The Daily Biotech Pulse: Gilead-Merck Collaborate For Breast Cancer Study, Decision Day For ANI Pharma, Pfizer Gets Canadian Regulatory Nod, 3 IPOs

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

Stocks In Focus

Gilead, Merck to Study Trodelvy-Keytruda Combo For Breast Cancer

Gilead, Inc. GILD announced it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc. MRK to evaluate the efficacy of Gilead's antibody-drug conjugate Trodelvy in combination with Merck's anti-PD-1 therapy, Keytruda as a first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer.

Separately, Gilead reported third-quarter revenues of $7.4 billion, up 13% year-over-year, and non-GAAP EPS of $2.65, up 26%. The company raised its guidance for fiscal-year 2021, citing stronger Veklury sales. The company, however, lowered its non-Veklury sales guidance.

Gilead shares were down 1.60% at $66.26 in premarket trading.

Reata Submits Application For European Regulatory Review Of Lead Drug In Chronic Kidney Disease

Reata Pharmaceuticals, Inc. RETA announced its submission of a marketing authorization application for bardoxolone methyl to the European Medicines Agency for the treatment of patients with chronic kidney disease caused by Alport syndrome.

Click here to access Benzinga's FDA Calendar

Agilent's Assay Labelled For Use to Identify Breast Cancer Patients For Treatment With Keytruda

Agilent Technologies, Inc. A announced that its PD-L1 IHC 22C3 pharmDx assay is now labeled for use in triple-negative breast cancer in the European Union. PD-L1 IHC 22C3 pharmDx is the only clinical trial proven PD-L1 assay CE-IVD–marked as an aid in identifying TNBC patients for treatment with Keytruda, the company said.

ARCA Says Data and Safety Monitoring Committee Recommends Completion of Phase 2 Study of COVID-19 Treatment Without Modification

ARCA biopharma, Inc. ABIO announced that the Data and Safety Monitoring Committee has completed a pre-specified interim analysis of the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with severe COVID-19.

Based on the DSMC's review of approximately 75% of the projected final efficacy and safety data, it has recommended completion of the clinical trial with no modifications to the trial design. The rNAPc2 development program has been granted fast track designation by the Food and Drug Administration. The company now anticipates completion of target enrollment of 160 patients by year end 2021 and reporting of topline data in the first quarter of 2022.

In premarket trading, the stock was jumping 14.89% to $3.01.

Pfizer's Next-gen Growth Hormone Injection Approved For Treating Pediatric Growth Hormone Deficiency In Canada

Pfizer, Inc. PFE's Canada unit announced that the company's next generation, long-acting growth hormone injection, Ngenla, has been approved by Health Canada. Ngenla is a once-weekly long-acting recombinant human growth hormone, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

Sanofi-Regeneron's Cancer Drug Libtayo Approved In Canada

Sanofi SNY and Regeneron Pharmaceuticals, Inc. REGN said Libtayo is now approved in Canada for the treatment of adults with locally advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor. The approval of Libtayo follows the European Commission approved announced in June and the US in February.

Earnings

Bio-Rad Laboratories, Inc. BIO's third-quarter revenues climbed 15.4% to $747.0 million, an increase of 15.4 percent, and non-GAAP net income per share rose from $3 to $3.71. The results exceeded estimates.

The stock was up 1.42% at $800 in premarket trading.

LeMaitre Vascular, Inc. LMAT said its third-quarter sales climbed 5% to $38.4 million. The earnings per share, however, fell 19% to 30 cents. The results trailed expectations. The company also issued lackluster guidance.

In premarketing trading, the stock was retreating 4.60% to 53.66.

Seagen Inc. SGEN reported a steep drop in third-quarter revenues from $1.06 billion in 2020 to $424.1 million, primarily due to a steep drop in collaboration and license revenues. Product revenues, however, increased year-over-year. The company reversed from a profit of $3.50 per share to a loss of $1.61 per share, wider than the 58-cent per loss consensus estimate.

The shares were advancing 1.24% to $179.99 in premarket trading.

ResMed Inc. RMD's first-quarter revenues climbed 20% to $904 million and non-GAAP EPS came in at $1.51, exceeding the consensus estimate of $1.36 per share.

The shares were rising 4.25% to $280.09 in premarket trading.

Offerings

4D Molecular Therapeutics, Inc. FDMT said it priced an underwritten public offering of 4.75 million shares of its common stock at $25 per share. The gross proceeds from the offering are expected to be approximately $118.8 million.

The stock was down 10.47% at $27.62 in premarket trading.

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

On The Radar

PDUFA Dates

ANI Pharmaceuticals, Inc. ANIP has a tryst with the FDA, as the regulator is scheduled to rule on the company's supplemental NDA for purified Cortrophin gel, a purified adrenocorticotropic hormone for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.

Earnings

AbbVie Inc. ABBV (before the market open)
ImmunoGen, Inc. IMGN (before the market open)
IRadimed Corporation IRMD (before the market open)

IPOs

Aura Biosciences, Inc. AURO, a clinical-stage oncology company developing a class of virus-like drug conjugate therapies for multiple oncology indications, priced its initial public offering of 5.4 million shares at $14 per share. The gross proceeds of the offering are expected to be $75.6 million. The shares will begin trading on the Nasdaq under the ticker symbol "AURA."

Woburn, Massachusetts-based Biofrontera, Inc. NASDAQBFRI, the U.S. unit of German-based Biofrontera AG, is offering 3.6 million shares units in an IPO. Biofrontera is a U.S.-based biopharma specializing in the commercialization of pharmaceutical products to treat dermatological conditions. Each unit consists of one share of common stock and one warrant to purchase a share of common stock, at a public offering price per unit of $5. The company's shares will begin trading on the Nasdaq under the symbol "BFRI." The gross proceeds to Biofrontera from the offering are expected to be $18 million.

Entrada Therapeutics, Inc. TRDA, an intracellular therapeutics company, priced its upsized IPO of 9.075 million shares of common stock, at $20 per share. All shares are being offered by Entrada. The gross proceeds to Entrada from the offering are expected to be approximately $181.5 million. The shares will begin trading on the Nasdaq under the ticker symbol "TRDA."