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Wednesday, November 17, 2021

PAVmed, Lucid Provide Business Update, Prelim Q3 Financial Results

For the three months ended September 30, 2021, EsoGuard related revenues were $0.2 million and gross profit was $56 thousand. Operating expenses were approximately $13.7 million as detailed below including $4.0 million in stock-based compensation expense. GAAP net loss attributable to common stockholders was approximately $12.3 million, or $(0.15) per common share. As shown below and for the purpose of illustrating the effect of derivative accounting and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the three months ended September 30, 2021 was approximately $8.2 million or $(0.10) per common share.

PAVmed had cash and cash equivalents of $37.3 million as of September 30, 2021, compared with $17.3 million as of December 31, 2020. On a proforma basis, had the Lucid Diagnostics IPO occurred on September 30, 2021, cash would have been approximately $93.7 million after giving effect to underwriting commissions and financial advisory fees.

The unaudited financial results for the three and six months ended September 30, 2021, will be filed with the SEC on Form 10-Q in the coming days and will be available at www.pavmed.com or www.sec.gov. PAVmed has elected the automatic 5-day extension for filing its Form 10-Q for the third quarter. If filed on or before November 22, 2021, the SEC report will be considered timely filed. The Lucid Diagnostics Form 10-Q is due 45 days from the effective date of the IPO registration, or November 29, 2021. We intend to file both 10-Q’s concurrently during the PAVmed extension period.

PAVmed Non-GAAP Measures

To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.

Non-GAAP financial measures are presented with the intent of providing greater transparency to information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.

Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.

A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and six months ended September 30, 2021, and 2020 is as follows:

	For the three months ended September 30,						For the nine months ended September 30,
(ooo's except per-share amounts)	2021			2020			2021			2020

Revenue	$	200		$	-		$	200		$	-
Gross profit		56			-			56			-
Operating expenses		13,724			5,528			34,770			15,795
Loss from operations		(13,668	)		(5,528	)		(34,714	)		(15,795	)
Net income (loss) per common share, basic and diluted	$	(0.15	)	$	(0.11	)	$	(0.42	)	$	(0.57	)
Net loss attributable to common stockholders		(12,294	)		(5,557	)		(33,345	)		(25,751	)
Preferred Stock dividends and deemed dividends		67			74			216			215
Net income (loss) as reported		(12,227	)		(5,483	)		(33,129	)		(25,536	)
Adjustments:
Depreciation and amortization expense1		38			8			60			17
Interest expense, net2		-			-			-			53
EBITDA		(12,189	)		(5,475	)		(33,069	)		(25,466	)

Other non-cash or financing related expenses:
Stock-based compensation expense3		3,991			586			10,629			1,458
Debt extinguishment/debt forgiveness2		-			663			3,415			4,600
Acquisition related1		-			-			133			-
Change in FV convertible debt2		-			(367	)		(1,682	)		5,521
Offering costs convertible debt2		-			50			-			660
Non-GAAP adjusted (loss)		(8,198	)		(4,543	)		(20,574	)		(13,227	)
Basic and Diluted shares outstanding		83,307			48,381			79,874			45,564
Non-GAAP adjusted (loss) income per share	($	0.10	)	($	0.09	)	($	0.26	)	($	0.29	)

1 Included in general and administrative expenses in the financial statements
2 Included in other income and expenses
3 Stock-based compensation ("SBC") expenses:
(ooo's except per-share amounts)	For the three months ended September 30,						For the nine months ended September 30,
	2021			2020			2021			2020
Commercial operations expense total		2,432			687			5,792			1,532
Stock-based compensation expense		(341	)		(85	)		(840	)		(183	)
Net commercial operations expense excluding SBC		2,091			602			4,952			1,349

General and administrative expense total		5,987			2,222			16,100			6,942
Stock-based compensation expense		(3,339	)		(363	)		(9,062	)		(948	)
Net general and administrative expense excluding SBC		2,648			1,859			7,038			5,994

Research and development expense total		5,305			2,619			12,878			7,321
Stock-based compensation expense		(310	)		(138	)		(727	)		(327	)
Net research and development expense excluding SBC		4,995			2,481			12,151			6,994

