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Pharma Stock Roundup: J&J Drug Gets CRL, Label Expansion for Merck and BMY Drugs
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Key highlights in the pharma sector include a complete response letter (“CRL”) from the FDA for Johnson & Johnson’s (JNJ - Free Report) investigational rheumatoid arthritis (“RA”) treatment and FDA approval for Merck’s (MRK - Free Report) and Bristol-Myers Squibb’s (BMY - Free Report) cancer drugs.
Recap of the Week’s Most Important Stories
CRL for J&J RA Drug: J&J’s Janssen Biotech got a CRL from the FDA for sirukumab for the treatment of moderately to severely active RA. The agency has asked for additional data on the safety of sirukumab. This does not come as a surprise considering the investigational treatment failed to get the support of an FDA advisory panel last month. Given the safety concerns raised by the panel, the request for additional data was more or less expected. J&J intends to meet with the agency to determine the requirements for gaining approval for the IL-6 inhibitor.
Meanwhile, the company has submitted a new drug application (“NDA”) for the first darunavir-based single tablet regimen for the treatment of HIV. Approval would make this combination the only complete regimen with the potential to deliver the advantages of a single table regimen with the high genetic barrier to resistance of darunavir and the demonstrated safety profile of TAF.
Another FDA Nod for Merck’s Keytruda: Merck’s anti-PD-1 therapy, Keytruda, has gained FDA approval for yet another indication. The cancer therapy, which is already available for a wide range of indications, can now be used in previously-treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1. This marks the tenth new indication for Keytruda over a three-year period.
Keytruda is a key product in Merck’s portfolio with the drug bringing in sales of $1.5 billion in the first half of 2017. The company is working on expanding the label of the drug which is currently in more than 550 studies covering a wide range of cancers and treatment settings (Read more: Merck's Keytruda Gets FDA Nod for Advanced Gastric Cancer).
Allergan Announces Share Buy Back, CFO Departure: Allergan continues to work on returning capital to its shareholders with the company announcing its intention to buy back shares worth $2 billion. This comes shortly after the company completed a $15 billion share buyback program. Allergan also reaffirmed its commitment to increase its cash dividend every year while reiterating its commitment to maintaining investment grade credit ratings and paying down $3.75 billion of debt in 2018.
The company also announced the departure of Tessa Hilado, executive vice president and chief financial officer ("CFO"), who will be retiring from the company once a successor is appointed.
Bristol-Myers’ Opdivo Gets Another Approval: Bristol-Myers also gained approval for another indication for its immune-oncology therapy, Opdivo. With the latest approval, Opdivo can now be used for the treatment of hepatocellular carcinoma patients previously treated with Nexavar (sorafenib). This makes Opdivo the first and only immuno-oncology agent to be approved for this patient population (Read more: Bristol-Myers Opdivo Gets Approval for Liver Cancer).
The company also gained approval in Japan for the use of Opdivo for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. Gastric cancer is highly prevalent in Asian countries and is the second most commonly diagnosed cancer in Japan.
Bristol-Myers also entered into a clinical trial collaboration with AbbVie under which a combination of Opdivo and AbbVie’s investigational antibody drug conjugate ABBV-399 will be evaluated in c-met overexpressing non-small cell lung cancer (NSCLC).
Bristol-Myers stock has gained 8.1% year to date, compared to the 17.1% rally of the industry it belongs to.
Priority Review for Aradigm Drug: Aradigm got priority review for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with pseudomonas aeruginosa (P. aeruginosa). A response from the agency regarding the approval status of the drug should be out by Jan 26, 2018. NCFBE, a severe, chronic and rare disease, affects more than 150,000 people in the United States and over 200,000 people in Europe. With no drug currently approved for the treatment of this condition, there is significant unmet need. Aradigm’s shares were up 32.8% on the news.
Watch out for the usual pipeline and regulatory updates.
Can Hackers Put Money INTO Your Portfolio?
