US IPO Week Ahead: Health insurer Oscar Health leads a 2 IPO week

 Two IPOs are scheduled to raise $1.3 billion in the week ahead.

 
While the IPO calendar is relatively quiet at the moment, several issuers could launch, including pool equipment supplier Hayward Holdings (HAYW) and crafts-focused companies Cricut (CRCT) and JOANN (JOAN).

Online health insurer Oscar Health (OSCR) plans to raise $1.0 billion at a $7.7 billion market cap. The company provides individual, small group, and Medicare Advantage health insurance products and services to over 529,000 members through its online platform. The company is highly unprofitable and saw its adjusted EBITDA loss nearly double in 2020, though its direct premiums increased by 73% in the same period, and it has improved its medical loss ratio.

Senior care provider InnovAge Holding (INNV) plans to raise $300 million at a $2.4 billion market cap. The company provides care to over 6,600 seniors under the Program of All-Inclusive Care for the Elderly (PACE) with 17 centers in five states. InnovAge Holding has seen steady growth with expanding EBITDA margins, despite net income swinging negative in the 1H21. 

U.S. IPO Calendar
Issuer Business	Deal Size Market Cap	Price Range Shares Filed	Top Bookrunners
Oscar Health (OSCR) New York, NY	$1,023M $7,745M	$32 - $34 31,000,000	Goldman Morgan Stanley
Provides direct-to-consumer online health insurance products and services.
InnovAge Holding (INNV) Denver, CO	$300M $2,398M	$17 - $19 16,666,667	JP Morgan Barclays
Provides care services to high-cost dual-eligible seniors through PACE.

Street research is expected for fourteen companies. On Sunday, 2/28: ON24 (ONTF), and TELUS International (TIXT). On Monday, 3/1: Atotech (ATC), Landos Biopharma (LABP), Sana Biotechnology (SANA), and Sensei Biotherapeutics (SNSE). On Tuesday, 3/2: Angion Biomedica (ANGN), Bolt Therapeutics (BOLT), Evaxion Biotech (EVAX), Immunocore Holdings (IMCR), Lucira Health (LHDX), Pharvaris (PHVS), Terns Pharmaceuticals (TERN), and Vor Biopharma (VOR).

Lock-up periods will be expiring for six companies. On Monday, 3/1: Airbnb (ABNB). On Wednesday, 3/3: Affirm Holdings (AFRM), and Docebo (DCBO). On Thursday, 3/4: Mohawk Group Holdings (MWK), and Ondas Holdings (ONDS). On Friday, 3/5: Snowflake (SNOW).

https://www.renaissancecapital.com/IPO-Center/News/78444/US-IPO-Week-Ahead-Health-insurer-Oscar-Health-leads-a-2-IPO-week

Krystal Biotech (KRYS) PT Raised to $103 at H.C. Wainwright

 Analyst Joseph Pantginis raised the price target on Krystal Biotech (NASDAQ: KRYS) to $103.00 (from $84.00) while maintaining a Buy rating.

The analyst commented, "This morning, Krystal announced 4Q20 and full year results, posting EPS of ($0.53) and ($1.71) compared to our estimate of ($0.50) and ($1.68) and consensus of ($0.61) and ($1.79). The company ended the year financially strong with $271.3 million in cash, excluding the net proceeds from a recently completed public offering of $151 million. Current funding should support all ongoing clinical programs, the pipeline expansion to pulmonary indications, and the company’s manufacturing initiatives to support the growing pipeline demand. Key operational updates are projecting important milestones upcoming in the next six to 12 months. We see multiple value-creating opportunities in 2021, adding confidence to our thesis."

https://www.streetinsider.com/Analyst+Comments/Krystal+Biotech+%28KRYS%29+PT+Raised+to+%24103+at+H.C.+Wainwright/18055454.html

Apollo Endosurgery Gets Breakthrough Tag for Orbera Intragastric Balloon for NASH

 Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today that it has received a Breakthrough Device Designation from the U.S. Food and Drug Administration for the Orbera® Intragastric Balloon, specifically for the indication for use in treating patients with BMI between 30-40 kg/m2 with noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Non-alcoholic steatohepatitis (NASH) is a severe form of fatty liver disease, which is associated with liver inflammation and can progress to cirrhosis and liver failure. Patients with NASH have an increased risk of morbidity and mortality from liver-related causes, and NASH is one of the top three conditions leading to liver transplant.1 The adult US NASH population having a BMI between 30-40 kg/m2 is approximately 10 million, and while there are currently no FDA approved treatments for NASH, weight loss is the recommended treatment and essential for meaningful improvement in NASH. Current treatment guidelines aim for 7-10% Total Body Weight Loss (TBWL). With this degree of weight loss, NASH histologic characteristics improve in a significant percentage of patients, with resolution of liver inflammation, fat leaving the liver, and regression of fibrosis over time. However, patients typically fail to achieve these requisite levels of weight loss using lifestyle management programs alone.