Total operating expenses		13,724			5,528			34,770			15,795
Stock-based compensation expense		(3,990	)		(586	)		(10,629	)		(1,458	)
Net operating expenses excluding SBC		9,734			4,942			24,141			14,337

Lucid Diagnostics (Nasdaq: LUCD) Preliminary Financial Results

For the three months ended September 30, 2021, EsoGuard related revenues were $0.2 million and gross profit was $56 thousand. Operating expenses were approximately $6.6 million as detailed below including $2.8 million in stock-based compensation expense. GAAP net loss was approximately $7.0 million, or $(0.49) per common share. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the three months ended September 30, 2021 was approximately $3.7 million or $(0.26) per common share.

Lucid had cash and cash equivalents of $21 thousand as of September 30, 2021, compared with $111 thousand as of December 31, 2020. On proforma basis had the Lucid Diagnostics IPO occurred on September 30, 2021, cash would have been approximately $64.4 million after giving effect to underwriting commissions and financial advisory fees.

The unaudited financial results for the three and six months ended September 30, 2021, will be filed with the SEC on Form 10-Q in the coming days and will be available at www.luciddx.com or www.sec.gov. The Lucid Diagnostics Form 10-Q is due 45 days from the effective date of the IPO registration, or November 29, 2021. We intend to file Lucid’s 10-Q concurrently with PAVmed’s Form 10-Q during the PAVmed extension period.

Lucid Non-GAAP Measures

To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.

	For the three months ended September 30,						For the nine months ended September 30,
(ooo's except per-share amounts)	2021			2020			2021			2020

Revenue	$	200		$	-		$	200		$	-
Gross profit		56			-			56			-
Operating expenses		6,566			2,022			16,234			5,549
Interest expense		447						594
Net loss		(6,957	)		(2,022	)		(16,772	)		(5,549	)
Net income (loss) per common share, basic and diluted	$	(0.49	)	$	(0.14	)	$	(1.19	)	$	(0.39	)
Adjustments:
Depreciation and amortization expense1		-			-			3			-
Interest expense, net3		447			-			594			-
EBITDA		(6,510	)		(2,022	)		(16,175	)		(5,549	)

Other non-cash or financing related expenses:
Stock-based compensation expense3		2,772			16			6,157			49
Non-GAAP adjusted (loss)		(3,738	)		(2,006	)		(10,018	)		(5,500	)
Basic and Diluted shares outstanding		14,115			14,115			14,115			14,114
Non-GAAP adjusted (loss) income per share	($0.26		)	($0.14		)	($0.71		)	($0.39		)

1 Included in general and administrative expenses in the financial statements
2 Included in other income and expenses

	For the three months ended September 30,						For the nine months ended September 30,
	2021			2020			2021			2020
3 Stock-based compensation ("SBC") expenses:
Commercial operations expense total		978			335			2,689			672
Stock-based compensation expense		-			-			-			-
Net commercial operations expense excluding SBC		978			335			2,689			672

General and administrative expense total		3,398			471			7,731			1,260
Stock-based compensation expense		(2,695	)		-			(5,988	)		-
Net general and administrative expense excluding SBC		703			471			1,743			1,260

Research and development expense total		2,190			1,216			5,814			3,617
Stock-based compensation expense		(77	)		(16	)		(168	)		(49	)
Net research and development expense excluding SBC		2,113			1,200			5,646			3,568

Total operating expenses		6,566			2,022			16,234			5,549
Stock-based compensation expense		(2,772	)		(16	)		(6,156	)		(49	)
Net operating expenses excluding SBC		3,794			2,006			10,078			5,500

https://finance.yahoo.com/news/pavmed-lucid-business-preliminary-third-211300907.html

Boost for Amazon’s telehealth business, as Hilton signs up

Amazon’s push into the provision of remote healthcare services has been rewarded with a top-tier corporate client – the Hilton hotel chain.

The deal – first reported by Reuters – involves the Amazon Care platform, which includes remote, online consultations with clinicians, as well as home visits in some areas. It provides primary and preventive care, ongoing support for chronic conditions, and referrals to secondary and tertiary care.

Amazon can also offer prescription medicine delivery services within a few hours through its recently-launched Amazon Pharmacy service, kicked off with its acquisition of PillPack in 2018.

