The Daily Biotech Pulse: Immutep Extends Run, FDA Nod For Gilead, Merck, Bristol-Myers Squibb Release Late-Stage Cancer Immunotherapy Data

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs April 7)

• Aclaris Therapeutics, Inc. ACRS
• MiMedx Group, Inc. MDXG
• Oncternal Therapeutics, Inc. ONCT (reacted to a positive analyst action)
• Medtronic plc MDT
• PAVmed Inc. PAVM
• Seelos Therapeutics, Inc. SEEL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 7)

• Adagene Inc. ADAG
• Bellerophon Therapeutics, Inc. BLPH
• ContraFect Corporation CFRX
• FibroGen, Inc. FGEN (disclosed regulatory submission of manipulated safety data for its anemia drug candidate)
• Homology Medicines, Inc. FIXX (announced a common stock offering)
• IMARA Inc. IMRA
• Immunocore Holdings plc IMCR
• Longboard Pharmaceuticals, Inc. LBPH
• Lucira Health, Inc. LHDX
• NeuBase Therapeutics, Inc. NBSE
• Sigilon Therapeutics, Inc. SGTX

Stocks In Focus

Immutep's Lead Drug Gets Fast Track Designation In Head and Neck Cancer 

Immutep Limited IMMP said its lead product candidate eftilagimod alpha, a soluble LAG-3 protein, has received fast track designation from the FDA in first-line recurrent or metastatic head and neck squamous cell carcinoma.

The stock was up 17.3% at $3.73 premarket Thursday.

Gilead Gets Full Approval For Trodelvy In Previously Treated Breast Cancer Patients

Gilead Sciences, Inc. GILD said the FDA has granted full approval to Trodelvy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, with at least one of them being for metastatic disease.

The antibody-drug conjugate came into Gilead's stable through its acquisition of Immunomedics.

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death, extending median progression-free survival from 1.7 months to 4.8 with chemotherapy, Gilead said.

Trodelvy also extended median overall survival from 6.9 months to 11.8 months.

The stock was up 0.63% premarket at $66.01. 

Lilly-Incyte COVID-19 Treatment Fails Late-Stage Study In Hospitalized Patients

Eli Lilly and Company LLY and Incyte INCY announced the results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily, plus standard of care versus placebo plus SoC, showing the study did not meet statistical significance on the primary endpoint.

The primary endpoint was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation or death by day 28.

Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation or death, a difference that was not statistically significant.

Related Link: The Week Ahead In Biotech: Regeneron, Supernus FDA Decisions, Cancer Conference Presentations In The Spotlight

Merck's Keytruda Aces Late-Stage Study In Kidney Cancer Patients

Merck MRK announced that the pivotal Phase 3 KEYNOTE-564 trial evaluating Keytruda met its primary endpoint of disease-free survival for the potential adjuvant treatment of patients with renal cell carcinoma following nephrectomy or following nephrectomy and resection of metastatic lesions.

Based on an interim analysis conducted by an independent Data Monitoring Committee, Keytruda monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The company said the trial will continue to evaluate overall survival, a key secondary endpoint.

The stock was up 0.2% to $76.27 premarket Thursday.

Bristol-Myers Squibb Announces Positive Results For Late-Stage Esophageal Cancer Study

Bristol-Myers Squibb BMY announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo plus chemotherapy or Opdivo plus Yervoy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

Aurinia Presents Positive Data For Kidney Inflammation Drug

Aurinia Pharmaceuticals Inc. AUPH presented at the National Kidney Foundation 2021 spring clinical meet with additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of Lupkynis in lupus nephritis, showing the investigational asset, in combination with mycophenolate mofetil and low-dose corticosteroids, led to treatment benefits across biopsy class subgroups compared with treatment with MMF and low-dose corticosteroids alone.

MMF and low-dose corticosteroids are considered standard of care for the treatment of LN. Lupkynis was approved in January to be used in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

The stock was down 1.11% to $12.51 premarket Thursday.

Intellia Retreats On Insider Selling

Intellia Therapeutics, Inc. NTLA shares moved to the downside after a SEC filing showed Jean-Francois Formela, a director of the company's board, sold 800 shares at a price of $84.98.

In after-hours trading, the stock lost 2.94% to $69.

Offerings

Otonomy, Inc. OTIC priced an underwritten public offering of 6.289 million shares of its common stock at a price of $2.25 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 7.11 million shares of its common stock at a purchase price of $2.249 per each pre-funded warrant.

The aggregate gross proceeds from this offering are expected to be approximately $30.1 million.

The stock was down 3.27% premarket at $2.37. 

Crinetics Pharmaceuticals, Inc. CRNX priced an underwritten public offering of 4.562 million shares of its common stock at a price of $16.44 per share. All of the shares to be sold in the offering are being sold by the company. The gross proceeds to Crinetics from the offering will likely be approximately $75 million. The offering is expected to close on or about April 12.

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates