Novan on Strategic Priorities, Key Milestones

 Company planning for three potential New Drug Application (NDA) filings in three years with the first submission expected in Q3 2022 for lead program SB206 in molluscum contagiosum –

– Late-stage product candidate, SB204 for the treatment of acne vulgaris, selected to advance as second lead program toward pivotal Phase 3 study –

– SB019 SARS-CoV-2 development program advancing toward Phase 1 study in healthy volunteers, targeted for 1H 2022 –

– Company to host conference call and webcast today at 8:30 AM ET –

Upcoming Targeted Milestones:

• Initiation of Phase 1 study in healthy volunteers targeted for 2022.

• Phase 2/3 study(s) targeted for 2023, subject to obtaining additional financing or strategic partnering.

• Potential submission of an NDA targeted for 2024.
  

Conference Call and Webcast Details

As previously announced, Novan will host a corporate update conference call and webcast today, Thursday, September 9th at 8:30 a.m. ET. The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6243828. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

https://finance.yahoo.com/news/novan-announces-strategic-priorities-outlines-110000040.html

Roche to Acquire Biotech Company TIB Molbiol Group

Roche Holding AG said Thursday that it has entered into a definitive share purchase agreement to acquire 100% of the outstanding shares in TIB Molbiol Group, a Germany-based biotechnology company focused on diagnostics and research. The Swiss pharmaceutical major said the acquisition, which is expected to close in the fourth quarter of 2021, will enhance its molecular-diagnostics portfolio, including the identification of coronavirus variants. "With this acquisition, we can expand our offering of tests of existing pathogens and our response to emerging pathogens and potential health threats," Thomas Schinecker, head of Roche Diagnostics, said. No financial details of the acquisition were disclosed. https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-to-Acquire-Biotech-Company-TIB-Molbiol-Group-36380114/

Myovant, Pfizer: FDA to Review Myfembree for Endometriosis Pain

Myovant Sciences Ltd. and Pfizer Inc. on Thursday said the U.S. Food and Drug Administration accepted their application for expanded approval of Myfembree for the management of moderate to severe pain associated with endometriosis.

The companies said the agency, which in May approved Myfembree for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, set a target action date of May 6 for the new indication.

Myovant and Pfizer, which are jointly developing and commercializing Myfembree in the U.S., said approval would provide a one-pill, once-daily treatment option for endometriosis, an inflammatory disease in which tissue similar to the uterine lining grows outside the uterine cavity.

https://www.marketscreener.com/quote/stock/MYOVANT-SCIENCES-LTD-31698733/news/Myovant-Pfizer-FDA-to-Review-Myfembree-for-Endometriosis-Pain-36383019/

Eloxx Pharma Gets FDA Fast Track Designation for ELX-02 in Cystic Fibrosis

 Eloxx Pharmaceuticals Inc. Thursday said the U.S. Food and Drug Administration gave fast track designation for ELX-02.

ELX-02 is a drug candidate intended to treat cystic fibrosis patients with nonsense mutations. ELX-02 is currently in Phase 2 clinical trials in CF patients affected by nonsense mutations in the CF transmembrane conductance regulator gene for whom there are no effective disease modifying therapies.

Shares were up 6% to $1.47 in premarket trading.

FDA grants fast track designation to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. Sponsors of drugs that receive fast track designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.

https://www.marketscreener.com/quote/stock/ELOXX-PHARMACEUTICALS-IN-43180289/news/Eloxx-Pharmaceuticals-Gets-FDA-Fast-Track-Designation-for-ELX-02-in-Cystic-Fibrosis-36385929/

Acorda Therapeutics Announces Corporate Restructuring, Management Changes

 

• 15% reduction in headcount

• Greater than $20 million in expected annualized cost savings from headcount and budget reductions

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced a corporate restructuring to reduce costs and more closely align operating expenses with expected revenue. The Company also announced changes to its management team.

Corporate Restructuring

As a result of the restructuring, the Company is reducing headcount by 15%. Most of the reduction in personnel will take place immediately, with the balance completed in the first quarter of 2022.