The online retail giant first started offering the telemedicine service to some of its own employees in 2019, setting it up in collaboration with Oasis Medical Group, but in March this year announced its intention to offer it to all US employees as well as other companies.

The launch of Amazon Care is bringing the company closer to a true ‘end-to-end’ healthcare model, similar to turnkey solutions offered by the likes of Hims, Ro and others.

Meanwhile, Amazon is running a biotech-like digital health accelerator to identify startups with promising new technologies that could be layered into its healthcare portfolio. It is also entering the health wearables market with its own Halo device, and bolstering the health-related capabilities of its Alexa virtual assistant.

Reuter said the financial details of the agreement with Hilton Worldwide Holdings have not been disclosed, but is the e-commerce giant’s first hospitality customer and only its second disclosed client after Washington-based fitness equipment company Precor, now part of Peloton.

It will be offered to Hilton employees across the US from next year, according to the report. Hilton employs around 141,000 people worldwide.

Amazon’s push into telemedicine has not been without its setbacks however. In 2018 it formed a partnership with JP Morgan and Berkshire Hathaway to explore how to cut healthcare expenses, but maintain service quality, for the three organisations 1.2 million employees, but brought that to a close earlier this year.

https://pharmaphorum.com/news/boost-for-amazons-telehealth-business-as-hilton-signs-up/

Why Bill Gates Is Pivoting On Existing COVID Vaccines

by Jeffrey Tucker via The Brownstone Institute,

In a surprising interview, Bill Gates said the following: “We didn’t have vaccines that block transmission. We got vaccines that help you with your health, but they only slightly reduce the transmission. We need new ways of doing vaccines.”

It’s odd how he speaks of medicines as if they are like software. Try it out, observe how it works. When you find a problem, put the technicians to work. Every new iteration is an experiment. Free to try until you finally buy. Surely over time, we’ll find the answer to the problem of blocking or blotting out pathogens.

Software. Hardware. Applications. Subscriptions! This is how he thinks, as if the human body and its deadly dance with viruses is a recent problem and we are only at the very beginning of finding solutions, without realizing that this reality has been present for the whole of human existence and that we had tremendous success in the course of the 20th century minimizing bad pathogenic outcomes without his guidance and benefaction.

Essentially, he has long promoted the idea that traditional public health praxis was for the analog age; in the digital age, we need government planning, advanced technology, mass surveillance, and the ability to control human beings the way a software company manages personal computers.

Most people have no idea how such a rich and smart person could be so dim on essential matters of complex cell biology. Hacking the human body, improving it with uploads and downloads, is surely a more ominous challenge than inventing and managing man-made computers. So herein I try to present the reasons for Gates’s way of thinking.

The relative deficiencies of this vaccine to stop infection and transmission are now well known. There is some reason to believe that they achieve that much at least for the vulnerable population.

What can we make of Gates’s passing statement: “We need a new way of doing vaccines”?

Let’s travel back in time to examine his career at Microsoft and his shepherding into existence the Windows operating system. By the early 1990s, it was being billed as the essential brain of the personal computer. Security considerations against viruses were not part of its design, however, simply because not that many people were using the internet so the threat level was low. The browser was not invented until 1995. Security of personal computers was not really a question that Microsoft had dealt with.

The neglect of this consideration turned into a disaster. By the early 2000s, there were thousands of versions of malware (also called bugs) floating around the internet and infecting computers running Windows worldwide. They ate hard drive. They sucked out data. They forced ads on people. They invaded your space with strange popups. They were wrecking the user experience and threatening the future of an entire industry.

The problem of malware was dubbed viruses. It was a metaphor. Not real. It’s not clear that Gates ever really understood that. Computer viruses aren’t anything like biological viruses. To maintain a clean and functioning hard drive, you want to avoid and block a computer virus at all costs. Any exposure is bad exposure. The fix is always avoidance until eradication.

With biological viruses, we have evolved to confront them through exposure and let our immune system develop to take them on. A body that blocks all pathogens without immunity is a weak one that will die at the first exposure, which will certainly come at some point in a modern society. An immune system that confronts most viruses and recovers grows stronger. That’s a gigantic difference that Gates never understood.

