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Friday, April 8, 2022

Why Novavax Stock Dropped 23.6% This Week

 Shares of biotech company Novavax NVAX 5.05% ) plummeted by 23.6% this week, according to data from S&P Global Market Intelligence. The stock opened on Monday at $74.98 and rose to as high as $75 on Tuesday before it began to plummet. It sunk to a new 52-week low of $56.80 in the early afternoon on Thursday.

It's becoming clear that Novavax is falling behind its peers in its ongoing efforts to get an Emergency Use Authorization (EAU) for its COVID-19 vaccine to be used as a booster shot in the U.S.

On March 29, the Food and Drug Administration (FDA) amended the EUAs for the mRNA COVID-19 vaccines produced by Moderna and the Pfizer-BioNTech partnership to allow second booster shots to be given to individuals 50 and over and to people who are immunocompromised.

undefined Stock Quote

NASDAQ: NVAX

Novavax, Inc.
Today's Change
(5.05%) $3.00
Current Price
$62.51

KEY DATA POINTS

Market Cap
$5B
Day's Range
$58.49 - $63.55
52wk Range
$56.80 - $277.80
Volume
2,643,702
Avg Vol
4,149,083
P/E (ttm)

Novavax's vaccine, NVX-CoV2373, is protein-based, not mRNA-based, and has been approved already in 35 countries, including Australia, Canada, Great Britain, and all of the members of the European Union -- but not in the U.S. The concern among investors is that by the time Novavax does get U.S. approval for its vaccine, the potential market for the shot here will have shrunk considerably.

Part of the problem is that Novavax didn't complete its U.S. EAU request until Jan. 31. Given the delays that have stalled its vaccine approval here, it may be too late to catch up.

It's not all bad news. The company sold plenty of vaccines elsewhere. Last year, thanks mostly to its COVID-19 vaccine, the company reported sales of $1.1 billion, up from $476 million in 2020. However, its sales in the fourth quarter slowed year over year to $222 million compared to $280 million in the prior-year period. For the year, the company had a net loss of $1.7 billion compared to a loss of $418 million in 2020. In Q4, it reported a loss of $846 million, compared to a loss of $178 million in the same period in 2020.

Management says it expects the biotech company to finally turn things around this year, guiding for 2022 revenue in the $4 billion to $5 billion range.

Based on management's outlook, the stock is trading at a forward price-to-earnings ratio of 2.78, so if it hits its targets, investors should look back on today's share prices as a great bargain. The question is, given its late start in the U.S., can the company achieve those results purely from international sales?

In the short term, the stock was already bouncing back a little on Friday, but much of that likely reflects the fact that it had dropped to a new 52-week low the day before.

https://www.fool.com/investing/2022/04/08/why-novavax-stock-dropped-236-this-week/

Why BioCryst Crashed

 Shares of BioCryst Pharmaceuticals BCRX -34.84% ) were crashing 32.9% lower as of 10:38 a.m. ET on Friday. The steep decline came after the company announced that it has paused enrollment in three clinical studies evaluating experimental drug BCX9930.

NASDAQ: BCRX

BioCryst Pharmaceuticals, Inc.
Today's Change
(-34.84%) -$6.23
Current Price
$11.65

KEY DATA POINTS

Market Cap
$3B
Day's Range
$11.55 - $13.99
52wk Range
$9.23 - $19.99
Volume
24,804,429
Avg Vol
3,442,521
P/E (ttm)


BioCryst stated in a press release that patient enrollment in the Redeem-1, Redeem-2, and Renew clinical trials is being paused while it "investigates elevated serum creatinine levels seen in some patients." Creatinine levels that are too high can indicate severe kidney damage.

We don't know at this point how serious the potential issues are. However, BioCryst said that patients already enrolled in the clinical trials will continue to receive BCX9930 for now.

Redeem-1 and Redeem-2 are phase 2 clinical studies evaluating BCX9930 in treating rare blood disease paroxysmal nocturnal hemoglobinuria (PNH). Renew is also a phase 2 study, evaluating the experimental drug in treating rare kidney diseases complement 3 glomerulopathy, immunoglobulin A nephropathy, and membranous nephropathy.


While today's sell-off of the biotech stock is understandable, it could prove to be an overreaction. It's possible that BioCryst will resume patient enrollment after completing its investigation. On the other hand, the situation could get worse if the three studies must be placed on clinical hold due to the elevated serum creatinine levels.

BioCryst isn't solely dependent on BCX9930, though. The company's hereditary angioedema drug Orladeyo is already on the market in the U.S. and in several other countries. BioCryst expects the drug to generate sales of at least $250 million this year and reach peak annual sales of around $1 billion.  

https://www.fool.com/investing/2022/04/08/why-biocryst-pharmaceuticals-stock-is-crashing-tod/

BioNTech wins 5-year mRNA vaccine deal with German government

 BioNTech has won a five-year contract with the German health ministry to produce and supply mRNA vaccines in emergency situations in the country, the Germany-based biotechnology company said on Friday.

Under the framework agreement, BioNTech would reserve and maintain manufacturing capabilities to produce at least 80 million mRNA-based vaccine doses each year to address potential public health threats, the company said in a statement.

"There is growing evidence that viral pandemics will continue to pose a public health challenge for years," said Sean Marett, BioNTech's chief business and chief commercial officer.

BioNTech did not specify any financial details of the agreement.

https://finance.yahoo.com/news/biontech-wins-5-mrna-vaccine-132759780.html

Lyra Therapeutics Announces $100.5 Million Private Placement

 Lyra Therapeutics, Inc. (Nasdaq: LYRA) today announced that it has entered into a securities purchase agreement to sell securities in a private placement that is expected to result in gross proceeds of approximately $100.5 million, before deducting offering expenses.

