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Pharma Stock Roundup: NVS, MRK Get FDA Nod, PFE Ulcerative Colitis Study Succeeds
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There were not many developments in the drugs sector this week. The FDA approved Novartis’ (NVS - Free Report) Pluvicto for a certain type of advanced prostate cancer and Merck’s (MRK - Free Report) Keytruda for a second indication in endometrial carcinoma. Pfizer (PFE - Free Report) announced positive top-line data from a late-stage ulcerative colitis study on pipeline candidate, etrasimod.
Recap of the Week’s Most Important Stories
FDA Approves Novartis’ Pluvicto for Advanced Prostate Cancer: The FDA approved Novartis’ targeted radioligand therapy (RLT) Pluvicto for treating patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) These patients with progressing mCRPC were pre-treated with multiple lines of anti-cancer therapies and have limited treatment options.
The FDA also approved a complementary diagnostic imaging agent, Locametz for the identification of PSMA-positive lesions in adult patients with mCRPC. Pluvicto’s approval was based on data from the pivotal phase III VISION study. Data from the study showed that pre-treated PSMA-positive mCRPC patients who were given Pluvicto plus standard of care experienced a statistically significant reduction in risk of death. Two other pivotal late-stage studies are ongoing on Pluvicto in earlier lines of treatment for metastatic prostate cancer.
FDA Approves Merck’s Keytruda for 2nd Indication in Endometrial Cancer: The FDA approved Merck’s Keytruda as a single agent for certain patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial carcinoma who have disease progression, following prior systemic therapy and are not candidates for curative surgery or radiation. The approval was based on data from two cohorts of the KEYNOTE-158 study. This is the second indication for Keytruda in endometrial cancer. In endometrial carcinoma, Keytruda is already approved in combination with partner Eisai’s Lenvima for treating endometrial carcinoma that is not MSI-H/dMMR in patients who have disease progression, following prior systemic therapy and are not candidates for curative surgery or radiation.
Pfizer’s Etrasimod Meets Goal in Ulcerative Colitis Study: Pfizer’s phase III study evaluating pipeline candidate, etrasimod for the treatment of moderately to severely active ulcerative colitis (UC) met primary and key secondary endpoints. Data from the ELEVATE 12 study showed that patients treated with etrasimod (2 mg once daily) achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. The secondary endpoints of the study were also met with statistical significance. The 354 UC patients enrolled in the study had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy. Another study, ELEVATE 52, is also ongoing on the candidate, data from which are expected to be announced by the end of the first quarter. Data from ELEVATE 12 and ELEVATE 52 studies are expected to form the basis of the regulatory submissions.
Pfizer is voluntarily recalling some lots of its hypertension medicine, Accuretic and its authorized versions due to the presence of a nitrosamine, N-nitroso-quinapril. Nitrosamines are impurities present in water and food items and people are exposed to them. However, if these impurities are present above acceptable levels and people are exposed to them over the long term, these may increase the risk of cancer.
The NYSE ARCA Pharmaceutical Index rose 1% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: NVS, MRK Get FDA Nod, PFE Ulcerative Colitis Study Succeeds
There were not many developments in the drugs sector this week. The FDA approved Novartis’ (NVS - Free Report) Pluvicto for a certain type of advanced prostate cancer and Merck’s (MRK - Free Report) Keytruda for a second indication in endometrial carcinoma. Pfizer (PFE - Free Report) announced positive top-line data from a late-stage ulcerative colitis study on pipeline candidate, etrasimod.
Recap of the Week’s Most Important Stories
FDA Approves Novartis’ Pluvicto for Advanced Prostate Cancer: The FDA approved Novartis’ targeted radioligand therapy (RLT) Pluvicto for treating patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) These patients with progressing mCRPC were pre-treated with multiple lines of anti-cancer therapies and have limited treatment options.
The FDA also approved a complementary diagnostic imaging agent, Locametz for the identification of PSMA-positive lesions in adult patients with mCRPC. Pluvicto’s approval was based on data from the pivotal phase III VISION study. Data from the study showed that pre-treated PSMA-positive mCRPC patients who were given Pluvicto plus standard of care experienced a statistically significant reduction in risk of death. Two other pivotal late-stage studies are ongoing on Pluvicto in earlier lines of treatment for metastatic prostate cancer.
FDA Approves Merck’s Keytruda for 2nd Indication in Endometrial Cancer: The FDA approved Merck’s Keytruda as a single agent for certain patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial carcinoma who have disease progression, following prior systemic therapy and are not candidates for curative surgery or radiation. The approval was based on data from two cohorts of the KEYNOTE-158 study. This is the second indication for Keytruda in endometrial cancer. In endometrial carcinoma, Keytruda is already approved in combination with partner Eisai’s Lenvima for treating endometrial carcinoma that is not MSI-H/dMMR in patients who have disease progression, following prior systemic therapy and are not candidates for curative surgery or radiation.
Pfizer’s Etrasimod Meets Goal in Ulcerative Colitis Study: Pfizer’s phase III study evaluating pipeline candidate, etrasimod for the treatment of moderately to severely active ulcerative colitis (UC) met primary and key secondary endpoints. Data from the ELEVATE 12 study showed that patients treated with etrasimod (2 mg once daily) achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. The secondary endpoints of the study were also met with statistical significance. The 354 UC patients enrolled in the study had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy. Another study, ELEVATE 52, is also ongoing on the candidate, data from which are expected to be announced by the end of the first quarter. Data from ELEVATE 12 and ELEVATE 52 studies are expected to form the basis of the regulatory submissions.
Pfizer is voluntarily recalling some lots of its hypertension medicine, Accuretic and its authorized versions due to the presence of a nitrosamine, N-nitroso-quinapril. Nitrosamines are impurities present in water and food items and people are exposed to them. However, if these impurities are present above acceptable levels and people are exposed to them over the long term, these may increase the risk of cancer.
The NYSE ARCA Pharmaceutical Index rose 1% in the last five trading sessions.
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.
Image Source: Zacks Investment Research
In the last five trading sessions, Roche rose the most (3.8%) while Pfizer declined the most (1.4%).
In the past six months, AbbVie has recorded the maximum gain (50.4%) while Novartis recorded the least gain (6.4%).
(See the last pharma stock roundup here: PFE, SNY, ABBV’s Pipeline Updates, BAYRY’s Unit Sale)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.