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Gapping up
In reaction to earnings/guidance:

  • OTIS +2.2%, KO +1.4%

Other news:

  • ERYP +53.3% (ells U.S. manufacturing facility and enters long-term supply agreement with Catalent (CTLT))
  • NKTX +48.5% (announces positive preliminary dose finding data for two lead engineered natural killer cell programs)
  • ARDX +42.7% (FDA to convene Advisory Committee for XPHOZAH (tenapanor))
  • CANG +22.9% (announced the declaration of a special cash dividend and a new share repurchase program)
  • TWTR +5.4% (on track to reach deal with Elon Musk)
  • OTIS +2.2% (increases its quarterly dividend 20.8% to $0.29/share)

Analyst comments:

  • MRVL +0.4% (upgraded to Outperform from Mkt Perform at Raymond James)
  • AMD +0.2% (upgraded to Strong Buy from Outperform at Raymond James)

WSJ : FDA Faces Push to Loosen Rules for Sperm Donations

FDA Faces Push to Loosen Rules for Sperm Donations
Families, medical groups and sperm banks are asking the agency to make it easier for gay and bisexual men to be donors

After years of public criticism, the Food and Drug Administration in 2020 relaxed its rules regarding blood donation by men who have sex with men. Now the agency is being asked to consider revising its policy again—this time to facilitate sperm donations by these men.

The FDA requires sperm banks to test all donors for HIV, the virus that causes AIDS, and other pathogens and to quarantine vials for at least six months so that the donors can be retested. In addition to establishing these precautions, the agency has long prohibited donations from men who acknowledge having had a male sex partner within the previous five years.

“The FDA believes that overlapping safeguards in place for anonymous semen donations adequately and appropriately reduce the risk of transmission of communicable diseases,” an agency spokeswoman said.

Professional and advocacy groups are seeking changes to the agency’s policies.

The American Association of Tissue Banks has asked the FDA to apply its updated rule for blood donation to all types of tissue, a term that encompasses corneas and skin as well as sperm. Blood donations are allowed from men who have sex with other men as long as the last such contact occurred at least three months before donation.

The group GLMA: Health Professionals Advancing LGBTQ Equality has said the same standards should apply to all donors, regardless of their sexual orientation or gender identity. The American Medical Association maintains that the FDA should re-evaluate the tissue donor rules, especially since HIV tests can now detect the virus as early as seven days following infection.

Medical organizations aren’t alone in pressing for change.

“We want the FDA to overturn the ban,” said Suzanne Currie, who along with her wife, Caroline, had two children in recent years using sperm donated by a man who had acknowledged having sex with men. “If someone is healthy and passes all the tests, then their sexuality should have nothing to do with donating.”

The executive director of the Sperm Bank of California in Berkeley, which sold the donor’s sperm to the Curries despite the agency’s prohibition, said she, too, felt the time had come for the FDA to change its policy. “I am hopeful that what has happened in blood donation can now happen in sperm donation,” Alice Ruby said, adding that some couples prefer gay or bisexual donors because they believe these men may be more accepting of families that some view as nontraditional.

“If you are worried about how a donor will respond to your two-mom family, you might feel more comfortable using a donor who is also part of the community,” she said.

The FDA spokeswoman declined to comment on the Curries’ situation and a handful of similar ones that have arisen at the Sperm Bank of California. The agency said it would review donor eligibility rules this year. An agency-funded study is evaluating the reliability of a questionnaire designed to gauge a blood donor’s risk of transmitting HIV, the spokeswoman said, adding that the findings—which are expected this year—could also be applicable to sperm donation.

“The FDA has a difficult job balancing different competing priorities,” said Dr. Joshua Sharfstein, a former principal deputy commissioner of the FDA who is now vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health. “Trying to work through the thicket of new information can be hard.”