"Orbera has consistently shown, both in the pivotal study and the post-market approval study, the ability to help patients lose an average of 7-10% TBWL over 6-12 months, which is significantly greater than lifestyle modification alone," said Dr. Christopher Gostout, Apollo Endosurgery, Chief Medical Officer. "The literature and the Mayo IDE study suggest that these levels of weight loss can have a positive effect in resolving or delaying the progression of NASH. With Breakthrough Designation, we will be able to further build the body of clinical evidence and seek label expansion for the use of Orbera for patients with NASH."

https://finance.yahoo.com/news/apollo-endosurgery-receives-fda-breakthrough-113000519.html

US FDA approval tracker - February

 Backed by a positive panel meeting Johnson & Johnson’s JNJ-78436735 became the third Covid-19 vaccine granted US emergency use authorisation (EUA), but it is the first that requires only one dose. The company plans to deliver 100 million doses to the US during the first half of the year. An EUA was also granted to Lilly’s bamlanivimab plus etesevimab after the antibody combo significantly cut Covid-19-related hospitalisations and deaths in studies. February saw Bristol Myers Squibb’s Breyanzi become the third anti-CD19 Car-T therapy approved, and the project’s efficacy looks on a par with Gilead’s Yescarta, with less toxicity. However, Breyanzi is even more expensive to manufacture than existing Car-T products. Novartis’s Entresto gained approval in a broad heart failure population, but the group will need to make the most of this before generic competition hits. And Athenex had a knockback for Oraxol, a combination of oral paclitaxel and encequidar, in metastatic breast cancer. The FDA cited toxicity concerns and requested another clinical study. The Pdufa was scheduled for the last day of February and the news, released today, knocked half a billion dollars off the company's market cap.

Notable first-time US approval decisions in February
Project	Company	2026e sales by indication ($m)	Outcome
Breyanzi (liso-cel)	Bristol Myers Squibb	1,096	Approved
Oraxol (oral paclitaxel + encequidar)	Athenex	781	CRL
Cosela (trilaciclib)	G1 Therapeutics	583	Approved
Tepmetko (tepotinib)	Merck KGaA	505	Approved
Pepaxto (melphalan flufenamide/melflufen)	Oncopeptides	490	Approved
Ukoniq (umbralisib)	TG Therapeutics	296	Approved*
Defencath/Neutrolin	Cormedix	230	CRL
Amondys 45 (casimersen)	Sarepta	202	Approved
Posimir	Durect	195	Approved
StrataGraft	Mallinckrodt	59	Deferred (manufacturing inspection)
Nulibry (fosdenopterin)	Bridgebio	29	Approved
Evkeeza (evinacumab)	Sanofi/Regeneron	-	Approved
*Gained approval in marginal zone lymphoma and follicular lymphoma. Sources: EvaluatePharma & company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-february-0

Single AstraZeneca, Pfizer Jab Cuts Hospitalizations by 80%: U.K.

 New data from a large study of elderly people in the U.K. provides further evidence that vaccines against Covid-19 are highly effective after just one dose.

British researchers said in preliminary findings published online Monday that a single dose of the Covid-19 vaccines developed either by Pfizer Inc. and BioNTech SE or the University of Oxford and AstraZeneca PLC reduced the risk of hospitalization among the over 70s by 80%, compared with those of a similar age who weren't vaccinated.

The study, which hasn't yet been reviewed by other scientists, looked at health records associated with 7.5 million people over 70 in England, making it one of the largest such studies published to date.

The data provide further strong evidence the vaccines being rolled out across the world are potent weapons against Covid-19. They should also help dispel concerns in parts of Europe that AstraZeneca's shot doesn't have enough data to back up its rollout to at-risk over-65s.

The scientists found a single dose of either vaccine reduced the risk of symptomatic Covid-19 and hospitalization from as little as 10 days after injection, with the strongest effects seen after 28 days.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Single-AstraZeneca-Pfizer-Jab-Cuts-Hospitalizations-by-80-U-K-Says-32574929/

Fraudsters offer 1 billion COVID-19 doses across EU, agency warns

 Such middleman are asking for advance payments and giving no delivery details, Ville Itala, the head of the European anti-fraud office OLAF, said, stressing that pharmaceutical companies insist they sell directly to governments.

“It’s quite massive,” he added.

“They send an offer, which is not a real one. In fact, there is as such no vaccines attached to the offer from what we have seen so far,” he said.

The scams OLAF was investigating came from both professional criminals and individual opportunists tied in a long chain of intermediaries often leading outside the EU, Itala said.

In Italy, authorities said they were investigating an offer for COVID-19 vaccines made by unnamed intermediaries to Veneto regional authorities amid warnings of growing vaccine fraud.

Itala said OLAF was not yet aware of counterfeit vaccines being pushed on the EU market but that was bound to come: “Where there is a lot of money, the fraudsters find their way there.”

“There can be financial consequences. But there is also another aspect - trust of the people. That’s why it’s important now to prevent this, so that people can trust that if they go to take the vaccine, they are the real ones,” he said.

OLAF was working with EU governments, law enforcement agencies and pharmaceutical companies to bring criminals to justice though it was not aware for now of an EU government falling for such scams.

Increasing fraud adds to problems in the EU’s botched inoculation campaign, which has been marred by cuts in promised deliveries, roll-out delays and some social resistance, especially to the AstraZeneca shot.

The bloc has so far administered vaccines to only around 5% of adult population - way behind Britain, Israel or the United States - compared to its target of 70% by the end of the summer.

https://www.reuters.com/article/us-health-coronavirus-eu-vaccines-olaf/fraudsters-offer-1-billion-covid-19-doses-across-eu-agency-warns-idUSKBN2AT355

Biden not mulling sharing COVID vaccines with Mexico: White House

 U.S. President Joe Biden is not currently considering sharing coronavirus vaccines with Mexico but is instead focused on ensuring every American is vaccinated, White House press secretary Jen Psaki said on Monday.

The remarks came hours before Biden is slated to meet virtually with Mexican President Andres Manuel Lopez Obrador, who is expected to ask the Democratic leader to consider sharing part of the U.S. coronavirus vaccine supply with its poorer southern neighbor, Reuters reported.

https://www.reuters.com/article/us-usa-biden-mexico-coronavirus/biden-not-mulling-sharing-covid-vaccines-with-mexico-white-house-idUSKCN2AT3CE