Dutch cancer biotech LAVA Therapeutics sets terms for $101 million US IPO

 LAVA Therapeutics, a Dutch Phase 1/2a biotech developing gamma-delta T cell therapies for cancer, announced terms for its IPO on Thursday.

The Utrecht, Netherlands-based company plans to raise $101 million by offering 6.7 million shares at a price range of $14 to $16. At the midpoint of the proposed range, LAVA Therapeutics would command a fully diluted market value of $405 million.

The company is focused on developing a platform of novel bispecific antibodies engineered to selectively induce gamma-delta T cell-mediated immunity against tumor cells. Its lead candidate, LAVA-051, is a unique, humanized gamma-delta bsTCE targeting CD1d-expressing hematologic cancers, including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and acute myeloid leukemia (AML). In November 2020, the company filed a CTA to conduct a Phase 1/2a trial with LAVA-051 in relapsed and/or refractory CLL, MM and AML, which it expects to begin enrolling in the 1H21.

LAVA Therapeutics was founded in 2016 and booked $4 million in research and license revenue for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol LVTX. J.P. Morgan, Jefferies and SVB Leerink are the joint bookrunners on the deal. It is expected to price during the week of March 22, 2021.

Relevant Profile: LVTX

https://www.renaissancecapital.com/IPO-Center/News/79581/Dutch-cancer-biotech-LAVA-Therapeutics-sets-terms-for-$101-million-US-IPO

Insulet upped to Buy from Hold by Canaccord

 Target $280

https://finviz.com/quote.ashx?t=PODD

Stocks To Watch Ahead Of Today's Quad-Witch Gamma 'Unclenching'

 Brace for the 'unclenching'...

Today's quad-witching options expirations are likely to remove even more potential stabilizing flows from US equity markets as roughly 25% of S&P gamma rolls off, with 40% of QQQ and 50% of single stocks. As SpotGamma reminds us, the bulk of SPX gamma expires at 9:30AM EST, but that position is heavily outsized by SPY/QQQ which expires  at the 4pm EST close. This gamma unclench and delta de-risk lower could accelerate any downside moves in the markets.

SpotGamma says that the S&P must hold the 390/3900 critical flip line, even though we see little in the way of S&P put positions (and therefore negative S&P500 gamma) below

As SpotGamma concludes, said another way, “buying the dip” is not advised if SPX breaks 3900. However, the post-quad-witch picture is more optimistic because while the QQQ puts expiring today provide downside fuel, they will also be very sensitive to implied volatility and decay, and so if there is a bounce at the open it could setup a decent QQQ rally into the 315-320 area as dealers quickly cover their corresponding short hedges.

Into Monday these tech puts could provide a decent dealer short hedge (and therefore market tailwind) and reduce QQQ volatility next week. The lower QQQ closes the larger the dealer short will be that is tied to todays close. Therefore a lower close provides more “bounce fuel” into the start of next week.

Also brace for higher single stock volatility today due to the large amount of single stock options expiring today. As Goldman notes,$655bn of options set to expire today, a record for non-January expiries and the third largest overall. Today’s expiry could be important for stocks with large open interest in at-the-money (ATM) options; market makers delta-hedging their unusually large options portfolios will be active.

Here are the stocks where option activity could have big impact

Stocks where a large percentage of contracts, relative to their average daily volume traded, expire on Friday, potentially leading to “pinning”. However, if delta-hedgers are net short ATM options (have a “negative gamma” position), their hedging activity could exacerbate stock price moves. This flow is likely to dampen volatility in some names while exacerbating stock price moves in others.

https://www.zerohedge.com/markets/here-are-stocks-watch-ahead-todays-quad-witch-gamma-unclenching

FDA grants its first full approval to a COVID-19 diagnostic test

 For the first year of the pandemic, the FDA worked hard to make it clear that each green light it gave to a COVID-19 diagnostic test kit—over 340 to date—amounted to only an emergency authorization and not a full approval, meaning it had not been reviewed to its highest standards and could only be used for a limited time as the country fought off the pandemic.

Now, the agency has granted its first official endorsement, allowing a respiratory panel test from BioFire Diagnostics to be sold into the foreseeable future. 

The diagnostic is designed to screen deep nasal swab samples for multiple infections to help identify coronavirus cases among people with symptoms similar to the flu, respiratory syncytial virus and the bugs behind the common cold.

“While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways,” said the FDA’s acting commissioner, Janet Woodcock, M.D., the longtime head of the agency’s drug center.

At the same time, the FDA streamlined its review process for granting emergency use authorizations in the first place, aimed at cultivating broad COVID-19 screening programs at schools, workplaces, communities and other locations—where individuals may be tested repeatedly to catch new cases as they appear. 

This includes new regulatory submission templates for developers of tests for the laboratory and points of care as well as out in the field, such as in sports venues or airports.

