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Friday, September 13, 2024

Bicara Therapeutics Announces Pricing of Upsized IPO

 Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the pricing of its initial public offering of 17,500,000 shares of its common stock at a public offering price of $18.00 per share. Bicara Therapeutics’ shares are expected to begin trading on the Nasdaq Global Market on September 13, 2024 under the ticker symbol “BCAX.” The offering is expected to close on September 16, 2024, subject to the satisfaction of customary closing conditions. In addition, Bicara Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 2,625,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Bicara Therapeutics.

Morgan Stanley, TD Cowen, Cantor and Stifel are acting as joint bookrunners for the offering.

https://www.globenewswire.com/news-release/2024/09/13/2945680/0/en/Bicara-Therapeutics-Announces-Pricing-of-Upsized-Initial-Public-Offering.html

Aurinia Announces Board Restructuring

 

  • Peter Greenleaf, President and Chief Executive Officer of Aurinia, remains a Director
  • Kevin Tang, President of Tang Capital Management, LLC, appointed as a Director
  • The Board has accepted the conditional resignations of three directors who received less than majority support at the 2024 Annual General Meeting

The restructured Board consists of seven members: Jeffrey A. Bailey; Robert T. Foster, Pharm.D., Ph.D., DSc; Peter Greenleaf; David R.W. Jayne, M.D., FRCP, FRCPE, FMedSci; Jill Leversage; Karen Smith, M.D., Ph.D., MBA, LLM; and Kevin Tang.

https://www.businesswire.com/news/home/20240912372456/en/

MBX Biosciences Announces Pricing of Initial Public Offering

 MBX Biosciences, Inc. (Nasdaq: MBX) (“MBX Biosciences”), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the pricing of its initial public offering of 10,200,000 shares of its common stock at a price to the public of $16.00 per share. The gross proceeds to MBX Biosciences from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $163.2 million. All of the shares are being offered by MBX Biosciences. In addition, MBX Biosciences has granted the underwriters a 30-day option to buy an additional 1,530,000 shares of its common stock at the initial public offering price, less underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Select Market on September 13, 2024 under the ticker symbol “MBX.” The offering is expected to close on September 16, 2024 subject to the satisfaction of customary closing conditions.

J.P. Morgan, Jefferies, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering.

https://www.globenewswire.com/news-release/2024/09/12/2945666/0/en/MBX-Biosciences-Announces-Pricing-of-Initial-Public-Offering.html

Zenas BioPharma Announces Pricing of Upsized Initial Public Offering

 Zenas BioPharma, Inc. (“Zenas”), (Nasdaq: ZBIO) a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies, today announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. All of the shares are being offered by Zenas. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $225.0 million. Zenas’ common stock is expected to begin trading on the Nasdaq Global Select Market on September 13, 2024 under the ticker symbol “ZBIO”. The offering is expected to close on September 16, 2024, subject to the satisfaction of customary closing conditions. In addition, Zenas has granted the underwriters a 30-day option to purchase up to an additional 1,985,294 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

Morgan Stanley, Jefferies, Citigroup, and Guggenheim Securities are acting as joint book-running managers for the offering.

https://www.globenewswire.com/news-release/2024/09/13/2945685/0/en/Zenas-BioPharma-Announces-Pricing-of-Upsized-Initial-Public-Offering.html

Well, Well, Well: Biden And Harris Drop Trump-Esque Tariffs On Temu, Shein

 The very same day Vice President Kamala Harris slammed Donald Trump's plan to institute new tariffs on products Americans buy from abroad as a "Trump sales tax," the Biden administration dropped... new tariffs on products Americans buy from abroad.

On Thursday, the White House announced new measures - largely aimed at Chinese e-commerce platforms such as Temu and Shein - aimed at reducing the range of low-value imports eligible for duty and tax exemptions. The new tariffs expand on Trump-era tariffs on China that the Biden administration kept in placeSCMP reports.

In 2018, then president Donald Trump imposed tariffs of 7 to 25 per cent on US$300 billion of Chinese imports under Section 301 of the Trade Act of 1974, citing “unfair” trade practices.

His successor Joe Biden retained most of these tariffs and expanded them to include Chinese solar panels, electric vehicles and batteries – with tariffs on electric vehicles reaching up to 100 per cent. -SCMP

According to US deputy national security adviser for international economics Daleep Singh, the measures will address the 'de minimis rule,' which exempts shipments valued at less than $800 from import duties, taxes, and rigorous screening.

