Perrigo acquires OTC skin care products in Europe from Sanofi

Perrigo (PRGO +2.9%) will acquire three Eastern European OTC skincare and hair loss treatment brands including Emolium, Iwostin and Loxon, from Sanofi, for an undisclosed consideration.

Trailing twelve months net sales ending June 30, of the acquired products were ~€21M (~$23)

The transaction is expected to close in the next quarter

https://seekingalpha.com/news/3604206-perrigo-acquires-otc-skin-care-products-in-europe

FDA accepts Protalix application for enzyme replacement therapy for Fabry

Under Priority Review status, the FDA accepts for review Protalix BioTherapeutics’ (NYSEMKT:PLX) marketing application seeking approval of enzyme replacement therapy pegunigalsidase alfa for the treatment of adults with Fabry disease, an inherited disorder characterized by the buildup of a type of fat in the body’s cells due to the absence or dysfunction in a particular enzyme.

The agency’s action date is January 27, 2021.

https://seekingalpha.com/news/3603925-fda-accepts-protalix-application-for-enzyme-replacement-therapy-for-fabry

Putin claims Russia has developed the first coronavirus vaccine

“As far as I know, a vaccine against a new coronavirus infection has been registered this morning, for the first time in the world,” Russian President Vladimir Putin declared, according to RIA Novosti.

“I know that it works quite effectively, forms a stable immunity and, I repeat, has passed all the necessary checks.”

He added that one of his daughters was vaccinated against the coronavirus and stressed that “many people do not have any external manifestations at all” or temperature after immunization (that’s despite Phase 3 trials that normally last for months and involve thousands of people).

“I hope that we will be able to begin in the near future the mass production of this drug. Whoever wants to, could take advantage of the developments and achievements of our specialists.”

At the end of July, the WHO said that there were 26 candidate vaccines in the clinical evaluation stage, including one registered in Russia that was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology.

Related tickers: Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX), Novavax (NASDAQ:NVAX), Inovio Pharmaceuticals (NASDAQ:INO), Moderna (NASDAQ:MRNA), AstraZeneca (NYSE:AZN), Dynavax (NASDAQ:DVAX), GlaxoSmithKline (NYSE:GSK), iBio (NYSEMKT:IBIO), Altimmune (NASDAQ:ALT) and VBI Vaccines (NASDAQ:VBIV).

https://seekingalpha.com/news/3603880-putin-claims-russia-developed-first-coronavirus-vaccine

BioNTech Q2 top-line driven by deals for BNT162 vaccine program against Covid-19

BioNTech (BNTX) Q2 results:

Revenues: 41.8M (+62.0%), consisting primarily from collaboration agreements signed with Pfizer and Fosun Pharma as part of BNT162 vaccine program against COVID-19.

Net loss: (88.3M) (-76.2%); loss/share: (0.38) (-58.3%).

Cash used in Operations: 70.2M (+18.1%).

2020 Guidance: As a result of increased spending related to BNT162, BioNTech now expects net cash used in operating activities to be between €450M and €600M.

The company initiated a Phase 2b/3 study for BNT162b2 in up to 30,000 participants aged 18 to 85 years at ~120 sites globally; if successful, BioNTech and Pfizer plan to file for market authorization or regulatory approval as early as October 2020.

BNTX has announced initial commercial supply agreements totaling more than 250M doses with the UK, U.S., Japan and Canada in 2020 and 2021, with an option to purchase up to an additional 500M doses.

BNT111 – BioNTech expects to initiate this Phase 2 trial with registrational potential in H2.

BNT113 – Planned initiation of a registrational Phase 2 trial in HPV16+ head and neck cancer expected in H2.

BNT122 – Two Phase 2 clinical trials are planned in the adjuvant setting. The first Phase 2 study is currently recruiting for patients with early and adjuvant stage NSCLC and first patient dosing is expected in H2.

The second Phase 2 study will be in colorectal cancer in adjuvant setting and is expected to initiate in second half of 2020.

BNT221 – Initiation of a Phase 1 dose escalation trial of BNT221 is expected in 2H 2020 for the treatment of metastatic melanoma.

BNT311 – BioNTech expects to provide a data update in H2 from the Phase 1/2 trial in multiple solid tumors for GEN1042/BNT311 (PD-L1x4-1BB). The program is partnered with Genmab.

https://seekingalpha.com/news/3603928-biontech-q2-top-lineplus-62-driven-deals-signed-for-bnt162-vaccine-program-against-covidminus

Fennec Pharma craters on FDA rejection of Pedmark application

Thinly traded micro cap Fennec Pharmaceuticals (NASDAQ:FENC) slumps 32% premarket on average volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval of Pedmark (sodium thiosulfate) for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors.

The CRL cited deficiencies at its manufacturing facility. The review team noted no issues with safety or efficacy.

The company plans to meet with the agency to clarify the necessary steps to resolve the issues.

Management will host a conference call this morning at 8:30 am ET to discuss the matter.

https://seekingalpha.com/news/3603898-fennec-pharma-craters-on-fda-rejection-of-pedmark-application

Trump explores tax cuts for capital gains, middle-income families

In addition to several weekend executive actions that included a payroll tax holiday, President Trump is “very seriously” considering a capital gains tax cut, which would “create a lot more jobs.”

While the president can’t unilaterally slash the 20% long-term capital gains rate without Congress, some advisers say he could issue an executive order that would slash tax bills for investors when they sell assets.

The move, known as indexing capital gains to inflation, would likely face legal challenges, and comes as Trump also explores “an income tax cut for middle-income families.”

“There is no reason the economy can’t grow at a 20% pace in the third quarter,” Trump added during a press conference at the White House. “That would be a record and interestingly, it’ll be a number that’s going to be announced before November 3.”

https://seekingalpha.com/news/3603882-trump-explores-tax-cuts-for-capital-gains-middle-income-families

Qiagen up 3% ahead of announcement on Thermo Fisher bid

Diagnostic test maker Qiagen N.V. (NYSE:QGEN) perks up 3% premarket on light volume. The deadline for Thermo Fisher Scientific’s (NYSE:TMO) €43.00 per share offer was yesterday at 6:00 pm ET.

TMO, which upped its bid from €39.00 after institutional investors balked, stated that the revised offer was final and would automatically terminate if less than 66 2/3% of QGEN shares were tendered.

https://seekingalpha.com/news/3603910-qiagen-up-3-ahead-of-announcement-on-thermo-fisher-bid