Theravance Biopharma and Mylan settle a patent dispute with Eugia Pharma over Yupelri, delaying generic entry until 2039
https://seekingalpha.com/news/4456186-theravance-and-mylan-settle-patent-dispute-with-eugia-pharma
Friday, June 6, 2025
Arcutis to Present New Long-Term Results of ZORYVE
Arcutis Biotherapeutics (ARQT) presented new long-term data for ZORYVE cream at the 2025 RAD Conference, showing significant efficacy in treating atopic dermatitis. The Phase 3 INTEGUMENT-OLE study demonstrated that children ages 2-5 who achieved disease clearance and switched to twice-weekly ZORYVE cream 0.05% maintained disease control for a median of 238 days. By week 52, 63.1% of participants aged 2-5 years and 55.7% of those 6 years and over achieved disease clearance or almost clear status. Notable improvements in itch reduction were observed, with about half of participants achieving no or minimal itch. The treatment showed strong safety profile with low treatment-related adverse events: 2.5% in ages 2-5 and 4.7% in ages 6 and over.
Arvinas, Pfizer Seek FDA Approval of Vepdegestrant in Breast Cancer
Arvinas and Pfizer have filed for U.S. Food and Drug Administration approval of their proposed breast-cancer drug vepdegestrant in certain patients with estrogen-receptor mutations.
Arvinas on Friday said the application covers vepdegestrant in patients with ER-positive/human epidermal growth factor receptor 2-negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.
Clinical-stage biotechnology company Arvinas and drugmaker Pfizer in 2021 announced plans to collaborate on the development and commercialization of vepdegestrant, with the companies to share expenses and profits.
Recursion rises on launch of Boltz-2 in partnership with MIT
Recursion (NASDAQ:RXRX) shares rose after the company and MIT launched Boltz-2, an open-source biomolecular model.
https://seekingalpha.com/news/4456233-recursion-rises-on-launch-of-boltz-2-in-partnership-with-mit
Teva, Amneal rated Buy, Viatris Neutral as Goldman Sachs reviews generics space
Goldman Sachs on Friday reviewed the generic drug industry, initiating the coverage of Teva Pharmaceutical (NYSE:TEVA) and Amneal Pharmaceuticals (NASDAQ:AMRX) with Buy ratings and Viatris (NASDAQ:VTRS) with a Neutral rating.
The analyst Matt Dellatorre issued mostly positive remarks on the industry, citing opportunities to benefit from the sector's “undemanding” valuations driven by recent micro volatility and macro concerns.
“Broadly speaking, while the pace of legacy product erosion remains the key risk to near-term top-line growth and tariffs represent an overhang on margins (in our view, manageable), we are optimistic on the forward outlook,” Dellatorre wrote.
As reasons for the bullish outlook, the analyst cited multiple factors, including ongoing portfolio changes favoring higher-value products such as branded drugs and a stable pricing outlook for U.S. generics.
With a 12-month per-share target of $24 on Teva (NYSE:TEVA), the analyst pointed to an improvement in the Israeli drugmaker’s core business, which he said could generate upside to near-mid-term EBITDA consensus driven by strong growth in its branded portfolio.
“We see the strongest (above consensus) earnings’ growth potential for TEVA (where the branded portfolio now represents the key growth engine and a significant valuation lever) with recent clinical updates demonstrating the company’s ability to innovate,” Dellatorre wrote.
For Amneal (NASDAQ:AMRX), the analyst issued a 12-month target of $12, citing a positive growth outlook for the company’s core business due to its robust pipeline and track record of business execution.
With a 12-month target of $10 on Viatris (NASDAQ:VTRS), Goldman Sachs argued that the FactSet consensus Pfizer (PFE) spinoff appears “fair” and noted a lack of clarity in the company’s growth outlook due to structural dynamics in its core business.
Biotech Stock Vera Is Slumping After Monster Gain
A face-off between two experimental treatments for a common kidney disease is sending shares of the biotech Vera Therapeutics on a wild ride.
Vera, based in Brisbane, Calif., unveiled data Monday that showed its drug for a rare and serious kidney condition called immunoglobulin A nephropathy had led to a steep reduction in the amount of protein measured leaking into patients’ urine.
That suggested that the drug, called atacicept, was working far better than investors had expected at improving kidney function, and the stock jumped 67.5% in Monday trading.
Then came Friday morning, when Otsuka Pharmaceutical, a Japanese drugmaker, announced the results of a study of its own competing medicine to treat immunoglobulin A nephropathy. Patients on Otsuka’s drug, sibeprenlimab, saw what appears to have been an even steeper reduction in protein levels in patients’ urine over a similar period of time.
While Otsuka’s drug led to a 51.2% reduction, patients in Vera’s trial saw a 46% reduction.
It isn’t necessarily a huge difference, and the eventual impact for patients is far from clear. But it was enough to burst Vera shareholders’ bubbles, and the stock was shedding its Monday gains on Friday.
Vera stock was down 27.9% in Friday trading to $22.09. That’s a sharp decline from its Monday close of $31.74, but still 16.6% better than its closing price last Friday of $18.95.
Otsuka stock trades over the counter in the U.S., and was up 4% on Friday.
Immunoglobulin A nephropathy is a chronic condition caused by buildup of a blood protein in the kidneys. It can eventually lead to kidney failure, leaving patients reliant on dialysis or a transplant. Current treatment options are limited. Otuska and Vera are two of a handful of companies working on new antibody treatments that target cells that contribute to the condition.
The hope is that the drugs could keep patients from progressing to end-stage kidney disease.
At least some of the selloff in Vera’s shares seem warranted: It seems now, at the very least, that Vera’s drug won’t be the obvious best-in-class. But analysts warned early Friday that the Otsuka result wasn’t different enough from the Vera result to definitively show that it Otsuka’s drug works better.
In a note early Friday, Evercore ISI analyst Liisa Bayko wrote that the data suggests that “clinically, these medicines are similar.”
Other analysts agreed. “We don’t think this is a referendum on the overall efficacy of these drugs,” Raymond James analyst Ryan Deschner wrote Friday.
Deschner noted, among other things, that what actually matters is improvement in kidney function, and that the amount of protein in urine is only meant to help indicate whether kidney function is improving. Data from the two trials on a more direct measure of kidney function are not yet available.
Otsuka has applied for Food and Drug Administration approval of sibeprenlimab, and the agency is expected to make its decision in late November. Vera plans to apply for approval for atacicept later this year.
Phathom Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA
- The FDA grants Phathom Pharmaceuticals (PHAT, Financial) 10 years of regulatory exclusivity for VOQUEZNA, extending through May 3, 2032.
- This decision protects VOQUEZNA from generic competition, enhancing Phathom's market position and revenue potential.
- VOQUEZNA treats Non-Erosive GERD, Erosive GERD, and H. pylori infection.
Phathom Pharmaceuticals, Inc. (PHAT) announced a significant victory as the U.S. Food and Drug Administration (FDA) approved their Citizen Petition, affirming 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets until May 3, 2032. This exclusivity prevents generic manufacturers from entering the market with a similar product until the specified period ends.
VOQUEZNA is a first-in-class potassium-competitive acid blocker (PCAB) and is currently marketed in the United States for the treatment of heartburn associated with Non-Erosive GERD in adults, as well as the healing and maintenance of Erosive GERD. In addition, it is available as VOQUEZNA TRIPLE PAK and DUAL PAK for the treatment of H. pylori infections in adults.
The FDA's decision to correct the Orange Book and grant the full exclusivity period enhances Phathom's competitive edge, securing their intellectual property rights for an extended duration and providing a robust commercial runway.
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