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DNLI Halts DNL747 Development, IMRN Skyrockets, XENT's Sinus Implant Gets New C-Code

denali june10 lt

Today's Daily Dose brings you news about Denali halting the development of DNL747 in Alzheimer's disease and amyotrophic lateral sclerosis; the update on Immuron's research collaboration with the U.S. Naval Medical Research Center that was inked last October; the retirement plan of Inogen CEO and Intersect ENT's Sinus implant getting approval for reimbursement with a new C-Code.

Read on…

1. Denali Halts Development Of DNL747; To Focus On Backup Compound DNL788

Denali Therapeutics Inc. (DNLI) and its partner Sanofi (SNY) have decided to pause the clinical activities of DNL747 in Alzheimer's disease and amyotrophic lateral sclerosis (ALS), based on molecule-specific toxicity findings and a superior profile of backup compound DNL788.

In two phase Ib studies in Alzheimer's disease and ALS, and in an open-label extension study of ALS, DNL747 has been shown to be safe and well-tolerated at the dose tested with no significant treatment-related adverse events. But chronic toxicity studies with DNL747 in cynomolgus monkeys, conducted in parallel with clinical studies, have shown dose- and duration-dependent adverse preclinical findings at exposures higher than those tested in the clinic.

In addition, data from the completed phase I study with DNL758, the backup compound to DNL747, in healthy volunteer subjects suggest an encouraging profile, as the molecule appears safe and tolerable at doses tested, added the Company.

DNLI closed Tuesday's trading at $25.71, down 1.42%. In after-hours, the stock fell another 6.85% to $23.95.

2. Fate Prices Offering

Fate Therapeutics Inc. (FATE) has offered to sell 6.18 million shares of its common stock at a public offering price of $28.31 per share. The underwriters have a 30-day option to purchase up to an additional 927,234 shares of its common stock.

The proceeds from this offering are expected to be approximately $164.2 million. The offering is expected to close on or about June 11, 2020.

Subject to the completion of the offering, the Company also expects to sell to Johnson & Johnson Innovation-JJDC, Inc. in a private placement, 1.77 million shares of common stock for an aggregate purchase price of approximately $50.0 million.

FATE closed Tuesday's trading at $32.72, up 15.58%.

3. Immuron Soars On US DoD Naval Medical Research Center Collaboration Update

Shares of Immuron Limited (IMRN) jumped as much as 1,280 percent in intraday trading on Tuesday, following an update on the Company's research collaboration with the U.S. Naval Medical Research Center that was inked last October.

The research collaboration is intended to develop a new oral therapeutic targeting Campylobacter and enterotoxigenic E. coli (ETEC) to prevent acute infectious diarrhea.

The Naval Medical Research Center plans to file an investigational new drug (IND) application for the new oral therapeutic later this year and commence two phase II clinical studies during the first half of 2021. One trial will focus on the ability of the drug candidate to protect volunteers against moderate to severe campylobacteriosis while the second trial will focus on ETEC infections.

Immuron's flagship product is Travelan, a novel, over the counter ("OTC") product for the prevention of Travellers' diarrhea. For the third quarter of fiscal 2020, which ended on March 31, 2020, global sales of Travelan were A$983 thousand compared to A$616 thousand in the year-ago quarter.

IMRN touched a new high of $28.99 in intraday trading on Tuesday, before closing the day at $20, up 809.09%. In after-hours, the stock fell 21.25% to $15.75.

4. Inogen CEO To Retire Before End Of 2021

Inogen Inc.'s (INGN) Chief Executive Officer and President Scott Wilkinson has announced his intention to retire before the end of 2021. Wilkinson will remain in his current position until a successor is appointed.

The Company has begun the process to identify a successor for Wilkinson and intends to engage an executive search firm to support the search.

INGN closed Tuesday's trading at $40.15, down 1.47%.

5. Intersect ENT's Sinus Implant Approved For Reimbursement with New C-Code

Intersect ENT Inc.'s (XENT) SINUVA Sinus Implant has been approved by the Centers for Medicare and Medicaid Services for transitional pass-through payment status for reimbursement with a new C-Code. The new Code 'C9122 Mometasone furoate sinus implant' is slated to take effect July 1, 2020, and the pass-through payment status will last for three years.

According to the Company, the new C code will simplify the reimbursement process for ENT physicians and their practices, as well as provide Medicare patients easier access to this novel drug-eluting sinus implant.

Thomas West, President & Chief Executive Officer of Intersect ENT, said, " With over 70 percent of commercial lives already covered for SINUVA, this new C Code assignment further expands access to SINUVA in a very important patient population, Fee for Service Medicare, comprised of approximately 40 million additional lives."

XENT closed Tuesday's trading at $14.53, up 14.5%.

6. Stocks That Moved On No News

Plus Therapeutics Inc. (PSTV) closed Tuesday's trading at $2.33, up 33.91%.

Aptorum Group Limited (APM) closed Tuesday's trading at $4.71, up 34.57%.

Enlivex Therapeutics Ltd. (ENLV) closed Tuesday's trading at $6.20, up 16.54%.

Zynex Inc. (ZYXI) closed Tuesday's trading at $20, down 12.63%.

Community Health Systems Inc. (CYH) closed Tuesday's trading at $3.65, down 11.19%.

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