Dr. Jaime Shamonki, chief medical officer of the Los Angeles-based California Cryobank, said previous efforts to get the FDA to change its sperm donor rules failed to gain traction. But many sperm banks have had trouble getting donors during the Covid-19 pandemic as young professional men relocated away from the cities where sperm banks are typically located, she said, adding that California Cryobank currently turns away 13% of applicants because they acknowledge having had a male sex partner during the previous five years. “If you lose a donor, there is nobody else like him,” she said.

It is the very argument Caroline and Suzanne Currie made when they asked the FDA to make an exception to the rules.

The Curries married in 2016 and started reviewing donor profiles a year later at the Sperm Bank of California, ultimately choosing a highly educated man with a passion for CrossFit and an openness to meeting any offspring—and who told the sperm bank that he had had sex with men. Despite the FDA rules, Ms. Ruby said, the bank had a longstanding practice of allowing donations by men—like the Curries’ donor—who were deemed to be at low risk after undergoing screening tests and answering questions about their sexual activity.

By 2020, Caroline and Suzanne had each given birth to a child using his sperm, and had plans to build a large family. Then their fertility doctor dropped a bombshell: If they wanted to have more children, Caroline recalled him saying at the time, they were going to have to find another donor.

The FDA warned Ms. Ruby after a 2019 inspection of the facility that its practice was impermissible and that it would have to alert all families and doctors who bought or used sperm from men who acknowledged having sex with men, she said. The bank sent out hundreds of emails and letters regarding the Curries’ donor and many others, she said, adding that to be in compliance with FDA rules the bank now bars donors who report having a male sex partner.

Caroline recalled sobbing when she got the news from the doctor. “We aren’t going to be able to do this anymore,” she said to Suzanne. “The baby you carried will not be genetically related to any future baby I have.”

The couple decided to petition the FDA for permission to use their already-purchased vials, which remained locked away at their doctor’s fertility clinic. They persuaded a pair of law firms—Arnold & Porter Kaye Scholer in Washington, D.C., and Orrick, Herrington & Sutcliffe in San Francisco—to press their case with the agency on a pro bono basis. They also joined forces with Ms. Ruby, who submitted the donor’s medical records showing that he repeatedly tested negative for HIV and other diseases and that his sperm had led to the births of 13 healthy children, including the Curries.’

The lawyers argued in a letter to the FDA last year that the agency policy interfered with the women’s right to decide when to have children as well as their children’s rights to have future siblings who are biological relatives.

Dr. Mark McClellan, a former FDA commissioner who is now director of the Duke-Margolis Center for Health Policy at Duke University, said he had no knowledge of the Curries’ case, but that “real world evidence can really help in the FDA’s thinking” about whether its policies need changing.

Ms. Ruby said the agency notified her in July that the Curries could use their long-sequestered vials. Since then, she added, the bank has gotten the FDA’s approval for five more families who want to use already-purchased vials from a banned donor.

When the Curries heard about the FDA’s decision, they hugged in celebration. Caroline said she is pregnant again. The couple’s third child is expected in July.

Business Of Fashion : Is It Time for Gap Inc. to Go Private?

if u missed it yesterday - GPS slighty higher

From: Laurent Chekroun (MAKOR CAPITAL MARKET) At: 04/24/22 21:30:58 UTC+2:00
Subject: Business Of Fashion : Is It Time for Gap Inc. to Go Private?

Is It Time for Gap Inc. to Go Private?
Market share is shrinking, discounts are deepening and the group’s once-powerful grip on the consumer has disintegrated. As a public company, its options are limited.

Gap is in crisis, once again.
On Thursday, the San Francisco-based apparel retailer announced the abrupt exit of Old Navy chief executive officer Nancy Green, whose success building the company’s activewear brand Athleta earned her the top job at Old Navy when Sonia Syngal was promoted to boss of the group.
Green may have done well with Athleta — the business reached nearly $1 billion in sales when she was running it — but she was generally not viewed as a good leader, according to former and current executives.
“The sudden nature of Green’s exit indicates that Gap’s casual statement about it being time to bring in someone new to head up the brand is somewhat fanciful,” said GlobalData retail analyst Neil Saunders in a note. “There has clearly been tension or something which has led to this abrupt change during a critical time.”

