Reata Holders OK Merger Transaction With Biogen

 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a global, biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that at a special meeting held today, preliminary results indicate that the stockholders of the Company voted to approve the Company’s previously announced acquisition (the "Merger") by Biogen Inc., a Delaware corporation ("Biogen").

Approximately 99.65 percent of the votes cast by the Company’s Class A common stockholders and Class B common stockholders, voting as a single class, entitled to vote at the special meeting, voted to approve the Merger, which represents approximately 87.99 percent of the total voting power of the shares of the Company’s Class A common stock and Class B common stock entitled to vote at the special meeting. The Company will file a Current Report on Form 8-K disclosing the full results of the vote. The expected closing date of the Merger is September 26, 2023.

https://finance.yahoo.com/news/reata-pharmaceuticals-stockholders-approve-merger-140800824.html

Apple's Chinese supplier Luxshare's production of some iPhone 15s doubled in a year

 Apple Inc's Chinese supplier Luxshare Precision Industry is producing three models of iPhone 15 series this year, and the business has doubled in a year, Luxshare's chairwoman said on Thursday.

The manufacturer is also making production preparations for Apple Vision Pro, a wearable headset device that will be available early next year, chairwoman Wang Laichun told state-backed newspaper The Paper.

Luxshare has increased the production types and numbers of Apple's iPhone products in recent years, Wang added.

"Luxshare is continuing to expand its production capacity in China to meet Apple's needs," Wang said, adding the company built a new plant in Kunshan last year to support the development and mass production of iPhone.

"The fact that Luxshare Precision can have this scale this year is inseparable from Apple's support," Wang told the Paper.

Founded in 2004, Luxshare became an Apple supplier in 2011 and has steadily moved up the hardware giant's value chain, from making connector cables for the iPhone and Macbook to manufacturing Airpods.

Apple's largest assembler of iPhones in China is Foxconn.

https://finance.yahoo.com/news/apples-chinese-supplier-luxshares-production-135653187.html

Leaked images show Biden admin's planned ICE ID card for illegal immigrants

 New images obtained by Fox News Digital shed light on the Biden administration's planned ID for illegal immigrants, as officials look for ways to track the volume of migrants being released into the U.S.

Fox News, along with other outlets, reported last year on the ICE Secure Docket Card program last year, which Immigration and Customs Enforcement said will "modernize various forms of documentation provided to provisionally released noncitizens through a consistent, verifiable, secure card."

Migrants who arrive at the border illegally and are not removed but instead released into the interior are often given a number of documents depending on their situation. The images show a card with room for a photograph, a QR code and identifying information and security details, as well as the ICE logo in the top left corner.

Images show the ICE Secure Docket card. (Fox News)

ICE said the ID will have a photograph, biographic identifiers and "cutting-edge" security features, with the aim being to "improve current, inconsistent paper forms that often degrade rapidly in real-world use." The agency said the program was still in development and would be considered for further expansion pending the outcome of the pilot. 

The card could be used to check in and schedule reporting meetings with ICE. The agency hopes that it can be used in the field to easily verify an alien’s identity and to see if they are deportable. But the program has alarmed conservatives, who see it as part of an agenda for welcoming, rather than removing, those in the country illegally.

"ICE is a federal law enforcement agency, not the DMV. When will Congress wake up and put an end to these open-borders, anti-enforcement programs that defy the agency’s mission and enable the crisis?" RJ Hauman, president of the National Immigration Center for Enforcement (NICE) and a visiting adviser at the Heritage Foundation, told Fox News Digital this week.

"ICE should be arresting, detaining, and removing those who come here illegally, not doling out social services," he said.

That echoes concerns expressed by lawmakers on the House Oversight Committee last year, who said they feared that it is "yet another Biden Administration move encouraging illegal immigration by rewarding illegal immigrants for breaking our laws."

They also fear that the card will include QR codes that link to court documents and other information that they say raises security concerns "as well as questions regarding the likelihood that significant taxpayer resources will be diverted from immigration enforcement to uploading documents into and maintaining a secure system."

Images show the ICE Secure Docket Card program. (Fox News)

ICE has pushed back against those concerns, with a spokesperson telling Fox last year that the ID would not be an official form of federal identification and would only be used for DHS agencies

"Moving to a secure card will save the agency millions, free up resources, and ensure information is quickly accessible to DHS officials while reducing the agency’s FOIA backlog. For provisionally released noncitizens, the digital modernization will provide ongoing access to important immigration documents through the secure card and connected portal."

The program marks one of a number of efforts by the administration to tackle the ongoing crisis at the border, which has shown signs recently of escalating.

Video

Officials have been overwhelmed at the border in recent weeks as numbers have shot up through August and September. Multiple border sectors have been overwhelmed and have resorted to street releases of migrants in Tucson and San Diego.

On Wednesday, thousands of predominantly Venezuelan migrants surged into Eagle Pass, Texas and gathered under a bridge in Eagle Pass in the hope of being processed and released into the U.S. 

