Friday, February 1, 2019
B. Riley FBR downgrades Corcept to Neutral on Q4 sales miss
B. Riley FBR analyst David Buck downgraded Corcept Therapeutics to Neutral from Buy and cut his price target for the shares to $12 from $22. The analyst cites the company’s “disappointing” preliminary Q4 sales for the downgrade. The stock in midday trading is down 10%, or $1.16, to $10.02.
https://thefly.com/landingPageNews.php?id=2857897
https://thefly.com/landingPageNews.php?id=2857897
Why AC Immune SA Is Imploding
Shares of AC Immune (NASDAQ:ACIU), a clinical-stage biopharma focused on neurodegenerative diseases, are being annihilated The stock is down 66% as of 9:55 a.m. EST on Wednesday after the company announced that two important phase 3 trials are being discontinued.
AC Immune’s collaboration partner Roche Holdings (NASDAQOTH:RHHBY) announced today that it is discontinuing the CREAD 1 and CREAD 2 studies. These phase 3 trials were testing AC Immune’s drug crenezumab as a potential treatment for Alzheimer’s disease.
The decision to stop the trial was made after an interim analysis by a third party showed that crenezumab was unlikely to meet the study’s primary endpoint.
AC Immune’s CEO, Andrea Pfeifer, stated, “We are extremely disappointed about the outcome of the Phase III CREAD 1 interim analysis and we also would like to thank patients and caregivers for their participation.”
Pfeifer stated that she remains “optimistic” about the drug’s future as the company awaits the outcomes of its Colombian API study.
Traders are thrashing the company’s stock in response to the disappointing news.
Crenezumab is AC Immune’s most advanced pipeline compound, so this clinical update deals a big blow to the bull case for owning AC Immune’s stock. Thankfully, AC Immune also has a number of other compounds in various stages of development, so crenezumab isn’t the company’s only potential shot on goal.
Still, this clinical news represents a huge step backward for the business. That’s why I do not consider today’s massive drop to be a buying opportunity.
CTI Update on CHMP Explanation for Action on MyelofibrosisTreatment
CTI BioPharma Corp. (NASDAQ:CTIC) today announced that the Company will withdraw its European Marketing Authorization Application (MAA) for pacritinib as a treatment for myelofibrosis. The decision follows recent interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), during which the Company learned that the committee was likely to formally adopt a negative opinion in its evaluation of the application. The CHMP indicated that the risk-benefit profile for pacritinib for the intended indication has not been sufficiently established with the clinical data available to date.
The Company is continuing to develop pacritinib for both U.S. and European registration as a treatment for myelofibrosis patients with severe thrombocytopenia. CTI plans to seek scientific guidance from the EMA before beginning the planned Phase 3 study, having already discussed the protocol design with the FDA last month. The Phase 3 trial is expected to begin enrollment in the third quarter of 2019.
In addition, the Company announced that on January 23, 2019, a planned third interim review of the PAC203 study was held by the Independent Data Monitoring Committee (IDMC) and the study will continue as scheduled. The IDMC did not identify significant drug- or dose-related safety concerns and specifically did not identify any concerns around hemorrhagic or cardiac toxicity.
Stryker Voluntary ‘Field Action’ for LIFEPAK® 15 Monitor/Defibrillators
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 Monitor/Defibrillators.
The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.
The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include an update to the firmware for a component on the System Printed Circuit Board Assembly. Stryker anticipates that all devices subject to this field action will be serviced by December 31, 2019. If a customer experiences this issue, they should contact Stryker as soon as possible at 1 800 442 1142 and selecting option 7.
Since the initial commercialization of LIFEPAK 15 in 2009, Stryker has become aware of 58 complaints reported globally for this issue, including 6 events in which the patient died following a delay in therapy. In all six of these cases, at least one shock was delivered prior to the device experiencing the lock-up condition. There are 13,003 devices potentially impacted by this issue and within scope of this field action.
The company is instructing customers to continue to use their LIFEPAK 15 Monitor/Defibrillator according to the Operating Instructions until the correction can be completed. Device Automatic Self-Tests do not identify this fault, as it occurs during defibrillation. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK-COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 Monitor/Defibrillator Operator’s Checklist, number 7).
