ATXI Plunges On Thumbs-down, VYGR’s Huntington’s Disease Trial On Hold, Deal Or No Deal For SURF?

Today’s Daily Dose brings you news about FDA declining approval for Avenue Therapeutics/Fortress Biotech’s pain drug IV Tramadol, encouraging data from Gilead/ Galapagos’ Ulcerative Colitis trial, reports of Surface Oncology receiving a takeover offer from GlaxoSmithKline, and clinical hold slapped by the FDA on Voyager’s Investigational New Drug application for VY-HTT01 for the treatment of Huntington’s disease.

Read on…

1. Avenue Therapeutics Reels from FDA Rejection

Shares of Avenue Therapeutics Inc. (ATXI) plunged to a 52-week low of $4.46 on Monday, following a disappointing regulatory update related to its investigational intravenous (“IV”) Tramadol.

The FDA has refused approval to IV Tramadol, proposed for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

In its Complete Response Letter, the FDA has stated that IV Tramadol is not safe for the intended patient population. Specifically, if a patient requires an analgesic between the first dose of IV Tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid “stacking” and increase the likelihood of opioid-related adverse effects. The regulatory agency has also sought an adequate terminal sterilization validation before IV Tramadol could be approved, which is planned for later this quarter.

Avenue Therapeutics is a majority-controlled subsidiary company of Fortress Biotech (FBIO).

ATXI closed Monday’s trading at $4.53, down 58.97%.

2. Gilead/Galapagos’ SELECTION Trial in Ulcerative Colitis Yields Encouraging Data

Gilead Sciences Inc. (GILD) and Galapagos NV’s (GLPG) phase 2b/3 trial of Filgotinib in adult patients with moderately to severely active ulcerative colitis has yielded encouraging results.

According to the trial results, compared to placebo, a significantly higher proportion of patients treated with Filgotinib 200 mg achieved clinical remission at Week 10 and maintained *remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission.

Ulcerative colitis is characterized by inflammation of the mucosal lining of the colon and rectum. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea, and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep, and fatigue. (*Remission refers to either the reduction or disappearance of the signs and symptoms of a disease).

The study, dubbed SELECTION, involved 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis.

Filgotinib (200 mg and 100 mg tablets) is approved in Europe and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis but is not approved anywhere for the treatment of ulcerative colitis.

The FDA declined to approve Filgotinib for moderately to severely active rheumatoid arthritis in August of this year, expressing concerns regarding the overall benefit/risk profile of the drug.

GLPG closed Monday’s trading at $148.25, up 1.13%.

3. Surface Oncology – Deal or No Deal?

Shares of Surface Oncology Inc. (SURF) closed at a two-year high of $9.39 on Monday, following reports that it has received a takeover offer from GlaxoSmithKline plc (GSK).

Surface Oncology is a clinical-stage immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. The company’s pipeline includes two wholly-owned lead programs – SRF617, which is under a phase 1/1b study in patients with solid tumors, and SRF388, which is under a phase I trial in patients with advanced solid tumors. Surface Oncology has a collaboration with Merck (MRK) to evaluate the safety and efficacy of combining SRF617 with Merck’s blockbuster drug KEYTRUDA.

Another clinical program of the company is a phase I trial evaluating NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers.

Novartis has a worldwide exclusive license to develop and commercialize NZV930 as part of its broad strategic collaboration with Surface.

SURF closed Monday’s trading at $9.39, up 32.07%.

4. FDA Slaps Clinical Hold on Voyager’s IND for Huntington’s disease Trial

Voyager Therapeutics Inc.’s (VYGR) Investigational New Drug application for VY-HTT01 for the treatment of Huntington’s disease has been placed on clinical hold by the FDA.

Huntington’s disease, caused by mutations in the HTT gene, is a fatal genetic disease affecting approximately 40,000 people in the U.S. that results in the progressive decline of motor and cognitive functions. There are currently no approved treatments targeting the underlying cause of the disease.

Voyager’s investigational VY-HTT01 is a one-time AAV-based gene therapy treatment designed to knockdown expression of the HTT gene, and potentially slow the progression of both motor and cognitive symptoms.

Last month, the company submitted the Investigational New Drug application to begin the first-in-human clinical trial of VY-HTT01 in Huntington’s disease patients. The application has been placed on hold pending the resolution of certain chemistry, manufacturing, and controls (CMC) matters.

VYGR closed Monday’s trading at $12.02, up 3.80%. In after-hours, the stock fell 11.06% to $10.69.

5. Stocks That Moved On No News

Shineco Inc. (TYHT) closed Monday’s trading at $3.23, up 14.13%.

Five Prime Therapeutics Inc. (FPRX) closed Monday’s trading at $6.09, up 13.20%.

Organovo Holdings Inc. (ONVO) closed Monday’s trading at $10.11, up 11.71%.

AgeX Therapeutics Inc. (AGE) closed Monday’s trading at $2.02, down 21.09%.

ProPhase Labs Inc. (PRPH) closed Monday’s trading at $4.76, down 19.05%.

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