FDA approvals fall in 2024, Transcarent acquires Accolade

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The U.S. Food and Drug Administration wrapped up 2024 with 50 latest drug approvals, clearing a wave of long-awaited treatments. 

That is in accordance with the agency’s official tally of latest treatments not previously approved or marketed within the U.S. The entire drugs cleared dipped barely from 55 in 2023, but there have been several firsts and other notable medications that the agency gave a green light last 12 months. 

That features the first-ever treatment for metabolic dysfunction-associated steatohepatitis (MASH,) a typical and potentially deadly liver disease that affects thousands and thousands worldwide. The drug, Rezdiffra, is from Madrigal Pharmaceuticals, which has now succeeded in a disease area that several large corporations have failed in or are still attempting to break into. 

The FDA also cleared the primary two treatments for a rare progressive genetic disorder called Niemann-Pick disease type C. The condition causes damage to the nervous system over time since the body cannot properly transport cholesterol and other fatty substances inside cells, resulting in a buildup of those substances within the body. 

The agency handed the primary approval to a drug called Miplyffa from Zevra Therapeutics, which reached the finish line on the second try after a previous rejection in 2021. Privately-held IntraBio’s Aqneursa also won FDA approval for the treatment of Niemann-Pick disease type C. 

The FDA  last 12 months also approved several drugs designed to treat familiar diseases in latest ways. 

For instance, Bristol Myers Squibb‘s Cobenfy is the primary novel treatment approved for schizophrenia in many years. It’s the primary drug from a latest class that does not directly block dopamine to enhance symptoms.

Pfizer‘s latest drug for hemophilia A or B, genetic bleeding disorders, can also be the primary to focus on a selected protein within the blood-clotting process. The treatment, Hympavzi, can also be the primary hemophilia medicine approved within the U.S. that’s specifically administered using a pre-filled, auto-injector pen. 

Merck‘s Winrevair became the primary drug to focus on the foundation explanation for pulmonary arterial hypertension, a progressive and life-threatening lung condition. Other available medicines only help manage symptoms. 

Meanwhile, the FDA approved Amgen‘s therapy, Imdelltra, as a second or later line treatment for individuals with advanced small-cell lung cancer. It’s the primary and only so-called T-cell engager therapy approved for that deadly type of lung cancer. 

Amgen’s drug is specifically designed to redirect the immune system’s T-cells to acknowledge and kill cancer cells. 

Other notable FDA approvals include Eli Lilly‘s long-awaited drug for early symptomatic Alzheimer’s disease, which faced several obstacles in its path to market. The treatment, Kisunla, is expanding the limited treatment options within the U.S. for the disease that causes mental degeneration.

Notably, lots of the FDA approvals were for products from a mixture of little known private and non-private corporations, reminiscent of Allecra Therapeutics, Iovance Biotherapeutics and BridgeBio Pharma. It signals that smaller biotech corporations are more willing to bring their products to market on their very own versus partnering or getting acquired by a big pharmaceutical company.

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Digital health startup Transcarent on Wednesday announced it can acquire Accolade in a deal valued at roughly $621 million. 

Transcarent, which earned a spot on CNBC’s Disruptor 50 list last 12 months, offers at-risk pricing models to self-insured employers to assist their staff quickly access care and navigate advantages. As of May, the corporate had raised around $450 million at a valuation of $2.2 billion. 

Accolade offers care delivery, navigation and advocacy services. The corporate went public throughout the coronavirus pandemic in 2020 as investors began pouring billions of dollars into digital health, however the stock has mostly been in freefall within the years since. Accolade is the newest in a string of digital health corporations to exit the general public markets because the sector readjusts after Covid. 

Transcarent will acquire Accolade for $7.03 per share in money, which represents a premium of roughly 110% over its closing stock price on Tuesday, Transcarent said. The deal is anticipated to shut next quarter, though it’s still subject to shareholder and regulatory approvals. 

“Combining Transcarent’s complex care experience with Accolade’s people and 16 years of healthcare data, we are going to create a more personalized healthcare experience for people while improving outcomes and driving down costs,” Accolade CEO Rajeev Singh said in a press release Wednesday. 

Evercore served because the financial adviser to Transcarent for the deal. Morgan Stanley advised Accolade. 

Transcarent’s CEO Glen Tullman isn’t any stranger to flashy deals within the digital health space. Tullman previously helmed Livongo, which was acquired by the virtual-care provider Teladoc in a 2020 agreement that valued the corporate at $18.5 billion.

When Teladoc acquired Livongo, the businesses had a combined enterprise value of $37 billion. Teladoc’s market cap now sits at roughly $1.7 billion.

“Since Livongo, I feel there was some energy loss concerning the power of digital health care,” Tullman told CNBC in an interview Wednesday. “We’re creating now an experience that folks don’t similar to, they really love.”

Tullman said Transcarent and Accolade have “very similar visions.” Accolade has a longtime expertise with medical opinions, primary care and patient advocacy services, for instance, which he said Transcarent’s client base has sought. 

“I feel this was an ideal fit,” Tullman said. 

Read the total release here.

Be happy to send any suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.