Target to $100 from $130
Monday, February 10, 2025
Pliant Therapeutics Pauses Lead Product Mid-Stage Trial
Pliant Therapeutics, Inc. (NASDAQ:PLRX) stock is trading lower on Monday.
On Friday, during after-hours trading, Pliant Therapeutics announced it has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), a chronic lung disease that causes scarring and stiffening of the lung tissue.
Patients currently enrolled in BEACON-IPF will remain in the trial.
The move follows a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board.
Enrollment and dosing have been paused while data are reviewed to understand the DSMB’s rationale for their recommendation. The study will be blinded to preserve trial integrity.
In May 2024, On Tuesday, Pliant Therapeutics announced topline data from a Phase 2a PET Imaging trial of bexotegrast (PLN-74809) evaluating change in total collagen levels in the lungs of patients with idiopathic pulmonary fibrosis (IPF) characterized by excessive collagen deposition in the lung.
Bexotegrast-treated patients showed reduced total lung collagen post-treatment as measured by positron emission tomography (PET) imaging, compared to increased total lung collagen in the placebo group, suggesting potential reversal of fibrosis.
Last February, Pliant Therapeutics released 12-week interim data from the 320 mg dose group of INTEGRIS-PSC Phase 2a trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis.
The 320 mg group met its primary and secondary endpoints, demonstrating that bexotegrast was well tolerated over a 12-week treatment period, and its plasma concentrations increased with dose.
There was no dose relationship for adverse events. Pruritus and cholangitis occurred less frequently on bexotegrast than on placebo.
https://finance.yahoo.com/news/pliant-therapeutics-pauses-lead-product-133204055.html
Axsome Resolves Patent With Teva, Maintained As 'Top Pick For 2025'
On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) signed a settlement agreement with Teva Pharmaceuticals Inc (NYSE:TEVA).
The settlement resolves all patent litigation related to Axsome’s Auvelity (dextromethorphan HBr – bupropion HCl) product.
Auvelity is approved in the U.S. for major depressive disorder.
The litigation resulted from Teva submitting an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Auvelity in the U.S. before the expiration of applicable Axsome patents.
Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of Auvelity beginning on or after March 31, 2039, if pediatric exclusivity is granted for Auvelity, or on or after September 30, 2038, if no pediatric exclusivity is granted.
The parties will terminate all ongoing litigation between Axsome and Teva regarding Auvelity patents pending in the U.S. District Court for the District of New Jersey.
In January, Axsome Therapeutics reported preliminary Auvelity net product sales are expected to be approximately $92.6 million and $291.4 million for the fourth quarter and full year of 2024, respectively.
Recently, the FDA approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
“Axsome is our top pick for 2025,” William Blair writes. Analyst Myles Minter reiterates the Outperform rating based on favorable litigation settlement and clarity on Auvelity’s generic launch timing.
“We also remain impressed with the Auvelity launch, which showed 15% growth in revenue over the prior quarter and is annualizing about $370 million after two years of launch,” William Blair adds.
Axsome now has three commercial products with the approval of Symbravo for migraines. While investors are mainly watching Auvelity's rollout for depression and its potential use in Alzheimer's-related agitation, analyst Minter writes Symbravo's potential in treating acute migraines is being overlooked.
William Blair also views Axsome as a takeout candidate with Johnson & Johnson buying Intra-Cellular Therapies Inc. for $14.6 billion.
Needham analyst Ami Fadia reiterates Axsome Therapeutics with a Buy and maintains a $133 price target.
https://finance.yahoo.com/news/axsome-therapeutics-resolves-generic-patent-173347905.html
Biodexa US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Underscores unmet need for a therapeutic alternative with the potential to delay or prevent surgical removal of the colon and/or rectum
Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced today that the US Food and Drug Administration (“FDA”) has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Qiagen at low since July, Merck weak - USA cuts research
The shares of Qiagen and Merck KGaA were at the bottom of the index on Monday with losses in the barely changed Dax. JPMorgan analyst Richard Vosser sees slight headwinds for European diagnostics specialists in particular due to cuts in research spending in the US healthcare system. Qiagen continued its slide to its lowest level since July 2024 and is now down 13 percent for the year; Merck KGaA is down two percent.
The shares of pharmaceutical and laboratory supplier Sartorius remained under pressure with a drop of just under one percent. The jump in the share price at the end of January following preliminary business figures for the past year is now completely gone. However, after a very weak 2024, the shares are still up around 16 percent in 2025.
Chinese Nationals Arrested For Allegedly Smuggling Counterfeit Goods Through SoCal Ports
Two Chinese nationals living in Los Angeles were recently arrested for allegedly running a scheme to smuggle counterfeit goods from China through Southern California ports, according to the US Attorney's Office of the Central District of California.
Zhongliang Wang, 39, and Chenyu Zhao, 31, both of Hacienda Heights, were taken into custody last week over an alleged "cargo-swapping scheme" operating out of the ports of Los Angeles and Long Beach - by which they are accused of taking cargo ship containers selected for inspection by the US Customs and Border Protection (CBP), breaking the security seals, removing the contraband, and then stuffing the containers with junk cargo before replacing the broken seals with counterfeit ones.
Wang and Zhao's co-conspirators would then transport the containers to a CBP-authorized location for inspection, according to prosecutors. The co-conspirators were allegedly paid much higher than normal trucking fees - $15,000 for each cargo container diverted from inspection in November and December 2024.
As the Epoch Times notes further, a photo in the complaint showed a fake luxury handbag bearing the brand name Christian Dior, while another photo showed several boxes with the word Prada.
Wang and Zhao allegedly began their scheme in July 2023, according to the complaint.
“Protecting our nation’s borders from illegal smuggling is a top priority,” U.S. Attorney Joseph McNally said in a statement. “These arrests highlight the unrelenting efforts of law enforcement to dismantle criminal networks that seek to exploit our trade system and endanger American businesses and consumers.”
Zhao, a Chinese citizen and lawful permanent U.S. resident, was arrested at the Los Angeles International Airport on Jan. 30, just before he returned to China on a one-way flight, prosecutors said.
According to the complaint, Zhao told law enforcement officials at the airport that he was aware of media coverage that some individuals had been charged with similar smuggling activities via the Ports of Los Angeles and Long Beach.
On Jan. 27, the U.S. Attorney’s Office of the Central District of California announced charges against nine individuals, including executives of logistic companies, warehouse owners, and truck drivers, after prosecutors seized $130 million in contraband. Eight were arrested while one was a fugitive at the time of the announcement.
As of Feb. 6, prosecutors said local law enforcement officials had seized more than $1.3 billion of contraband in connection with cargo-swapping schemes, including in Wang and Zhao’s case.
Wang and Zhao have been charged with conspiracy and illegally removing goods from customs custody. They face a maximum sentence of five years in prison for each conspiracy count and up to 10 years of imprisonment for each count of breaking customs security seals.
In fiscal year 2024, CBP seized more than 32 million counterfeit items, which would have been worth more than $5.4 billion if they had been genuine, according to a report.
The report also found that counterfeit goods from China and Hong Kong accounted for about 90 percent of the total quantity seized.
The top five commodities seized in fiscal year 2024 were pharmaceuticals, sunglasses, consumer electronics, perfumes, and personal care items, according to the report.
On Feb. 6, the CBP officials in Louisville, Kentucky, announced that it had seized 28 shipments in January, most of which came from either China or Hong Kong. The shipment contained fake designer watches, bracelets, rings, necklaces, and earrings, all of which would have a combined manufacturer’s suggested retail price of $27.5 million if the items were genuine.
It’s not known if Wang and Zhao have attorneys.
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