In the private placement, investors had the option to purchase either (a) shares of the Company's common stock at a price of $4.22 per share, or (b) in lieu thereof, pre-funded warrants to purchase shares of the Company's common stock, with an exercise price of $0.001 per share, at a purchase price of $4.219 per share (for aggregate consideration equating to $4.22 per share). Accordingly, pursuant to the securities purchase agreement, (i) certain investors agreed to purchase an aggregate of 18,815,159 shares of common stock at the purchase price described in the foregoing sentence and (ii) certain investors agreed to purchase pre-funded warrants to purchase an aggregate of 5,000,000 shares of common stock, with the exercise price and at the purchase, in each case, described in the foregoing sentence. Each pre-funded warrant will be exercisable immediately.

The closing of the offering is subject to certain conditions and is expected to occur on April 12, 2022.

https://finance.yahoo.com/news/lyra-therapeutics-announces-100-5-113400622.html

Medavail (MDVL) Stock: Why The Price Surged

The stock price of Medavail Holdings Inc (NASDAQ: MDVL) increased yesterday and again today. Investors are responding positively to what was revealed in a regulatory filing.

The regulatory filing showed that Redmile Group acquired a large number of shares in the company. One of those transactions was 14,117,646 shares at an average price of $1.0625 each.

This was expected as MedAvail recently announced the first closing of a private placement for the sale of approximately 37.6 million shares of common stock at an offering price of $1.0625 per share, together with the issuance of warrants to purchase approximately 18.8 million shares of common stock. And the first closing of the private placement resulted in gross proceeds to MedAvail of $40 million, before deducting placement agent commissions and other offering expenses.

MedAvail plans to utilize the net proceeds for general corporate purposes and to fund its strategic initiatives.

https://pulse2.com/medavail-nasdaq-mdvl-stock-why-the-price-surged-today/

MediciNova: Secondary Analysis of Phase 2 in Alcohol Use Disorder Published

 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that a secondary analysis of a Phase 2 clinical trial of MN-166 (ibudilast) in alcohol use disorder (AUD) was published in the journal Alcoholism: Clinical and Experimental Research.

The publication entitled, “The effect of neuroimmune modulation on subjective response to alcohol in the natural environment,” co-authored by MediciNova’s collaborator, Dr. Lara Ray, Professor, Department of Psychology and Department of Psychiatry and Biobehavioral Sciences, Brain Research Institute at the University of California, Los Angeles and colleagues, describes a secondary analysis of a two-week clinical trial of MN-166 (ibudilast) that enrolled 52 non-treatment seeking participants with AUD.

Eligible participants were randomized to MN-166 (ibudilast) or matched placebo and completed daily diary assessments (DDAs) during the two-week period. Each morning, participants retrospectively reported on their mood and craving levels both before and during the previous day’s drinking episode, as well as stimulation and sedation levels during the previous day’s drinking episode. Multilevel models compared the effects of MN-166 (ibudilast) and placebo on subjective alcohol response. Exploratory analyses evaluated whether MN-166 (ibudilast) moderated the relationship between daily stimulation / sedation and alcohol intake and whether withdrawal-related dysphoria moderated the effects of MN-166 (ibudilast) on subjective response.

Key take-aways about MN-166 (ibudilast) in the publication include:

  • Initial findings showed that MN-166 (ibudilast), a neuroimmune modulator, reduces rates of heavy drinking and measures of alcohol craving

  • MN-166 (ibudilast) did not significantly alter mean levels of stimulation or sedation

  • MN-166 (ibudilast) moderated the effect of daily stimulation on same-day number of drinks consumed (p=0.045)

  • MN-166 (ibudilast) attenuated alcohol-induced increases in craving compared with placebo (p=0.047) but no other subjective response measures

  • MN-166 (ibudilast) may reduce the acute and chronic proinflammatory effects of alcohol, either indirectly through suppression of peripheral inflammation or directly by altering cAMP signaling pathways and suppressing cytokine expression and in the brain (e.g., rewards regions relevant to craving)

  • Among individuals without withdrawal-related dysphoria, MN-166 (ibudilast) significantly tempered daily alcohol-induced changes in urge to drink (p=0.021) and positive mood (p=0.001)

  • This tempering of alcohol’s effects may reflect MN-166 (ibudilast)’s enhancement of anti-inflammatory and neurotrophic factors suspected to impact dopaminergic signaling in rewards regions, such as the nucleus accumbens, where PDE4 and PDE10 are highly expressed

  • Consistent with previous findings, reductions in alcohol craving may represent a primary mechanism of MN-166 (ibudilast)


Amphastar Receives FDA Approval for Ganirelix Acetate Fertility Med

 Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. The FDA determined Amphastar's ganirelix is bioequivalent and therapeutically equivalent to Organon Pharmaceuticals' Ganirelix Acetate Injection.

Amphastar's CEO and President, Dr. Jack Zhang, commented: "We are excited about the FDA approval of our Ganirelix Acetate Injection. Ganirelix is the Company's fourth injectable peptide product approval. It represents our capabilities in executing our pipeline while furthering the development of our diabetes product portfolio."

According to IQVIA, the U.S. brand and generic sales for ganirelix acetate injection were approximately $89 million for the 12 months ended December 31, 2021.

Amphastar plans to launch its Ganirelix Acetate Injection during the second quarter of 2022.

https://finance.yahoo.com/news/amphastar-receives-fda-approval-ganirelix-100000681.html