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Pharma Stock Roundup: Merck Gets CRL for Label Expansion Effort, Roche Cancer Drug Tops

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It was a relatively slow week with key highlights including a complete response letter (CRL) for Merck’s (MRK - Free Report) label expansion efforts for its diabetes drugs and positive data on Roche’s (RHHBY - Free Report) lung cancer treatment.

Recap of the Week’s Most Important Stories

Roche Cancer Drug Tops Pfizer Drug in Study: Roche’s cancer drug, Alecensa, once again topped Pfizer’s (PFE - Free Report) Xalkori in a study conducted in patients with ALK-positive non-small cell lung cancer (NSCLC). Results from the late-stage head-to-head study showed that patients on Alecensa lived significantly longer without their disease progressing compared to those on Xalkori. Roche intends to submit this data to regulatory authorities. Alecensa has Breakthrough Therapy Designation (BTD) for the treatment of people with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor. Alecensa is currently approved for use in ALK-positive NSCLC patients whose disease has progressed after being on Xalkori or who are intolerant to the drug. Label expansion into the first-line indication would expand the patient population and Alecensa’s sales potential immensely (Read more: Roche's Lung Cancer Drug Alecensa Meets Primary Endpoint).

Roche is a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.

Merck Diabetes Drug Label Expansion Effort Fails: Merck failed in its efforts to get TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) study data added to the labels of its diabetes drugs - Januvia, Janumet and Janumet XR. With death from cardiovascular disease being significantly higher in adults with diabetes compared to those without diabetes, the addition of positive cardiovascular outcomes data would have helped drive sales of these drugs. Last year, the FDA had added cardiovascular data to the label of Lilly and Boehringer Ingelheim’s diabetes drug Jardiance. (Read more: Merck's Bid to Add Cardiovascular Data on Januvia Label Fails).

Bristol-Myers Apexigen in Clinical Trial Collaboration: Bristol-Myers (BMY - Free Report) is collaborating with clinical-stage biopharma company Apexigen for the evaluation of Apexigen’s APX005M in combination with Bristol-Myers’ PD-1 immune checkpoint inhibitor Opdivo in patients with advanced solid tumors. The combination will be studied in second-line metastatic NSCLC patients who have failed prior chemotherapy and metastatic melanoma patients who have failed prior immuno-oncology therapy (Read more: Bristol-Myers Collaborates with Apexigen for Opdivo).

Year-to-date, Bristol-Myers has underperformed the Zacks categorized Large Cap Pharmaceuticals industry with the company’s shares declining 9.4% compared to the industry gain of 5.6%.

FDA Warning Letter for Mylan Facility in India: Mylan (MYL - Free Report) got a warning letter from the FDA for one of its drug manufacturing facilities located in India. The letter mentioned significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. This is not the first time that Mylan has received a warning letter from the agency for its manufacturing facilities (Read more: Mylan Down on FDA Warning Letter to Manufacturing Facility).


The NYSE ARCA Pharmaceutical Index dipped slightly (0.11%) over the last five trading sessions. Among major pharma stocks, Lilly was up 0.7% while AstraZeneca (AZN - Free Report) was down 1.1%. Over the last six months, Lilly gained 7.1% while AstraZeneca was down 2.1%.

What's Next in the Pharma World?

First quarter earnings season is round the corner with industry bellwether Johnson & Johnson (JNJ - Free Report) expected to report results on Apr 18.

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