Pharma Stock Roundup: Pipeline & Regulatory Updates By MRK, GSK, SNY

This week was relatively quiet for the pharma sector ahead of a string of earnings releases toward the end of this month. Glaxo (NYSE:GSK) provided pipeline and regulatory updates on a couple of its two-drug HIV regimens. The FDA accepted Merck’s (NYSE:MRK) regulatory application looking for a more flexible dosing option for its blockbuster PD-L1 inhibitor Keytruda and Sanofi’s (NASDAQ:SNY) biologics license application (BLA) for multiple myeloma candidate isatuximab.

Recap of the Week’s Most Important Stories

HIV Update From Glaxo: Glaxo’s phase III TANGO study evaluating the antiviral efficacy and safety of switching to its newly approved two drug HIV regimen, Dovato in HIV-1 infected patients who are virally suppressed and stable on a three-drug TAF based regimen, met the primary endpoint. Dovato, a single tablet regimen of Tivicay (dolutegravir) + lamivudine for treatment-naïve HIV patients, was approved in the United States in April and in the EU in July. The 48-week data from the study demonstrated that Dovato was non-inferior in maintaining viral suppression in such patients to the three-drug TAF based regimen. This suggests that such patients can maintain viral suppression if they switch from the three-drug regimen to the two-drug regimen, thereby reducing their pill burden.

Glaxo also said that the regulatory application for its long-acting, injectable two-drug regimen of cabotegravir plus rilpivirine was granted priority review designation by the FDA in June. With this, a decision is expected on Dec 29, 2019. ViiV Healthcare also announced the start of the first-ever study — CUSTOMIZE — to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in the real world. This approach can be different and an improvement from the controlled setting of a clinical study.

FDA Accepts Sanofi’s Isatuximab BLA: Sanofi (PA:SASY) announced that the FDA has accepted its biologics license application (BLA) for isatuximab for review. Sanofi is looking for approval of isatuximab, its anti-CD38 monoclonal antibody, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The FDA is expected to give its decision on the BLA on Apr 30, 2020.

FDA Accepts Merck’s sBLA for Six-Week Dosing Option of Keytruda: The FDA accepted Merck’s supplemental BLAs looking for approval of a six-week 400 mg dosing option of Keytruda for melanoma and multiple other indications. The new recommended dose will provide greater flexibility than the currently approved dose of 200 mg every three weeks. The FDA will give its decision on Feb 18, 2020.

Update From Haemophilia Conference: A few big pharma companies presented data from studies on their haemophilia candidates at the International Society on Thrombosis and Haemostasis (ISTH) held in Melbourne, Australia.

At ISTH, Novo Nordisk (NYSE:NVO) presented data from the main phase (24 weeks) of two phase II studies on its haemophilia candidate concizumab. The data demonstrated concizumab’s potential as a safe and efficacious subcutaneous prophylaxis treatment for the prevention of bleeding episodes in patients with haemophilia A (explorer5) and haemophilia A/B with inhibitors.

Sangamo Therapeutics and its partner Pfizer, Inc. (NYSE:PFE) presented promising new results from the phase I/II Alta study, evaluating their gene therapy candidate — SB-525 — in patients with severe hemophilia A.

Roche (OTC:RHHBY) presented a broad range of data for Hemlibra across multiple pivotal studies in haemophilia A patients. New analyses from phase III HAVEN studies demonstrated the long-term safety, efficacy and quality of life benefit of Hemlibra in people with haemophilia A with and without factor VIII inhibitors. First data from the phase IIIb STASEY study reinforced the safety profile of Hemlibra seen in pivotal HAVEN 1 study.

Bayer (DE:BAYGN) and J&J (NYSE:JNJ) presented results from the phase III EINSTEIN-Jr. study, which showed a strong efficacy and safety profile of Xarelto (rivaroxaban) in children with venous thromboembolism (VTE).

The NYSE ARCA Pharmaceutical Index declined 3.1% in the last five trading sessions.

Here is how the seven major stocks performed in the last five trading sessions:

AstraZeneca recorded the highest rally (6.7%) while Lilly declined the most (6.0%).

In the past six months, AstraZeneca has been the biggest gainer (13.8%) while Bristol-Myers declined the most (7.2%).

(See the last pharma stock roundup here: PFE's Regulatory/Pipeline Updates, CHMP Nod for Several Drugs)

What's Next in the Pharma World?

Watch out for J&J’s second-quarter earnings and regular pipeline and regulatory updates next week.

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