The Company expects to realize annualized cost savings of approximately $20 million from the headcount reductions and the outsourcing of certain operations, beginning in 2022. Acorda estimates that it will incur approximately $3.0 million of pre-tax charges for severance and other costs related to the restructuring, through the first quarter of 2022.

Management Changes

Lauren Sabella, currently Acorda’s Chief Commercial Officer, has been named Chief Operating Officer. She will have responsibility for Quality, Information Technology, Technical Operations, and Business Operations / Strategic Planning. Kerry Clem, Acorda’s Executive Vice President of Sales, Market Access, and Operations, has been named Chief Commercial Officer.

"We have made substantial progress over the past year, growing sales of Inbrija, maintaining Ampyra revenue to a substantial degree, and retiring our short-term debt. We have achieved these outcomes despite the significant impact of the pandemic on our business. When the pandemic subsides, we believe that we will have the opportunity to accelerate Inbrija’s trajectory, as in-person interactions with health care providers and patients return to more normal levels. The headcount reductions and structural changes we have made will enable us to operate more efficiently and further align our expenses with revenue, while continuing to grow Inbrija sales," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are deeply grateful to the associates who are leaving Acorda for their commitment, hard work, and many contributions."

https://finance.yahoo.com/news/acorda-therapeutics-announces-corporate-restructuring-120100493.html

Moderna shares rise after company reveals single-shot vaccine booster for Covid and flu

 Moderna shares rose Thursday after it announced it’s developing a two-in-one vaccine booster shot that protects against both Covid-19 and the seasonal flu.

The new vaccine, which the company is calling mRNA-1073, combines Moderna’s current Covid vaccine with a flu shot that’s also under development, according to a press release. Shares of Moderna jumped by more than 5% after the announcement.

“Today we are announcing the first step in our novel respiratory vaccine program with the development of a single dose vaccine that combines a booster against COVID-19 and a booster against flu,” CEO Stephane Bancel said in a statement Thursday. “We are making progress on enrolling patients in our rare disease programs, and we are fully enrolled in our personalized cancer vaccine trial. We believe this is just the beginning of a new age of information-based medicines.”

The announcement comes on the heels of Moderna’s highly successful launch of its mRNA-based two-dose Covid vaccine, which was authorized for emergency use by the Food and Drug Administration in December. More than 147 million of the Moderna shots have been administered in the U.S., according to data compiled by the Centers for Disease Control and Prevention.

Messenger RNA, or mRNA, technology has been under development for years, but Moderna’s and Pfizer’s vaccines are the first time mRNA has been cleared for use in humans. The mRNA-based Covid vaccines work by tricking the body to produce a harmless piece of the virus, triggering an immune response. It’s said to be easier to produce than traditional vaccines, which generally use a dead or weakened virus to produce an immune response.

Bancel previously said the company hoped to have a booster shot that would combine protection against both viruses.

“What we’re trying to do at Moderna actually is to get a flu vaccine in the clinic this year and then combine our flu vaccine to our Covid vaccine so you only have to get one boost at your local CVS store ... every year that would protect you to the variant of concern against Covid and the seasonal flu strain,” Bancel said in April.

Moderna also announced Thursday it is developing a pediatric vaccine, called mRNA-1365, which would combine vaccines for respiratory syncytial virus and human metapneumovirus.

https://www.cnbc.com/2021/09/09/moderna-says-its-developing-a-single-vaccine-for-covid-and-flu-boosters-shares-gain.html

Pieris Pharma: Upcoming Investor Conferences

 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that members of the management team will participate in the following upcoming investor conferences:

H.C. Wainwright 23rd Annual Global Investment Conference
Monday, September 13, 2021 at 7:00 AM EDT. A webcast of the Company's presentation will be available at this link.

Cantor Global Healthcare Conference
Thursday, September 30, 2021 at 12:00 PM EDT. A webcast of the Company's presentation will be available at this link.

About Pieris Pharmaceuticals:
Pieris is a clinical-stage biotechnology company that combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and locally-activated bispecifics for immuno-oncology. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by respiratory and immuno-oncology focused partnerships with leading pharmaceutical companies. For more information, visit www.pieris.com.

https://finance.yahoo.com/news/pieris-pharmaceuticals-participate-upcoming-investor-120000558.html