“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” the FDA said in a statement. 

BioFire’s test, meanwhile, received a de novo clearance, which creates a simpler pathway to approval for other coronavirus diagnostics. Future tests would only have to prove they are substantially equivalent to the first approved product. The company’s RP2.1 test was previously granted an emergency authorization in May 2020; however, additional lab testing may be needed, such as bacterial or viral cultures, to confirm an individual patient’s infection.

https://www.fiercebiotech.com/medtech/fda-grants-its-first-full-approval-to-a-covid-diagnostic-test

Bristol Myers : FDA to Review Mavacamten in Hypertrophic Cardiomyopathy

 Bristol Myers Squibb Co. on Friday said the U.S. Food and Drug Administration accepted its new-drug application for mavacamten for patients with symptomatic obstructive hypertrophic cardiomyopathy.

The New York biopharmaceutical company said the agency set a target action date of Jan. 28, 2022, for the application.

Bristol Myers said mavacamten is a first-in-class myosin inhibitor developed to address the underlying molecular defect of hypertrophic cardiomyopathy, the most common inherited heart disease.

The company said its FDA filing is based on the results of a Phase 3 study in which mavacamten showed a robust treatment effect and met all primary and secondary endpoints.

Mavacamten was the lead product candidate of MyoKardia Inc., which Bristol Myers bought last year for about $13.1 billion.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-nbsp-FDA-to-Review-Mavacamten-in-Hypertrophic-Cardiomyopathy-32737855/

India's Stelis Biopharma to make 200 million doses of Sputnik V vaccine

  India’s Stelis Biopharma has partnered with Russia’s sovereign fund to make at least 200 million doses of Sputnik V, its parent company said on Friday, taking the nation’s total output of the COVID-19 vaccine to more than half a billion doses.

The announcement by the parent, Strides Pharma Science, of a pact with the Russian Direct Investment Fund (RDIF) follows similar deals by Indian pharmaceutical firms Gland Pharma and Hetero.

"The significant vaccine volumes which will be produced jointly with Stelis will help to widen access to the vaccine on a global scale," Kirill Dmitriev, chief executive of the Fund, said in a statement.

Stelis and the Fund plan to start supplies of the vaccine doses in the third quarter of this year, while Stelis works to provide added volumes beyond the initial agreement.

Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6% effective against COVID-19 and has been approved for use in more than 50 countries, with the Fund signing supply deals with more than 13 nations.

India, the world’s largest vaccine maker, has now become one of the biggest producers of the shot outside Russia. Other countries producing it include Brazil, China and South Korea.

India has gifted or sold doses produced locally to other countries. While nations like the United States are being accused of vaccine nationalism, India has been praised for sending doses to 71 countries.

The statement gave no details of which countries would receive the Stelis-made doses.

India has given emergency use approval to AstraZeneca Plc’s vaccine and a homegrown one made by Bharat Biotech.

Dr. Reddy’s Laboratories Ltd, which has run small clinical studies of Sputnik V domestically, sought emergency-use approval for the vaccine last month, but India’s drug regulator asked for more data.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-ind/indias-stelis-biopharma-to-make-200-million-doses-of-sputnik-v-vaccine-idUSKBN2BB0UV

Merck Keytruda Plus Eisai Lenvima Cuts Risk Of Death By 38% In Endometrial Cancer Trial

 Merck & Co (NYSE: MRK) has announced data from Phase 3 KEYNOTE-775/Study 309 trial evaluating Keytruda combined with Eisai Co Ltd's (OCTMKTS: ESALY) Lenvima for advanced, metastatic, or recurrent endometrial cancer following one prior platinum-based regimen in any setting.

• The data were presented at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer. 
• A statistically significant and clinically meaningful improvement in PFS was seen in the all-comer population. Keytruda plus Lenvima reduced the risk of disease progression or death by 44%, with a median PFS of 7.2 months versus 3.8 months for patients who received chemotherapy.
• Keytruda plus Lenvima reduced the risk of death by 38%, with a median OS of 18.3 months versus 11.4 months in patients who received physician's choice chemotherapy.
• In the all-comer population, the objective response rate was 31.9%, with a complete response (CR) rate of 6.6% and a partial response (PR) rate of 25.3%, in Keytruda plus Lenvima group, versus 14.7%, with a CR rate of 2.6% and a PR rate of 12.0% in the chemo group.
• For patients who responded, the median duration of response (DOR) was 14.4 months for patients in the Keytruda plus Lenvima arm versus 5.7 months in the chemotherapy arm.
• KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the FDA 2019 accelerated approval of Keytruda plus Lenvima combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

https://www.benzinga.com/general/biotech/21/03/20252082/merck-keytruda-plus-eisais-lenvima-cuts-risk-of-death-by-38-in-endometrial-cancer-trial-compared-