This week the FDA approved
Merck ( MRK Quick Quote MRK - Free Report) and Bayer’s ( BAYRY Quick Quote BAYRY - Free Report) new heart failure drug, vericiguat and Glaxo ( GSK Quick Quote GSK - Free Report) / J&J’s ( JNJ Quick Quote JNJ - Free Report) long-acting regimen for HIV treatment, Cabenuva. The FDA also gave the green signal to AstraZeneca’s ( AZN Quick Quote AZN - Free Report) Enhertu and J&J’s Darzalex Faspro for new indications. Lilly ( LLY Quick Quote LLY - Free Report) signed a new deal with with Netherlands’ Merus to discover novel antibodies for cancer Recap of the Week’s Most Important Stories The FDA granted approval to Merck/Bayer’s vericiguat, a soluble guanylate cyclase (sGC) stimulator, for the treatment of symptomatic FDA Approves Merck’s Heart Failure Drug: chronic heart failure with reduced ejection fraction (HFrEF). Vericiguat will be marketed by the brand name of Verquvo. The approval comes with a boxed warning that indicates that the drug should not be given to pregnant ladies because it may cause fetal harm. The FDA approval for the candidate was based on data from the phase III VICTORIA study. Glaxo’s HIV subsidiary, ViiV Healthcare and J&J announced that the FDA has approved their long-acting injectable regimen of Glaxo’s cabotegravir and J&J’s Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults. The regimen will be marketed by the trade name of Cabenuva and will be provided as a co-pack with the two injectable medicines, cabotegravir and Edurant. Cabenuva is already approved in Canada and EU. The long-acting regimen will reduce the frequency of treatment days from 365 to 12 per year, thereby removing the need to take daily oral pills. The approval of Cabenuva is based on data from the pivotal phase III ATLAS and FLAIR studies. FDA Approves J&J/Glaxo’s Cabenuva:
The FDA simultaneously approved Vocabria (cabotegravir oral tablets) for short-term HIV treatment in combination with rilpivirine tablets
AstraZeneca and its Japan-based partner Daiichi Sankyo’s antibody drug conjugate, Enhertu (trastuzumab deruxtecan) was approved in the FDA Approves AstraZeneca’s Enhertu for Gastric Cancer: United States for its second indication. Enhertu, which is already approved to treat HER2-positive metastatic breast cancer in the United States, was approved for HER2-positive metastatic gastric cancer for patients who have received a prior trastuzumab-based regimen. The approval was based on positive results from the randomized DESTINY-Gastric01 phase II study.
Enhertu was also approved in Europe for
metastatic HER2-positive breast cancer patients who have received two or more prior anti-HER2-based regimens. The approval was based on positive results from the randomized DESTINY-Breast01 phase II study. Enhertu is already approved for the same indication in the United States and Japan.
Meanwhile, the European Commission and regulatory authority in U.K. granted marketing approval for a new four-week, fixed-dose regimen of AstraZeneca’s PD-L1 inhibitor, Imfinzi in the approved indication of unresectable non-small cell lung cancer (NSCLC) after platinum-based chemoradiation therapy. Imfinzi is presently administered as a weight-based dosing of 10mg/kg every two weeks. The
four-week, fixed-dose regimen (1500 mg) will reduce patients’ medical visits by half, thereby improving patent convenience. The FDA approved J&J’s Darzalex Faspro in combination with bortezomib, cyclophosphamide and dexamethasone for treating newly diagnosed light chain amyloidosis, a FDA Approves J&J’s Darzalex Faspro for New Indication: rare blood cell disorder, in adult patients. Darzalex Faspro is presently approved to treat multiple myeloma. Darzalex Faspro is the subcutaneous formulation of J&J’s blockbuster multiple myeloma drug, Darzalex. Lilly’s subsidiary, Loxo Oncology Lilly’s Antibody Deal with Merus: signed a deal with Netherlands’ Merus N.V. to discover novel T-cell re-directing bispecific antibodies for cancer by leveraging Merus’ proprietary CD3 T-cell engager Biclonics platform. Lilly will make an upfront payment of $40 million to Merus while also investing in the latter’s stock worth $20 million. In addition, Merus will also be eligible to receive potential milestone payments and royalties on future sales.
Data from Lilly’s BLAZE-2 phase III study on bamlanivimab showed that the COVID-19 antibody candidate significantly reduced the risk of contracting symptomatic COVID-19 in residents and staff at long-term care facilities. The data showed that residents who received bamlanivimab have 80% lower risk of contracting COVID-19 infection versus residents in the same facility who received placebo.
Bamlanivimab was granted Emergency Use Authorization (EUA) by the FDA in November for the treatment of patients at high risk for progressing to severe COVID-19 illness or hospitalization based on data from the BLAZE-1 study. Early in-vitro study findings showed that Pfizer (PFE) and partner BioNTech COVID-19 vaccine, BNT162b2 elicits antibodies that neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage. The B.1.1.7 lineage, initially detected in the U.K, is a fast spreading variant of the COVID-19 infection. BNT162b2 is approved for emergency/temporary use in several countries including the United States and the EU. Pfizer’s COVID-19 Vaccine Can Protect Against U.K. Variant:
The NYSE ARCA Pharmaceutical Index rose 1.04% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Last week, Lilly recorded the maximum gain (9.1%) while Merck declined the most (1.4%).
In the past six months, Lilly recorded the maximum gain (25.3%) while Pfizer declined the most (5.0%).
(See the last pharma stock roundup here
: LLY’s Alzheimer’s Disease Data, NVS & SNY’s M&A Deals) What's Next in the Pharma World?
Watch out for J&J and Lilly’s fourth-quarter and full-year 2020 earnings and pipeline and regulatory updates next week.
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