Critics have blamed the crisis on the administration’s policies, including its moves to narrow enforcement priorities for ICE. The administration has said Congress needs to provide more funding and reform a "broken" immigration system. 

https://www.foxnews.com/politics/leaked-images-show-biden-admins-planned-ice-id-card-illegal-immigrants

Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting

 Following a Type A meeting with the FDA, Mesoblast claims it has a better understanding of what the regulator needs in order to consider approving remestemcel-L in the treatment of pediatric and adult steroid-refractory acute graft versus host disease, the company announced Thursday.

Mesoblast’s recent Type A meeting is the latest development in what has already been a long regulatory road for remestemcel-L. The company filed its first Biologics License Application in 2019 and even won strong support from the FDA’s Oncologic Drugs Advisory Committee in August 2020. Still, the regulator handed a surprise rejection in October 2020.

Mesoblast filed a resubmission, which the FDA accepted in March 2023—and subsequently denied last month.

In both rejections, the FDA pointed to the same issues that it raised during the Type A meeting: the potency assay and an adult-population study.

The FDA flagged the lack of a suitable potency assay for the candidate used during a Phase III trial in pediatric patients. According to the regulator, this has been a crucial roadblock in considering the trial an “adequate study” that could demonstrate remestemcel-L’s effectiveness.

To rectify this, Mesoblast plans to produce new potency assay data in the coming months, which should show that the product used in the Phase III study “was standardized as to its identity, strength, quality, purity, and dosage form,” according to the biotech’s press release. These new assay data should also prove that subsequent commercial batches for the pediatric indication will also meet the same standard, the company contends.

For remestemcel-L’s adult indication, Mesoblast has proposed an externally controlled single-arm registrational trial in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) who had failed prior treatment with both steroids and a second-line intervention.

This study will also be “underpinned by a suitable potency assay,” the company said in its Thursday announcement, adding that the additional assay data “will provide a link” between the remestemcel-L product used in the pediatric study and the one it plans to use in the adult trial.

However, Mesoblast has yet to align with the FDA regarding the design of its adult study, though it noted that the FDA was willing to consider its proposed protocol.

In a statement, CEO Silviu Itescu called the Type A meeting “very productive,” allowing the company to “establish the path forward for potential approval of remestemcel-L in SR-aGVHD.”

According to Mesoblast’s website, remestemcel-L is an investigational allogeneic cell therapy that uses culture-expanded mesenchymal stromal cells which, when administered, suppress pro-inflammatory cytokines and boosts the body’s anti-inflammatory response. This mechanism of action allows the candidate to dampen the immune response underlying aGVHD.

Remestemcel-L is still investigational in the U.S. but it has won regulatory approval in other territories, such as Canada and New Zealand, where it is marketed under the brand name Ryoncil.

https://www.biospace.com/article/mesoblast-sees-path-forward-for-twice-rejected-cell-therapy-after-fda-meeting/

BioLineRx: Pilot Phase Data from Phase 2 Combo Trial in Pancreatic Cancer

 Abstracts to be Published on American Association of Cancer Research (AACR)

Virtual Meeting Platform at 5:30 pm EDT on Wednesday, September 27, 2023

Oral Presentation on Thursday, September 28, 2023, in Boston, Massachusetts 

Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients.  A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

https://finance.yahoo.com/news/biolinerx-announces-acceptance-oral-presentation-110000805.html

Neptune Wellness Announces Intention to Spinout Sprout Organics

 Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (NASDAQ: NEPT), a consumer-packaged goods company focused on plant-based, sustainable and purpose-driven lifestyle brands, today announced that after careful consideration and evaluation of potential strategic alternatives to enhance the Company's value, the Board of Directors has approved a plan to proceed with a spinout to Neptune shareholders of a majority of its equity interest in Sprout Organics ("Sprout"), an organic baby food and toddler brand. Upon completion of the spinout, which would follow the previously announced exchange by Neptune of existing Sprout debt for Sprout equity, pursuant to the term sheet entered into with Morgan Stanley as previously announced on August 17, 2023, it is anticipated that Neptune would spinout a majority of its equity interest in Sprout to current Neptune shareholders, and Neptune would keep a retained interest of approximately 10-15%.

https://finance.yahoo.com/news/neptune-wellness-announces-intention-spinout-134100715.html

Rockwell Medical Enters into Products Purchase Agreement with its Largest Customer

Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company entered into an amended and restated products purchase agreement with its largest customer (the "Customer").

Under the agreement, Rockwell Medical and the Customer agreed to an increase in product pricing, effective September 1, 2023 and continuing until December 31, 2024, and a one-time payment to Rockwell on or after December 1, 2023. The Customer has the option to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term.

For more details about this amended and restated products purchase agreement, please reference the Form 8-K filed September 21, 2023.

https://finance.yahoo.com/news/rockwell-medical-enters-products-purchase-103000093.html