The Daily Biotech Pulse: Merck Reports Beat-And-Raise Quarter, Pfizer-BioNTech Snag Orders For Additional Vaccine Doses, HCW Cleared For Phase 1 Study Of Pancreatic Cancer Drug

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

Stocks In Focus

Corvus' China Partner Approved For Early Stage Study Of CPI-818 In Blood Cancer

Corvus Pharmaceuticals, Inc. CRVS announced that an investigational new drug application submitted by its partner in China, Angel Pharmaceuticals Ltd., has been approved by the Center for Drug Evaluation of the China National Medical Products Administration to initiate a Phase 1/1b clinical trial of Corvus' small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas in China.

The stock was down 3.07% at $4.42 in premarket trading.

Alnylam Reports Positive Phase 3 Data For RNAi Therapeutic

Alnylam Pharmaceuticals, Inc. ALNY announced that the HELIOS-A Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of the polyneuropathy associated with hereditary transthyretin-mediated amyloidosis, met all secondary endpoints measured at 18 months, relative to external placebo data from the APOLLO Phase 3 study of patisiran.

The final secondary endpoint, reduction in serum TTR levels with vutrisiran, demonstrated non-inferiority relative to the within-study patisiran arm, as expected. In addition, patients treated with vutrisiran showed improvements in exploratory endpoints and an improvement in technetium uptake relative to baseline in a majority of patients in a planned cohort, providing potential evidence for reduced cardiac amyloid burden. Vutrisiran continued to

demonstrate an encouraging safety and tolerability profile.

ViiV's Long-Acting Combo HIV Regimen Found Effective

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK, with Pfizer, Inc. PFE and Shionogi & Co., Ltd. SGIOY as shareholders, presented positive interim data from the CARISEL study, which was initiated and conducted during the COVID-19 pandemic.

The study evaluated perspectives of health care teams and people living with HIV, through surveys and interviews, around the implementation of Vocabria and Johnson & Johnson JNJ unit Janssen's Rekambys administered every two months, with data showing that implementation of the long-acting regimen is realistic and achievable in a variety of European health care settings.

Related Link: The Week Ahead In Biotech (Oct. 18-23): J&J, Biogen Kickstart Big Pharma Earnings, Regeneron-Sanofi, Roche Await FDA Decisions And IPOs

Pfizer, BioNTech Receive Additional 50M-Dose Vaccine Order From US Government

Pfizer and BioNTech SE BNTX said the U.S. government has purchased 50 million more doses of the companies' COVID-19 vaccine. The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age, should they receive regulatory authorization. The companies expect to deliver the doses by April 30, 2022.

Pfizer shares were up 0.33% at $43.11 in premarket trading, while BioNTech was advancing 2.04% to $284.47.

InflaRx Gains On Positive Analyst Action Following Positive Data Readout

InflaRx N.V. IFRX is surging higher after Raymond James analyst Steven Seedhouse upgraded the stock from Outperform to a Strong Buy and increased the price target from $10 to $14. The analyst attributed the action to strong physiological response in the Phase 2a proof-of-concept study.

The stock was jumping 54.9% to $4.43 in premarket trading.

HCW Biologics Gets Go-Ahead To Start Phase 1 Study Of HCW9218 In Pancreatic Cancer

HCW Biologics Inc. HCWB announced that it has been cleared by the U.S. Food and Drug Administration to proceed to evaluate its lead drug candidate, HCW9218, in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer.

The stock was trading 9.59% higher at $3.20 in premarket trading.

Earnings

Edwards Lifesciences Corporation EW's third-quarter sales rose 15% to $1.3 million and adjusted earnings per share came in at 54 cents, a penny ahead of the consensus.

The company said it continues to expect full-year sales to fall within the previous guidance range of $5.2 billion to $5.4 billion and EPS to come in at the high end of the previous guidance of $2.07-$2.27.

For the fourth quarter, the company expects sales of $1.3 billion to $1.38 billion and adjusted EPS of 53-59 cents.

The stock was slipping 3.4% to $112.12.

Merck & Co., Inc. MRK reported third-quarter sales of $13.2 billion, up 20% year-over-year, powered by strong sales of its Keytruda cancer immunotherapy. Non-GAAP EPS from continuing operations came in at $1.75. Analysts, on average, estimated EPS of $1.55 and revenues of $12.33 billion.

For 2021, the company expects revenues of $47.4 billion to $47.9 billion and non-GAAP EPS of $5.65-$5.70, upwardly revised from the previous guidance that called for revenues of $46.4 billion-$47.4 billion and non-GAAP EPS of $5.47-$5.57.

The stock was up 2.4% at $83.50 in premarket trading.

Offerings

Repare Therapeutics Inc. RPTX priced its upsized underwritten public offering of 4 million of its common shares at a public offering price of $22 per share, for total gross proceeds of $88 million.

The stock was slipping 4.17% to $22.51 in premarket trading.

Brickell Biotech, Inc. BBI said it has commenced a proposed underwritten public offering of shares of its common stock.

The stock was plunging 18.81% to 43.50 cents in premarket trading.

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On The Radar

Earnings

• Aldeyra Therapeutics, Inc. ALDX (before the market open)
• Evelo Biosciences, Inc. EVLO (before the market open)
• Baxter International Inc. BAX (before the market open)
• NovoCure Limited NVCR (before the market open)
• Repligen Corporation RGEN (before the market open)
• Blueprint Medicines Corporation BPMC (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• Genocea Biosciences, Inc. GNCA (before the market open)
• Laboratory Corporation of America Holdings LH (before the market open)
• Alimera Sciences, Inc. ALIM (before the market open)
• Bio-Rad Laboratories, Inc. BIO (after the close)
• PTC Therapeutics, Inc. PTCT (after the close)
• Merit Medical Systems, Inc. MMSI (after the close)
• LeMaitre Vascular, Inc. LMAT (after the close)
• Travere Therapeutics, Inc. TVTX (after the close)
• Taro Pharmaceutical Industries Ltd. TARO (after the close)
• ResMed Inc. RMD (after the close)
• CareDx, Inc CDNA (after the close)

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