Regardless, the advent of the army of computer pathogens fundamentally threatened his proudest achievement. Microsoft frantically searched for a solution, but the creativity of the malware army moved too fast for its engineers.

Others sensed an opportunity. Companies specializing in anti-virus software had been doing business since the 1990s but grew more sophisticated in the early 2000s. Once the internet became fast enough, these software packages could be updated daily. There were ever newer companies, each with a different method and a different marketing and pricing model.

Eventually, the problem was mostly solved on the personal computer, but it took ten years. Even now, Microsoft’s products are less protected than Apple’s, and Microsoft has yet to come close to mitigating the problem of spam on its own native email client.

In short, keeping viruses out of computers constitutes the single biggest professional struggle in Gates’ life. The lesson he learned was that pathogen blocking and eradication was always the path forward. What he never really understood is that the word virus was merely a metaphor for unwanted and unwelcome computer code. The analogy breaks down in real life.

After finally stepping back from Microsoft’s operations, Gates started dabbling in other areas, as newly rich people tend to do. They often imagine themselves especially competent at taking on challenges that others have failed at simply because of their professional successes. Also by this point in his career, he was only surrounded by sycophants who would not interrupt his descent into crankiness.

And what subject did he pounce on? He would do to the world of pathogens what he did at Microsoft: he would stamp them out! He began with malaria and other issues and eventually decided to take on them all. And what was his solution? Of course: antivirus software. What is that? It is vaccines. Your body is the hard drive that he would save with his software-style solution.

At the beginning of the pandemic, I noted that Gates was pushing hard for lockdowns. His foundation was now funding research labs the world over with billions of dollars, plus universities and direct grants to scientists. He was also investing heavily in vaccine companies.

Early on in the pandemic, to get a sense of Gates’s views, I watched his TED talks. I began to realize something astonishing. He knew much less than anyone could discover by reading a book on cell biology from Amazon. He couldn’t even give a basic 9th-grade-level explanation of viruses and their interaction with the human body. And yet here he was lecturing the world about the coming pathogen and what should be done about it. His answer is always the same: more surveillance, more control, more technology.

Once you understand the simplicity of his core confusions, everything else he says makes sense from his point of view. He seems forever stuck in the fallacy that the human being is a cog in a massive machine called society that cries out for his managerial and technological leadership to improve to the point of operational perfection.

The rich, their pretenses, their influence: sometimes charming, sometimes beneficent, sometimes deeply malicious. Gates’s influence over epidemiology has been tremendously baneful, but it’s unclear whether he even knows it. In fact, I don’t think that he does. In some ways, that’s even more dangerous.

Readers might be quick to point out that Gates has benefited enormously from lockdowns and vaccine mandates, both seeing his former company grow to enormous size and from his stock ownership in vaccine makers. So yes, his ignorance has been rewarded handsomely. As for his influence on the world, history will not likely be forgiving.

https://www.zerohedge.com/covid-19/why-bill-gates-pivoting-existing-covid-vaccines

Santhera and ReveraGen: Successful FDA Pre-NDA Meeting for Vamorolone in Duchenne

https://www.marketscreener.com/quote/stock/SANTHERA-PHARMACEUTICALS-195471/news/Santhera-and-ReveraGen-Announce-Successful-FDA-Pre-NDA-Meeting-for-Vamorolone-in-Duchenne-Muscular-D-37049274/

Siemens Healthineers Sets Medium-Term Earnings, Revenue Growth Targets

Siemens Healthineers AG on Wednesday set revenue and earnings-per-share growth targets for fiscal years 2023 to 2025 as it launched the third phase of its strategy through 2025.

The German medical-equipment maker said it expects revenue growth of 6% to 8% annually for fiscal years 2023 to 2025, while adjusted earnings-per-share growth is expected at 12% to 15% a year based on broad-based margin expansion.

The goals are part of the latest phase of the company's strategy, which begins in fiscal year 2022 after Siemens Healthineers said it completed the previous plan a year ahead of schedule.

Siemens Healthineers said it expects research-and-development spending at 8% to 9% of revenue, and selling, general and administrative expenses at 15% to 17%.

