Alzamend Neuro: Positive Pre-IND FDA Response for Alzheimer's Candidate

 FDA Agrees to Alzamend’s Plan to Conduct a Combined Phase 1 and 2 Clinical Trial for AL002

Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received a written response to its meeting request relating to its Type B Pre‑Investigational New Drug ("IND") application from the U.S. Food and Drug Administration (the "FDA") providing a path for Alzamend’s planned clinical development of AL002. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s.

Based on the FDA’s written feedback, Alzamend anticipates filing the IND by the end of November 2021 and initiating the clinical trial of AL002 in the first quarter of 2022.

https://finance.yahoo.com/news/alzamend-neuro-receives-positive-pre-141100659.html

Perrigo Stock Soars After Settling Irish Tax Dispute

 Perrigo  (PRGO) - Get Perrigo Co. Plc Report shares jumped on Thursday after the drugmaker said it had settled a dispute with Irish tax officials for about $344 million.

At last check shares of the Dublin company were up nearly 15% to $49.89.

Perrigo, formerly known as Elan, said in a statement that it had settled with the Irish Office of the Revenue Commissioners regarding an amended assessment from Nov. 29, 2018. That assessment claimed income tax of 1.6 billion euros, or roughly $1.9 billion, not including penalties or interest.

Irish Revenue Commissioners had charged that intellectual property sales by Elan Pharma, including the multiple-sclerosis drug Tysabri, were taxed as trading income at 12.5%, when they should have been treated as a chargeable gain at a rate of 33%.

In July, the company said, tax officials said they did not have all the relevant facts when the notice was issued and allowed adjustments that cut about $764 million from the original amount.

Perrigo said that while it believed that its tax position was correct and would have been confirmed on appeal, it agreed to settle "given the risks inherent in any litigation, as well as the ongoing costs of what could have been years of litigation and the uncertainty that would create."

The company agreed to pay 297 million euros, or $344 million, as a full and final settlement of all liabilities arising from the sale of the Tysabri patents. And it agreed to be taxed in periods from fiscal 2013 to fiscal 2021 inclusive.

In addition, Irish Revenue will give Perrigo credit for certain taxes already paid and for certain unused R&D credits, all of which will be applied against the 297 million euros.

So the total cash payment that Perrigo makes as part of the settlement will be 266.1 million, or about $308.1 million.

No interest is due and no penalties apply, the company said, and Irish Revenue will take no further action in relation to the amendment or any Tysabri-related income or transactions.

Earlier this month, Perrigo said it had agreed to acquire peer Héra SAS for 1.8 billion euros, or about $2.1 billion, cash.

https://www.thestreet.com/investing/perrigo-stock-climbs-after-settling-irish-tax-dispute

OptimizeRx Set to Join S&P SmallCap 600

 OptimizeRx Corp. (NASD:OPRX) will replace Lydall Inc. (NYSE:LDL) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, October 4. Clearlake Capital Group is acquiring Lydall in a deal that is expected to close on or about October 1.

Following is a summary of the changes that will take place prior to the open of trading on the effective date:

Effective Date	Index Name	Action	Company Name	Ticker	GICS Sector
October 4, 2021	S&P SmallCap 600	Addition	OptimizeRx	OPRX	Health Care
	S&P SmallCap 600	Deletion	Lydall	LDL	Industrials

For more information about S&P Dow Jones Indices, please visit www.spdji.com

https://finance.yahoo.com/news/optimizerx-set-join-p-smallcap-223900267.html

DiaMedica Fast Tracked for the Treatment of Acute Ischemic Strok

 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation to the Company’s lead candidate DM199 for the treatment of acute ischemic stroke (AIS) where tissue plasminogen activator and/or mechanical thrombectomy are not indicated or medically appropriate.

https://finance.yahoo.com/news/diamedica-therapeutics-announces-fast-track-124500117.html

Lilly, Incyte : Olumiant Superior to Placebo in Scalp Hair Regrowth as Early as 24 Weeks

 Eli Lilly & Co. and Incyte Corp. on Thursday said a pair of Phase 3 studies showed that once-daily four-milligram doses of their arthritis drug Olumiant was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata.

