FDA approvals fall in 2024, Transcarent acquires Accolade

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The US Food and Drug Administration concluded 2024 with the approval of 50 new drugs, ending a wave of long-awaited treatments.

That's according to the agency's official count of new treatments not approved or previously marketed in the U.S. The total number of approved drugs fell slightly from 55 in 2023, but there were several firsts and other notable drugs that the agency shed light on green last year.

This includes the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), a common and life-threatening liver disease that affects millions of people worldwide. The drug, Rezdiffra, is Madrigal Pharmacywhich has now succeeded in a disease area where several large companies have failed or are still trying to enter.

The FDA also authorized the first two treatments for a rare progressive genetic disorder called Niemann-Pick disease type C. The condition causes damage to the nervous system over time because the body cannot properly transport cholesterol and other fatty substances into cells. , which leads to an accumulation of these substances in the body.

The agency granted the first approval to a drug called Miplyffa from Zevra Therapeuticswhich reached the finish line on the second attempt after a previous rejection in 2021. Aqneursa, from private company IntraBio, also won FDA approval for the treatment of Niemann-Pick disease type C.

Last year, the FDA also approved several drugs designed to treat familiar diseases in new ways.

For example, Bristol-Myers SquibbCobenfy is the first novel treatment approved for schizophrenia in decades. It is the first drug in a new class that does not directly block dopamine to improve symptoms.

PfizerThe new drug for hemophilia A or B, the genetic bleeding disorders, is also the first to target a particular protein in the blood clotting process. The treatment, Hympavzi, is also the first hemophilia medication approved in the U.S. that is specifically administered via a prefilled autoinjector pen.

merckWinrevair became the first drug to target the root cause of pulmonary arterial hypertension, a progressive and life-threatening lung condition. Other medications available only help control the symptoms.

Meanwhile, the FDA approved amgen's therapy, Imdelltra, as a second or subsequent line treatment for people with advanced small cell lung cancer. It is the first and only T-cell activation therapy approved for that deadly form of lung cancer.

Amgen's drug is specifically designed to redirect the immune system's T cells to recognize and kill cancer cells.

Other notable FDA approvals include Eli LillyThe long-awaited drug for early symptomatic Alzheimer's disease, which faced several obstacles on its way to market. The treatment, Kisunla, is expanding limited treatment options in the United States for the disease that causes mental degeneration.

Notably, many of the FDA approvals were for products from a mix of little-known public and private companies, such as Allecra Therapeutics, Iovance Biotherapeutics and BridgeBio Pharmacist. He notes that smaller biotech companies are more willing to bring their products to market on their own rather than partnering with or being acquired by a large pharmaceutical company.

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Digital health startup Transcarent announced Wednesday that it will acquire Accolade in a deal valued at approximately $621 million.

Transcarent, which earned a spot on CNBC's Disruptor 50 list last year, offers at-risk pricing models to self-insured employers to help their workers quickly access care and navigate benefits. As of May, the company had raised around $450 million at a valuation of $2.2 billion.

Accolade offers care delivery, navigation and advocacy services. The company went public during the coronavirus pandemic in 2020, when investors began pouring billions of dollars into digital health, but shares have been in free fall in the years since. Accolade is the latest in a series of digital health companies exiting public markets as the sector readjusts post-Covid.

Transcarent will acquire Accolade for $7.03 per share in cash, representing a premium of about 110% to its closing share price on Tuesday, Transcarent said. The deal is expected to close next quarter, although it is still subject to regulatory and shareholder approvals.

“By combining Transcarent's complex care experience with Accolade's people and 16 years of healthcare data, we will create a more personalized healthcare experience for people while improving outcomes and reducing costs,” the CEO said Wednesday. of Accolade, Rajeev Singh, in a statement.

Evercore acted as financial advisor to Transcarent for the deal. Morgan Stanley advised Accolade.

Transcarent CEO Glen Tullman is no stranger to eye-catching deals in the digital health space. Tullman previously led Livongo, which was acquired by virtual care provider Teladoc in a 2020 deal that valued the company at $18.5 billion.

When Teladoc acquired Livongo, the companies had a combined enterprise value of $37 billion. Teladoc's market capitalization now stands at approximately $1.7 billion.

“Since Livongo, I think there's been some loss of energy about the power of digital healthcare,” Tullman told CNBC in an interview Wednesday. “Now we're creating an experience that people not only like, but actually love.”

Tullman said Transcarent and Accolade have “very similar visions.” Accolade has established expertise in medical opinions, primary care and patient advocacy services, for example, something he said Transcarent's customer base has sought.

“I think this was a perfect fit,” Tullman said.

Read the full statement here.

Please feel free to send any tips, suggestions, story ideas, or information to Ashley at [email protected].