Search This Blog

Thursday, June 20, 2019

Personalis Prices Initial Public Offering of Common Stock

Personalis, Inc., a leader in advanced genomics for cancer, today announced the pricing of its initial public offering of 7,921,500 shares of common stock at a price to the public of $17.00 per share. All of the shares of common stock are being offered by Personalis. In addition, Personalis has granted the underwriters a 30-day option to purchase up to an additional 1,188,225 shares of common stock from Personalis at the public offering price less underwriting discounts and commissions. The company’s shares are expected to begin trading on The Nasdaq Global Market on Thursday, June 20, 2019 under the trading symbol “PSNL.” The offering is expected to close on June 24, 2019, subject to the satisfaction of customary closing conditions.
Morgan Stanley, BofA Merrill Lynch and Cowen are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. is acting as co-manager for the offering.

Akero Therapeutics Announces Pricing of Initial Public Offering

Akero Therapeutics, Inc. (NASDAQ: AKRO), a clinical-stage biotechnology company developing transformational treatments for people with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced the pricing of its initial public offering of 5,750,000 shares of common stock at a public offering price of $16.00 per share. All of the shares are being offered by Akero. The shares are expected to begin trading on the Nasdaq Global Select Market on June 20, 2019 under the ticker symbol “AKRO.” The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Akero, are expected to be approximately $92.0 million. The offering is expected to close on June 24, 2019, subject to the satisfaction of customary closing conditions. In addition, Akero has granted the underwriters a 30-day option to purchase up to an additional 862,500 shares of common stock at the initial public offering price.
J.P. Morgan Securities LLC, Jefferies LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Roth Capital Partners is acting as lead manager for the offering.

Prevail Therapeutics Announces Pricing of Initial Public Offering

Prevail Therapeutics Inc. (Nasdaq: PRVL) (Prevail), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative disorders, today announced the pricing of its initial public offering of 7,353,000 shares of its common stock at a price to the public of $17.00 per share. In addition, Prevail has granted the underwriters a 30-day option to purchase up to an additional 1,102,950 shares of its common stock at the initial public offering price less underwriting discounts and commissions.
The shares are expected to begin trading on the Nasdaq Global Market on June 20, 2019 under the symbol “PRVL.” The offering is expected to close on June 24, 2019, subject to customary closing conditions.
Morgan Stanley, BofA Merrill Lynch and Cowen are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager.

Wednesday, June 19, 2019

San Francisco set to become first US city to ban e-cigarettes

San Francisco has edged towards becoming the first US city to ban sales of e-cigarettes, as well as the manufacturing and distribution of them on city property. A preliminary vote saw city supervisors unanimously approve a ban on e-cigarettes the Food and Drug Administration has yet to review. It hasn’t assessed any yet and companies have until 2021 to apply for reviews of their products under the agency’s draft guidelines.
A final vote on the measure will take place next week, and it seems likely to pass into law. Dennis Herrera, San Francisco’s city attorney, said young people “have almost indiscriminate access to a product that shouldn’t even be on the market” as things stand.
The ban could have a big impact on Juul, perhaps the best-known e-cigarette brand. Its headquarters are in the city’s port, and it has butted heads with officials. In March, Herrera asked the company to explain why it has a tobacco distributor license at its HQ when it has denied selling tobacco products or cigarettes on the premises. Juul would still be able to maintain its port offices if the ban comes into effect, though it revealed this week it would expand into a downtown office block it bought.
“The prohibition of vapor products for all adults in San Francisco will not effectively address underage use and will leave cigarettes on shelves as the only choice for adult smokers, even though they kill 40,000 Californians every year,” a Juul spokesman told the Associated Press.
The FDA has also put e-cigarettes (and Juul, in particular) in its sights. In November, it limited the sales of flavored e-cigarettes, and has suggested Juul and investor (and tobacco giant) Altria aren’t doing enough to stop teens from vaping. The Centers for Disease Control and Prevention reported earlier this year that more than a fifth of high schoolers had used an e-cigarette product in 2018. Juul is also facing investigations from federal lawmakers over teen vaping use.
The San Francisco ban wouldn’t go into effect for at least seven months, the San Francisco Chronicle reports. Juul, meanwhile, is backing an effort to collect signatures for a November ballot measure to block the ban.

FTC posts conditions for DaVita/UnitedHealth deal

The Federal Trade Commission says DaVita (NYSE:DVA) and UnitedHealth Group (NYSE:UNH) have agreed to a settlement to resolve concerns over UnitedHealth’s proposed $4.3B acquisition of DaVita Medical Group.
No later than 40 days after the acquisition closes, UnitedHealth will divest DMG’s healthcare provider organization in the Las Vegas area to Utah-based Intermountain Healthcare.
It will also be required to provide transition assistance to Intermountain, including transferring confidential business information and giving Intermountain the opportunity to interview and hire employees in key roles.
The FTC’s complaint alleged that the deal would reduce competition in the markets for MCPO services sold to Medicare Advantage insurers, as well as Medicare Advantage plans sold to members.
DaVita closed the day up 3.1%; UnitedHealth up 1.8%.