Whatever was going on behind the scenes, it’s clear that Old Navy, once the brand carrying the rest of the business, is in trouble. The company said sales would be down by the low double digits in the first quarter of its 2022 fiscal year. It’s blaming “macroeconomic challenges,” but also poor execution, warning that there would be even more discounting than usual.
On Friday, the stock dipped 20 percent to $11.50 per share after the news of Green’s exit, down about two-thirds from a year ago, illustrating why this firing and the sales warning felt like catastrophic news for the parent company. Old Navy accounted for nearly 55 percent of Gap Inc.’s sales in its most recent fiscal year, and has historically has been a reliable growth engine as Gap and Banana Republic’s market share continued to shrink. But its cute branding is no longer enough for many price-driven consumers, who are buying online from Amazon and Shein, which offer trendier, and sometimes cheaper, garments.
Gap Inc. has spent the last few years pruning its portfolio, selling off smaller, less-aligned companies like multi-brand store Intermix and kid’s label Janie and Jack. And as it closed more Gap stores in order to “right size” the business, it used that prime real estate to open Athleta stores, capitalising on the demand for activewear through broadened distribution.
More sales don’t always equal more profits, however, and Gap Inc.’s margins continue to suffer. An attempted revival of Banana Republic, which garnered favourable press, has attracted higher income shoppers and helped to increase the average amount of money people spend at the store, but has yet to result in growth. Gap, the brand, has made headlines over the past year with its Yeezy collaboration, but has yet to prove that the theoretical popularity of that collection — which is not sold in Gap stores and does not include many products — has driven sales to the core brand.
While many consumers still seem to have a sentimental attachment to Gap, it’s not enough to make it their go-to retailer. The products simply aren’t as compelling as they used to be, and the stores feel like they haven’t been updated in decades.
Over the past 10 years, the company has considered selling off one of its bigger divisions — like Gap or Banana Republic — according to former executives. It also publicly made a play for Old Navy to IPO in hopes of improving overall prospects. However, it may now be time for the business to be taken private in the face of dwindling returns. The likely buyer, should the company pursue this option, would be a private equity firm that deals with retailers in transition.
The challenge for the board of directors — which still includes three members of the founding Fisher family, who own more than 40 percent of the company — is that it would have to sell at what they might consider a discount. At the same time, the turnaround efforts have so far proven that the company is not currently able to do more than play the price game, a competition that is increasingly difficult to win.
Added Saunders, “Although the Gap group has been more creative of late, there is a still a sense that this is a retailer which is really struggling to focus its efforts around a coherent plan for success.”

WWD : NFL Teams With Streetwear Artist Warren Lotas

NFL Teams With Streetwear Artist Warren Lotas
The capsule of Ts and hoodies is tied to the start of this year's NFL Draft on April 28.

The Warren Lotas-designed hoodie for the L.A. Rams.



The National Football League has tapped streetwear artist and designer Warren Lotas to create a capsule collection in celebration of this week’s NFL Draft.
Lotas partnered with sports brand Mitchell & Ness for a line of hoodies and T-shirts for the Los Angeles Rams, Cincinnati Bengals, New England Patriots and Tampa Bay Buccaneers that feature his signature skeleton illustration and heavy-metal-inspired designs.
Although these designs are authorized, the young artist ran afoul of Nike when he customized versions of the brand’s SB Dunk sneakers, resulting in the sporting goods giant filing a trademark infringement lawsuit. The suit has since been settled.
The collection is timed to the start of this year’s draft.
Lotas has also worked with The Weeknd on a collaboration collection as well as with streetwear designer Eric Emanuel on mesh shorts that launched on Friday. He has also created product for the Brooklyn Nets.


The NFL collection will launch exclusively on the NFL Shop’s e-commerce site as well as the Warren Lotas site at 5 p.m. April 28, the first day of the draft.
The fan-based collection will retail for $95 to $180.