Synergy targets from the acquisition of Varian are going to be raised to more than 350 million euros ($396.3 million) by 2025, according to the company. It said that it will partially reinvest cost synergies to generate future revenue synergies, and that those will be effective to profit-and-loss primarily in fiscal 2024 and 2025.

The company also set targets for its different segments for fiscal years 2023 to 2025, saying it expects comparable revenue growth in the imaging segment to be between 5% and 8% a year, with margins expanding by 20 to 80 basis points yearly.

Diagnostics is expected to see comparable revenue growth progressing toward 4% to 6% yearly, and margins moving toward the mid teens until fiscal 2025, the company said.

Varian is expected to show comparable revenue growth between 9% to 12% yearly, with margins moving to well above 20% in fiscal 2025, the company said. The advanced therapy business is expected to have comparable revenue growth of between 5% to 8% yearly, with margins progressing toward 20% in fiscal 2025, Siemens Healthineers said.

https://www.marketscreener.com/quote/stock/SIEMENS-HEALTHINEERS-AG-42379342/news/Siemens-Healthineers-Sets-Medium-Term-Earnings-Revenue-Growth-Targets-Update-37050063/

Imugene in Clinical Trial Supply Agreement with Merck KGaA, Pfizer

New clinical trial supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. Avelumab (BAVENCIO®) to be provided to Imugene for Phase 2 clinical study in HER-2 positive gastric or gastroesophageal junction adenocarcinomas (neoHERIZON)neoHERIZON will assess HER-Vaxx in combination with chemotherapy with or without avelumab in HER-2 positive gastric cancer

Imugene (ASX: IMU) today announced a new clinical trial supply agreement with Merck KGaA, Darmstadt, Germany (ETR: MRK) and Pfizer Inc. (NYSE: PFE) to evaluate the safety and efficacy of Imugene’s HER-Vaxx, a B-cell activating immunotherapy, in combination with avelumab, an immune checkpoint inhibitor targeting PD-L1, in patients with HER-2 positive gastric cancer. Avelumab, which is marketed as BAVENCIO®, is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

neoHERIZON is an open-label, multi-center, randomized, Phase 2 clinical trial designed to assess the safety and efficacy of perioperative HER-Vaxx combined with chemotherapy with or without avelumab compared to chemotherapy alone in patients with HER-2 positive gastric or gastroesophageal junction adenocarcinomas. The study’s primary endpoint is pathologic complete response. Secondary endpoints include safety and biomarker evaluation.

https://www.kulr8.com/news/money/imugene-announces-clinical-trial-supply-agreement-with-merck-kgaa-darmstadt-germany-and/article_ba13236f-09c7-5b57-8f8e-086bead0f46c.html

Tuesday, November 16, 2021

Biotech Investors: Mark Your Calendar For November PDUFA Dates

The loaded Prescription Drug User Fee Act (PDUFA) calendar for October produced mixed outcomes.

PDUFA dates are key binary events for biotech stocks that can move the needle in a big way. These are the dates by which the Food and Drug Administration is required to announce its decision regarding approvability/non-approvability of drugs.

ChemoCentryx, Inc.'s

CCXI -2.89%

(Get Free Alerts for CCXI) avacopan was the only new molecular entity approved during the month. NMEs are new drug products containing an active ingredient that is marketed for the first time in the U.S. Avacopan, which is to go by the brand name Tavneos, has been approved for treating small blood vessel damage.

Also approved in the month were an application seeking label expansion for Gilead Sciences, Inc.'s

GILD -0.46%

(Get Free Alerts for GILD) CAR T-cell therapy Tecartus for use in advanced lymphoblastic leukemia and Oyster Point Pharma, Inc.'s

OYST -1.28%

OC-01 (varenicline) nasal spray for treating dry eye disease.

Among the disappointments were Omeros Corporation's

OMER -0.6%

narsoplimab as a treatment option for hematopoietic stem cell transplant-associated thrombotic microangiopathy, Eyenovia, Inc.'s

EYEN -3.01%

MydCombi for use as a pupil dilation agent for eye examination and United Therapeutics Corporation's

UTHR -0.87%

Tyvaso DPI (inhaled treprostinil) for pulmonary arterial hypertension.

Here are the key PDUFA catalysts for the rest of November.

