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Pharma Stock Roundup: FDA Updates on MRK, AZN's Cancer Drugs, Bayer's Q3 Earnings

This week FDA granted approval for a new indication of Merck’s MRK cancer PD-1 inhibitor, Keytruda and gave priority review to label expansion applications filed by AstraZeneca AZN/Merck and Roche RHHBY for their cancer drugs. Bayer BAYRY reported strong third-quarter results.

Recap of the Week’s Most Important Stories

Merck’s Keytruda Gets FDA Nod for Liver Cancer: Merck’s supplemental biologics license application (sBLA) looking to expand the label of Keytruda for previously treated patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, was approved by the FDA. The sBLA filing was based on data from the phase II KEYNOTE-224 study.

Keytruda also met the primary endpoint of overall survival in a phase III study, evaluating it for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma, a difficult to treat cancer. Keytruda significantly improved overall survival (OS) compared to standard chemotherapy in the study

Merck also began a rolling submission of the biologics license application (BLA) for its investigational vaccine for Ebola Zaire disease, V920. The rolling submission is expected to be completed in 2019.

AstraZeneca/Merck’s sNDA for Lynparza Gets FDA’s Priority Review: AstraZeneca announced that the FDA granted priority review to a supplemental New Drug Application (sNDA) looking for label expansion of its advanced ovarian cancer drug, Lynparza in the first-line setting. The sNDA filing was based on data from the phase III SOLO-1 study, which demonstrated that Lynparza led to a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to placebo in women with BRCA-mutated (BRCAm) advanced ovarian cancer. The FDA’s decision is expected in the first quarter of 2019. If approved for expanded use in the first-line setting, sales of Lynparza can improve in the future quarters.

AstraZeneca announced an agreement with Swedish pharma company, Sobi to sell the U.S. rights of its pediatric lung infection medicine, Synagis for an upfront consideration of $1.5 billion plus further contingent payments. About 130 AstraZeneca employees will also shift to Sobi as part of the transaction. In addition, the transaction gives rights to Sobi, officially, Swedish Orphan Biovitrum AB, to participate in the future U.S. profits and losses of AstraZeneca’s pipeline candidate, MEDI8897, which is also being developed for the same indication as Synagis. The Synagis sale is the latest of the several divestiture deals announced this year by AstraZeneca as it streamlines its portfolio.

AstraZeneca presented detailed data from a phase III cardiovascular outcomes study, DECLARE- -TIMI 58, on type II diabetes drug Farxigaat the annual session of the American Heart Association.

In September, AstraZeneca had announced that Farxiga led to statistical significant reduction in hospitalization for heart failure (hHF) or CV death in the study, thereby meeting one of the two primary efficacy endpoints. Along with the latest release, AstraZeneca said that Farxiga significantly reduced the combined risk of hHF or CV death by 17% versus placebo. Meanwhile, for the other endpoint, though fewer major adverse cardiovascular events (MACE) were observed in the Farxiga arm, it did not reach statistical significance (8.8% for Farxiga vs. 9.4% for placebo).

Roche’s Tecentriq sBLA Gets FDA’s Priority Review: Roche’s supplemental Biologics License Application (sBLA) looking for label expansion of its cancer drug, Tecentriq plus Abraxane (nab-paclitaxel) for the first-line treatment of people with PD-L1-positive, metastatic triple-negative breast cancer was accepted by the FDA. With the FDA granting priority review to the sBLA, a decision is expected by Mar 12, 2019.

Bayer Reports Strong Q3 Results: Bayer beat estimates for both earnings and sales in the third quarter. Sales rose more than 23.4% (on a reported basis) in the quarter. While the company registered sales growth at Pharmaceuticals, sales declined at Consumer Health and Animal Health segments on a reported basis. The company reaffirmed its outlook for 2018.

Lilly Updates on Migraine Candidates: Lilly LLY provided an update on its headache disorder medicines, lasmiditan and Emgality. It filed a new drug application to the FDA for approval of lasmiditan for the acute treatment of migraine headaches. Lilly also plans to submit a supplemental biologics license application (sBLA) to the FDA for label expansion of its newly approved CGRP antibody, Emgality (galcanezumab) for another indication - preventive treatment of episodic cluster headache, a type of headache disorder. Emgality was approved by the FDA for the preventive treatment of migraine in adults in late September. The FDA also granted Breakthrough Therapy status to Emgality for the episodic cluster headache indication.

AbbVie Presents Mavyret Study Data: AbbVie’s ABBV HCV medicine, Mavyret demonstrated high virologic cure rates in the phase IIIb EXPEDITION-8 study, evaluating it for an expanded patient population. The study is evaluating Mavyret in treatment naïve HCV patients with compensated cirrhosis across all major genotypes (GT1-6). Mavyret is presently marketed in the United States for treatment-naïve patients without cirrhosis. New data from cohort 1 of the study showed that on eight weeks of treatment with Mavyret, 100% of genotype 1, 2, 4, 5 and 6 treatment-naïve HCV patients with compensated cirrhosis achieved SVR12 per protocol analysis. Mavyret recorded sales of $2.6 billion in the first nine months of 2018, commanding a global market share of 50%.

Bristol-Myers Gets Positive CHMP Opinion for Cancer Combo:  Bristol-Myers BMY received a positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The CHMP recommended approval of its immuno-oncology combination of Opdivo (nivolumab) and low-dose Yervoy (ipilimumab) as first-line treatment option for patients with intermediate- and poor-risk advanced renal cell carcinoma. The positive CHMP opinion was based on positive data phase III CheckMate -214 study.

Glaxo Gets EU Nod to Add IMPACT Data to Telegy Ellipta’s Label: Glaxo’s filing looking for inclusion of data from the IMPACT study on the label of Trelegy Ellipta was approved by the European Commission. With the approval, Telegy Ellipta, a single inhaler triple therapy, can be prescribed as a maintenance treatment to a broader COPD patient population - who are not adequately treated by a LABA/LAMA combination in Europe. Until now Trelegy Ellipta was approved as a maintenance treatment to treat those COPD patients who are not adequately treated by an ICS/LABA combination. A similar label update was approved by the FDA in April.

The NYSE ARCA Pharmaceutical Index declined 1.1% 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 in the last five trading sessions:

 

Lilly recorded the highest gain (2%) while Glaxo declined the most (2%) in the last five trading sessions.

In the past six months, Lilly has been the biggest gainer (37.4%) while Glaxo recorded the lowest gain (0.8%).

(See the last pharma stock roundup here: LLY, AZN Report Q3 Earnings, PFE Gets FDA Nod for Cancer Drug)

What's Next in the Pharma World?

Watch out for pipeline and regulatory updates next week.

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AbbVie Inc. (ABBV) : Free Stock Analysis Report
 
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
 
Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report
 
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