Earlier this month, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Image: Bigstock
Pharma Stock Roundup: J&J Drug Gets CRL, Label Expansion for Merck and BMY Drugs
Key highlights in the pharma sector include a complete response letter (“CRL”) from the FDA for Johnson & Johnson’s (JNJ - Free Report) investigational rheumatoid arthritis (“RA”) treatment and FDA approval for Merck’s (MRK - Free Report) and Bristol-Myers Squibb’s (BMY - Free Report) cancer drugs.
Recap of the Week’s Most Important Stories
CRL for J&J RA Drug: J&J’s Janssen Biotech got a CRL from the FDA for sirukumab for the treatment of moderately to severely active RA. The agency has asked for additional data on the safety of sirukumab. This does not come as a surprise considering the investigational treatment failed to get the support of an FDA advisory panel last month. Given the safety concerns raised by the panel, the request for additional data was more or less expected. J&J intends to meet with the agency to determine the requirements for gaining approval for the IL-6 inhibitor.
Meanwhile, the company has submitted a new drug application (“NDA”) for the first darunavir-based single tablet regimen for the treatment of HIV. Approval would make this combination the only complete regimen with the potential to deliver the advantages of a single table regimen with the high genetic barrier to resistance of darunavir and the demonstrated safety profile of TAF.
Another FDA Nod for Merck’s Keytruda: Merck’s anti-PD-1 therapy, Keytruda, has gained FDA approval for yet another indication. The cancer therapy, which is already available for a wide range of indications, can now be used in previously-treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1. This marks the tenth new indication for Keytruda over a three-year period.
Keytruda is a key product in Merck’s portfolio with the drug bringing in sales of $1.5 billion in the first half of 2017. The company is working on expanding the label of the drug which is currently in more than 550 studies covering a wide range of cancers and treatment settings (Read more: Merck's Keytruda Gets FDA Nod for Advanced Gastric Cancer).
Merck is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allergan Announces Share Buy Back, CFO Departure: Allergan continues to work on returning capital to its shareholders with the company announcing its intention to buy back shares worth $2 billion. This comes shortly after the company completed a $15 billion share buyback program. Allergan also reaffirmed its commitment to increase its cash dividend every year while reiterating its commitment to maintaining investment grade credit ratings and paying down $3.75 billion of debt in 2018.
The company also announced the departure of Tessa Hilado, executive vice president and chief financial officer ("CFO"), who will be retiring from the company once a successor is appointed.
Bristol-Myers’ Opdivo Gets Another Approval: Bristol-Myers also gained approval for another indication for its immune-oncology therapy, Opdivo. With the latest approval, Opdivo can now be used for the treatment of hepatocellular carcinoma patients previously treated with Nexavar (sorafenib). This makes Opdivo the first and only immuno-oncology agent to be approved for this patient population (Read more: Bristol-Myers Opdivo Gets Approval for Liver Cancer).
The company also gained approval in Japan for the use of Opdivo for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. Gastric cancer is highly prevalent in Asian countries and is the second most commonly diagnosed cancer in Japan.
Bristol-Myers also entered into a clinical trial collaboration with AbbVie under which a combination of Opdivo and AbbVie’s investigational antibody drug conjugate ABBV-399 will be evaluated in c-met overexpressing non-small cell lung cancer (NSCLC).
Bristol-Myers stock has gained 8.1% year to date, compared to the 17.1% rally of the industry it belongs to.
Priority Review for Aradigm Drug: Aradigm got priority review for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with pseudomonas aeruginosa (P. aeruginosa). A response from the agency regarding the approval status of the drug should be out by Jan 26, 2018. NCFBE, a severe, chronic and rare disease, affects more than 150,000 people in the United States and over 200,000 people in Europe. With no drug currently approved for the treatment of this condition, there is significant unmet need. Aradigm’s shares were up 32.8% on the news.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index is down 0.1% so far this week. Among major stocks, Lilly (LLY - Free Report) is up 0.9% while Pfizer (PFE - Free Report) is down 1.3%. Over the last six months, Bristol-Myers was up 14.7% while Glaxo (GSK - Free Report) declined 1.6% (See the last pharma stock roundup here: Pfizer Files Suit against J&J, Supernus Hit by Study Update).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
Can Hackers Put Money INTO Your Portfolio?
Earlier this month, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Download the new report now>>