Will BioMarin Successfully Take Its Short-limbed Dwarfism Drug Past The Finish Line?

Company: BioMarin Pharmaceutical Inc.
BMRN -0.94%
Type of Application: NDA
Candidate: Vosoritide
Indication: achondroplasia
Date: Nov. 20

The regulatory application for vosoritide was accepted for review in November 2020 with a PDUFA date of Aug. 20. Subsequently, in April, the company said the FDA considered the submission of two-year results from the Phase 3 extension study as a major amendment to the application, and extended the PDUFA date to Nov. 20.

Vosoritide is an investigational, once daily injection for treating children with achondroplasia, the most common form of disproportionate short stature in humans.

Will FDA Tow In Line With Adcom Verdict On Takeda's CMV Antiviral Drug

Company: Takeda Pharmaceutical Company Limited
TAK -2.22%
Type of Application: NDA
Candidate: maribavir (TAK-620)
Indication: cytomegalovirus infection in transplant recipients
Date: Nov. 23

Maribavir is being evaluated for the treatment of refractory cytomegalovirus infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. FDA's Antimicrobial Drugs Advisory Committee, which met in early October, voted unanimously, recommending approval of the treatment candidate.

Aadi Seeks Approval For Drug to Treat Rare Tumors

Company: Aadi Bioscience, Inc.
AADI +6.69%
Type of Application: NDA
Candidate: Fyarro
Indication: advanced malignant PEComa
Date: Nov. 26

Fyarro is Aadi's lead product that is being evaluated for PEComa, which are rare tumors that form in the soft tissues of the stomach, intestines, lungs, female reproductive organs, and genitourinary organs. The FDA accepted the NDA for priority review on July 26.

Can Fennec's Pedmark Cross The FDA Hurdle In its Second Try?

Company: Fennec Pharmaceuticals Inc.
FENC +0.62%
Type of Application: NDA
Candidate: Pedmark (sodium thiosulfate)
Indication: chemotherapy-induced hearing loss in Children
Date: Nov. 27

Pedmark is a unique formulation of sodium thiosulfate, and is being evaluated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors. Following the receipt of a complete response letter in August 2020, Fennec resubmitted the application, which was accepted by the FDA in late June 2021.

'Go' or ‘No-Go' For VBI's Hepatitis B Virus Shot

Company: VBI Vaccines Inc.
VBIV +2.36%
Type of Application: BLA
Candidate: Sci-B-Vac
Indication: hepatitis B virus
Date: Nov. 30

Sci-B-Vac is a 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. It is the only 3-antigen hepatitis B vaccine, comprising S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially available in Israel.

VBI's BLA was accepted for review on Feb. 2.

Hepatitis B is one of the world's most significant infectious disease threats with more than 290 million people infected globally. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

Amryt Has Tryst With FDA For Rare Skin Disorder Drug

Company: Amryt Pharma plc
AMYT -0.09%
Type of Application: NDA
Candidate: Filsuvez (Oleogel-S10)
Indication: epidermolysis bullosa
Date: Nov. 30

Filsuvez is a potential treatment for the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa, a rare genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez has been selected as the brand name for Oleogel-S10.

BeyondSpring Seeks Nod For Combo Treatment In Chemotherapy-Associated Toxicity

Company: BeyondSpring Inc.
BYSI -3.64%
Type of Application: chemotherapy-induced neutropenia
Candidate: plinabulin + G-CSF Combination
Indication: NDA
Date: Nov. 30

Plinabulin. in combination with granulocyte colony-stimulating factor, is being studied for the prevention of chemotherapy-induced neutropenia
Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever.

CTI BioPharma Awaits Word On Rare Blood Cancer Drug

Company: CTI BioPharma Corp.
CTIC +3.83%
Type of Application: NDA
Candidate: pacritinib
Indication: myelofibrosis patients with severe thrombocytopenia
Date: Nov. 30

The FDA accepted the regulatory application for priority review on June 1. Pacrotinib, if approved, is expected to addresses the unmet medical need of myelofibrosis patients with severe thrombocytopenia.

https://www.benzinga.com/general/biotech/21/11/23804727/attention-biotech-investors-mark-your-calendar-for-november-pdufa-dates

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