If a device exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10-18) of the LIFEPAK 15 Monitor/Defibrillator Operating Instructions should be immediately followed:
- Press and hold ON until the LED turns off (~5 seconds). Then press ON to turn the device back on.
- If the device does not turn off, remove both batteries and disconnect the device from the power adapter, if applicable. Then reinsert batteries and/or, reconnect the power adapter, and press ON to turn the device back on.
Information about this notice is available at: http://www.strykeremergencycare.com/productnotices. Impacted customers will be notified by letter and will be requested to verify their device status. Customers with questions regarding this notification, please contact Stryker by calling 1 800 442 1142, option 7, 6:00 a.m. to 4:00 p.m. (Pacific) Monday – Friday, or by email to rsfa281@stryker.com or fax to 1 425 867 4948.
In addition to contacting Stryker, any potential quality problems or adverse reactions or events associated with the use of a product from Stryker may be reported to the U. S. Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program online at https://www.fda.gov/safety/medwatch/, by phone 1 800 332 1088 or fax 1 800 FDA 0178.
HHS Secretary Azar Floats Plan to Lower Prescription Drug Costs
As lawmakers in Congress are exploring potential price-lowering options for prescription drugs, Department of Health and Human Services Secretary Alex Azar is floating a proposed rule to lower the prices and out-of-pocket expenses by encouraging manufacturers to pass discounts to patients instead of insurers.
The HHS plan is aimed at providing new transparency to the prescription drug market and remove the veil of hidden rebates and other pricing methods currently conducted between companies and pharmacy benefits managers. The rebates and other pricing initiates conducted between the companies, PBMs and insurers are not typically passed along to patients, an HHS fact sheet noted.
Azar, a former executive with Eli Lilly, said the “hidden system of kickbacks to middlemen” has forced people to pay more for their medications. Under the proposed rule, prescription drug rebates that today amount to, on average, 26 to 30 percent of a drug’s list price may be passed on directly to patients and reflected in what they pay at the pharmacy counter. Azar said this proposal will benefit all people who buy prescription drugs, but particularly senior citizens who use Medicare Part D. He said the proposal is projected to provide the greatest benefits to seniors with high drug costs.
The proposed pricing plan is something that President Donald Trump has been touting since he was first elected. He most famously claimed that pharmaceutical companies are “getting away with murder” when it comes to the prices the companies charge for medication. Last year, the White House laid out the American Patients First pricing blueprint that called for more transparency in prescription drug pricing, something that drugmakers have criticized. In October, the administration announced a plan to propose changes to Medicare drug pricing. Part of the proposal included requiring the disclosure of list prices in television ads, increasing negotiated discounts in Medicare, banning pharmacy gag clauses, adopting real-time prescription benefit tools, and boosting low-cost generic and biosimilar competition.
Under the proposal, the new rules would exclude from safe harbor protection under the Anti-Kickback Statute rebates on prescription drugs paid by manufacturers to pharmacy benefit managers, Part D plans and Medicaid managed care organizations. The new plan would create a new safe harbor for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs, the government agency said.
In the announcement, Azar said since the proposal addresses the notion of drug rebates, this would relieve drugmakers of the pressure to provide larger and larger rebates to the PBMs, which are then reflected in annual price hikes, most typically on branded drugs. In January, multiple companies raised the price of drugs, an increase of 6 to 7 percent on certain drugs by Johnson & Johnson. The life sciences giant followed other companies such as Pfizer, Allergan, Sanofi, GlaxoSmithKline and others who had already announced plans to increase prices this year.
“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” Azar said in a statement.
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb touted the proposal on Twitter. Gottlieb said the “highly significant new proposed rule” put forth by Azar “has the potential to transform how drugs are priced; in the process generating significant savings for patients and improving access to lifesaving medicines.”
As Congress bandies about several bills and holds pricing hearings, Azar said the new proposal could be passed into law immediately and begin to save patients money. He said the plan is a “major departure from a broken status quo that serves special interests.”
Corcept downgraded to Neutral from Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Charles Duncan downgraded Corcept Therapeutics to Neutral and lowered his price target for the shares to $14 from $20. The company’s lower than projected Korlym revenue for Q4 and 2019 guidance points to limited upside potential, Duncan tells investors in a post-earnings research note. Further, the analyst says investors need visibility on relacorilant.
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