal. (Read More: AbbVie Stock Falls on Weak Lung Cancer Study Outcome)
J&J Gets $2.1B Offer for LifeScan Unit: J&J said it has received a $2.1 billion binding offer from a private equity firm, Platinum Equity, for its LifeScan diabetes device unit. J&J has time until Jun 15 to accept the offer, failing which it will expire. J&J has been evaluating potential strategic options for its Diabetes Care units specifically, LifeScan, Animas Corporation, and Calibra Medical since early last year. (Read More: J&J Gets $2.1B Offer for LifeScan Diabetes Device Unit)
Pfizer Gets FDA’s Priority Review to Expand Label of Xtandi: Pfizer (PFE - Free Report) and its Japanese partner Astellas gained FDA’s priority review for a regulatory filing, which was looking to expand the label of its prostate cancer drug Xtandi to include an early-stage patient population. The regulatory applications to add the non-metastatic Castration-Resistant Prostate Cancer (“CRPC”) indication to the drug’s label were based on the results of the PROSPER study on Xtandi. With the FDA granting priority review, a decision is expected in July. (Read More: Pfizer’s Xtandi Label Expansion Filing Gets Priority Review).
Meanwhile, British company Reckitt Benckiser Group pulled out of the discussion with Pfizer to buy the latter’s Consumer Health segment. Last October, Pfizer had said that it was exploring strategic alternatives for its Consumer Healthcare segment including a partial or a full separation through a spin-off, sale or other transaction. A decision regarding the same is expected to be made this year and it may ultimately opt to retain the business. Glaxo also said it has withdrawn from the race to buy Pfizer’s unit.
Heron’s HTX-011 Succeeds in Phase III: Heron Therapeutics’ pipeline candidate, HTX-011 met the primary endpoint in two pivotal phase III studies, evaluating it in post-operative pain control, following bunionectomy and hernia repair, respectively. Top-line data from both the studies showed that treatment with HTX-011 led to statistically significant reductions in pain intensity and opoid use through 72 hours following surgery. The candidate was also superior to bupivacaine solution, which is the current standard-of care local anesthetic for postoperative pain control. (Read More: Heron's Pain Candidate Meets Endpoint in Pivotal Studies
Roche’s Tecentriq Succeeds in Lung Cancer Combo Study: Roche’s Tecentriq met the co-primary endpoint of progression-free survival in a phase III study, evaluating the PD-L1 inhibitor in combination with chemotherapy (carboplatin and Abraxane) for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC). Tecentriq is already marketed for the treatment of second-line metastatic NSCLC. Label expansion in the first line setting should boost the drug’s sales further. However, Roche awaits overall survival data and the study will continue.(Read More: Roche Tecentriq Phase III Combo Study Meets Primary Endpoint).
Novartis Tasigna Gets FDA Nod for Label Expansion: Novartis’s (NVS - Free Report) leukemia drug Tasigna was granted FDA approval for use in the pediatric (one year of age or older) population for the first- and the second-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Glaxo Begins New Combo Study on Benlysta: Glaxo (GSK - Free Report) has initiated a late-stage study - BLISS-BELIEVE - which will evaluate its systemic lupus erythematosus medicine Benlysta in combination with Roche’s Rituxan. Benlysta, in previous late-stage studies, has demonstrated its consistent efficacy in reducing disease activity in SLE. The aim of the new combination study is to achieve clinical remission in SLE patients apart from demonstrating low disease activity. (Read More: GlaxoSmithKline Initiates Phase III Combo Study on Benlysta
The NYSE ARCA Pharmaceutical Index declined 3.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed this week:
AstraZeneca (AZN - Free Report) was the only stock to record a gain (1.9%) in the last five trading sessions. While J&J declined 4.3%, Bristol-Myers (BMY - Free Report) was down 3.5%.
In the last six months, while AstraZeneca was the biggest gainer (4.2%), Merck (MRK - Free Report) was the biggest loser, declining 15.5%.
(See the last pharma stock roundup here: ABBV's Elagolix Meets Study Goal, MRK's Keytruda in Focus)
What's Next in the Pharma World?
Watch out for regulatory and pipeline news from pharma stocks.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>