FDA clears J&J and Grifols’ blood-stopping protein spray for surgical bleeds

Johnson & Johnson’s Ethicon unit has received a 510(k) clearance from the FDA for its Vistaseal applicators, which spray a biological sealant to stem moderate bleeding during open or laparoscopic surgical procedures.
The airless spray products are the first fruit of a broad partnership between the devicemaker and plasma-derived medicine manufacturer Grifols, which developed the human fibrin sealant for use when standard bleeding control techniques like suturing are impractical.
Ethicon’s Vistaseal dual applicator delivers both of the product’s two biological components at once. Made of the clotting proteins fibrinogen and thrombin, the sealant is expected to be available in the second half of this year, according to Barcelona-based Grifols, and will be sold as Veraseal in markets outside the U.S.
As the partnership moves forward, J&J and Grifols plan to develop additional adjunctive blood stoppers for surgery—including pairing lyophilized thrombin with Ethicon’s Surgiflo Hemostatic Matrix, which provides a place for platelets to stick and form fibrin clots.
In addition, Grifols previously inked a deal to exclusively supply Ethicon with its thrombin for use in a range of current products over the next several years. The latter company’s biosurgery portfolio includes the Surgicel line of absorbable hemostats, such as a powder to control continuous oozing of blood across broad surfaces, as well as the Evicel Fibrin Sealant for high-risk patients.
J&J estimates that between one- and two-thirds of open surgery procedures experience disruptive bleeding events, with potentially harmful complications from both fluid and air leaks. In addition, the medtech giant expects those numbers to rise as more patients present with comorbidities and other factors that increase the risk of surgical bleeding, due to an aging population.

Few heart patients use cardiac rehab after stenting

Just one in three patients enrolls in recommended cardiac rehabilitation after having a blocked heart artery cleared and a stent inserted, a Michigan study suggests.
Despite benefits from rehabilitation such as better quality of life and lower rates of rehospitalization, patients may not attend these sessions because of issues related to insurance, costs and access to a rehab facility, the study authors report in the Journal of the American College of Cardiology.
Efforts to get doctors to increase their referrals of patients for cardiac rehab have worked, the authors write, but more needs to be done to make sure patients attend the sessions.
“The use of cardiac rehabilitation after coronary stenting carries the strongest recommendation in our clinical practice guidelines,” said lead author Dr. Devraj Sukul of the University of Michigan in Ann Arbor.
“Unfortunately, the use of cardiac rehabilitation among eligible patients remains low,” he told Reuters Health by email.
Sukul and colleagues analyzed data on more than 42,000 Michigan patients who underwent percutaneous coronary intervention (PCI), a common procedure to clear a blocked heart artery that typically includes placement of a tiny tubular stent to keep the blood vessel open. Using two databases of medical and health insurance records, researchers tracked patients who received care at one of 47 Michigan hospitals between 2012 and 2016, noting who was referred to cardiac rehab, who attended and what factors may have influenced their participation.
The study team found that 30,075 patients were discharged alive to their homes with a referral for cardiac rehab, and 8,000 attended at least one session within 90 days after discharge. People were more likely to attend if they had an “acute” reason for getting PCI, such as certain types of heart attack. And those who had other health problems, such as diabetes and peripheral artery disease, were less likely than others to attend rehab.
In addition, patients covered by Medicare Fee-For-Service insurance were less likely to attend cardiac rehab than those covered by private Blue Cross Blue Shield of Michigan plans. Among all the patients with Medicare, those also covered by Medicaid, the state-run insurance plan for the poor, were less likely to attend a session.

Geography played an interesting role as well, the researchers note. The distance from the center of a patient’s home ZIP code to the nearest cardiac rehab session didn’t make a difference in who was likely to attend rehab. But if the cardiac rehab location was more than two miles from the site where the PCI procedure took place, a patient was less likely to attend cardiac rehab.
“We found it interesting that there were a diverse set of factors associated with patients ultimately attending cardiac rehabilitation,” Sukul said. “This suggests that multi-faceted strategies, such as insurance redesign, may need to be tested and implemented to improve cardiac rehabilitation use.”
“Ideally, cardiac rehab would be provided without cost to all patients who qualify regardless of financial ability,” said Dr. Ellen Keeley of University of Florida Health in Gainesville, who wasn’t involved in the study.
Keeley and colleagues run a clinic that evaluates heart attack patients after hospital discharge, which includes a conversation about cardiac rehab. Patients are more likely to enroll after hearing details about what it involves, such as exercise, nutrition counseling and smoking cessation, she noted.
“I think the one-on-one aspect – and the fact they have been out of the hospital for about one week – allows them to ask a lot of questions in a relaxed fashion, and then they see that this type of program has a lot to offer them,” Keeley said by email.

Making cardiac rehab more accessible through “pop-up” sites that use space in a community center, as well as mobile units and telemedicine, could help those who live far away, she added.
“Even if a patient cannot attend all the sessions due to finances or distance or both, I encourage them to at least attend one or two sessions,” she said. “They can learn a significant amount about diet and exercise and gain pointers on how to create their own program at home.”
SOURCE: bit.ly/31JTjak Journal of the American College of Cardiology, online June 17, 2019.