Sanofi Mulls Mirati Buy as KRAS Battle Heats Up

 Sanofi appears to be considering a buyout of cancer drugmaker Mirati Therapeutics, according to Bloomberg reporting on Thursday, citing sources familiar with the matter.

Deliberations surrounding the potential acquisition are ongoing and there is no certainty that Sanofi will push through with the deal, Bloomberg noted. Still, the possibility of the buyout has energized the market and Mirati was trading 45% higher Thursday afternoon in reaction to the rumors.

A Sanofi spokesperson declined to confirm or deny the acquisition in a statement to Reuters, saying that the company does not comment on market rumors. Mirati was likewise tight-lipped about the matter.

This is not new territory for Mirati. In October 2021, Merck had expressed interest in acquiring Mirati, according to people briefed on the matter. In November 2022, Mirati was attracting “fresh takeover interest” from large pharma companies, also reported by Bloomberg. At the time, the California-based biotech was still ushering its KRAS inhibitor adagrasib through the clinical space.

A month later, in December 2022, the molecule won the FDA’s accelerated approval for the treatment of locally advanced or metastatic non-small cell lung cancer with the G12C mutation in the KRAS gene. Adagrasib is currently being sold under the brand name Krazati and is Mirati’s only approved product.

Despite the regulatory win, however, Krazati still trails behind Amgen’s first-to-market G12C KRAS inhibitor Lumakras (sotorasib). In its second-quarter 2023 earnings report, Mirati reported net revenue of $13.4 million for Krazati. During the same period, Lumakras made $77 million.

Thursday’s buyout rumors also come as Mirati is facing clinical and business challenges. In May 2023, the company’s investigational kinase inhibitor sitravatinib failed the Phase III SAPPHIRE trial. When given as part of a combination regimen with Bristol Myers Squibb’s Opdivo (nivolumab), sitravatinib did not significantly improve overall survival in patients with non-squamous, non-small cell lung cancer.

The disappointing SAPPHIRE results convinced Mirati to terminate all development of sitravatinib outside the Asia-Pacific region.

In August 2023, CEO David Meek announced that he was relinquishing his leadership position at Mirati as well as his seat on the company’s board of directors. Meek has since stayed with the company as a consultant, but that is set to end on Oct. 15.

Despite these headwinds, Mirati isn’t the only player to face challenges in the space. On Thursday, Mirati’s chief KRAS competitor Amgen suffered a defeat at the hands of the FDA’s Oncologic Drugs Advisory Committee. The panel of external experts voted 10-2 that Amgen’s progression-free survival data for Lumakras could not be reliably interpreted due to concerns of study bias.

Amgen is seeking to convert Lumakras’ accelerated approval to traditional approval, and the adcomm convened to discuss the company’s Phase III confirmatory trial CodeBreaK 200. The FDA is set to release its decision on the matter by Dec. 14.

https://www.biospace.com/article/sanofi-mulls-mirati-therapeutics-buy-as-kras-battle-heats-up-bloomberg-/

GSK Sells $1.1 Billion Stake in Former Consumer Unit Haleon

 The British drug company sold 270 million shares at a price of 328 pence, according to a regulatory announcement Friday. The price reflects a discount of about 2.5% to Haleon’s closing price on Thursday.

Accelerated offerings are typically priced at a discount to entice shareholders to buy into the deal.

Haleon stock dropped 2% in early trading in London. GSK was little changed.

The sale leaves GSK’s with a 7.4% stake in Haleon, the maker of Aquafresh toothpaste and Panadol.

Haleon was originally formed from a combination of GSK’s and Pfizer Inc.’s consumer health units.

GSK decided to separate Haleon so it could better focus on its pharma and vaccines business. Headed by Chief Executive Officer Emma Walmsley, GSK is trying to strengthen its drug pipeline, with recent success on a vaccine against RSV, a common virus that can be deadly.

The spinoff aimed at strengthening the prospects of both GSK and Haleon following pressure from activist investor Elliott Investment Management.

Since the spinoff, GSK has said that it intended to treat its stake in Haleon like a financial investment, using proceeds raised to strengthen its balance sheet and help support its aim to improve its drug pipeline.

Read More: GSK’s £30 Billion Consumer-Health Arm Makes London Debut

The stake sale comes less than six months after GSK offloaded about £804 million ($978 million) worth of Haleon stock. Pfizer has also indicated it will gradually sell down its stake in Haleon as part of its move to focus on pharma innovations.

https://finance.yahoo.com/news/gsk-offloads-stake-worth-1-162414110.html

U.S. doesn't want to build new sections of border wall, Mexico says

 "It's pure publicity," Lopez Obrador said in a regular morning press conference, after the Biden administration announced it would build additional sections of border wall, carrying forward a signature policy of the Trump administration.

A high-ranking delegation of U.S. officials met Thursday with their Mexican counterparts, among them U.S. Secretary of State Antony Blinken.

"They don't want to (build more sections of the wall), that's what they told us," Lopez Obrador said.

U.S. President Joe Biden said on Thursday that the funds allocated for the construction were

appropriated by Congress

and that he could not, by law, redirect the money.

Biden, when he took office in 2021, pledged that "no more American taxpayer dollars be diverted to construct a border wall."

Mexico's president added that in the meetings the day before, the Mexican delegation expressed that Mexico "does not believe (additional border wall construction) to be the answer to the migration problem."

https://finance.yahoo.com/news/1-u-doesnt-want-build-144103788.html

Wainwright Reaffirms Positive Outlook on Adagene with 5 Price Target

 On October 4, 2023, Arthur, an analyst from HC Wainwright & Co., expressed his positive outlook on Adagene (NASDAQ:ADAG) by reaffirming his Buy rating and maintaining a price target of $5. His belief in the stock‘s undervaluation suggests that there is potential for its price to increase up to $5. Arthur’s assessment of Adagene’s financial performance, growth prospects, and various other factors contribute to his favorable rating. It is worth noting that two other analysts have also assigned a Buy rating to Adagene, aligning with the overall consensus.

https://beststocks.com/analyst-reaffirms-positive-outlook-on-adagene/

PTC cut to Hold from Buy by Truist

 Target to $25 from $45

https://finviz.com/quote.ashx?t=PTCT&ty=c&ta=1&p=d

FDA says it is not satisfied with Philips breathing device recall

Philips has recalled millions of sleep apnea and respiratory devices since 2021.

In the update published overnight, the FDA said it believed Amsterdam-headquartered Philips should conduct additional testing on the risk posed to people who used recalled devices.

Philips could not immediately be reached for comment.

"This is negative news," analysts from Bernstein said in a note. "The FDA is clearly still not happy with the way the recall is being handled."

The long-running recall wiped out more than two-thirds of Philips' market valuation in 2021-2022, but it has staged a modest recovery in 2023.

Shares were down 6.6% at 17.32 euros at 0703 GMT on Friday

https://finance.yahoo.com/news/1-fda-says-not-satisfied-070700025.html

FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children

 

Expanded indication for ZORYVE provides new, steroid-free topical for children 6 to 11 with plaque psoriasis, including intertriginous psoriasis

https://www.globenewswire.com/news-release/2023/10/06/2756044/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-Treatment-of-Psoriasis-in-Children-Ages-6-to-11.html