|Bid||372.95 x 800|
|Ask||373.28 x 1400|
|Day's Range||373.01 - 377.18|
|52 Week Range||281.89 - 505.49|
|PE Ratio (TTM)||27.14|
|Earnings Date||Nov 6, 2018 - Nov 12, 2018|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||406.05|
On August 16, Teva Pharmaceutical Industries (TEVA) stock ended the trading day at $24.11, a rise of ~7.3% compared to the previous day’s closing price. TEVA stock was trading 123.0% higher than its 52-week low of $10.85 on November 2, 2017. It was trading ~4.0% lower than its 52-week high of $25.14 on June 29.
Regeneron (REGN) along with partner Teva announces positive top-line results from a late-stage candidate on fasinumab in patients with chronic pain from osteoarthritis of the knee or hip.
This marks a turnaround from earlier in the week when the U.S. regulator had issued a complete response letter which indicated it was not yet satisfied with the information provided by Regeneron. Regeneron did not give any reason for the change in its statement on Friday. Eylea is currently approved in wet AMD for dosing intervals of every four or eight weeks after three initial monthly doses.
TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). "We are pleased that the FDA has approved an updated label for EYLEA," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. EYLEA is also approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
Today, Teva Pharmaceutical Industries (TEVA) received FDA approval for the generic version of Mylan’s (MYL) allergy products EpiPen and EpiPen Jr. The epinephrine autoinjector is used to treat allergic reactions, including life-threatening condition of anaphylaxis. The company received FDA approval for the use of the product in adults as well as children weighing more than 33 pounds. In 2016, Teva’s generic version of EpiPen was unable to secure FDA approval.
How Is Vertex Pharmaceuticals Positioned in August? In its Q2 2018 earnings conference call, Vertex Pharmaceuticals (VRTX) reiterated its projection for non-GAAP combined selling, general, and administrative (or SG&A) and research and development (or R&D) expenses to come in in the range of $1.5 billion and $1.55 billion for fiscal 2018. In Q2 2018, the company reported non-GAAP combined R&D and SG&A expenses close to $388 million.
In its Q2 2018 earnings conference call, Vertex Pharmaceuticals (VRTX) updated its revenue guidance for fiscal 2018 from the previously projected range of $2.65 billion–$2.8 billion to $2.9 billion–$3.0 billion. The midpoint of this guidance range would imply a 36% year-over-year (or YoY) rise in revenues in fiscal 2018. This expectation has mainly been driven by the solid adoption of Symdeko since its launch in US markets. The company has not assumed the impact of securing new reimbursement for its CF drugs in markets outside the US in its fiscal 2018 revenue guidance.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. “We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. Fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo. "We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
SunPower in 2007, Regeneron Pharmaceuticals in 2015, and Randgold in 2016 both triggered an important sell signal: a sharp reversal to the downside in unusually heavy volume.
Regeneron (REGN) suffers setback as the FDA issues a CRL to its application for label expansion of Eylea for wet AMD with a modified 12-week dosing schedule.
Regeneron Pharmaceuticals (REGN) seems well-positioned for future earnings growth and it is seeing rising earnings estimates as well, coupled with a solid Zacks Rank.
In the third quarter, OPKO Health (OPK) expects research and development expenses of $33 million–$38 million, and foresees its total operating expenses falling to $285 million–$305 million. The company has projected a single-digit effective tax rate for Q3 2018. In fiscal 2018, analysts expect OPKO Health’s adjusted diluted EPS to rise ~51.0% to -$0.24, while peers Novartis (NVS), Merck (MRK), and Regeneron (REGN) are expected to report adjusted diluted EPS of approximately $5.20, $2.60, and $20.40, respectively.
In the third quarter, OPKO Health (OPK) expects service revenue of $200 million–$220 million, assuming stable reimbursement rates and a small rise in volumes. Meanwhile, the company expects product revenue of $28 million–$32 million, and Rayaldee revenue of $5.7 million–$6.5 million.
Alnylam Pharmaceuticals’ (ALNY) investigational RNAi therapeutic drug lumasiran is being developed for the treatment of primary hyperoxaluria type 1 (or PH1). Alnylam expects to initiate a Phase 3 trial of the drug in 2018, with its results expected in late 2019.
TARRYTOWN, N.Y., Aug. 13, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that due to ongoing labeling discussions the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on the second year data from the VIEW studies during which patients were treated with a modified 12 week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.
Alnylam Pharmaceuticals’ (ALNY) interest income increased from $2.58 million in the second quarter of 2017 to $6.1 million in the second quarter of 2018.
Sarepta Therapeutics (SRPT), a commercial-stage biopharmaceutical company, develops unique RNA-targeted therapeutics, gene therapies, and other medicines for neuromuscular diseases. It released its Q2 2018 earnings on August 8 and surpassed Wall Street analysts’ estimates for EPS and revenues. It reported adjusted EPS of -$0.43 on revenues of $73.5 million compared to the estimated EPS of -$0.89 on revenues of $71.6 million.
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Ionis Pharmaceuticals (IONS), a leading RNA-targeted therapeutics developing company, aims to develop best-in-class drugs for life-threatening diseases. Ionis commercializes the approved products in collaboration with other pharmaceuticals companies. Ionis reported revenues of $118 million in Q2 2018, a 5% increase in year-over-year (or YoY) revenues as compared to the second quarter of 2017.
As discussed earlier, Ionis Pharmaceuticals (IONS) reported year-over-year (or YoY) growth of 5% in revenues to $118 million during Q2 2018 as compared to revenues of $112 million during the second quarter of 2017. Ionis missed Wall Street analyst estimates for revenues and EPS in Q2 2018. Ionis reported commercial revenues of $57 million during Q2 2018, over 100% growth as compared to commercial revenues of $24 million during the second quarter of 2017.
The last leg of Q2 earnings in the biotech sector saw Regeneron firing all cylinders. The company also collaborated with bluebird bio, which impressed investors.