Pharma Stock Roundup: LLY's Cyramza Shines in Cancer Study, PFE & AZN in Focus

It was a happening week for pharma stocks, Key developments this week included a new CAR-T deal for Pfizer PFE, successful study results from Pfizer, Lilly LLY and Allergan AGN and positive regulatory updates from AstraZeneca AZN.

Recap of the Week’s Most Important Stories

Pfizer in CAR-T Deal; Tafamidis Succeeds in Late-Stage Study: Pfizer announced an alliance with private biotech, Allogene Therapeutics, to expedite the development of its allogeneic CAR-T therapy. Pfizer will own a 25% stake in Allogene and also get a representation on the latter’s board.

Meanwhile, a CNBC report said Pfizer is in talks with consumer giant Procter & Gamble regarding the sale of its Consumer Healthcare segment. Last month, Glaxo GSK and Reckitt Benckiser Group pulled out of the discussion with Pfizer to buy the same unit. (Read More: Pfizer Inks New CAR-T Deal, In Talks With P&G for Unit Sale).

Pfizer’s pipeline candidate tafamidis, developed for the treatment of transthyretin cardiomyopathy (TTR-CM), met the main goal in a late-stage study — ATTR-ACT. Top-line data from the ATTR-ACT study showed that treatment with tafamidis led to a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations – the primary endpoint - compared with the placebo at 30 months. (Read More: Pfizer’s Rare Disease Candidate Meets Endpoint in Phase III).

Pfizer’s regulatory application for its pipeline candidate, dacomitinib was accepted for priority review in the United States with a response expected in September 2018. The company is looking to get the drug approved for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations. (Read More: Pfizer's Lung Cancer Candidate Gets FDA's Priority Review).

Lilly’s Cyramza Meets OS Endpoint in Liver Cancer Study: Lilly announced that its already approved cancer drug, Cyramza showed an overall survival benefit, thereby meeting the primary endpoint in a late-stage study, evaluating it for the second-line treatment of liver cancer. The study also met the secondary endpoint of progression-free survival. (Read More: Lilly's Cyramza Shows Survival Benefit in Liver Cancer Study).

AstraZeneca Provides Regulatory Updates: AstraZeneca’s diabetes treatment, Bydureon gained FDA approval as add-on therapy to insulin glargine.

Also, a biologics license application (“BLA”) seeking approval of AstraZeneca’s anti-CD22 recombinant immunotoxin candidate, moxetumomab pasudotox for the second or later-line treatment of hairy cell leukaemia (“HCL”) was granted priority review by the FDA. With the FDA granting priority review, a decision is expected in the third quarter of 2018.

In another regulatory development, AstraZeneca and partner Merck’s MRK regulatory submission looking to expand the label of its PARP inhibitor, Lynparza to include the breast cancer indication, was accepted in the EU. Lynparza is already approved for treating ovarian cancer in EU. With the latest filing, AstraZeneca looks to get Lynparza approved for BRCA-mutated HER2-negative metastatic breast cancer in the EU. In the United States, Lynparza was approved for the same indication in January. (Read More: AstraZeneca's Bydureon Gets FDA Nod for Expanded Use).

Allergan Vraylar Succeeds in Label Expansion Study: Allergan and its partner Gedeon Richter said that Vraylar (cariprazine) met the primary endpoint in a late-stage study in adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). This is the third of the three pivotal studies conducted for the indication. Data from all three studies will be included in the companies’ label expansion application, which the company plans to file in the second half of 2018. (Read More: Allergan's Vraylar Meets Endpoints in Bipolar I Phase III).

Bio-Path’s Mid-Stage Study on Leukemia Candidate Shows Positive Early Data:  Bio-Path Holdings announced positive interim data from phase II study (BP1001-201) of its lead pipeline candidate, prexigebersen, which is being evaluated in combination with low-dose cytarabine (LDAC) for the treatment of patients with acute myeloid leukemia (AML) who cannot or elect not to be treated with more intensive chemotherapy. The combination therapy demonstrated early anti-leukemic activity in nearly 50% of evaluable AML patients in the study. In total, 47% of the patients achieved some form of response from the combo treatment. Shares of Bio-Path shot up around 25% in response.(Read More: Bio-Path Leukemia Combo Study Shows Positive Early Data).

FDA Approves Sonoma’s Skin Gel: Sonoma Pharmaceuticals, a small solutions maker for skin conditions and advanced tissue care, gained FDA approval for an antimicrobial post-treatment gel. The gel aims to treat itch and pain associated with procedures including laser skin resurfacing, post-microdermabrasion therapy and chemical peels. Shares of Sonoma shot more than 14% in response.

The NYSE ARCA Pharmaceutical Index rose 0.3% in the last four 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:

All stocks recorded a gain except Bristol-Myers BMY. J&J and Glaxo were the biggest gainers rising 2% each while Bristol Myers declined 0.9%.

In the last six months, while AstraZeneca has been the biggest gainer (5.3%), Merck declined the most (13.8%).

(See the last pharma stock roundup here: Pharma Stock Roundup: ABBV’s Rova-T Disappoints, J&J Unit Gets Buyout Offer).

What's Next in the Pharma World?

Watch out for regulatory and pipeline news from pharma stocks.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report
 
Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
 
Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Eli Lilly and Company (LLY) : Free Stock Analysis Report
 
Allergan plc (AGN) : Free Stock Analysis Report
 
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
 
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
 
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