|Bid||149.38 x 20000|
|Ask||150.17 x 9000|
|Day's range||149.30 - 151.91|
|52-week range||134.40 - 161.45|
|PE ratio (TTM)||48.94|
|Forward dividend & yield||4.48 (3.00%)|
|1y target est||N/A|
Lisa DeLeonardo set a Google alert so she would know exactly when the first in a new class of migraine drugs was approved. It happened Thursday, when the U.S. Food and Drug Administration approved Amgen and Novartis’ application for erenumab, whose brand name is Aimovig. It’s an injectable drug touted as the first treatment designed specifically to prevent migraines, and is expected to be available to patients within a week for an annual price of $6,900.
Migraine is one of the top 10 causes of years lived with disability globally. With Aimovig receiving FDA approval for treatment of migraine, investors' attention is on future regulatory decisions.
Aimovig from Amgen and Novartis could become a $1 billion to $2 billion business in five years, say one Wall Street analyst.
Novartis' (NVS) CGRP antibody, Aimovig gains FDA approval for prevention of migraine. Zoetis (ZTS) and Lilly (LLY) announce deals to buy smaller companies.
On May 17, Amgen (AMGN) stock rose ~0.5% to the closing price of $174.65 per share following FDA approval of Aimovig. The company’s stock price has risen ~2.3% in the last week following recent drug approvals. Amgen’s stock price has risen ~11.2% over the last 12 months.
BlueBird Bio (BLUE) is a biotechnology company focused on developing gene therapy, cancer immunotherapy, and gene editing for the treatment of serious diseases. On May 17, Bluebird Bio (BLUE) stock jumped over 6.1% to the closing price of $189.30 per share, following positive news.
Shares of drugmakers Amgen Inc. and Novartis AG rose in after-hours trading Thursday after jointly announcing FDA approval of Aimovig, a first-of-its-kind treatment for migraines. In a statement, Novartis said the Federal Drug Administration approved Aimovig's use for the preventive treatment of migraines in adults. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine," Novartis Chief Executive Paul Hudson said in the statement.
The U.S. Food and Drug Administration has approved Amgen’s erenumab (which it’s calling Aimovig) to prevent migraines. “We feel pretty strongly this is a huge opportunity to help patients with a targeted, migraine specific medication that’s broadly efficacious, and can be administered in a patient-friendly way,” said Rob Lenz, VP, development at Amgen who lead the development of Aimovig. Amgen is commercializing Aimovig with Novartis in the U.S.
Amgen Inc. will charge a lower-than-expected $6,900 a year for a novel migraine treatment that investors hope will become the biotechnology giant’s next blockbuster. The Food and Drug Administration approved the drug, which will be marketed under the brand name Aimovig, on Thursday. Amgen’s pricing plans for Aimovig have been closely watched amid a wider U.S. debate over high prescription costs.
Today, Immunomedics (IMMU) announced positive results from a Phase 2 trial evaluating its investigational antibody drug conjugate (or ADC) sacituzumab govitecan in patients suffering from estrogen receptor-positive (or ER+)/human epidermal growth factor receptor 2-negative (or HER2-) metastatic breast cancer who have previously received at least two therapies. The investigational ADC therapy demonstrated an overall response rate of 31% in these heavily pretreated patients. Immunomedics plans to file its first biologics license application with the FDA later this month for the approval of sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer (mTNBC).
Amgen (AMGN) gets European Commission's approval to incorporate a new indication into the European label of its PCSK9 inhibitor, Repatha.
Pfizer's (PFE) Retacrit, a biosimilar of Amgen's Epogen and J&J's Procrit gets FDA approval. The drug will be available for the treatment of anemia.
Eli Lilly's (LLY) galcanezumab meets the primary endpoint in a late-stage study evaluating it for the prevention of episodic cluster headache.
During Teva’s (TEVA) 1Q18 earnings release on May 3, the company provided an update on the approval and launch of its anti-CGRP (calcitonin gene-related peptide) monoclonal antibody Fremanezumab, a preventive migraine treatment. The company stated that it now doesn’t expect to get FDA (U.S. Food and Drug Administration) approval for Fremanezumab in mid-June as it had earlier estimated. The reason that Teva doesn’t expect approval in June is that Celltrion, which is Teva’s API (active pharmaceutical ingredients) supplier of Fremanezumab, got a warning letter from the FDA in 2017.
For Amgen Inc., the launch of its next would-be blockbuster medicine may be a chance to avoid pitfalls of the past. After sales of heart drug Repatha finally showed signs of traction in last month’s quarterly earnings, investors are focusing on Amgen’s first-in-class migraine therapy as the stock seeks to recover from a rough few months for mature biotech companies. Amgen and its partner Novartis AG are due to hear by May 17 from U.S. regulators about Aimovig.
MAY 11: U.S. President Donald Trump listens to Health and Human Services Secretary Alex Azar deliver remarks during an announcement about drug prices in the Rose Garden at the White House May 11, 2018 in Washington, DC. Trump announced a 'blueprint' for lowering the cost of perscription medications. On Friday, in the White House Rose Garden, President Trump announced a comprehensive new effort to lower drug prices.
In 1Q18, Eylea generated net global revenue of $1.6 billion compared to $1.3 billion in 1Q17, which reflected a ~20% rise on a YoY (year-over-year) basis.
Regeneron Pharmaceuticals (REGN) reported its 1Q18 earnings results on May 3. It generated revenue of $1.5 billion in the quarter compared to $1.3 billion in 1Q17, which reflected a ~15% rise on a YoY (year-over-year) basis and a ~4% fall quarter-over-quarter.
Merck’s (MRK) diabetes products include blockbuster drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin hydrochloride). Both drugs are used to control blood sugar levels in patients with diabetes.
In 1Q18, Celgene’s (CELG) Idhifa generated revenue of $14 million. Celgene and bluebird bio will commercialize the drug in the US market and share 50% of US expenditure and profits. Of the 31 analysts tracking Celgene (CELG) in May, seven analysts have recommended “strong buys,” while nine have recommended “buys” on its stock.