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Tuesday, January 16, 2024

Adagene to present on interim Phase 1b/2 results for antibody colorectal cancer trial

  Interim results in MSS CRC suggest that SAFEbody precision masking technology enables a new standard for anti-CTLA-4 therapy at higher, more frequent and repeat doses by overcoming longtime safety-limited efficacy challenges with this proven immunotherapy target -

Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Gastrointestinal (GI) Cancers Symposium, taking place January 18-20 in San Francisco.

https://www.globenewswire.com/news-release/2024/01/04/2803770/0/en/Adagene-To-Present-Interim-Results-of-Masked-anti-CTLA-4-SAFEbody-ADG126-muzastotug-in-Combination-with-Pembrolizumab-in-MSS-CRC-at-ASCO-GI-Symposium.html

Qiagen stock quickly ticks higher amid takeover speculation

 Qiagen (NYSE:QGEN) quickly rose 1.3% amid a report that the diagnostics company is seeing some renewed takeover talk.

https://seekingalpha.com/news/4055247-qiagen-quickly-ticks-higher-amid-takeover-speculaiton

Solid Bio Gets Orphan Designation for Duchenne Gene Therapy

 Patient dosing expected to begin mid-to-late Q1 2024 –

 Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has been granted orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate.

https://www.globenewswire.com/news-release/2024/01/16/2809854/0/en/Solid-Biosciences-Granted-FDA-Orphan-Drug-Designation-for-Duchenne-Muscular-Dystrophy-Gene-Therapy-Candidate-SGT-003.html

Vaxart: $10.0 Million Registered Direct Offering with RA Capital

 Vaxart, Inc. (Nasdaq: VXRT) today announced that it has entered into a common stock purchase agreement with RA Capital Management for the sale of 15,384,615 shares of its common stock in a registered direct offering at an offering price of $0.65 per share.

Gross proceeds are approximately $10.0 million, before deducting expenses payable by Vaxart. Vaxart intends to use the net proceeds from the offering primarily for general corporate purposes, including working capital, operating expenses and capital expenditures.

“We appreciate the financial backing by RA Capital as we continue to progress our oral pill vaccine platform,” said Dr. Michael J. Finney, Vaxart’s Interim Chief Executive Officer. “We believe the clinical proof of data we have generated to date has validated our platform, which carries transformative potential to change how people get vaccinated globally. With this financing, we can continue to advance our programs, with the goal of bringing to market oral pill vaccine(s) that carries significant public health benefits.”

The closing of the registered direct offering is expected to occur on or about January 18, 2024, subject to the satisfaction of customary closing conditions.

The shares of common stock are being offered by Vaxart pursuant to a shelf registration statement on Form S-3. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and is available on the SEC’s website at www.sec.gov.

https://www.globenewswire.com/news-release/2024/01/16/2810011/25416/en/Vaxart-Announces-10-0-Million-Registered-Direct-Offering-with-RA-Capital-Management.html

Sarepta starts Phase 3 of Limb-Girdle Muscular Dystrophy trial

 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that screening is underway in Study SRP-9003-301. Also known as EMERGENE, Study 9003-301 is a Phase 3, multi-national, open-label study of SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy Type 2E (LGMD2E/R4), or beta sarcoglycanopathy. EMERGENE will enroll 15 participants (ambulatory and non-ambulatory), aged 4 and older, and uses commercially representative process SRP-9003 material.

https://www.businesswire.com/news/home/20240116971158/en/

Argentina's Milei heads to Davos criticizing 'socialist agenda'

 Argentina's President Javier Milei was en route by commercial jet to the World Economic Forum in Davos in Switzerland on Tuesday, taking selfies with passengers on board and criticizing what he called the event's "socialist agenda".

The trip marks the right-wing Milei's first overseas tour since he took office last month following a rapid ascent for the relative political newcomer who made his name as an acid-tongued economist and television pundit.

At home he is battling to fix Argentina's worst economic crisis in decades with an austerity package that he hopes can tame annual inflation above 200%, build up foreign currency reserves now in the red and lure back investment.

