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Saturday, July 10, 2021

Healthcare mergers, 'pay for delay' deals get added scrutiny under Biden order

 

  • President Joe Biden on Friday announce he would call on the Department of Justice and Federal Trade Commission "to enforce the antitrust laws vigorously" in healthcare and other key industries. The White House said it's urging antitrust regulators to recognize that "the law allows them to challenge prior bad mergers that past Administrations did not previously challenge."
  • The executive order instructs antitrust regulators to "review and revise" their merger guidelines to ensure patients are not harmed by a potential tie-up.
  • The order also tackles prescription drugs, calling on regulators to ban "pay for delay" arrangements, and instructs the FDA to work with states to import drugs from Canada.

Consolidation in healthcare is a persistent issue as mergers and acquisitions have continued at a steady clip for years, with a slew of research finding the unions lead to higher prices.

Biden's executive order notes that lack of competition in the healthcare market can lead to price increases without improving quality of care.

"Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market," the release from the White House said, citing research from Deloitte.

So far this year, there have been 27 health system mergers and acquisitions, representing total revenue of $17.2 billion. Although the number of deals are below last year's levels, the deals are larger, according to the latest report from consultancy Kaufman Hall.

Although the executive order calls on regulators to make the healthcare industry a priority, the FTC has signaled it is already doing so in various ways.

Last year, the FTC said it was expanding its retrospective merger review program to consider and research new areas of study that could ultimately help the agency police future deals. The agency followed up, earlier this month, by signaling it is prioritizing healthcare as part of its enforcement strategy over the next decade. After a vote of the commissioners, the agency agreed to focus on a number of key sectors, including technology companies and healthcare, which includes hospitals, pharmacy benefit managers and pharmaceutical companies.

The​ executive order also directs the U.S. Department of Health and Human Services to finish implementing rules on the surprise billing ban, continue to support price transparency efforts and standardize health plans on the Affordable Care Act marketplace to make it easier to comparison shop.

The price transparency rule requiring hospitals to publish some of the rates they negotiate with insurance companies went into effect at the beginning of this year, but various reviews have found most hospitals are not complying in full. The penalty for noncompliance is $300 a day, which researchers have said may be too low give the requirement teeth.

https://www.biopharmadive.com/news/healthcare-mergers-pay-for-delay-deals-get-added-scrutiny-under-biden-or/603115/

Sigilon Therapeutics Shares Lower After Clinical Hold on Hemophilia Study

 Shares of biotechnology company Sigilon Therapeutics Inc. touched a 52-week low Friday after the company said the U.S. Food and Drug Administration placed its Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A on clinical hold.

Sigilon said the hold was initiated after it submitted a serious adverse event and temporary enrollment halt to the FDA and other agencies.

At 1:05 p.m. ET, the company's shares were trading 24% lower at $7.06. Volume at the time topped 1.4 million shares. The stock's 65-day average volume is 159,069.

Earlier in the session, the shares touched a 52-week low of $6.28.

The company said one of three patients dosed with SIG-001 developed inhibitors to Factor VIII. The patient is responding well to medical treatment and his condition continues to improve, it said.

"Patient safety is our top priority, and we are encouraged that the patient is recovering," said Rogerio Vivaldi, the company's president and chief executive. "In collaboration with the regulatory agencies and our advisors, we are conducting a thorough investigation of this event to confirm whether there was a causal relationship between the development of inhibitors and SIG-001. We are committed to working with the FDA to resolve the clinical hold."

https://www.marketscreener.com/quote/stock/SIGILON-THERAPEUTICS-INC-116081124/news/Sigilon-Therapeutics-Shares-Lower-After-Clinical-Hold-on-Hemophilia-Study-35829612/

EU delivers enough doses to vaccinate 70% adults: von der Leyen

 The European Union (EU) has delivered enough coronavirus vaccine doses to member states to vaccinate at least 70% of adults, European Commission chief Ursula von der Leyen said in a statement.

Von der Leyen urged the EU countries to increase vaccinations and said that about 500 million doses would be distributed across the union by Sunday.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-EU-delivers-enough-doses-to-vaccinate-70-adults-von-der-Leyen-says-35831160/

Intraocular lens platform provider RxSight files for a $100 million IPO

 RxSight, a commercial-stage provider of an intraocular lens that can be adjusted after cataract surgery, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


RxSight markets its RxSight Light Adjustable Lens system, comprised of the RxSight Light Adjustable Lens and the RxSight Light Delivery Device, to offers the first and only commercially available intraocular lens technology that enables doctors to customize and optimize visual acuity for patients after cataract surgery.

The Aliso Viejo, CA-based company was founded in 1997 and booked $15 million in sales for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol RXST. J.P. Morgan, BofA Securities, SVB Leerink, Wells Fargo Securities, and BTIG are the joint bookrunners on the deal. No pricing terms were disclosed.

Gene therapy biotech Omega Therapeutics files for a $100 million IPO

 Omega Therapeutics, a preclinical biotech developing gene therapies for cancer and other diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Omega Therapeutics aims to use its proprietary OMEGA Epigenomic Programming platform to pioneer a new class of DNA-sequence-targeting, mRNA-encoded therapeutics. Its pipeline consists of preclinical programs that span regenerative medicine, multigenic diseases including immunology, oncology, and select monogenic diseases. The company has conducted in vivo preclinical studies in hepatocellular carcinoma, non-small cell lung cancer, and acute respiratory distress syndrome.

The Cambridge, MA-based company was founded in 2016 and plans to list on the Nasdaq under the symbol OMGA. Omega Therapeutics filed confidentially on May 10, 2021. Goldman Sachs, Jefferies, Piper Sandler, and Wedbush PacGrow are the joint bookrunners on the deal. No pricing terms were disclosed.

Oncology biotech Immuneering files for a $100 million IPO

 Immuneering, a preclinical biotech targeting signaling pathways to treat cancer and neurological diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Immuneering's oncology programs target mutations of the MAPK and mTOR pathways, which run parallel to each other and are inappropriately activated in over half of all cancers. The company's lead program, IMM-1-104, is a highly selective dual-MEK inhibitor being developed for the treatment of advanced solid tumor patients harboring RAS mutant tumors. Immuneering plans to submit an IND for IMM-1-104 in the first quarter of 2022 and anticipates filings at least one additional oncological IND in both 2023 and 2024.

The Cambridge, MA-based company was founded in 2008 and plans to list on the Nasdaq under the symbol IMRX. Immuneering filed confidentially on May 13, 2021. Morgan Stanley, Jefferies, Cowen, and Guggenheim Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Oral capsule developer Rani Therapeutics files for a $100 million IPO

 Rani Therapeutics, which develops ingestible capsules for oral dosing of medication, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Rani Therapeutics is a clinical stage biotherapeutics company advancing technologies to enable the development of orally administered biologics, which they believe have the potential to transform medicine and improve patient outcomes. Rani Therapeutics has developed the RaniPill capsule, which is their novel, proprietary and patented platform technology, intended to replace subcutaneous or IV injection of biologics with oral dosing. 

The San Jose, CA-based company was founded in 2012 and plans to list on the Nasdaq under the symbol RANI. BofA Securities, Stifel, Cantor Fitzgerald, and Canaccord Genuity are the joint bookrunners on the deal. No pricing terms were disclosed.