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Pharma Stock Roundup: FDA Nod for MRK, PFE Products & New Use of LLY, GSK Drugs

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This week, the FDA approved Merck’s (MRK - Free Report) Welireg (belzutifan) to treat certain types of von Hippel-Lindau (VHL) disease-associated tumors and Pfizer’s (PFE - Free Report) tick-borne encephalitis (TBE) vaccine, TICOVAC. The FDA also approved Lilly’s (LLY - Free Report) type II diabetes medicine, Jardiance and Glaxo’s (GSK - Free Report) cancer drug, Jemperli for new indications.

Recap of the Week’s Most Important Stories

FDA Approves Merck’s Welireg: The FDA granted approval to Merck’s novel HIF-2α inhibitor Welireg (belzutifan) to treat some von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), or pancreatic neuroendocrine tumors (pNET), in patients who do not require immediate surgery. The approval was based on data from a phase II study on the candidate in patients with such VHL-associated tumors.

FDA Approves Pfizer’s TBE Vaccine: The FDA approved Pfizer’s TICOVAC, its tick-borne encephalitis (TBE) vaccine to prevent TBE in people 1 year of age and older. TBE is a viral infection of the brain and spine, which has been declared an endemic in parts of Europe and Asia. TICOVAC may help reduce the risk of TBE infection for people in the United States traveling to the endemic areas.

Pfizer/BioNTech’s booster dose of COVID-19 vaccine elicited antibody levels that were much higher than that seen after the two-dose primary schedule, per data from the phase I part of the phase I/II/III study. The higher antibody levels were elicited against the initial SARS-CoV-2 virus (wild type) as well as against the Beta variant and the rapidly spreading highly infectious Delta variant.

FDA Approves Glaxo’s Jemperli for Second Indication: The FDA also approved a new indication for Glaxo’s new cancer drug, PD-1 inhibitor, Jemperli (dostarlimab) based on data from a cohort of the ongoing GARNET study. The accelerated approval is for mismatch repair-deficient (dMMR) recurrent or advanced solid tumors for patients whose disease has progressed or who have no satisfactory alternative treatment option. Jemperli (dostarlimab) was approved for second-line endometrial cancer in the United States and EU in April 2021.

FDA Approves Lilly’s Jardiance for HFrEF: The FDA approved Lilly’s SGLT-2 inhibitor, Jardiance to treat heart failure with reduced ejection fraction (HFrEF). The supplemental new drug application (sNDA) for the HFrEF indication was based on data from the phase III EMPEROR-Reduced study, which showed that Jardiance is associated with a significant 25% relative risk reduction in time to cardiovascular death or hospitalization due to heart failure. Jardiance is also being evaluated for another form of heart failure, heart failure with preserved ejection fraction (HFpEF).

Lilly’s two pivotal phase III studies on IL-13 inhibitor, lebrikizumab in patients with moderate-to-severe atopic dermatitis (“AD”),met the primary and all key secondary endpoints including skin clearance and itch improvement, at Week 16.. Data from the studies showed that lebrikizumab significantly improved skin clearance and itch. The top-line data from the two studies showed that more than half the patients treated with lebrikizumab, as a monotherapy, experienced at least 75% skin clearance as measured by Eczema Area and Severity Index (EASI) score.

The FDA approved a new delivery option for Lyumjev, Lilly’s new rapid-acting insulin. Lyumjev 100 units/mL has been approved for use in an insulin pump to improve glycemic control in adults with type I and II diabetes.

J&J’s CEO to Step Down: J&J (JNJ - Free Report) announced that its present chairman and chief executive officer (CEO), Alex Gorsky, is stepping down from his role as CEO. Joaquin Duato, currently vice chairman of the company’s Executive Committee, will succeed him, effective Jan 3, 2022. Duato will subsequently join the board of directors. Alex Gorsky, will however, continue to serve as the executive chairman of the company.

Data from a phase I study, CHRYSALIS, evaluating J&J’s Rybrevant (amivantamab) demonstrated that thelung cancerdrug shows anti-tumor activity for the treatment of non-small cell lung cancer (NSCLC) that targets mesenchymal-epithelial transitionexon 14 skipping mutations. Rybrevant (amivantamab) was approved in May for NSCLC that targets EGFR exon 20 insertion mutations in the United States based on data from the same study.

The NYSE ARCA Pharmaceutical Index rose 2.2% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the last five trading sessions.

Zacks Investment Research
Image Source: Zacks Investment Research

In the last five trading sessions, all the stocks were in the green with Pfizer risingthe most (3.3%) while Novartis (NVS - Free Report) recording the least gain (0.4%)

In the past six months, Pfizer has recorded the maximum gain (42.5%) while Merck has seen the least gain (4.7%)

(See the last pharma stock roundup here: FDA Nod for SNY’s Pompe Drug & New Use of MRK’s Keytruda)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.