FDA Expands Approved Use Of PFE's Xalkori, LXRX Soars On Sotagliflozin Update, BCYC Hits New High

(RTTNews) - Today's Daily Dose brings you news about Lexicon's regulatory update on Sotagliflozin in heart failure; FDA approval of Pfizer's XALKORI in a new indication; Bicycle's pipeline progress update and Organogenesis' progress in knee osteoarthritis trial.

Read on…

1. Bicycle Rides High on Pipeline Progress Update

Shares of Bicycle Therapeutics plc (BCYC) touched a new high on Thursday on the back of its pipeline progress update.

The company's lead drug candidate BT1718 is progressing in the phase IIa portion of the Cancer Research UK sponsored phase I/IIa clinical trial in patients with advanced solid tumors. Enrollment in two solid tumor cohorts, one in squamous non-small cell lung cancer (NSCLC) and the other in an all-comers "basket" cohort is ongoing at four clinical sites, with additional sites expected to begin enrolling patients during the first half of 2021.

Up next in the pipeline is BT5528-100 under a phase I/II trial in patients with advanced solid tumors associated with EphA2 expression. Dose finding for the phase II portion of the trial remains ongoing and additional weekly and every other week doses are currently being explored. Enrollment in the trial remains on track and additional sites are expected to begin enrolling patients in 2021.

BT8009, being developed for patients with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency, is progressing in the phase I/II trial, with the first clinical site outside of the United States expected to open for patient recruitment this quarter.

IND-enabling activities for BT7480, an immuno-oncology candidate, are ongoing and the phase I trial is on track to commence in the second half of the year.

BCYC touched a new high of $26.33 in intraday trading Thursday, before closing at $25.50, up 28.46%.

2. Lexicon Soars on Regulatory Update Related To Sotagliflozin

Shares of Lexicon Pharmaceuticals Inc. (LXRX) jumped more than 100% on Thursday, following a regulatory update on Sotagliflozin in heart failure.

Last November, the company had announced that two phase III trials of Sotagliflozin, dubbed SOLOIST and SCORED, achieved their primary endpoints.

The SOLOIST study evaluated the cardiovascular efficacy of Sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The SCORED trial evaluated the cardiovascular efficacy of Sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease, and risks for cardiovascular disease.

The company had made a request relating to the potential submission of a New Drug Application based on the results of the two studies.

Now the FDA has informed the company that the results of its SOLOIST and SCORED phase III clinical studies can support an NDA submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.

The regulatory feedback clears a key hurdle for partnership discussions around Sotagliflozin in heart failure and enables a potential NDA filing in 2021, noted the company.

LXRX closed Thursday's trading at $8.05, up 105.36%.

3. Organogenesis Forges Ahead

Organogenesis Holdings Inc. (ORGO) has enrolled the first patient in its pivotal phase III clinical trial evaluating the safety and efficacy of ReNu, a cryopreserved amniotic suspension allograft, for the management of symptoms associated with knee osteoarthritis.

The trial is designed to enroll 474 subjects with moderate to severe symptomatic knee osteoarthritis and the primary efficacy endpoint is the difference in pain from baseline to 6 months as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Earlier in the week, the company reported better-than expected revenue outlook for the fourth quarter and full year 2020. The net revenue for Q4, 2020 is expected to be between $104.6 million and $106.0 million, well above analysts' consensus revenue estimate of $80.84 million. The net revenue in the fourth quarter of 2019 was $74.6 million.

ORGO closed Thursday's trading at $9.49, up 29.29%.

4. FDA Expands Approved Use of Pfizer's Xalkori

The FDA has expanded the use of Pfizer Inc.'s (PFE) lung cancer drug XALKORI to treat relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive in children and young adults.

Aanaplastic large cell lymphoma (ALCL) is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people. Approximately 90% of ALCL cases in young people are ALK-positive.

XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people. The drug is already indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test. Sales of Xalkori totaled $409 million in the first nine months of 2020 compared to $385 million in the year-ago period.

PFE closed Thursday's trading at $36.75, down 0.30%.

5. Stocks That Gained/Lost the Most

Bionano Genomics Inc. (BNGO) closed Thursday's trading at $6.95, up 23.45%.

Calithera Biosciences Inc. (CALA) closed at $3.66, up 21.59%.

Generation Bio Co. (GBIO) closed at $34.88, up 20.69%.

Viveve Medical Inc. (VIVE) closed at $3.18, down 20.50%.

Ocugen Inc. (OCGN) closed at $2.18, down 12.80%.