While he has moderated after a brash election campaign where he often wielded a chainsaw to reflect his plans to slash the size of the state, Milei has stood by some of his more extreme pledges including plans to eventually shut the central bank.

Asked by reporters on his flight about his plans at Davos, he said he aimed to "seed ideas of freedom in a forum that is contaminated by the 2030 socialist agenda, which will only bring misery to the world".

Milei took selfies and videos with surprised passengers on board, a reflection of his penchant for the dramatic but also underscoring how he has been able to click with regular people in Argentina fed up with the political status quo.

On his personal account on X, Milei re-posted videos from on board the plane. His spokesman Manuel Adorni explained in a post that the president had traveled commercial to save what he calculated as over $300,000.

Milei traveled with a small delegation including his foreign minister Diana Mondino, Cabinet chief Nicolás Posse, Minister of Economy Luis Caputo and his sister Karina Milei, who is also the Secretary General of the Presidency.

In addition to Davos, the delegation will meet International Monetary Fund (IMF) chief Kristalina Georgieva, a week after reaching an agreement with IMF staff over the latest review of the country's troubled $44 billion program. 

https://finance.yahoo.com/news/argentinas-milei-heads-davos-taking-145033339.html

US Supreme Court sidesteps fight over transgender student bathroom access

 The U.S. Supreme Court on Monday declined to hear an Indiana public school district's defense of a policy barring transgender students from using bathrooms corresponding with their gender identity, as the justices steered clear - at least for now - of a contentious issue in the nation's culture wars.

The justices turned away the Metropolitan School District of Martinsville's appeal of a lower court's ruling that a middle school's policy on bathroom access likely violated the rights under the U.S. Constitution and a federal anti-discrimination law of a transgender student who was prohibited from using the boys' bathroom.

The Martinsville district appealed a 2023 ruling by the Chicago-based 7th U.S. Circuit Court of Appeals that the student, identified in court papers as "A.C.," is protected under a law called Title IX that bars sex discrimination in education and the Constitution's 14th Amendment requirement that people be protected equally under the law.

The Supreme Court has said relatively little about transgender rights and in the past avoided hearing arguments on the issue of bathroom access in public schools, with no national legal precedent in place.

Transgender rights are a major area of controversy. Republicans in various states have pursued a wave of laws affecting transgender people including restricting bathroom access, limiting transgender participation in sports and access to gender-affirming medical care, and the teaching of subjects related to gender identity.

In the Indiana case, A.C. is a transgender boy who was a seventh grade student in 2021 when his mother brought a lawsuit on his behalf against the school district and his school's principal. A.C. sought unspecified money damages and a court order to be allowed to use bathrooms for males.

U.S. District Judge Tanya Pratt in 2022 ruled in favor of A.C., ordering the school to allow bathroom access corresponding with the student's gender identity. The 7th Circuit affirmed Pratt's ruling, prompting the school's appeal to the Supreme Court, which has a 6-3 conservative majority.

According to the lawsuit, A.C. was diagnosed with gender dysphoria, a condition involving distress resulting from a discrepancy between a person's gender identity and sex at birth, and was in the process of having his name and gender legally changed on his birth certificate.

The school district in a court filing argued that Title IX lets schools provide separate bathrooms on the basis of sex and that equal-protection concerns do not bar schools from protecting the interests of other students "in shielding their bodies from exposure to the opposite sex."

Federal courts have been divided on school policies requiring transgender students to use the restroom corresponding to their birth sex. The Richmond, Virginia-based 4th U.S. Circuit Court of Appeals found a Virginia school's policy illegal, while the Atlanta-based 11th Circuit upheld one in a Florida school.

The Supreme Court in 2021 declined to take up a legal battle involving a transgender public high school student named Gavin Grimm who had been barred by a Virginia county school board from using the bathroom corresponding with his gender identity. The court's denial of the school board's appeal left in place the 4th Circuit ruling favoring Grimm, who had graduated from high school by the time the justices acted.

More recently, the Supreme Court in April 2023 refused to let West Virginia enforce a state law banning transgender athletes from female sports teams at public schools, one of many Republican-backed measures across the country targeting LGBT rights.

https://news.yahoo.com/us-supreme-court-snubs-fight-143754690.html