"Since approximately 70 per cent of Chinese textile and apparel imports are subject to section 301 tariffs, this step will drastically reduce the number of shipments entering through the de minimis exemption," said Singh, adding that the intent was to "curtail de minimis overuse and abuse."

The new tariffs are built on existing measures under Section 201 of the Trade Act and Section 232 of the Trade Expansion Act of 1962, which covers industry, national security and human rights concerns. The now-plugged de minimis exemption has long been considered a "loophole" that allows Chinese e-commerce companies and fentanyl traffickers to evade tariffs and threaten public safety, according to the report.

Last June, a House Select Committee report on the CCP concluded that Temu and Shein alone are likely responsible "for more than 30 per cent of all packages shipped to the United States daily under the de minimis provision."

According to a fact sheet released by the Biden administration, the number of annual shipments coming into the US under the de minimis rule has gone from roughly 140 million a decade ago to over 1 billion as of last year.

"That is just too high a volume for our officials to be able to target and block the shipments that are unsafe, illegal, or violate our laws in any other way, or are unfairly traded," said a senior Biden administration official, who added "We are very concerned about large foreign companies exploiting the de minimis loophole in unprecedented ways, creating a scale and volume that we believe constitutes abuse."

To ensure greater visibility into de minimis shipments, the US government also proposed new information collection requirements and stricter safety standards. Products that do not meet these standards will be blocked from entering the market.

Singh emphasised that the Biden administration will “always act” to protect Americans and enforce laws to “level the playing field for American workers, retailers and manufacturers”.

We’re making sure foreign companies respect our laws and don’t endanger American families,” he said. -SCMP

Singh also suggested that Congress should pass legislation to "comprehensively reform" the de minimis exemption.

In August, a bipartisan group of lawmakers targeted textiles and clothing in a new bill.

"We’ll be specific about textiles and apparel, because they make up a huge percentage of the de minimis shipments that we’re seeing now," the senior official told SCMP. "There may be others, and this is an area where we’d really like to work with Congress to figure out, how do we make sure that any changes we’re taking or making to de minimis now take into account how trade volumes might shift in the future."

Looks like the "Trump sales tax" works?

https://www.zerohedge.com/political/well-well-well-biden-drops-trump-esque-tariffs-temu-shein

Atea Covid Therapy Phase 3 Trial Misses Primary Endpoint

 Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated.

“We are disappointed by the outcome of the SUNRISE-3 trial. Variants of COVID-19 are constantly evolving and the natural history of the disease trended toward milder disease, which has resulted in fewer hospitalizations and deaths. In particular, hospitalization due to severe respiratory disease caused by COVID was not observed in SUNRISE-3, in contrast to our prior study. In an environment where there is much less COVID-19 pneumonia, it becomes more difficult for a direct-acting antiviral to demonstrate impact on the course of the disease,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “I am proud of our team’s rigorous execution of this trial in a constantly changing pandemic environment.”

https://www.globenewswire.com/news-release/2024/09/13/2945844/0/en/Atea-Pharmaceuticals-Provides-Update-on-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Bemnifosbuvir-for-Treatment-of-COVID-19.html

Moderna Slashed Its Sales Guide, R&D Budget

 Despite becoming a household name during the pandemic, Moderna (MRNA) stock has mostly fallen over the past three years amid decelerating sales and clinical pitfalls.

Shares crashed on Sept. 12 after the company cut its sales guidance for the year to $2.5 billion to $3.5 billion. This is Moderna's second guidance cut this year. The company started 2024 projecting at least $4 billion in sales. Moderna also pushed out its breakeven point by two years to 2028. And, for 2027, the company now expects to cut its research and development budget by $1.1 billion.

That's amid a massive commercial push. Today, Moderna sells two products — its Covid vaccine called Spikevax and a respiratory syncytial virus vaccine, mResvia. But it's going up against giants. Pfizer (PFE) and BioNTech (BNTX) continue to lead the market for Covid shots, and both GSK (GSK) and Pfizer entered the respiratory syncytial virus market a year before Moderna.

"We have a cautious outlook on both (Spikevax and mResvia)," Leerink Partners analyst Joseph Stringer said in a report. "We believe Covid vaccination rates will decline faster than expected and mResvia will face competitive pressure from approved RSV vaccines Arexvy and Abrysvo."

https://www.investors.com/news/technology/mrna-stock-buy-now/