The companies earlier this year had reported that the studies showed significant improvements in scalp hair regrowth compared with placebo at 36 weeks for patients taking 2- and 4-milligram doses.

Eli Lilly said it plans to file for U.S. Food and Drug Administration approval for Olumiant in alopecia areata by the end of the year. There are currently no FDA-approved treatments for the autoimmune disorder, which can cause unpredictable hair loss on the scalp, face and other areas of the body.

Olumiant is approved in dozens of countries around the world for adults with moderate to severe rheumatoid arthritis and for adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. The drug is also approved for the treatment of hospitalized patients with Covid-19 in several countries, including Japan and Switzerland.

Indianapolis-based Eli Lilly signed an exclusive world-wide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize Olumiant and other compounds for inflammatory and autoimmune diseases.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Lilly-Incyte-Olumiant-Superior-to-Placebo-in-Scalp-Hair-Regrowth-as-Early-as-24-Weeks-36557124/

Regeneron Covid-19 Trial Meets Primary Endpoint

 Regeneron Pharmaceutical Inc. said Thursday that a clinical trial of its REGN-COV candidate treatment for Covid-19 met the drug's primary endpoint of significantly reducing viral load within seven days in hospitalized patients.

Regeneron said that the drug, an antibody cocktail of casirivimab and imdevimab, reduced the risk of death by 36% about a month after treatment began in the study's patient population.

The Phase 2/3 trial included 1,197 patients hospitalized with Covid-19, including some using supplemental oxygen and some who weren't. Patients got either a placebo, or one of two dose levels of REGN-COV.

REGN-COV hasn't been approved by the Food and Drug Administration, but its use has been authorized in some high-risk patients for treatment and post-exposure prophylaxis. Regeneron shares climbed 2.2% in pre-market trading.

https://www.marketscreener.com/quote/stock/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Covid-19-Trial-Meets-Primary-Endpoint-36557162/

Merck to buy Acceleron for about $11.5 billion in rare disease drugs push

 

Merck & Co will buy drugmaker Acceleron Pharma Inc for about $11.5 billion, the companies said on Thursday, as the U.S. pharmaceutical giant looks to beef up its portfolio with drugs for rare diseases.

Merck will pay $180 per Acceleron share in cash, representing a premium of about 2.6% to the stock's closing price on Wednesday, according to Refinitiv data.

The deal gives Merck, which makes the blockbuster cancer drug Keytruda, access to a potentially lucrative rare disease drug candidate, sotatercept.

Cambridge, Massachusetts-based Acceleron focuses on therapeutics that treat cardiovascular and other blood-related disorders. Its sotatercept drug, which is currently in a late-stage study, is aimed at treating a rare cardiovascular disease called pulmonary arterial hypertension (PAH), a type of high blood pressure that affects the lungs.

The market for treatments targeting rare diseases has become lucrative, as drugmakers typically charge higher prices for drugs which serve small patient populations.

An estimated 25-30 million Americans are living with a rare disease, according to the U.S. National Institute Of Health, prompting a number of drugmakers to eye that slice of the market.

Along with sotatercept, Merck will gain access to Reblozyl, which is approved for the treatment of two blood-related disorders, including anemia in patients with beta thalassemia.

"Although the acquisition of Acceleron will not fully remove the overhang of generic competition for MRK's single largest drug Keytruda (we estimate 37% of 2021 sales), it does help diversify sales, which addresses a large shareholder concern," Cantor Fitzgerald analyst Louise Chen said in a client note.

The transaction is expected to close in the fourth quarter.

https://www.marketscreener.com/news/latest/Merck-to-buy-Acceleron-for-about-11-5-billion-in-rare-disease-drugs-push--36557138/