CVS Health (CVS) unit Aetna on Friday revised its policy to state that colorectal cancer screening is considered medically necessary for average-risk persons aged 45 years and older when recommended by their physician, Baird analyst Catherine Ramsey Schulte tells investors in a research note. Aetna’s previous version covered for average-risk persons beginning at age 50 years, the analyst points out. While admitting further uptake in ages 45-49 will require medical education among doctors, Ramsey Schulte views Aetne’a update as “incrementally positive” for Exact Sciences. She keeps an Outperform rating on the shares with a $102 price target. The stock in early trading is up 1% to $93.57.
https://thefly.com/landingPageNews.php?id=2873793
Monday, March 4, 2019
Novavax flu vaccine potential being overlooked, say B. Riley FBR
Investors did not interpret Novavax’s trial results for its respiratory syncytial virus vaccine properly and are overlooking its flu vaccine potential, B. Riley FBR analyst George Zavoico tells investors in a research note. Prepare would have been a successful registrational Phase III trial if it had incorporated some minor design changes understood now but unknown when the trial was planned, says the analyst. He points out that Novavax will meet with the FDA in the next 30-90 days to present a case for accepting a biologics license application for review this year, based on “robust” vaccine efficacy reported for clinically meaningful secondary endpoints. Zavoico ascribes a low probability to this outcome, but notes it would be a game-changer for Novavax if the FDA makes a decision to review a ResVax BLA, based only on the available data set. He lowered his price target for the shares to $1.75 from $10 and keeps a Buy rating on the name.
https://thefly.com/landingPageNews.php?id=2873693
https://thefly.com/landingPageNews.php?id=2873693
Evoke Pharma receives preliminary DR letter from FDA for Gimoti NDA
Evoke Pharma announced the receipt of a multi-disciplinary review, or DR, letter from the FDA in association with the Gimoti 505 new drug application, or NDA. A DR letter is used by the FDA to convey preliminary thoughts on deficiencies identified during the initial stage of NDA review. The letter described concerns in three sections of the NDA: chemistry, clinical and clinical pharmacology. Although a DR letter reflects preliminary comments that are subject to change and does not reflect a final FDA decision on the NDA, approval of Gimoti by the PDUFA date of April 1 is uncertain given the letter. The company plans to respond to the deficiencies raised in the DR letter to allow time for potential FDA review prior to the PDUFA date. “We were disappointed by this FDA notification and are in the process of evaluating and addressing FDA’s comments. We remain focused on seeking approval for Gimoti to provide patients with an effective treatment that bypasses the stomach where oral medications are known to be erratically absorbed,” said Dave Gonyer, CEO. “Predictably delivered therapeutic options for patients that suffer from gastroparesis remains of high interest to the Company and an important need for physicians and patients that suffer from gastroparesis.”
https://thefly.com/landingPageNews.php?id=2873723
https://thefly.com/landingPageNews.php?id=2873723
ImmunoGen oversold with some potential path to market for Mirv: RBC
RBC Capital analyst Kennen MacKey kept his Outperform rating and $6 price target on Immunogen, saying the stock selloff in response to its lead asset mirvetuximab soravtansine missing the end point for treatment of ovarian cancer is overdone. The analyst notes that the drug “unequivocally demonstrated efficacy in FRalpha-high patients across all efficacy measures”, adding that there is still potential for its path to market given the FDA flexibility in areas of high unmet medical need such as ovarian cancer after the company runs another Phase 3 trial that will take about 2 years.
https://thefly.com/landingPageNews.php?id=2873725
https://thefly.com/landingPageNews.php?id=2873725
Ascendis Pharma: Phase 3 heiGHt trial met primary objective
Ascendis Pharma announced positive top-line results from the phase 3 heiGHt Trial, a randomized, open-label, active-controlled trial that compared once-weekly TransCon Growth Hormone to a daily growth hormone in children with pediatric growth hormone deficiency. The trial met its primary objective, demonstrating that TransCon hGH was observed to be non-inferior and, additionally, superior to the daily hGH on the primary endpoint of annualized height velocity at 52 weeks. In the primary analysis of the intent-to-treat population using ANCOVA, TransCon hGH demonstrated an AHV of 11.2 cm/year compared to 10.3 cm/year for the daily hGH. The treatment difference was 0.86 cm/year with a 95% confidence interval of 0.22 to 1.50 cm/year. The AHV for TransCon hGH was significantly greater than the daily hGH. The AHV was greater for TransCon hGH than for the daily hGH at each visit, with the treatment difference reaching statistical significance from and including week 26 onward. The incidence of poor responders was 4% and 11% in the TransCon hGH and daily hGH arms, respectively. All sensitivity analyses completed from the trial support the primary outcome, indicating the robustness of these results. Results from the trial indicate that TransCon hGH was generally safe and well-tolerated, with adverse events consistent with the type and frequency observed with daily hGH therapy and comparable between arms of the trial.
Lilly to make generic insulin available at half of Humalog’s current price
Eli Lilly & Co. LLY, +2.02% said Monday it will introduce a generic version of Humalog insulin in the U.S., at a price that’s half the current list price. The lower priced version, called insulin Lispro, has the same molecule as Humalog and will be available in vial and pen options. A single vial will be priced at $137.35, while a KwikPens five pack will be $265.20. The lower-priced insulin will be made available in pharmacies “as quickly as possible.” Humalog will also remain available. “”Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help,” said Lilly Chief Executive David Ricks. “We’re eager to bring forward a low-priced rapid-acting insulin.” Lilly’s stock, which is still inactive in premarket trade, has run up 67% over the past 12 months, while the S&P 500 SPX, +0.69% has gained 4.2%.
Invitae initiated at Chardan
Invitae initiated with a Buy at Chardan. Chardan analyst Steven Wardell initiated Invitae with a Buy and $29 price target. Wardell said Invitae is the cost and quality leader in the genetic testing market with a centralized testing and data strategy that positions the company to compete in this large, and attractive market. The analyst expects strong topline growth over the next three years and likes management’s ability to execute and their confidence on where the sector is going and their place in it. He believes shares are mispriced versus peers given it is a growth leader among high-growth digital health companies.
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